WO2016116038A1 - 肺隔离导管 - Google Patents

肺隔离导管 Download PDF

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Publication number
WO2016116038A1
WO2016116038A1 PCT/CN2016/071430 CN2016071430W WO2016116038A1 WO 2016116038 A1 WO2016116038 A1 WO 2016116038A1 CN 2016071430 W CN2016071430 W CN 2016071430W WO 2016116038 A1 WO2016116038 A1 WO 2016116038A1
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catheter
openings
bronchial
tube
main
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PCT/CN2016/071430
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English (en)
French (fr)
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肖金仿
苏亮
肖鸣
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肖金仿
苏亮
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Priority claimed from CN201520043774.2U external-priority patent/CN204766920U/zh
Priority claimed from CN201510031807.6A external-priority patent/CN104524678A/zh
Application filed by 肖金仿, 苏亮 filed Critical 肖金仿
Publication of WO2016116038A1 publication Critical patent/WO2016116038A1/zh

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    • 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 invention relates to a medical device, and more particularly to a lung isolation catheter.
  • Endotracheal intubation is a common medical consumable used in anesthesia surgery, especially in thoracic surgery.
  • a double-lumen endotracheal intubation is needed to block the lung ventilation at the surgical site, to collapse the lungs, enlarge the surgical field, and facilitate the operation, while the contralateral lung has bronchi.
  • the function of the balloon can be ventilated separately to meet the oxygenation needs of the surgical patient.
  • the diameter of the tracheal intubation is larger, and the glottis is usually smaller, and some patients even have unilateral vocal cord paralysis and cannot open.
  • the patent No. CN201558393 discloses an endotracheal tube in which a tracheal tube opening is left in the portion connecting the lower end of the bronchial tube and the endotracheal tube, achieving a single lumen double outlet.
  • the catheter opening must have a large area, which makes the catheter opening weaken the strength of the endotracheal tube connection, which is easy to bend and damage, bringing surgery inconvenient.
  • the patient's breathing makes the body undulating, and the tracheal tube is easily displaced. If the position of the catheter opening after the displacement is blocked or partially blocked by the patient's tracheal wall, the ventilation may be insufficient, so that the patient is There is a risk of hypoxia.
  • the present invention provides a single-lumen bronchial catheter which can be conveniently and effectively applied to both lung isolation and single lung ventilation.
  • the pulmonary isolation catheter comprises: a main tracheal tube, the outer wall of which is provided with a first air bag, the first air bag is connected to the first inflation valve; the bronchial catheter is connected to the lower end of the main airway tube; the outer wall of the bronchial catheter is provided a second air bag, the second air bag is connected to the second inflation valve; the inside of the bronchial catheter is provided with a sealing member; the first opening is opened at the end of the bronchial catheter; and the second opening is opened at the lower end of the main tracheal tube
  • the tube wall is located below the first balloon; the number of the second openings is at least two, distributed along the circumferential surface of the main tracheal tube.
  • the seal is a cuff seal; the cuff seal is connected to the third inflation valve by a venting pressure control device.
  • the opening portion of the lower end of the endotracheal tube is made of a hard material.
  • the angle between the bronchial catheter and the extension of the lower end of the main endotracheal tube is 20° to 50°.
  • At least one of the second openings is a shaped aperture or a shaped aperture.
  • the second opening is a plurality of mesh openings.
  • the number of the second openings is two, and is symmetric or asymmetric along the circumferential surface of the main tracheal tube.
  • the number of the second openings is three and is symmetrically or asymmetrically distributed along the circumferential surface of the main tracheal tube.
  • the number of the second openings is four and is symmetrically or asymmetrically distributed along the circumferential surface of the main tracheal tube.
  • the number of the second openings is five and is symmetrically or asymmetrically distributed along the circumferential surface of the main tracheal tube.
  • the number of the second openings is six or more even openings and is symmetrically or asymmetrically distributed along the circumferential surface of the main tracheal tube.
