WO2021232570A1 - 引导鞘管及引导鞘管的使用方法 - Google Patents

引导鞘管及引导鞘管的使用方法 Download PDF

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Publication number
WO2021232570A1
WO2021232570A1 PCT/CN2020/102577 CN2020102577W WO2021232570A1 WO 2021232570 A1 WO2021232570 A1 WO 2021232570A1 CN 2020102577 W CN2020102577 W CN 2020102577W WO 2021232570 A1 WO2021232570 A1 WO 2021232570A1
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WIPO (PCT)
Prior art keywords
sheath
guide
guide sheath
tube
present
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PCT/CN2020/102577
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English (en)
French (fr)
Inventor
孙加源
陈军祥
谢芳芳
袁海宾
张琴
潘玉均
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上海市胸科医院
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Application filed by 上海市胸科医院 filed Critical 上海市胸科医院
Publication of WO2021232570A1 publication Critical patent/WO2021232570A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Definitions

  • the invention relates to the technical field of medical devices, in particular to a guiding sheath and a method for using the guiding sheath.
  • the probe and the sheath are made of soft materials, and the soft materials can easily control the probe to reach the treatment or sampling tissue.
  • the Chinese invention patent with publication number CN103284775A discloses an intracranial thrombus removal device, which includes a thrombus removal system, a delivery and release system, a handle system and a guide sheath, the guide sheath is made of polymer material polytetrafluoroethylene. It can be seen that the entire guide sheath is made of one material. If a biopsy sample is taken through this type of guide sheath, since the sheath is soft, the tissue sample is easy to fall off during the pulling process. , Resulting in low sampling efficiency or even failure.
  • the purpose of the present invention is to provide a guide sheath and a method for using the guide sheath to improve the sampling efficiency of tissue samples.
  • the guiding sheath of the present invention includes:
  • the first sheath has a hollow tubular shape and is made of flexible material
  • the second sheath tube has a hollow tube shape, is connected to the first sheath tube, and is made of rigid material;
  • the locking structure is partially or fully arranged on the outer side of the second sheath and is used to lock the position of the second sheath in the human bronchus.
  • the beneficial effects of the present invention are: the first sheath is made of flexible material, which can make the guide sheath easily reach the target tissue position, and the second sheath is made of rigid material, which can play a supporting role, thereby avoiding the tissue sample from falling off and improving Sampling efficiency of tissue samples.
  • the first sheath and the second sheath are bonded or fused to each other.
  • the second sheath tube includes:
  • the joint is in a hollow tube shape, and the outer wall is attached to the inner wall of the metal tube and connected with the first sheath tube.
  • the second sheath tube is made of a hard polymer material, and a developing ring is provided on the outside of one end of the second sheath tube away from the first sheath tube, and is away from the second sheath tube.
  • the distance at one end port of the first sheath is 2-5mm.
  • the length of the second sheath is 5-10 mm.
  • the beneficial effect is that it can not only play a supporting role, but can also prevent the guide sheath from being difficult to reach the target tissue position due to the excessive length.
  • the length of the joint part located in the metal tube is 2-7 mm. The beneficial effect is to prevent the metal tube from falling off the joint part.
  • one end of the second sheath tube has a broken structure, and the broken structure is expanded to form a bell mouth structure.
  • the beneficial effect is that the resistance of the tissue sample into the second sheath is reduced, and the resistance of the tissue sample is prevented from falling off due to excessive resistance.
  • the breach structure includes breaches, and the number of breaches is 2-16.
  • the maximum inner diameter of the bell mouth structure is greater than the minimum inner diameter by 0.05 mm-1.5 mm.
  • the beneficial effect is to prevent the maximum inner diameter of the bell mouth structure from being too large and causing harm to the human body.
  • the guide sheath tube further includes an outer tube, the outer tube is sleeved on the outside of the second sheath tube, and the side of the outer tube away from the breach structure is provided with a control structure, the The control structure is used to control the outer sleeve to slide outside the second sheath to control the opening or contraction of the breach structure.
  • the beneficial effect is that it assists the break structure and realizes the shrinkage and expansion of the break structure.
  • the material of the breach structure is a memory alloy.
  • the guiding sheath further includes a gas pipeline, and the gas pipeline is arranged inside or outside of the first sheath and the second sheath.
  • the locking structure includes an airbag, at least one inflation port is provided on the airbag, and the inflation port is in communication with the gas pipeline.
