WO2024016802A1 - 一种困难气道通气装置 - Google Patents

一种困难气道通气装置 Download PDF

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Publication number
WO2024016802A1
WO2024016802A1 PCT/CN2023/094124 CN2023094124W WO2024016802A1 WO 2024016802 A1 WO2024016802 A1 WO 2024016802A1 CN 2023094124 W CN2023094124 W CN 2023094124W WO 2024016802 A1 WO2024016802 A1 WO 2024016802A1
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WIPO (PCT)
Prior art keywords
airway
tube
guide
ventilation device
outer tube
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PCT/CN2023/094124
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English (en)
French (fr)
Inventor
徐懋
魏滨
张天昊
王玉洁
张睿
Original Assignee
北京大学第三医院（北京大学第三临床医学院）
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Application filed by 北京大学第三医院（北京大学第三临床医学院） filed Critical 北京大学第三医院（北京大学第三临床医学院）
Publication of WO2024016802A1 publication Critical patent/WO2024016802A1/zh

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    • 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
    • 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
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a difficult airway ventilation device.
  • Safe airway management is an important measure to ensure the safety of patients during the perioperative period and is one of the most challenging tasks in the perioperative period. Difficult airway often occurs in clinical work. Proper airway management is related to patient safety and directly affects patient prognosis and outcome.
  • Difficult airway manifests as difficulty in ventilation, difficulty in intubation, or both clinical conditions. Difficulties in ventilation are mostly caused by obstruction of tissues at different levels of the upper respiratory tract, while difficulties in intubation are caused by difficulty in exposing the glottis or anatomical abnormalities. Patients with non-difficult airways may also develop emergency difficult airways due to improper clinical management, thus affecting the accuracy of airway assessment methods in predicting difficult airways and the effectiveness of airway management.
  • embodiments of the present application aim to provide a difficult airway ventilation device to solve the problem of inability to effectively ventilate due to airway obstruction in difficult airways.
  • a difficult airway ventilation device includes a guide assembly and an airway stent assembly, the guide assembly is used to guide the airway stent assembly; the guide assembly includes an airbag, and the airbag is used to guide the airway stent assembly; the airway
  • the stent assembly includes an inner tube, an outer tube and a locking unit.
  • the outer tube is set on the inner tube.
  • the locking unit is set on the inner tube and the outer tube. The locking unit is used to lock the inner tube and the outer tube.
  • the airway stent assembly Can be used as a path for ventilation and tracheal intubation.
  • the air bag is provided with an air guide tube, which inflates and deflates the air bag.
  • the air bag is provided with a first through hole, the flexible intubation scope passes through the first through hole, and the air bag can be fixedly connected to the flexible intubation scope through the first through hole.
  • an anti-slip layer is provided on the inner wall of the first through hole.
  • the airbag becomes spindle-shaped after being inflated, the airbag includes a central axis, and the first through hole is coaxial with the airbag.
  • the guide assembly further includes a guide wire.
  • the air bag is provided with a second through hole.
  • the guide wire passes through the second through hole and is movably connected to the air bag.
  • the guide wire is used to guide the flexible intubation scope and the air bag into the difficult airway.
  • the guide wire includes a bending portion, which is provided at one end of the guide wire.
  • the bending portion can be bent at will and maintain the bent shape.
  • one end of the outer tube is provided with an outer edge portion, the outer edge portion protrudes from the outer wall of the outer tube, the locking unit includes an inner edge portion, the inner edge portion is provided on the inner wall of the locking unit, and the inner diameter of the inner edge portion is smaller than the outer edge portion.
  • the outer diameter of the rim, the outer rim and the inner rim cooperate with each other to limit the movement of the locking unit.
  • the locking unit further includes a groove
  • the inner tube includes a convex rib.
  • the convex rib is provided at one end of the inner tube, and the groove and the convex rib engage.
  • the length of the support frame is telescopic and the inner diameter can be adjusted.
  • the support frame includes a support body, a recovery unit and a tail support unit.
  • the recovery unit is provided at one end of the support body, and the tail support unit is provided at the other end of the support body.
  • the tail support unit forms a hollow blade shape.
  • the recovery unit includes a first support rod, a second support rod, a tail ring and a drawbar.
  • the first support rod is located between the two second support rods.
  • the two second support rods One end of the first support rod and one end of the first support rod are both connected to the tail ring, and the drawbar is connected to the tail ring to recover the support frame.