  • the number of the second openings is seven or more odd openings and is symmetrically or asymmetrically distributed along the circumferential surface of the main tracheal tube.
  • the outer diameter of the tube can be made smaller, effectively reducing the damage, and the application range can be expanded, even if it has All the functions of the double-lumen endotracheal tube overcome the shortcomings of the double-lumen bronchial catheter which is not conducive to endotracheal intubation and ventilation, and easily cause airway damage;
  • At least two open types are more conducive to the insertion of the healthy side suction tube, which is convenient for the healthy side suction, and the built-in cuff seal is partially embedded in the bronchial tube wall, and does not affect the suction and the full open ventilation effect.
  • Figure 1 is a schematic view showing the structure of a first embodiment of a pulmonary isolation catheter of the present invention
  • Figure 2 is a schematic view showing the structure of a second embodiment of the pulmonary isolation catheter of the present invention.
  • Figure 3 is a schematic view showing the structure of a third embodiment of the pulmonary isolation catheter of the present invention.
  • Figure 4 is a schematic view showing the structure of a fourth embodiment of the pulmonary isolation catheter of the present invention.
  • Figure 5 is a schematic view showing the structure of a fifth embodiment of the pulmonary isolation catheter of the present invention.
  • Figure 6 is a schematic view showing the structure of a sixth embodiment of the pulmonary isolation catheter of the present invention.
  • Figure 7 is a schematic illustration of the working process of the cuff seal of the pulmonary isolation catheter of the present invention.
  • a lung isolation catheter 1 includes a main tracheal catheter 2 and a bronchial catheter 3, and an outer wall of the main tracheal catheter 2 is provided with a first balloon 6, which is connected to a first inflation valve 61, and a bronchial catheter 3
  • the lower end of the main tracheal tube 2 is connected, and the outer wall of the bronchial tube 3 is provided with a second air bag 5, which is connected to the second inflation valve 51.
  • the bronchial catheter 4 is further provided with a sealing member.
  • the sealing member is a set of capsule sealing members 4, and the cuff sealing member 4 is connected to the third inflation valve 41 through a ventilation pressure control device 42; the ventilation pressure control device 42
  • the air pressure charged into the cuff seal 4 by the third inflation valve 41 is controlled, thereby controlling the cuff seal 4 to change its size to achieve the purpose of controlling the bronchial ventilation flow.
  • the end of the bronchial catheter 3 is the first opening 21, as shown in Fig. 7, when the cuff seal 4 is full of gas under full pressure (the dotted line in Fig. 7), the cuff seal 4 can completely block the bronchial catheter 3 (For clarity, the bronchial catheter 3 in Fig. 7 shows only a half section), the lung isolation catheter 1 cannot be ventilated from the first opening 21 with the bronchus.
  • the ventilation pressure control device 42 is adjusted to reduce the size of the cuff seal 4 after inflation (solid line portion in Fig. 7), a gap is left between the inner wall of the bronchial catheter 3 and the cuff seal 4, and the first opening 21 is ventilated. And the flow rate is affected by the size of the cuff seal 4.
  • a second opening 22 is opened at the wall of the lower end of the main endotracheal tube 2, and the second opening 22 is located below the first air bag 6.
  • the number of the second openings 22 is five, and a plum-like asymmetric distribution is present along the circumferential surface of the main tracheal tube 2, and a plurality of second openings 22 are provided on the main tracheal tube 2 for surgery.
  • the other second openings 22 can continue to be ventilated to avoid the problem of poor ventilation.
  • the opening structure may also adopt other manners, for example, the number of the second openings 22 is two, the shape is circular, and the distribution is asymmetric (as shown in FIG. 2); or the total number of the second openings 22 is nine, and the shape is elliptical. And uniformly distributed (as shown in FIG. 3); or the number of the second openings 22 is plural, the shape is a special-shaped hole, and is unevenly distributed (as shown in FIG. 4); or the shape of the second opening 22 is S-shaped (FIG.