  • the airbag can play the role of fixing and canceling the fixation, and when bleeding in the bronchus, the airbag can compress the blood vessel to stop the bleeding.
  • the length of the airbag when it is not inflated is 5-10 mm.
  • the beneficial effect is that it can play a fixed role and avoid damage to the human bronchus caused by excessive volume.
  • the outer sides of the first sheath and the second sheath are provided with continuous graduation lines distributed along the length direction.
  • the beneficial effect is that it is convenient to determine the length of the first sheath tube and the second sheath tube extending into the human bronchus.
  • the present invention also provides a method for using the guiding sheath, which includes the following steps:
  • the sampling device is inserted into the guiding sheath for sampling.
  • the beneficial effect is that the tissue sample is prevented from falling off, and the sampling efficiency of the tissue sample is improved.
  • Figure 1 is a schematic diagram of the structure of the guiding sheath of the present invention.
  • FIG. 2 is a schematic diagram of the structure of the guiding sheath in still other embodiments of the present invention.
  • Figure 3 is a schematic view of the structure of the second sheath of the present invention.
  • FIG. 4 is a schematic diagram of the guide sheath when the breach structure is not expanded in some embodiments of the present invention.
  • Figure 5 is a schematic diagram of the guide sheath after the break structure is expanded in some embodiments of the present invention.
  • Figure 6 is a schematic view of the structure of an uninflated balloon on the second sheath of the present invention.
  • Figure 7 is a schematic view of the structure of the inflated balloon on the second sheath of the present invention.
  • Fig. 8 is a flow chart of the method of using the guide sheath of the present invention.
  • the guide sheath 10 includes:
  • the first sheath 11 has a hollow tubular shape and is a flexible material
  • the second sheath 12 has a hollow tubular shape, is connected to the first sheath 11, and is made of rigid material;
  • the locking structure 13 is partially arranged on the outer side of the second sheath 12 and is used to lock the position of the second sheath 12 in the human bronchus.
  • Fig. 2 is a schematic diagram of the structure of the guiding sheath in still other embodiments of the present invention.
  • the guiding sheath 10 includes:
  • the first sheath 11 has a hollow tubular shape and is a flexible material
  • the second sheath 12 has a hollow tubular shape, is connected to the first sheath 11, and is made of rigid material;
  • the locking structure 13 is all arranged on the outer side of the second sheath 12 for locking the position of the second sheath 12 in the human bronchus.
  • the rigid material referred to in the present invention is a material with an elastic modulus greater than or equal to 6.11 N/mm 2
  • the flexible material referred to in the present invention is a material with an elastic modulus less than 6.11 N/mm 2 .
  • the materials of the first sheath and the second sheath are both medical plastics.
  • the outer sides of the first sheath and the second sheath are provided with continuous graduation lines distributed along the length direction.
  • the first sheath and the second sheath are connected by bonding or fusion.
  • Fig. 3 is a schematic structural diagram of a second sheath in some embodiments of the present invention.
  • the second sheath 12 includes:
  • the metal tube 121 is a hollow tube
  • the joint 122 is in a hollow tube shape, and the outer wall is attached to the inner wall of the metal tube 122 and connected with the first sheath tube (not marked in the figure).
  • the second sheath 12 is made of a hard polymer material, and the second sheath 12 is far away from one end of the first sheath 11
  • a developing ring 123 is provided on the outside of the second sheath tube 12, and the distance from the end port of the second sheath tube 12 away from the first sheath tube 11 is 2-5mm, which is convenient for assisting imaging equipment to determine that the second sheath tube 12 is in a person. Position in the body.
  • the length of the second sheath is 5-10 mm.
  • the length of the joint located in the metal tube is 2-7 mm.
  • the length of the second sheath tube is 5 mm, and the length of the joint part located in the metal tube is 2 mm.
  • the length of the second sheath tube is 7 mm, and the length of the joint part located in the metal tube is 4 mm.
  • the length of the second sheath tube is 9 mm, and the length of the joint part located in the metal tube is 6 mm.
  • the length of the second sheath tube is 10 mm, and the length of the joint part located in the metal tube is 7 mm.
  • FIG. 4 is a schematic diagram of the guiding sheath when the breach structure is not expanded in some embodiments of the present invention.
  • one end of the second sheath tube 12 has a breach structure 125, the breach structure 125 includes a breach 126, the number of the breach 126 is 2-16, and the breach is a gap.