  • this application can achieve at least one of the following beneficial effects:
  • the support frame of the difficult airway ventilation device of the present application can quickly relieve upper respiratory tract obstruction and ensure ventilation in difficult airway conditions
  • the tail support unit of the support frame of this application can expose the airway and larynx, facilitate observation of the airway and glottis, assist in intubation, and establish an effective suction channel;
  • the airbag of the guiding device can guide the outer tube to the supraglottic position, and the intubation flexible scope is coaxial with the airbag, so that during the process of guiding the airway stent assembly, the airway stent assembly and the intubation tube
  • the flexible scope is coaxial, and the airway stent assembly no longer deviates from the axis of the flexible intubation scope, which greatly facilitates the guidance of the airway stent assembly by the flexible intubation scope;
  • the recessed portion of this application reduces the contact area between the airbag and the airway during the guidance of the outer tube, and can maintain airway ventilation;
  • the guide wire of this application is used to guide the flexible intubation scope.
  • the bending part allows one end of the guide wire to have a larger area when advancing in the larynx.
  • the impact on the larynx is reduced.
  • the pressure on the inner wall of the trachea to reduce damage to the larynx or trachea.
  • FIG. 1 is a schematic diagram of the overall structure of the ventilation device of the present application.
  • Figure 2 is a schematic diagram of the internal structure of the ventilation device
  • Figure 3 is a schematic structural diagram of the support frame in its released state
  • Figure 4 is a schematic diagram of the overall structure of the guide assembly
  • Figure 5 is a schematic diagram of the use state of the guide assembly.
  • a specific embodiment of the present application discloses a difficult airway ventilation device (hereinafter referred to as the ventilation device), which includes an airway stent assembly and a guide assembly.
  • the guide assembly is used to guide the airway stent.
  • the component is placed in a supraglottic position.
  • the airway stent assembly includes an inner tube 1, an outer tube 2 and a locking unit 3.
  • the outer tube 2 is set on the inner tube 1, and the locking unit 3 is arranged on the inner tube 1 and the outer tube 2.
  • the locking unit 3 is used to lock the inner tube 1 and the outer tube 2.
  • the relative position of the outer tube 2 and the inner tube 1 is locked by the locking unit 3 to prevent the outer tube 2 from sliding on the inner tube 1 during the intubation operation.
  • the airway stent assembly can open the narrowed and difficult airway to keep the patient breathing smoothly, and can also be used as an auxiliary device for tracheal intubation.
  • the inner tube 1 has a curvature adapted to the human body's airway, and is a round tube. Furthermore, the inner tube 1 is a hard round tube, and the inner tube 1 provides guidance and support for the outer tube 2 .
  • one end of the inner tube 1 protrudes from the end surface of the outer tube 2, and a vent hole 11 is opened on the side wall of the end of the inner tube 1 that protrudes from the outer tube 2, so that both ends of the inner tube 1 are ventilated and used for air circulation. Keep the airway open during intubation.
  • One end of the inner tube 1 protrudes from the outer tube 2 in a drop shape to prevent damage to the airway when the airway stent component is inserted into the airway.
  • the outer tube 2 is a round tube; the outer tube 2 has the same curvature as the inner tube 1; the outer tube 2 can enter difficult airways, and the combination of the inner tube 1 and the outer tube 2 can be used as a tracheal intubation; the outer tube 2 Able to slide along the inner tube 1.
  • one end of the outer tube 2 is provided with an outer edge portion 21, the outer edge portion 21 protrudes from the outer wall of the outer tube 2, and the locking unit 3 is provided on the outer edge portion 21.
  • the locking unit 3 includes an inner
  • the inner edge 31 is provided on the inner wall of the locking unit 3.
  • the inner diameter of the inner edge 31 is smaller than the outer diameter of the outer edge 21.
  • the outer edge 21 and the inner edge 31 cooperate with each other to limit the locking unit 3. movement to ensure that the locking unit 3 will not break away from the outer tube 2.
  • the locking unit 3 also includes a groove 32, and the inner tube 1 includes a convex rib 12.
  • the convex rib 12 is provided at one end of the inner tube 1.
  • the groove 32 and the convex rib 12 engage with each other, so that the locking unit 3 can lock.
  • the relative position of the outer tube 2 and the inner tube 1 is fixed to prevent the outer tube 2 from sliding on the inner tube 1 during the intubation operation.
  • the ventilation device of the present application also includes a support frame 4.
  • the support frame 4 is arranged inside the outer tube 2.
  • the support frame 4 is used to expand the difficult airway and maintain the expanded state.
  • the support frame 4 is an elastic frame to adapt to the shape within the airway.
  • the lower end of the outer tube 2 is protruding or flush with the lower end of the support frame 4, and the support frame 4 is constrained by the outer tube 2 and is in a radially contracted state.
  • the support frame 4 is composed of a grid structure spirally woven by a plurality of elastic material fibers.
