WO2021083357A1 - 气管导管 - Google Patents

气管导管 Download PDF

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Publication number
WO2021083357A1
WO2021083357A1 PCT/CN2020/125432 CN2020125432W WO2021083357A1 WO 2021083357 A1 WO2021083357 A1 WO 2021083357A1 CN 2020125432 W CN2020125432 W CN 2020125432W WO 2021083357 A1 WO2021083357 A1 WO 2021083357A1
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Prior art keywords
open area
introduction part
tracheal
tube
tracheal tube
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PCT/CN2020/125432
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English (en)
French (fr)
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田鸣
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田鸣
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Publication of WO2021083357A1 publication Critical patent/WO2021083357A1/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
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • 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
    • 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
    • A61M16/0434—Cuffs
    • 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
    • A61M16/0461—Nasoendotracheal tubes

Definitions

  • the invention belongs to the field of medical devices, and specifically relates to a tracheal catheter.
  • Tracheal intubation refers to the technique of inserting a special tracheal tube into the trachea through the glottis. This technique can provide the best conditions for airway patency, artificial ventilation, airway suction, and prevention of aspiration. Essential equipment for these functions. When conventional laryngoscopy is used to perform tracheal intubation, it is often encountered that the glottis is not fully exposed. At this time, the intubation operation is very difficult, and it is easy to cause injury to the patient, or even severe hypoxia and death.
  • the clinical countermeasures to solve the above problems are 1. Use video laryngoscope and stylet to assist tracheal intubation; 2. Intubation probe or video soft mirror to guide tracheal intubation; 3. Insert the tracheal mask through the intubation laryngeal mask catheter.
  • these technologies still have the following clinical problems:
  • Video laryngoscope and tube core The video laryngoscope makes the glottis exposure significantly improved, and the tracheal tube can also be aligned with the glottis with the help of the tube core. Because the tip of the conventional tube is hard and not easy to deform, it is difficult to continue to push into the trachea. And it is easy to cause damage to the anterior wall of the trachea. The reason is that there is a posterior curvature in the direction of the subglottic airway, which forms an S-shaped channel with the anterior curvature of the pharynx, and the anterior curvature under the video laryngoscope is more pronounced than when the direct laryngoscope is exposed.
  • the tip of the tube will reach the anterior wall of the upper end of the trachea and encounter resistance when the tube is pushed forward in the direction of the tube core.
  • the hard tip is easy to deform.
  • the catheter may be unintentionally taken out due to shallow insertion, which may lead to accidents.
  • the method of guiding the intubation probe requires that the tip of the tracheal tube is closely attached to the probe to be easy to introduce into the glottis without causing damage.
  • the tip of the conventional tracheal tube is on the side of the tube wall; It is easy to form a bifurcation with the tip of the tracheal tube to obstruct the intubation and cause damage to the tissues around the glottis.
  • video soft mirror or fiberoptic bronchoscope guided intubation is used to guide the tip of the tracheal tube.
  • Intubation laryngeal mask as an alternative to difficult intubation has been included in the guidelines for difficult airway management in China, the United States and the United Kingdom.
  • the catheter When inserting the tracheal tube through the laryngeal mask, the catheter is inserted into the glottis from the midline of the oral cavity, and the tip of the catheter needs to be lifted across the back wall of the larynx after exiting the airway of the laryngeal mask.
  • the conventional tracheal tube is left open, the tip is on the right wall and the texture is hard, which is easy to abrade the glottis and surrounding tissues.
  • the purpose of the present invention is to provide a tracheal tube in view of the shortcomings of the prior art.
  • the tracheal tube of the present invention adopts the introduction part structure different from the background technology, so that the tracheal tube has a streamlined structure with a centered tip, soft and deformable, overcomes the shortcomings of the conventional tracheal tube, and makes the tip of the tube easy to pass through the middle of the glottis.