  • the guide sheath tube further includes an outer tube 124, the outer tube sleeve 124 is connected to the outside of the second sheath tube 12, and the second sheath tube 12 can slide inside the outer tube 124.
  • the number of the breaches is one of 2, 5, 9, 12, and 16.
  • Fig. 5 is a schematic diagram of the guide sheath after the break structure is expanded in some embodiments of the present invention.
  • the material of the breach structure 125 is a memory alloy, specifically a nickel-titanium memory material.
  • the breach structure 125 expands to form a horn The mouth structure, and the smallest inner diameter of the bell mouth structure is equal to the inner diameter of the middle section of the second sheath 12.
  • the maximum inner diameter of the bell mouth structure is greater than the minimum inner diameter by 0.05-1.5 mm, wherein the maximum inner diameter of the bell mouth structure is the inner diameter of one end of the opening, and the minimum inner diameter of the bell mouth structure is the same as the minimum inner diameter of the bell mouth structure.
  • the outer sleeve 124 is provided with a control structure 127 on the side away from the breach structure, and the control structure 127 is used to control the outer sleeve 124 to slide outside the second sheath 12 , To control the opening or contraction of the breach structure 125.
  • the control structure 127 includes a first pushing portion 1271, a second pushing portion 1272, and a spring 1273.
  • the first pushing portion 1271 and the second pushing portion 1272 are connected by the spring 1273, and the first pushing portion 1273
  • the portion 1271 is fixed on the outer side of the outer sleeve 124, and the second pushing portion 1272 is fixedly connected to the first sheath 11 through a connecting rod 1274.
  • the first pushing portion 1271 and the second pushing portion 1272 are ring-shaped.
  • the maximum inner diameter of the bell mouth structure is greater than the minimum inner diameter by 0.05 mm.
  • the maximum inner diameter of the bell mouth structure is 0.25 mm larger than the minimum inner diameter.
  • the maximum inner diameter of the bell mouth structure is 0.5 mm larger than the minimum inner diameter.
  • the maximum inner diameter of the bell mouth structure is 0.75 mm larger than the minimum inner diameter.
  • the maximum inner diameter of the bell mouth structure is 1 mm larger than the minimum inner diameter.
  • the maximum inner diameter of the bell mouth structure is 1.25 mm larger than the minimum inner diameter.
  • the maximum inner diameter of the bell mouth structure is 1.5 mm larger than the minimum inner diameter.
  • the maximum inner diameter of the bell mouth structure is 3-4 mm
  • the maximum inner diameter of the first sheath and the second sheath is 2.3 mm
  • the first sheath and the second sheath are 2.3 mm
  • the maximum outer diameter of the second sheath is 2.95 mm.
  • the first sheath includes a hand-held end, and an operating rod is provided on the hand-held end, and the operating rod is used to stretch the breach structure so that the The rupture structure faces the outside of the second sheath, so that the size of the opening at one end of the second sheath is too large to facilitate the tissue sample to enter the second sheath.
  • Fig. 6 is a schematic structural diagram of an inflatable balloon on the second sheath in some embodiments of the present invention.
  • the locking structure (not shown in the figure) includes an airbag 131, the airbag 131 is provided with at least one inflation port 132, the inflation port (not shown in the figure) and the gas pipeline (in the figure) (Not marked) connection, wherein the gas pipeline is arranged inside or outside of the first sheath (not marked in the figure) and the second sheath 12.
  • the airbag 131 has a length of 5-10 mm when it is not inflated, and is attached to the outer wall of the second sheath 12.
  • the airbag 131 can play the role of fixing and canceling the fixation, and when bleeding in the bronchus, the airbag 131 can compress the blood vessel to stop bleeding.
  • the inflation port is provided on the balloon and the second sheath.
  • a protective layer is provided on the outside of the gas pipeline, and the protective layer covers the outside of the gas pipeline and is seamlessly connected to the inner walls of the first sheath and the second sheath .
  • the inflation port is arranged on the balloon facing the first sheath On the side.
  • a protective layer is provided on the outside of the gas pipeline, and the protective layer covers the outside of the gas pipeline and is seamlessly connected to the outer walls of the first sheath and the second sheath .
  • Fig. 7 is a schematic diagram of the structure of the inflated balloon on the second sheath in some embodiments of the present invention.