  • the length of the support frame 4 is telescopic and the inner diameter is adjustable.
  • the support frame 4 can be released. After release, the support frame 4 can resist and open the airway, increasing the air circulation in the airway.
  • the gaps in the grid structure can expose the airway and larynx, realize ventilation, and facilitate air flow. It can observe the tract and larynx, assist in intubation, and establish an effective suction channel, so that secretions or blood in the patient's mouth can be quickly extracted.
  • the support frame 4 includes a support body 41 , a recovery unit 42 and a tail support unit 43 .
  • the recovery unit 42 is provided at one end of the support body 41
  • the tail support unit 43 is provided at the other end of the support body 41 .
  • the support body 41 has openings at both ends, namely a first opening 411 and a second opening 412. After the support frame 4 is released in the airway, the first opening 411 is in the supraglottic hypopharyngeal position, and the second opening 412 is located in the oropharynx.
  • the support body 41 is a self-expanding elastic structure.
  • the support body 41 can be provided with a coating.
  • the coating wraps the outer wall of the support body 41.
  • the coating ensures the overall support of the throat by the support frame 4 and reduces the throat being affected by the mesh. Extrusion of lattice structure.
  • the recovery unit 42 includes a first support rod 421, a second support rod 422, a tail ring 423 and a drawbar 424.
  • the recovery unit 42 can be used to recover the support frame 4, and can also support the oral cavity to keep the second opening 412 open.
  • the first support rod 421 is located between the two second support rods 422.
  • One end of the two second support rods 422 and one end of the first support rod 421 are both connected to the tail ring 423. connect.
  • the drawbar 424 is connected to the tail ring 423 for recovering the support frame 4 .
  • the recovery unit 42 facilitates the removal of the support frame 4 and reduces damage to the patient's oral cavity and airway.
  • the tailstay unit 43 is woven from elastic material fibers. When the tailstay unit 43 is opened, it can resist the surrounding tissues of the supraglottis and expose the glottis, keeping the first opening 411 open; the tailstay unit 43 forms a hollow
  • the blade shape is so as to expose the airway area opened by the tail support unit 43 to facilitate ventilation, observation, assisted intubation, sampling or treatment of the airway.
  • the ventilation device of the present application also includes an indicator line 5.
  • the indicator line 5 is provided on the outer walls of the inner tube 1 and the outer tube 2 to facilitate reading the depth information of the outer tube 2 inserted into the oral cavity when the support frame 4 is placed. .
  • the guide assembly can be used for the second time to adjust the placement position of the ventilation device in conjunction with the flexible intubation scope 8 .
  • the guide assembly includes an air bag 6, and the air bag 6 is spindle-shaped.
  • the air bag 6 can be inflated and deflated. After being inflated, one end of the air bag 6 can fill one end of the outer tube 2 and be connected to the outer tube 2 .
  • the air bag 6 is provided with an air guide tube 61, and the air guide tube 61 inflates and deflates the air bag 6.
  • One end of the air bag 6 can be inserted into the blocked upper airway to guide the outer tube 2 to be placed at the supraglottic position.
  • the air bag 6 is provided with a first through hole 62, and the flexible intubation mirror 8 passes through the first through hole 62.
  • the air bag 6 can be fixedly connected to the flexible intubation mirror 8, thereby guiding the outer tube 2 to the supraglottic position. .
  • an anti-slip layer is provided on the inner wall of the first through hole 62.
  • the anti-slip layer increases friction to ensure that the air bag 6 and the flexible intubation scope 8 do not shift.
  • the balloon 6 includes a central axis
  • the first through hole 62 is coaxial with the balloon 6
  • the flexible intubation scope 8 is coaxial with the balloon 6
  • the maximum outer diameter of the balloon 6 is equal to the inner diameter of the airway stent assembly, so that when guiding the airway During the process of assembling the stent, the airway stent assembly is coaxial with the flexible intubation scope 8, and the airway stent assembly no longer deviates from the axis of the flexible intubation scope 8, which facilitates the guidance of the airway stent assembly by the flexible intubation scope 8.
  • the airbag 6 is also provided with a recessed portion (not shown in the figure), which is parallel to the central axis.
  • the recessed portion prevents the airbag 6 from completely blocking the airway and maintains Difficult airway ventilation.
  • the guide assembly also includes a guide wire 7 , and the guide wire 7 is movably connected to the air bag 6 .
  • the guide wire 7 is used to guide the flexible intubation scope 8 into the glottis.
  • the airbag 6 is also provided with a second through hole (not shown in the figure), and the guide wire 7 passes through the second through hole and is movably connected to the airbag 6 .