  • the second opening 22 is realized by a plurality of mesh holes; the number of the second openings 22 may also be six or more even openings (for example, thirty Or more than seven odd openings (for example fifteen) and are symmetrically or asymmetrically distributed along the circumferential surface of the main endotracheal tube.
  • the shape, number, and size of the second opening 22 can be designed according to aerodynamic physical principles, and the distribution state can be symmetric and asymmetric.
  • each second opening 22 of the lower end of the main tracheal tube 2 is large, each second opening 22 can be made smaller in size, effectively avoiding bending of the tube body; in order to increase the hardness, the corresponding portion is made of a hard material.
  • the angle between the bronchial duct 3 and the extension of the lower end of the main endotracheal tube 2 is 20° to 50°.
  • the present invention can be used for bilateral thoracic surgery, the bronchial catheter 3 is inserted into the left lung main bronchus, the built-in cuff seal 4 is partially embedded in the bronchial wall, the first balloon 6, the second balloon 5 is inflated, and the cuff seal is 4 does not inflate, can achieve simultaneous ventilation of both lungs; when the cuff seal 4 is partially inflated (ie, the ventilation pressure control device 42 is adjusted so that the cuff seal 4 is in a completely ventilated state), the ratio of the surgical side lung ventilation can be achieved respectively. 10%, 20%, 50% ventilation, complete ventilation of the contralateral lung; cuff seals 4 are inflated, can achieve only the contralateral lung ventilation.
  • the first airbag 6 and the second airbag 5 are inflated and supported, the plurality of second openings 22 can be prevented from sticking to the inner wall of the patient's trachea during the operation, thereby further ensuring ventilation.