  • the airbag 131 expands when inflated, forming an oval or circular shape on the outside of the second sheath 12 Play a fixed role.
  • Fig. 8 is a flowchart of a method of using the guide sheath in some embodiments of the present invention. Referring to Figure 8, the method of using the guiding sheath includes the following steps:
  • S4 The sampling device is inserted into the guiding sheath for sampling.

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Abstract

一种引导鞘管（10），包括第一鞘管（11），呈中空管状，且为柔性材料；第二鞘管（12），呈中空管状，与该第一鞘管（11）连接，且为刚性材料；锁定结构（13），部分或全部设置于第二鞘管（12）的外侧，用于锁定第二鞘管（12）在人体支气管内的位置。该引导鞘管（10）中，第一鞘管（11）为柔性材料，能够使引导鞘管（10）容易到达目标组织位置，第二鞘管（12）为刚性材料，能够起到支撑作用，从而避免组织样本脱落，提高了组织样本的取样效率。

Description

引导鞘管及引导鞘管的使用方法 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种引导鞘管及引导鞘管使用方法。
背景技术
针对肿块(例如支气管癌)或者在周围肺组织中的发炎的间质性肺病，需要从周围肺组织取得组织样本，通过组织样本对患者的疾病进行诊断。但现有的取样设备中，探头和鞘管均为软性材料，软性材料能够很容易的控制探针到达治疗或取样组织处。
公开号为CN103284775A的中国发明专利公开了一种颅内血栓取出装置，包括取栓系统、输送及解脱系统、手柄系统和引导鞘管，所述引导鞘管由聚合材料聚四氟乙烯制成。由此可以看出，所述引导鞘管整体由一种材料制成，若通过该种类的引导鞘管进行活检取样，由于鞘管是软的，组织样本容易在拉出的过程中很容易脱落，导致取样的效率不高，甚至失败。
因此，有必要提供一种新型的引导鞘管及引导鞘管的使用方法以解决现有技术中存在的上述问题。
发明内容
本发明的目的在于提供一种引导鞘管及引导鞘管的使用方法，提高组织样本的取样效率。
为实现上述目的，本发明的所述引导鞘管，包括：
第一鞘管，呈中空管状，且为柔性材料；
第二鞘管，呈中空管状，与所述第一鞘管连接，且为刚性材料；
锁定结构，部分或全部设置于所述第二鞘管的外侧，用于锁定所述第二鞘管在人体支气管内的位置。
本发明的有益效果在于：第一鞘管为柔性材料，能够使所述引导鞘管容易到达目标组织位置，第二鞘管为刚性材料，能够起到支撑作用，从而避免组织样本脱落，提高了组织样本的取样效率。
优选地，所述第一鞘管和所述第二鞘管相互粘合或融合。
优选地，所述第二鞘管包括：
金属管，呈中空管状；
接合部，呈中空管状，外壁与所述金属管的内壁贴合，并与所述第一鞘管连接。其有益效果在于：便于实现所述第一鞘管和所述第二鞘管的连接。
进一步优选地，所述第二鞘管为硬质高分子材料，且所述第二鞘管远离所述第一鞘管一端的外侧设有显影环，且距离所述第二鞘管远离所述第一鞘管的一端端口处的距离为2-5mm。其有益效果在于：便于辅助影像设备确定所述金属管在人体内的位置。
进一步优选地，所述第二鞘管的长度为5-10mm。其有益效果在于：既能起到支撑作用，还能避免长度过长导致所述引导鞘管不容易到达目标组织位置。
进一步优选地，所述接合部位于所述金属管内的长度为2-7mm。其有益效果在于：避免所述金属管从所述接合部上脱落。
进一步优选地，所述第二鞘管的一端呈破口结构，且所述破口结构撑开后形成喇叭口结构。其有益效果在于：减少组织样本进入所述第二鞘管的阻力，避免阻力过大而导致组织样本脱落。
进一步优选地，所述破口结构包括破口，所述破口的数量为2-16条。
进一步优选地，所述喇叭口结构的最大内径比最小内径大0.05mm-1.5mm。 其有益效果在于：避免所述喇叭口结构的最大内径过大而对人体产生伤害。