  • the guide wire 7 includes a bending portion 71 , which is provided at one end of the guide wire 7 .
  • the bending portion 71 can be bent at will and maintain the bent shape.
  • the bent portion 71 allows one end of the guide wire 7 to have a larger area when advancing in the throat.
  • the tail support unit 43 springs open in a trumpet shape; the support frame 4 further opens the airway and increases the air circulation in the airway.
  • the first opening 411 is in the supraglottic hypopharynx position, and the second opening 412 is in the oropharynx.
  • the intubation soft scope 8 assists under clear vision. Reposition the airway stent assembly, withdraw the guiding assembly, and put the inner tube 1 back to the outside. The inside of the tube 2 is used to prevent the support frame 4 from being withdrawn with the outer tube 2. Then the inner tube 1 does not move, and the outer tube 2 is withdrawn to release the support frame 4 again, and the inner tube 1 is withdrawn again.
  • the airbag 6 is put on the flexible intubation scope 8 through the first through hole 62 and inflated; the bent portion 71 is straightened and passed through the second through hole; the bent portion 71 is bent after passing through the second through hole. ;
  • the flexible intubation scope 8 carries the balloon 6 and the guide wire 7 into the airway.
  • the guide wire 7 first explores, and then the flexible intubation scope 8 reaches the supraglottic position; then the balloon 6 is deflated through the airway 61, and the flexible intubation scope 8 Remove the airbag 6 and guidewire 7 from the airway stent assembly.
  • the airbag 6 of the guiding device can guide the airway stent assembly to the supraglottic position, and the intubation flexible scope 8 is coaxial with the airbag 6, so that during the process of guiding the airway stent assembly , the airway stent assembly is coaxial with the flexible intubation scope 8, and the airway stent assembly no longer deviates from the axis of the flexible intubation scope 8, eliminating the obstruction of advancement caused by the difference in caliber, and facilitating the guidance of the airway stent assembly by the flexible intubation scope 8 ;