  • the arc-shaped back of the part contacts the wall of the throat, the vocal cords and the inner wall of the trachea, reducing airway injury and complications of tracheal intubation, and improving the success rate of tracheal intubation. It is more suitable for endotracheal intubation of video laryngoscope plus tube core technology, guided intubation through probe and video soft scope, and intubation through laryngeal mask or nasal endotracheal tube.
  • the tracheal tube has a tube body and an introduction part connected to one end of the tube body or an introduction part directly formed at one end of the tube body, characterized in that the introduction part is in the shape of a hollow bullet and a part of the tube near the tip The wall is removed, including:
  • a first open area arranged along the central axis of the introduction part, the first open area terminating at the end of the first side located on the central axis of the introduction part, and
  • a second open area formed continuously with the second open area and arranged obliquely with respect to the central axis of the introduction portion.
  • the tip of the tracheal tube of the present invention is located on the central axis of the introduction part, no matter in which direction the first side or the second side of the tracheal tube is rotated, the end of the first side is located at the center of the introduction part, which is advantageous for opening from the middle position And enter the glottis.
  • the first side is a rounded arc design, it effectively avoids damage to the glottis and tracheal mucosa when entering the glottis.
  • the first open area and the second open area are in a smooth transition, so the angle between the plane where the first open area is located and the plane where the second open area is located is 105-135 °.
  • the above-mentioned obtuse angle of the smooth transition is favorable for the tracheal tube to enter the glottis after its head end and the rear part continue to move forward smoothly until it transitions to the passage of the tube body and the balloon.
  • the ratio of the length of the first open area in the direction of the central axis of the introduction part to the inner diameter of the tube is 1.5-2:1.
  • the distance from the projection of the rear edge of the second open area on the central axis to the front edge of the first open area is less than 20 mm.
  • the introduction portion includes a Murphy's hole formed on the longitudinal centerline of the first side.
  • the introduction part becomes softer.
  • the introduction part enters the glottis, it is easy to deform when it encounters a little resistance, which reduces the damage of the introduction part to the airway. Improve the accuracy of the intubation operation.
  • the Murphy's hole is a rectangular blind hole with rounded corners.
  • the aspect ratio of the Murphy's hole is 2 ⁇ 2.5:1; the ratio of the width of the Murphy's hole to the inner diameter of the tube is 1:1.5-2.
  • this elongated Murphy's hole exceeds 80% of the cross-sectional area of the tube body, which can prevent the embedding of tissues such as epiglottis, and at the same time reduce the hardness of the tube wall on the first side where the introduction part is closed, and further Increase the softness of the lead-in part so that it can be deformed when it encounters resistance.
  • the tracheal tube further includes a balloon disposed on the tube body and adjacent to one side of the introduction part, and the distance from the leading edge of the balloon to the end of the first side Less than 35mm.
  • the distance from the front edge of the airbag to the rear edge of the Murphy's hole is less than 8 mm.
  • the tracheal tube further includes a marking line A arranged along the length of the tube body and a marking line B arranged along the circumference of the middle section of the tube body.
  • the above-mentioned marking line A4 serves as an indication mark for distinguishing the front (up) or the back (down) of the back of the tube body 1 during intubation.
  • the above-mentioned marking line B5 serves as an indicator mark for identifying the position of the introduction part 2 when the tube is intubated through the laryngeal mask.
  • the introduction part of the tracheal tube provided by the present invention is designed to be half a bullet streamline and has deformability.
  • the back side of the tube body is forward (upper), and the tip of the tube core reaches the rear edge of the Murphy's foramen.
  • the introduction part enters the glottis, hold the tube core and continue to push the tube body forward.
  • the introduction part is easy to bend backwards, and the streamlined introduction part continues to slide into the trachea. At this time, it exits the tube core and adjusts the tube body to a suitable depth.
  • the introduction part of the tracheal tube provided by the present invention is always located on the centerline of the entire tracheal tube.
  • the introduction part and the probe or the scope are closely attached to a streamlined shape, which is convenient for assisting the tracheal tube. Enter the glottis.