  • the invention has the following advantages: (1) using a single lumen of the tracheal tube and a regulatable seal in the bronchial catheter to regulate the ventilation flow of the bronchial catheter, ensuring incomplete collapse or collapse of the surgical side lung, and preventing and treating recurrent pulmonary edema during operation. And secondary to acute lung injury, lung infection; (2) the main end of the endotracheal tube with open porous principle, to ensure that the patient does not need to align ventilation in the state of general anesthesia.
  • the invention has better ventilation function than the double-lumen endotracheal tube currently used, and is safer, more convenient and more efficient, and is suitable for different ages and reduces the risk of existing double lumen intubation.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

一种肺隔离导管（1），包括：主管气管导管（2），其外壁设有第一气囊（6），该第一气囊（6）与第一充气阀（61）相连；支气管导管（3），其与所述主管气管导管（2）下端相连接；该支气管导管（3）的外壁设有第二气囊（5），该第二气囊（5）与第二充气阀（51）连接；该支气管导管（3）的内部设有密封件（4），密封件（4）通过通气压力控制装置（42）连接至第三充气阀（41）；第一开口（21），其开设于支气管导管（3）的末端；第二开口（22），其开设于主管气管导管（2）下端部的管壁处，且位于第一气囊（6）以下；第二开口（22）的数量至少为两个，沿着主管气管导管的周面分布。本肺隔离导管通气功能优异，安全便捷、操作高效，可降低现有双腔管插管的风险。

Description

肺隔离导管 技术领域
本发明涉及一种医用器具，特别涉及一种肺隔离导管。
背景技术
气管插管是麻醉手术科常用的医用耗材，特别是在胸外科手术中必须要使用到。手术过程中，在需要单肺通气时，就需要使用到双腔气管插管，目的是阻隔手术部位的肺通气，使肺萎陷，扩大手术野，方便手术操作，而对侧肺由于有支气管球囊的作用能够单独的进行通气，以满足手术患者的氧合需要。但是，在使用过程中，我们发现，由于双腔管各个通道的不同作用，使得气管插管的管径较大，而声门通常较小，部分病人甚至有单侧的声带麻痹而无法张开，所以，在插管过程中较易损伤到声带。特别在如误吸，血块堵塞等紧急情况下更是由于反复插管引起声带的水肿，损伤，术后出现声音嘶哑甚至上气道阻塞需紧急抢救治疗。
公告号CN201558393的专利公开了一种气管导管，在支气管导管与气管导管下端相连部分留有气管导管开口，实现了单腔双出口。但若要保证通气量，避免手术中患者肺部缺氧，该导管开口必须具有较大的面积，这就使得该导管开口削弱了气管导管连接处的强度，容易折弯损坏，为手术带来不便。另一方面，在施术时，患者呼吸使身体起伏，容易使气管导管移位，若移位后的导管开口位置被患者的气管壁封堵或部分封堵，则会导致通气不足，使患者存在缺氧的风险。
发明内容
为了克服现有单开口气管导管容易折弯，且容易发生通气不畅的缺点，本发明提供了一种单腔支气管导管，能方便有效的应用于两肺隔离和单肺通气。
为解决上述技术问题，本发明所采用的技术方案内容具体如下：
肺隔离导管，包括：主管气管导管，其外壁设有第一气囊，该第一气囊与第一充气阀相连；支气管导管，其与所述主管气管导管下端相连接；该支气管导管的外壁设有第二气囊，该第二气囊与第二充气阀连接；该支气管导管的内部设有密封件；第一开口，其开设于支气管导管的末端；第二开口，其开设于主管气管导管下端部的管壁处，且位于第一气囊以下；第二开口的数量至少为两个，沿着主管气管导管的周面分布。