  • the recessed portion reduces the contact area between the airbag 6 and the airway during the guidance of the airway stent assembly, facilitating assisted ventilation;
  • the guide wire 7 is used to guide the flexible intubation scope 8 into the glottis; the bent portion 71 allows the guide wire 7 to One end has a larger area when advancing in the larynx.
  • the airway stent component of the tracheal ventilation device can quickly relieve upper respiratory tract obstruction and establish a spacious endotracheal intubation passage in difficult airway conditions; the gaps in the mesh structure of the support frame 4 can expose the airway and larynx, making it easier to Observation of the airway and larynx, assisted intubation, sampling or treatment can also establish an effective suction channel, and can quickly extract secretions or blood from the patient's oral cavity; the recovery unit 42 of the support frame 4 makes the support frame 4. Easy to remove, reducing damage to the patient’s oral cavity and airway.

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Abstract

一种困难气道通气装置，属于医疗器械技术领域，将保障通气功能和引导插管功能进行有机整合，同步解决"有效通气"和"安全插管"两大难题。困难气道通气装置包括气道支架组件、导引组件和支撑架(4)，导引组件用于导引气道支架组件置于声门上位置；气道支架组件包括内管(1)、外管(2)和锁止单元(3)，外管(2)套设在内管(1)上，锁止单元(3)设置在内管(1)和外管(2)上，锁止单元(3)用于锁定内管(1)和外管(2)，气道支架组件能够作为保障通气和辅助气管插管设备使用；支撑架(4)能够使气道和声门暴露，解除上呼吸道梗阻，提供有效通气或进行相关治疗，并能够利用通道引导气管插管；同时，能够建立有效的吸引通道，便于口腔内分泌物的引流。

Description

一种困难气道通气装置 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种困难气道通气装置。
背景技术
安全的气道管理是保障患者围术期生命安全的重要举措，是围术期最具挑战性的工作之一。困难气道在临床工作中常有发生，气道管理得当与否事关患者安全，直接影响患者预后和转归。
困难气道表现为通气困难或插管困难，或二者兼具的临床情况等。通气困难的原因多为上呼吸道不同水平组织的阻塞，而插管困难的原因为声门暴露困难或解剖异常等。非困难气道患者也可能因临床处置不当而演化为紧急的困难气道，由此影响气道评估方法预测困难气道的准确度和气道处理的效果。
目前，临床工作中有效应对困难气道的技术和工具仍然不够完善，现有技术和工具因为暴露视野、空间、解剖异常和分泌物影响等因素，经常不能有效处理困难气道，尤其是不能通气不能插管的紧急气道，由此可能严重危及到患者生命，给气道管理带来严峻挑战。临床亟需提供新的困难气道解决方案，简化困难气道的处置流程，以克服目前困难气道管理技术的局限，同步解决核心的“有效通气”和“安全插管”两大难题，由此也会对困难气道处理会产生深远影响。
因此，研发新型困难气道管理工具，提高气道管理的安全性及有效性，简化困难气道的处置流程，是目前亟待解决的重大临床问题。
发明内容
鉴于上述的分析，本申请实施例旨在提供一种困难气道通气装置，用以解决困难气道时气道阻塞导致无法有效通气的问题。
本申请的目的主要是通过以下技术方案实现的：
一种困难气道通气装置，包括导引组件和气道支架组件，导引组件用于导引气道支架组件；所述导引组件包括气囊，气囊用于引导气道支架组件；所述气道支架组件包括内管、外管和锁止单元，外管套设在内管上，锁止单元设置在内管和外管上，锁止单元用于锁定内管和外管，气道支架组件能够作为通气和气管插管的路径使用。
进一步地，气囊上设有导气管，导气管为气囊充放气。
进一步地，气囊上设有第一通孔，插管软镜穿过第一通孔，气囊能够通过第一通孔与插管软镜固定连接。
进一步地，第一通孔的内壁上设有防滑层。