进一步优选地，所述引导鞘管还包括外套管，所述外套管套接在所述第二鞘管的外侧，所述外套管远离所述破口结构的一侧设有控制结构，所述控制结构用于控制所述外套管在所述第二鞘管外侧滑动，以控制所述破口结构撑开或收缩。其有益效果在于：辅助所述破口结构，实现所述破口结构的收缩与撑开。
进一步优选地，所述破口结构的材料为记忆合金。
优选地，所述引导鞘管还包括输气管道，所述输气管道设置于所述第一鞘管和所述第二鞘管的内侧或外侧。
进一步优选地，所述锁定结构包括气囊，所述气囊上设有至少一个充气口，所述充气口与所述输气管道连通。其有益效果在于：通过所述气囊能够起到固定和取消固定的作用，并且在支气管内出血时，气囊可以压迫血管，以起到止血的作用。
进一步优选地，所述气囊未充气时长度为5-10mm。其有益效果在于：能够起到固定的作用，且避免体积过大对人体支气管造成损伤。
优选地，所述第一鞘管和所述第二鞘管的外侧设有沿长度方向分布且连续的刻度线。其有益效果在于：便于确定所述第一鞘管和所述第二鞘管伸入人体支气管内的长度。
本发明还提供了一种引导鞘管的使用方法，包括以下步骤：
S1：将所述引导鞘管插入内窥镜的工作通道内；
S2：通过所述内窥镜观察人体支气管，将所述引导鞘管伸入人体支气管的目标位置；
S3：通过所述锁定结构锁定所述引导鞘管相对于人体支气管的位置；
S4：将取样器械接入所述引导鞘管内进行取样。其有益效果在于：避免组织样本脱落，提高了组织样本的取样效率。
附图说明
图1为本发明的引导鞘管的结构示意图；
图2为本发明又一些实施例中引导鞘管的结构示意图；
图3为本发明的第二鞘管的结构示意图；
图4为本发明的一些实施例中破口结构未撑开时引导鞘管的示意图；
图5为本发明的一些实施例中破口结构撑开后引导鞘管的示意图；
图6为本发明的第二鞘管上未充气气囊的结构示意图；
图7为本发明的第二鞘管上已充气气囊的结构示意图；
图8为本发明的引导鞘管的使用方法的流程图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明的附图，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在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。除非另外定义，此处使用的技术术语或者科学术语应当为本发明所属领域内具有一般技能的人士所理解的通常意义。本文中使用的“包括”等类似的词语意指出现该词前面的元件或者物件涵盖出现在该词后面列举的元件或者物件及其等同，而不排除其他元件或者物件。
针对现有技术存在的问题，本发明的实施例提供了一种引导鞘管，参照图1，所述引导鞘管10包括：
第一鞘管11，呈中空管状，且为柔性材料；
第二鞘管12，呈中空管状，与所述第一鞘管11连接，且为刚性材料；
锁定结构13，部分设置于所述第二鞘管12的外侧，用于锁定所述第二鞘管12在人体支气管内的位置。
图2为本发明又一些实施例中引导鞘管的结构示意图。参照图2，所述引导鞘管10包括：
第一鞘管11，呈中空管状，且为柔性材料；
第二鞘管12，呈中空管状，与所述第一鞘管11连接，且为刚性材料；
锁定结构13，全部设置于所述第二鞘管12的外侧，用于锁定所述第二鞘管12在人体支气管内的位置。
本发明所称的刚性材料为弹性模量大于或等于6.11N/mm 2的材料，本发明所称的柔性材料为弹性模量小于6.11N/mm 2的材料。
本发明的一些实施例中，所述第一鞘管和所述第二鞘管的材料均为医用塑料。
本发明的一些优选实施例中，参照图1，所述第一鞘管和所述第二鞘管的外侧设有沿长度方向分布，且连续的刻度线。
本发明的一些实施例中，所述第一鞘管和所述第二鞘管采用粘合或融合的方式连接。
图3为本发明的一些实施例中第二鞘管的结构示意图。参照图3，所述第二鞘管12包括：
金属管121，呈中空管状；
接合部122，呈中空管状，外壁与所述金属管122的内壁贴合，并与所述第一鞘管(图中未标示)连接。
本发明的一些优选实施例中，参照图1、图2和图3，所述第二鞘管12为硬质高分子材料，且所述第二鞘管12远离所述第一鞘管11一端的外侧设有显 影环123，且距离所述第二鞘管12远离所述第一鞘管11的一端端口处的距离为2-5mm，便于辅助影像设备确定所述第二鞘管12在人体内的位置。