  • the introduction part of the tracheal tube provided by the present invention is relatively soft, which is beneficial to overcome the shortcomings of the conventional tracheal tube, facilitates intubation through the laryngeal mask and through the nose, and achieves the purpose of increasing the success rate of intubation and reducing airway damage.
  • Figure 1 is a schematic diagram of the overall structure of the tracheal tube of the present invention.
  • Figure 2 is a side view of the introduction part of the tracheal tube of the present invention.
  • Figure 3 is a front view of the introduction part of the tracheal tube of the present invention.
  • Figure 4 is a rear view of the introduction part of the tracheal tube of the present invention.
  • Figure 5 is a bottom view of the introduction part of the tracheal tube of the present invention.
  • Fig. 6 is a schematic diagram of an introduction part of a tracheal tube in the prior art
  • Figures 1 and 2 show a tracheal tube provided by an embodiment of the present invention.
  • the tracheal tube mainly includes a tube body 1, an introduction part 2 and a tail end 3. Both sides of the tube body 1 are connected to the introduction part 2 and the tail end respectively. End 3 Unicom.
  • the introduction part 2 has a hollow bullet head shape, and a part of the tube wall near the front end is cut off. Specifically, the bullet-shaped lead-in part 2 cuts a part of the tube wall along a certain cutting trajectory to form a half bullet shape.
  • the cut curved surface formed after the cut divides the lead-in part 2 into a closed first side with an arc-shaped surface 8 And an open second side 7 adjacent to the first side 8.
  • the second side 7 is divided into two open areas.
  • the first open area 71 starts from the foremost end and is arranged along the central axis of the introduction part 2.
  • the second open area 72 is arranged obliquely along the central axis of the introduction portion 2 (radially outward toward the rear end of the introduction portion 2).
  • the first open area 71 and the second open area 72 are continuously formed.
  • the first open area 71 ends at the end of the first side 8 located on the central axis of the introduction part 2.
  • the end of the first side 8 of the tracheal tube provided in this embodiment is located at the center of the introduction part 2 (as shown in Figure 5), and the introduction part 2 is streamlined as a whole, regardless of the first side 8 or the second side of the introduction part 2.
  • the end of the closed first side 8 is located on the central axis of the introduction part 2, which facilitates opening and entering the glottis from the center position.
  • the tube wall of the first side 8 has a rounded arc surface design, it effectively avoids damage to the glottis and tracheal mucosa when entering the glottis.
  • first open area 71 and the second open area 72 have a smooth transition at the junction, and the angle between the planes where the two are located is an obtuse angle of 105 to 135°.
  • the introduction part 2 having a half bullet shape and being relatively soft is formed.
  • the ratio of the first open area 71 along the central axis direction of the introduction part 2 (the vertical direction as shown in FIG. 2) to the inner diameter of the pipe body 1 is designed to be 1.5-2:1.
  • the distance from the projection of the rear edge of the second open area 72 on the central axis of the introduction part 2 to the front edge of the first open area 71 is less than 20 mm.
  • the above-mentioned introduction portion 2 includes a Murphy hole 81 formed on the longitudinal centerline of the first side 8.
  • the introduction part 2 becomes softer.
  • the introduction part 2 enters the glottis, it is easy to deform when it encounters a little resistance, which reduces the air resistance of the introduction part 2.
  • the injury of the channel also improves the accuracy of the intubation operation.
  • the above-mentioned Murphy's hole 81 is a rectangular blind hole with rounded corners.
  • the aspect ratio of the Murphy's hole 81 is 2 ⁇ 2.5:1; the ratio of the width of the Murphy's hole 81 to the inner diameter of the tube body 1 is 1:1.5-2.
  • the area of the elongated Murphy's hole 81 exceeds 80% of the internal cross-sectional area of the tube body 1, which can prevent the embedding of tissues such as the epiglottis, and at the same time reduce the tube of the first side 8 closed by the introduction part 2.
  • the hardness of the wall further increases the softness of the introduction part 2 so that it can be deformed when it encounters resistance.