进一步地，气囊充气后为纺锤形，气囊包括中心轴，第一通孔与气囊同轴。
进一步地，导引组件还包括导丝，气囊上设有第二通孔，导丝穿过第二通孔与气囊活动连接，导丝用以引导插管软镜和气囊进入困难气道。
进一步地，导丝包括弯折部，弯折部设置在导丝的一端，弯折部能够随意弯折，并保持弯折后的形状。
进一步地，外管的一端设有外缘部，外缘部突出于外管的外壁，锁止单元包括内缘部，内缘部设置在锁止单元的内壁上，内缘部的内径小于外缘部的外径，外缘部和内缘部相互配合，限制锁止单元的运动。
进一步地，锁止单元还包括凹槽，内管包括凸棱，凸棱设置在内管的一端，凹槽和凸棱卡合。
进一步地，支撑架的长度可伸缩、内径能调节。
进一步地，支撑架包括支撑本体、回收单元和尾撑单元，回收单元设置在支撑本体的一端，尾撑单元设置在支撑本体的另一端；尾撑单元形成中空的叶片状。
进一步地，回收单元包括第一支撑杆、第二支撑杆、尾环和牵引杆，第二支撑杆为两根，第一支撑杆位于两根第二支撑杆之间，两根第二支撑杆的一端和第一支撑杆的一端均与尾环连接，牵引杆与尾环连接，用以回收支撑架。
与现有技术相比，本申请至少可实现如下有益效果之一：
(1)本申请的困难气道通气装置的支撑架能够在困难气道状况时，迅速解除上呼吸道梗阻，保障通气；
(2)本申请的支撑架的尾撑单元能够使气道和喉部暴露，便于对气道和声门部进行观察、辅助插管，还能够建立有效的吸引通道；
(3)本申请的支撑架的回收单元使支撑架方便移除，降低对患者口腔和气道的损伤；
(4)本申请提供的引导装置的气囊能够引导外管置于声门上位置，插管软镜与气囊同轴，使得在引导气道支架组件的过程中，将气道支架组件与插管软镜同轴，气道支架组件不再偏离插管软镜的轴线，极大便利插管软镜对气道支架组件的引导；
(5)本申请的凹陷部使得引导外管的过程中气囊与气道的接触面积减少，可以保持气道通气；
(6)本申请的导丝用以引导插管软镜，弯折部使导丝的一端在喉部前进时具有更大面积，在导丝接触喉部或气管内壁时，减小对喉部或气管内壁的压力，减小对喉部或气管的伤害。
附图说明
附图仅用于示出具体实施例的目的，而并不认为是对本申请的限制，在整个附图中，相同的参考符号表示相同的部件。
图1为本申请通气装置的整体结构示意图；
图2为通气装置内部结构示意图；
图3为支撑架的释放状态结构示意图；
图4为导引组件的整体结构示意图；
图5为导引组件的使用状态示意图。
附图标记：
1-内管；2-外管；3-锁止单元；4-支撑架；5-指示线；6-气囊；7-导丝；8-插管软镜；11-通气孔；12-凸棱；21-外缘部；31-内缘部；32-凹槽；41-支撑本体；42-回收单元；43-尾撑单元；61-导气管；62-第一通孔；71-弯折部；411-第一开口部；412-第二开口部；421-第一支撑杆；422-第二支撑杆；423-尾环；424-牵引杆。
具体实施方式
下面结合附图来具体描述本申请的优选实施例，其中，附图构成本申请一部分，并与本申请的实施例一起用于阐释本申请的原理，并非用于限定本申请的范围。
本申请的一个具体实施例，如图1所示，公开了一种困难气道通气装置(以下简称通气装置)，包括气道支架组件和导引组件，导引组件用于导引气道支架组件置于声门上位置。
优选地，如图1所示，气道支架组件包括内管1、外管2和锁止单元 3，外管2套设在内管1上，锁止单元3设置在内管1和外管2上，锁止单元3用于锁定内管1和外管2。通过锁止单元3锁定外管2和内管1的相对位置，防止插管操作时外管2在内管1上滑动。气道支架组件能够撑开已经狭窄的困难气道，保持患者呼吸畅通，还能够作为气管插管的辅助装置使用。
优选地，内管1具有适应人体气道的弧度，内管1为圆管，进一步地，内管1为硬质圆管，内管1为外管2提供导向和支撑。
优选地，内管1的一端凸出于外管2的端面，内管1凸出外管2的一端的侧壁上开有通气孔11，使得内管1的两端保持通气，用于在气道插管过程中保持气道畅通。内管1凸出外管2的一端为水滴状，气道支架组件插入气道过程中避免对气道造成损伤。
优选地，外管2为圆管；外管2具有与内管1相同的弧度；外管2能够进入困难气道，内管1和外管2的组合能够作为气管插管使用；外管2能够沿内管1滑动。
优选地，如图2所示，外管2的一端设有外缘部21，外缘部21突出于外管2的外壁，锁止单元3设置在外缘部21上，锁止单元3包括内缘部31，内缘部31设置在锁止单元3的内壁上，内缘部31的内径小于外缘部21的外径，外缘部21和内缘部31相互配合，限制锁止单元3的运动，确保锁止单元3不会脱离外管2。
优选地，锁止单元3还包括凹槽32，内管1包括凸棱12，凸棱12设置在内管1的一端，凹槽32和凸棱12相互卡合，使得锁止单元3能够锁止外管2和内管1的相对位置，防止插管操作时外管2在内管1上滑动。
优选地，本申请的通气装置还包括支撑架4，支撑架4设置在外管2内，支撑架4用于困难气道的撑开并保持撑开状态。
优选地，支撑架4是弹性支架,以适应气道内的形状。
优选地，外管2下端相对于支撑架4的下端凸出或齐平，支撑架4受外管2的约束，处于径向收缩状态。
优选地，支撑架4由多条弹性材料纤维螺旋编织成的网格结构组成，支撑架4的长度可伸缩、内径能调节。支撑架4能够被释放，释放后，支撑架4能够抵住并撑开气道，增加气道内的空气流通量，网格结构的空隙能够使气道和喉部暴露，实现通气，便于对气道和喉部进行观察、辅助插管，还能够建立有效的吸引通道，对于患者口腔内的分泌物或血液均可进行快速抽取。