进一步地，所述密封件为套囊密封件，；该套囊密封件通过通气压力控制装置连接至第三充气阀。
进一步地，所述气管导管下端的开口部位采用硬质材料制作。
作为优选，支气管导管与主管气管导管下端延长线的夹角为20°～50°。
作为优选，至少一个所述第二开口为形开孔或异形孔。
作为优选，所述第二开口为多个筛孔。
作为优选，所述第二开口的数量为二个，且沿主管气管导管的周面对称或非对称分
作为优选，所述第二开口的数量为三个，且沿主管气管导管的周面对称或非对称分布。
作为优选，所述第二开口的数量为四个，且沿主管气管导管的周面对称或非对称分布。
作为优选，所述第二开口的数量为五个，且沿主管气管导管的周面对称或非对称分布。
作为优选，所述第二开口的数量为六个以上偶数开孔，且沿主管气管导管的周面对称或非对称分布。
作为优选，所述第二开口的数量为七个以上奇数开孔，且沿主管气管导管的周面对称或非对称分布。
与现有技术相比，本发明的肺隔离导管的有益效果在于：
1)通过在单腔支气管内设置密封件，由于做成单腔，管子的外径可制造得更小，有效减小损伤；同时能扩大应用范围，可以用于对小孩的手术；即使其具备双腔气管导管的所有功能，克服了双腔支气管导管不利于气管内插管和通气，且易造成气道损伤的缺点；
2)单腔导管的操作更简便灵活，普通医生也能操作，易于推广应用；
3)节省材料成本，可大幅降低生产成本；
4)由于手术过程中，主管气管导管容易转动，通过在主管气管导管上设置多个第二开口，避免了手术过程中主管气管导管转动时阻塞开口，造成通气不畅的问题；
5)多个开口，每个开口的面积可设置更小，管体不易折弯，提高插管稳定性，解决了单孔导管因孔径大而导致导管管体容易折弯的问题；
6)第一气囊和第二气囊充气后，形成两端凸出的结构，使第二开口的部位悬空，手术时有效避免因患者呼吸而使导管移位，避免导管的开口贴壁；另外由于开口数量为多个，使气流能分流，减小气流冲击，与双气囊配合更有效避免导管的移位；
7)至少两个开口型更有利于健侧吸痰管的插入，方便健侧吸痰，内置套囊密封件部分嵌人支气管管壁，不影响吸痰和全开放通气效果。
上述说明仅是本发明技术方案的概述，为了能够更清楚了解本发明的技术手段，而可依照说明书的内容予以实施，并且为了让本发明的上述和其他目的、特征和优点能够更明显易懂，以下特举较佳实施例，并配合附图，详细说明如下。
附图说明
图1是本发明的肺隔离导管的第一种实施例的结构示意图；
图2是本发明的肺隔离导管的第二种实施例的结构示意图；
图3是本发明的肺隔离导管的第三种实施例的结构示意图；
图4是本发明的肺隔离导管的第四种实施例的结构示意图；
图5是本发明的肺隔离导管的第五种实施例的结构示意图；
图6是本发明的肺隔离导管的第六种实施例的结构示意图；
图7是本发明的肺隔离导管的套囊密封件工作过程示意图。
具体实施方式
为更进一步阐述本发明为达成预定发明目的所采取的技术手段及功效，以下结合附图及较佳实施例，对依据本发明的具体实施方式、结构、特征及其功效，详细说明如下：
如图1所示，肺隔离导管1，包括主管气管导管2和支气管导管3，主管气管导管2外壁设有第一气囊6，该第一气囊6与第一充气阀61相连，支气管导管3与主管气管导管2下端相连接，该支气管导管3外壁设有第二气囊5，该第二气囊5与第二充气阀51相连。该支气管导管4内部还设有密封件，优选的，述密封件为一套囊密封件4，该套囊密封件4通过通气压力控制装置42连接至第三充气阀41；通气压力控制装置42控制由第三充气阀41充进套囊密封件4内的空气压力，从而控制套囊密封件4改变其大小，达到控制支气管通气流量大小的目的。
支气管导管3的末端为第一开口21，如图7所示，当套囊密封件4在满压力状态下充满气时(图7中虚线部分)，套囊密封件4可完全堵塞支气管导管3(为示意清晰，图7中支气管导管3仅示出半截面)，肺隔离导管1不能从该第一开口21与支气管通气。调节通气压力控制装置42，使套囊密封件4充气后的大小缩小(图7中实线部分)，支气管导管3的内壁与套囊密封件4之间留有间隙，第一开口21可通气，且流量大小受套囊密封件4的大小影响。
主管气管导管2下端部的管壁处开设有第二开口22，所述第二开口22位于第一气囊6以下。本实施例中，所述第二开口22的数量为五个，沿着主管气管导管2的周面呈现梅花状的不对称分布，由于在主管气管导管2上设置多个第二开口22，手术过程中，即使主管气管导管2转动时阻塞其中一个第二开口22，其他的第二开口22也能继续通气，避免造成通气不畅的问题。