  • the tracheal tube further includes a balloon 6 arranged on the tube body 1 and adjacent to the side of the introduction part 2, and the front edge of the balloon 6 reaches the end of the first side 8 of the introduction part 2.
  • the distance is less than 35mm.
  • the distance from the front edge of the airbag 6 to the rear edge of the Murphy hole 81 is less than 8 mm.
  • the soft and smooth introduction part 2 can continue to move forward smoothly after entering the glottis, until it transitions to the passage of the tube body 1 and the airbag 6.
  • the tracheal tube further includes a marking line A4 arranged along the length of the tube body 1 (it can be designed as a straight line extending from the leading end 2 to the tail end 3 along the dorsal midline of the tube body 1), And a marking line B5 arranged in the middle section of the tube body 1 along its circumferential direction.
  • the above-mentioned marking line A4 serves as an indication mark for distinguishing the front (up) or the back (down) of the back of the tube body 1 during intubation.
  • the above-mentioned marking line B5 serves as an indicator mark for identifying the position of the introduction part 2 when the tube is intubated through the laryngeal mask.
  • the tube body 1 also has an indicating airbag 9 intersecting with the airbag 6.
  • the limitations on the direction, angle, arc length, and width of the opening of the introduction part 2 in the examples are obtained by the present invention after long-term clinical trials and continuous improvement, which makes it easier for the tracheal tube to pass through the larynx and sound.
  • the door can be deformed at the tip to adapt to the S-shaped anatomy of the upper and lower airways.
  • the tracheal catheter provided by the present invention improves the success rate of pushing the catheter into the trachea under the video laryngoscope with the help of the tube core, reduces the pressure and damage of the tracheal catheter to the front wall of the trachea in the trachea, and improves the guide intubation of the probe and the video soft mirror Or the success rate of fiberoptic bronchoscope guided intubation, which reduces the difficulty of operation and reduces its complications. Improve the insertion of the tracheal tube and the nasal intubation through the laryngeal mask, reduce damage and increase the success rate.