本发明的一些实施例中，所述第二鞘管的长度为5-10mm。优选地，所述接合部位于所述金属管内的长度为2-7mm。
本发明的一些优选实施例中，所述第二鞘管的长度为5mm，所述接合部位于所述金属管内的长度为2mm。
本发明的一些优选实施例中，所述第二鞘管的长度为7mm，所述接合部位于所述金属管内的长度为4mm。
本发明的一些优选实施例中，所述第二鞘管的长度为9mm，所述接合部位于所述金属管内的长度为6mm。
本发明的一些优选实施例中，所述第二鞘管的长度为10mm，所述接合部位于所述金属管内的长度为7mm。
图4为本发明的一些实施例中破口结构未撑开时引导鞘管示意图。参照图3，所述第二鞘管12的一端呈破口结构125，所述破口结构125包括破口126，所述破口126的数量为2-16条，所述破口即缝隙。所述引导鞘管还包括外套管124，所述外套管套124接在所述第二鞘管12的外侧，且所述第二鞘管12能够在所述外套管124内滑动。
本发明的一些具体实施例中，所述破口的数量为2、5、9、12和16中的一种。
图5为本发明的一些实施例中破口结构撑开后引导鞘管的示意图。参照图5，所述破口结构125的材料为记忆合金，具体为镍钛记忆材质，当所述破口结构伸出所述外套管124时，所述破口结构125撑开，以形成喇叭口结构，且所述喇叭口结构的最小内径大小等于所述第二鞘管12中段的内径大小。优选地，所述喇叭口结构的最大内径比最小内径大0.05-1.5mm，其中，所述喇叭口结构的最大内径，即开口一端的内径，所述喇叭口结构的最小内径，即与所述第二鞘 管12连接的一端的内径。
参照图3和图5，所述外套管124远离所述破口结构的一侧设有控制结构127，所述控制结构127用于控制所述外套管124在所述第二鞘管12外侧滑动，以控制所述破口结构125撑开或收缩。其中，所述控制结构127包括第一推动部1271、第二推动部1272和弹簧1273，所述第一推动部1271和所述第二推动部1272通过所述弹簧1273连接，所述第一推动部1271固定在所述外套管124的外侧，所述第二推动部1272通过连接杆1274与所述第一鞘管11固定连接。优选地，所述第一推动部1271和所述第二推动部1272为环状。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大0.05mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大0.25mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大0.5mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大0.75mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大1mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大1.25mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径比最小内径大1.5mm。
本发明的一些优选实施例中，所述喇叭口结构的最大内径为3-4mm，所述第一鞘管和所述第二鞘管的最大内径为2.3mm，所述第一鞘管和所述第二鞘管 的最大外径为2.95mm。
本发明的一些实施例中，所述第一鞘管包括手持端，所述手持端上设有操作杆，所述操作杆用于对所述破口结构起到拉伸作用，以使所述破口结构朝向所述第二鞘管的外侧，从而过大所述第二鞘管一端的开口大小，便于组织样本进入所述第二鞘管。
图6为本发明的一些实施例中第二鞘管上为充气气囊的结构示意图。参照图6，所述锁定结构(图中未标示)包括气囊131，所述气囊131上设有至少一个充气口132，所述充气口(图中未标示)与所述输气管道(图中未标示)连接，其中，所述输气管道设置于所述第一鞘管(图中未标示)和所述第二鞘管12的内侧或外侧。具体地，所述气囊131未充气时长度为5-10mm，且贴于所述第二鞘管12的外壁上。通过所述气囊131能够起到固定和取消固定的作用，并且在支气管内出血时，所述气囊131可以压迫血管，以起到止血的作用。
本发明的一些优选实施例中，当所述输气管道设置于所述第一鞘管和所述第二鞘管的内侧时，所述充气口设置于所述气囊与所述第二鞘管的贴合壁上，并穿过所述第二鞘管。更优选地，所述输气管道的外侧设有保护层，所述保护层覆盖于所述输气管道的外侧，且与所述第一鞘管和所述第二鞘管的内壁无缝连接。