优选地，如图3所示，支撑架4包括支撑本体41、回收单元42和尾撑单元43，回收单元42设置在支撑本体41的一端，尾撑单元43设置在支撑本体41的另一端。
优选地，支撑本体41两端开口，分别为第一开口部411和第二开口部412，支撑架4在气道内释放后，第一开口部411处于声门上喉咽位置，第二开口部412处于口咽部。
优选地，支撑本体41为自膨胀弹性结构，支撑本体41上可设有覆膜，覆膜包裹支撑本体41的外壁，覆膜保证支撑架4对喉部的整体支撑，减小喉部受到网格结构的挤压。
优选地，回收单元42包括第一支撑杆421、第二支撑杆422、尾环423和牵引杆424。回收单元42能够用于回收支撑架4，也能够支撑口腔保持第二开口部412开放。
优选地，第二支撑杆422为两根，第一支撑杆421位于两根第二支撑杆422之间，两根第二支撑杆422的一端和第一支撑杆421的一端均与尾环423连接。
优选地，牵引杆424与尾环423连接，用以回收支撑架4。
回收单元42使支撑架4方便移除，降低对患者口腔和气道的损伤。
优选地，尾撑单元43由弹性材料纤维编织而成，尾撑单元43弹开能够抵住声门上周围组织并显露声门，使第一开口部411保持开放；尾撑单元43形成中空的叶片状，以便使尾撑单元43撑开的气道区域暴露，便于对气道进行通气、观察、辅助插管、取样或治疗。
优选地，本申请的通气装置还包括指示线5，指示线5设置在内管1和外管2的外壁上，实施支撑架4的放置作业时方便读取外管2的插入口腔的深度信息。
由于支撑架4第一次放置是盲探下放置，可能存在安置位置欠佳的问题，导引组件能够用于二次联合插管软镜8调整通气装置的放置位置。
优选地，如图4所示，导引组件包括气囊6，气囊6为纺锤状。气囊6能够充放气，充气后气囊6的一端能够填满外管2的一端，并与外管2连接。气囊6上设有导气管61，导气管61为气囊6充放气。气囊6的一端能够插入阻塞的上气道，为外管2置于声门上位置做引导。
优选地，气囊6上设有第一通孔62，插管软镜8穿过第一通孔62，气囊6能够与插管软镜8固定连接，进而引导外管2置于声门上位置。
优选地，第一通孔62的内壁上设有防滑层，在气囊6充气状态下，防滑层增大摩擦力，保证气囊6与插管软镜8不发生位移。
优选地，气囊6包括中心轴，第一通孔62与气囊6同轴，插管软镜8与气囊6同轴，气囊6的最大外径等于气道支架组件的内径，使得在引导气道支架组件的过程中，将气道支架组件与插管软镜8同轴，气道支架组件不再偏离插管软镜8的轴线，便利插管软镜8对气道支架组件的引导。
优选地，气囊6上还开有凹陷部(图中未示出)，凹陷部与中心轴平行，引导外管2的过程中凹陷部使得气囊6不会完全堵塞气道，保持 困难气道通气。
优选地，导引组件还包括导丝7，导丝7与气囊6活动连接。导丝7用以引导插管软镜8进入声门。
优选地，气囊6上还设有第二通孔(图中未示出)，导丝7穿过第二通孔与气囊6活动连接。
优选地，导丝7包括弯折部71，弯折部71设置在导丝7的一端，弯折部71能够随意弯折，并保持弯折后的形状。弯折部71使导丝7的一端在喉部前进时具有更大的面积，在导丝7接触喉部或气管内壁时，减小对喉部或气管内壁的压力，减小对喉部或气管的伤害，确保患者安全。
在困难气道状况下，将气道支架组件插入困难气道，解除气道的堵塞状态；维持内管1的位置不变，转动锁止单元3，直至锁止单元3的凹槽32和内管1上的凸棱12完全脱离；支撑架4未释放时，由于受到外管2的约束呈径向收缩状态，尾撑单元43处于收拢状态；回收单元42处于内管1和外管2之间；向上拉起锁止单元3，锁止单元3带动外管2沿内管1向口腔外抽出，同时支撑架4得到释放，直至支撑架4在气道内完全展开，支撑架4释放后，尾撑单元43呈喇叭状弹开；支撑架4将气道进一步撑开，增加气道内的空气流通量。此时第一开口部411处于声门上喉咽位置，第二开口部412处于口咽部。
气道撑开后探查支撑架4的放置位置，如果放置位置欠佳，需要在气道内再次置入外管2并回收支撑架4，将牵引杆424勾住尾环423，再将牵引杆424从外管2的底端穿入，从顶端穿出；从口腔向外拉拽牵引杆424的同时，向口腔内插入外管2，牵引杆424拉拽尾环423进而拉动第一支撑杆421和第二支撑杆422，直至将支撑架4完全收入到外管2内；然后将导引组件插入至外管2的一端充气，并与外管2连接，插管软镜8辅助明视下将气道支架组件重新定位，退出导引组件，将内管1放回外 管2内用于防止支撑架4随外管2撤回，然后内管1不动，退回外管2再次释放支撑架4，再次撤出内管1。
具体地，将气囊6通过第一通孔62套在插管软镜8上并充气；弯折部71取直并穿过第二通孔；弯折部71穿过第二通孔后弯折；插管软镜8携带气囊6和导丝7进入气道，导丝7先先行探查，之后插管软镜8抵达声门上位置；之后气囊6通过导气管61放气，插管软镜8携带气囊6和导丝7从气道支架组件内移除。