开口结构也可以采用其他方式，例如第二开口22的数量为两个，形状为圆形，且不对称分布(如图2)；或第二开口22的数量总数为九个，形状为椭圆形，且均匀分布(如图3)；或第二开口22的数量为多个，形状为异形孔，且不均匀分布(如图4)；或第二开口22的形状为S形(如图5)；或第二开口22通过多个筛孔的形式实现；第二开口22的数量还可以为六个以上偶数开孔(例如三十 个)或七个以上奇数开孔(例如十五个)，且沿主管气管导管的周面对称或非对称分布。整体而言，第二开口22的形状、数量、大小可以根据空气动力学物理原理设计，其分布状态可为对称、与非对称形式。
由于主管气管导管2下端的第二开口22较多，每个第二开口22的大小都可以制作得更少，有效避免管体折弯；为增加硬度，其相应部位采用硬质材料制作。
优选地，支气管导管3与主管气管导管2下端延长线的夹角为20°～50°。
手术时，本发明可用于双侧胸腔手术，支气管导管3插入左肺主支气管，内置的套囊密封件4部分嵌人支气管管壁，第一气囊6、第二气囊5充气，套囊密封件4不充气，可实现双肺同时通气；当套囊密封件4部分充气时(即调节通气压力控制装置42，使套囊密封件4处于非完全通气状态)可以实现手术侧肺通气比例分别为10％、20％、50％通气，健侧肺完全通气；套囊密封件4均充气，可实现仅对健侧肺通气。同时，由于第一气囊6、第二气囊5充气后作为支持，可使得手术时多个第二开口22均不会贴到患者的气管内壁，进一步保障通气。
本发明具有如下优点：(1)采用气管导管单腔以及支气管导管内设置可以调控的密封件调节支气管导管的通气流量，保障手术侧肺不完全塌陷或萎陷，防治手术中复张性肺水肿并继发急性肺损伤、肺部感染；(2)主管气管导管下端采用周围多孔开放的原理，保障在病人在全麻插管状态下无需对位通气。
其特点克服目前临床使用的双腔气管导管的以下七大缺陷：1、导管粗，刮损口腔、气管壁，要充分暴露口、咽腔；2、容易发生对位不良、需要借助支纤镜插管对位；3、体位改变时，容易发生旋转移位，影响通气，造成生命风险；4、生产工艺复杂，成本高；5、原材料消耗高，不利于环保；6、价格高，医疗成本高；7、最重要的是容易造成手术侧完全肺塌陷或肺萎陷、术后增加急性肺损伤、复张性肺水肿、术后肺部感染等；8通气死腔大，不适用小儿。本发明具备比现在使用的双腔气管导管的更加优异通气功能，更加安全、方便、高效的操作，适用不同年龄，降低现有双腔管插管的风险。
上述实施方式仅为本发明的优选实施方式，不能以此来限定本发明保护的范围，本领域的技术人员在本发明的基础上所做的任何非实质性的变化及替换均属于本发明所要求保护的范围。

Claims (10)

  1. 肺隔离导管，其特征在于，包括：
    主管气管导管，其外壁设有第一气囊，该第一气囊与第一充气阀相连；
    支气管导管，其与所述主管气管导管下端相连接；该支气管导管的外壁设有第二气囊，该第二气囊与第二充气阀连接；该支气管导管的内部设有密封件，内置套囊密封件部分嵌人支气管管壁，密封件通过通气压力控制装置连接至第三充气阀；
    第一开口，其开设于支气管导管的末端；
    第二开口，其开设于主管气管导管下端部的管壁处，且位于第一气囊以下；第二开口的数量至少为两个，沿着主管气管导管的周面对称或非对称分布。
  2. 根据权利要求1所述的肺隔离导管，其特征在于：所述密封件为套囊密封件；该套囊密封件通过通气压力控制装置连接至第三充气阀。
  3. 根据权利要求1或2所述的肺隔离导管，其特征在于：所述气管导管下端的开口部位采用硬质材料制作。
  4. 根据权利要求1或2所述的肺隔离导管，其特征在于：支气管导管与主管气管导管下端延长线的夹角为20°～50°。
  5. 根据权利要求1或2所述的肺隔离导管，其特征在于：至少一个所述第二开口为S形开孔或异形孔。
  6. 根据权利要求1或2所述的肺隔离导管，其特征在于：所述第二开口为多个筛孔。
  7. 根据权利要求1或2所述的肺隔离导管，其特征在于：所述第二开口的数量为三个，且沿主管气管导管的周面对称或非对称分布。
  8. 根据权利要求1或2所述的肺隔离导管，其特征在于：所述第二开口的数量为五个，且沿主管气管导管的周面对称或非对称分布。
  9. 根据权利要求1或2所述的肺隔离导管，其特征在于：所述第二开口的数量为六个以上偶数开孔，且沿主管气管导管的周面对称或非对称分布。
  10. 根据权利要求1或2所述的肺隔离导管，其特征在于：所述第二开口的数量为七个以上奇数开孔，且沿主管气管导管的周面对称或非对称分布。
PCT/CN2016/071430 2015-01-21 2016-01-20 肺隔离导管 WO2016116038A1 (zh)

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