本发明的一些优选实施例中，当所述输气管道设置于所述第一鞘管和所述第二鞘管的外侧时，所述充气口设置于所述气囊面向所述第一鞘管的一侧。更优选地，所述输气管道的外侧设有保护层，所述保护层覆盖于所述输气管道的外侧，且与所述第一鞘管和所述第二鞘管的外壁无缝连接。
图7为本发明的一些实施例中第二鞘管上已充气气囊的结构示意图。参照图7，所述气囊131充气时膨胀，在所述第二鞘管12的外侧形成椭圆形或圆形，所述气囊131的外壁挤压人体支气管壁，而对所述第二鞘管12起到固定作用。
图8为本发明的一些实施例中引导鞘管的使用方法的流程图。参照图8，所 述引导鞘管的使用方法包括以下步骤：
S1：将所述引导鞘管插入内窥镜的工作通道内；
S2：通过所述内窥镜观察人体支气管，将所述引导鞘管伸入人体支气管的目标位置；
S3：通过所述锁定结构锁定所述引导鞘管相对于人体支气管的位置；
S4：将取样器械接入所述引导鞘管内进行取样。
虽然在上文中详细说明了本发明的实施方式，但是对于本领域的技术人员来说显而易见的是，能够对这些实施方式进行各种修改和变化。但是，应理解，这种修改和变化都属于权利要求书中所述的本发明的范围和精神之内。而且，在此说明的本发明可有其它的实施方式，并且可通过多种方式实施或实现。

Claims (16)

  1. 一种引导鞘管，其特征在于，包括：
    第一鞘管，呈中空管状，且为柔性材料；
    第二鞘管，呈中空管状，与所述第一鞘管连接，且为刚性材料；
    锁定结构，部分或全部设置于所述第二鞘管的外侧，用于锁定所述第二鞘管在人体支气管内的位置。
  2. 如权利要求1所述引导鞘管的使用方法，其特征在于，包括以下步骤：
    S1：将所述引导鞘管插入内窥镜的工作通道内；
    S2：通过所述内窥镜观察人体支气管，将所述引导鞘管伸入人体支气管的目标位置；
    S3：通过所述锁定结构锁定所述引导鞘管相对于人体支气管的位置；
    S4：将取样器械接入所述引导鞘管内进行取样。
  3. 根据权利要求1所述的引导鞘管，其特征在于，所述第一鞘管和所述第二鞘管相互粘合或融合。
  4. 根据权利要求1所述的引导鞘管，其特征在于，所述第二鞘管包括：
    金属管，呈中空管状；
    接合部，呈中空管状，外壁与所述金属管的内壁贴合，并与所述第一鞘管连接。
  5. 根据权利要求1所述的引导鞘管，其特征在于，所述第二鞘管为硬质高分子材料，且所述第二鞘管远离所述第一鞘管一端的外侧设有显影环，且距离所述第二鞘管远离所述第一鞘管的一端端口处的距离为2-5mm。
  6. 根据权利要求4所述的引导鞘管，其特征在于，所述第二鞘管的长度为5-10mm。
  7. 根据权利要求4所述的引导鞘管，其特征在于，所述接合部位于所述金属管内的长度为2-7mm。
  8. 根据权利要求4所述的引导鞘管，其特征在于，所述第二鞘管的一端呈破口结构，且所述破口结构撑开后形成喇叭口结构。
  9. 根据权利要求8所述的引导鞘管，其特征在于，所述破口结构包括破口，所述破口的数量为2-16条。
  10. 根据权利要求8所述的引导鞘管，其特征在于，所述喇叭口结构的最大内径比最小内径大0.05mm-1.5mm。
  11. 根据权利要求8所述的引导鞘管，其特征在于，还包括外套管，所述外套管套接在所述第二鞘管的外侧，所述外套管远离所述破口结构的一侧设有控制结构，所述控制结构用于控制所述外套管在所述第二鞘管外侧滑动，以控制所述破口结构撑开或收缩。
  12. 根据权利要求8所述的引导鞘管，其特征在于，所述破口结构的材料为记忆合金。
  13. 根据权利要求1所述的引导鞘管，其特征在于，还包括输气管道，所述输气管道设置于所述第一鞘管和所述第二鞘管的内侧或外侧。
  14. 根据权利要求13所述的引导鞘管，其特征在于，所述锁定结构包括气囊，所述气囊上设有至少一个充气口，所述充气口与所述输气管道连通。
  15. 根据权利要求14所述的引导鞘管，其特征在于，所述气囊未充气时长度为5-10mm。
  16. 根据权利要求1所述的引导鞘管，其特征在于，所述第一鞘管和所述第二鞘管的外侧设有沿长度方向分布且连续的刻度线。
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