与现有技术相比，本申请提供的引导装置的气囊6能够引导气道支架组件置于声门上位置，插管软镜8与气囊6同轴，使得在引导气道支架组件的过程中，将气道支架组件与插管软镜8同轴，气道支架组件不再偏离插管软镜8的轴线，消除口径差造成前进受阻，便利插管软镜8对气道支架组件的引导；凹陷部使得引导气道支架组件的过程中气囊6与气道的接触面积减少，便利辅助通气；导丝7用以引导插管软镜8进入声门；弯折部71使导丝7的一端在喉部前进时具有更大面积，在导丝7接触喉部或气管内壁时，减小对喉部或气管内壁的压力，减小对喉部或气管的伤害，确保患者安全；困难气道通气装置的气道支架组件能够在困难气道状况时，迅速解除上呼吸道梗阻，建立宽敞的气管内插管通路；支撑架4的网状结构的空隙能够使气道和喉部暴露，便于对气道和喉部进行观察、辅助插管、取样或治疗，还能够建立有效的吸引通道，对于患者口腔内的分泌物或血液均可进行快速抽取；支撑架4的回收单元42使支撑架4方便移除，降低对患者口腔和气道的损伤。
以上所述，仅为本申请较佳的具体实施方式，但本申请的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本申请的保护范围之内。

Claims (13)

  1. 一种困难气道通气装置，其特征在于，包括导引组件和气道支架组件，导引组件用于导引气道支架组件；
    所述导引组件包括气囊(6)，气囊(6)用于引导气道支架组件；
    所述气道支架组件包括内管(1)、外管(2)和锁止单元(3)，外管(2)套设在内管(1)上，锁止单元(3)设置在内管(1)和外管(2)上，锁止单元(3)用于锁定内管(1)和外管(2)，气道支架组件能够作为通气和气管插管的路径使用。
  2. 根据权利要求1所述的困难气道通气装置，其特征在于，所述气囊(6)上设有导气管(61)，导气管(61)为气囊(6)充放气。
  3. 根据权利要求1所述的困难气道通气装置，其特征在于，所述气囊(6)上设有第一通孔(62)，插管软镜(8)穿过第一通孔(62)，气囊(6)能够通过第一通孔(62)与插管软镜(8)固定连接。
  4. 根据权利要求3所述的困难气道通气装置，其特征在于，所述第一通孔(62)的内壁上设有防滑层。
  5. 根据权利要求3所述的困难气道通气装置，其特征在于，所述气囊(6)充气后为纺锤形，气囊(6)包括中心轴，第一通孔(62)与气囊(6)同轴。
  6. 根据权利要求1所述的困难气道通气装置，其特征在于，所述导引组件还包括导丝(7)，气囊(6)上设有第二通孔，导丝(7)穿过第二通孔与气囊(6)活动连接，导丝(7)用以引导插管软镜(8)和气囊(6)进入困难气道。
  7. 根据权利要求6所述的困难气道通气装置，其特征在于，所述导丝(7)包括弯折部(71)，弯折部(71)设置在导丝(7)的一端，弯折部(71)能够随意弯折，并保持弯折后的形状。
  8. 根据权利要求1所述的困难气道通气装置，其特征在于，所述外管(2)的一端设有外缘部(21)，外缘部(21)突出于外管(2)的外壁，锁止单元(3)包括内缘部(31)，内缘部(31)设置在锁止单元(3)的内壁上，内缘部(31)的内径小于外缘部(21)的外径，外缘部(21)和内缘部(31)相互配合，限制锁止单元(3)的运动。
  9. 根据权利要求8所述的困难气道通气装置，其特征在于，所述锁止单元(3)还包括凹槽(32)，内管(1)包括凸棱(12)，凸棱(12)设置在内管(1)的一端，凹槽(32)和凸棱(12)卡合。
  10. 根据权利要求1所述的困难气道通气装置，其特征在于，还包括支撑架(4)，支撑架(4)设置在外管(2)和内管(1)之间，支撑架(4)用于气道的撑开并保持撑开状态。
  11. 根据权利要求10所述的困难气道通气装置，其特征在于，所述支撑架(4)的长度可伸缩、内径能调节。
  12. 根据权利要求10所述的困难气道通气装置，其特征在于，所述支撑架(4)包括支撑本体(41)、回收单元(42)和尾撑单元(43)，回收单元(42)设置在支撑本体(41)的一端，尾撑单元(43)设置在支撑本体(41)的另一端；尾撑单元(43)形成中空的叶片状。
  13. 根据权利要求12所述的困难气道通气装置，其特征在于，所述回收单元(42)包括第一支撑杆(421)、第二支撑杆(422)、尾环(423)和牵引杆(424)，第二支撑杆(422)为两根，第一支撑杆(421)位于两根第二支撑杆(422)之间，两根第二支撑杆(422)的一端和第一支撑杆(421)的一端均与尾环(423)连接，牵引杆(424)与尾环(423)连接，用以回收支撑架(4)。
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CN206566325U (zh) * 2016-11-28 2017-10-20 扬州市第一人民医院 一种气管插管纤维支气管镜引导用的引导器
CN109717826A (zh) * 2019-01-22 2019-05-07 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 纤维支气管镜气管插管组件及其推送器
CN217138922U (zh) * 2022-07-08 2022-08-09 北京大学第三医院（北京大学第三临床医学院） 一种简便通气装置
CN217339690U (zh) * 2022-07-18 2022-09-02 北京大学第三医院（北京大学第三临床医学院） 一种可重复使用的气道通气装置

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