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Abstract

一种气管导管，具有管体(1)以及连接于管体(1)一端的导入部(2)或直接形成于管体(1)一端的导入部(2)，导入部(2)为中空的子弹头形状，靠近前端的部分管壁被切除，包括：由管壁形成的具有弧形表面的封闭的第一侧(7)；邻接于第一侧(7)的开放的第二侧(8)，第二侧(8)包括：沿导入部(2)的中心轴线布置的第一开放区域(71)，第一开放区域(71)终止于位于导入部(2)的中心轴线上的第一侧(7)的末端，和与第二开放区域(72)连续地形成，并相对于导入部(2)的中心轴线倾斜布置的第二开放区域(72)。该气管导管的导入部(2)为居中、柔软可变形的流线型结构，使气管导管易从声门中间经过，避免气道损伤和气管插管的并发症，提高了气管插管的成功率。

Description

气管导管 技术领域
本发明属于医疗器械领域，具体涉及一种气管导管。
背景技术
气管插管是指将一特制的气管导管经声门置入气管内的技术，这一技术能为气道通畅、人工通气、呼吸道吸引和防止误吸等提供最佳条件，而气管导管是实现这些功能的必备器具。临床采用常规喉镜实施气管插管时，经常遇到声门显露不全的情况，此时进行插管操作非常困难，而且容易造成患者损伤，甚或发生严重缺氧和死亡。目前，解决上述问题的临床对策有1.采用视频喉镜加管芯(Stylet)辅助气管插管；2.插管探条或视频软镜引导气管插管；3.经插管喉罩插入气管导管。但这些技术仍存在以下临床问题：
1、视频喉镜加管芯：视频喉镜使得声门显露明显改善，气管导管也能在管芯辅助下对准声门口，由于常规导管的尖端较硬不易变形，难以继续推入气管内，而且容易造成气管前壁损伤。原因是在声门下气道的走向有一个后屈弯度，与咽部的前屈弯度构成S形通道，而且在视频喉镜下的前屈弯度相对直接喉镜显露时更加显著。这样一来，采用常规的气管导管加管芯技术即使进入声门口，再沿着管芯方向向前推进导管时导管尖端就会抵达气管上端前壁而遇到阻力，硬质不易变形的尖端易于损伤气管黏膜、退管芯时因插入过浅又有可能将导管无意带出，从而导致意外发生。
2、插管探条引导的方法需要气管导管尖端与探条紧密贴合才容易导入声门且不造成损伤，目前常规的气管导管尖端是在管壁侧方；在进行导引时，探条 和气管导管尖端很容易形成分叉而阻碍插管并造成声门周围组织损伤。视频软镜或纤维支气管镜引导插管也会出现同样的问题。
3、插管喉罩作为困难插管的一种替代方案已经列入中国、美国和英国的困难气道处理指南。经喉罩插入气管导管时导管是从口腔正中线插入声门，而且导管尖端在出喉罩通气道后需要上抬跨过喉的后壁。而常规气管导管是左侧开口，尖端在右侧壁上且质地较硬，容易擦伤声门及周围组织。
因此，如何设计出使用更加高效的气管导管是目前需要解决的技术问题。
发明内容
本发明的目的是针对现有技术的不足，提供一种气管导管。本发明的气管导管采用与背景技术不同的导入部结构，使气管导管具有尖端居中、柔软可变形的流线型结构，克服常规气管导管的缺点，使该导管的尖端易从声门中间经过，其导入部的弧形背面接触喉口壁、声带和气管内壁，降低气道损伤和气管插管的并发症，提高了气管插管的成功率。更适合视频喉镜加管芯技术的气管插管、经探条和视频软镜引导插管，以及经喉罩或经鼻气管插管。
为实现上述目的，本发明采用如下技术方案：
气管导管，具有管体以及连接于所述管体一端的导入部或直接形成于所述管体一端的导入部，其特征在于，所述导入部为中空的子弹头形状，靠近前端的部分管壁被切除，包括：
由所述管壁形成的具有弧形表面的封闭的第一侧；
邻接于所述第一侧的开放的第二侧，所述第二侧包括：
沿所述导入部的中心轴线布置的第一开放区域，所述第一开放区域终止于位于所述导入部的中心轴线上的所述第一侧的末端，和
与所述第二开放区域连续地形成，并相对于所述导入部的中心轴线倾斜布 置的第二开放区域。
本发明的气管导管的尖端位于导入部的中心轴线上，无论气管导管的第一侧或第二侧旋转到哪个方向其第一侧的末端都位于导入部的中心上，有利于从正中位置打开和进入声门。同时由于第一侧为圆润的弧面设计，有效避免了在进入声门时对声门和气管黏膜的损伤。
在本发明的一些方式中，所述第一开放区域和所述第二开放区域为平滑过渡，所以第一开放区域所处平面和所述第二开放区域所处平面的夹角为105～135°。
上述圆滑过渡的钝角有利于气管导管的导入部进入声门后其头端后部继续顺利向前直至过渡到管体和气囊的通过。
在本发明的一些实施方式中，所述第一开放区域沿所述导入部的中心轴线方向的长度与所述管体内径的比为1.5-2:1。
在本发明的一些实施方式中，所述第二开放区域的后缘在所述中心轴线上的投影，至所述第一开放区域的前缘的距离小于20mm。
在本发明的一些实施方式中，所述导入部包括形成于所述第一侧的长度方向中线上的墨菲氏孔。
由于在封闭的第一侧上设置了墨菲氏孔，因此使得导入部变得更为柔软，当导入部进入声门内稍遇阻力便易于变形，减少了导入部对气道的损伤，也提高了插管操作的准确性。
在本发明的一些实施方式中，所述墨菲氏孔为经过圆角处理的矩形盲孔。
在本发明的一些实施方式中，所述墨菲氏孔的长宽比为2～2.5:1；所述墨菲氏孔的宽度与所述管体内径的比为1:1.5～2。
基于此，这种细长形的墨菲氏孔的面积超过了管体内截面积的80％，能防止 会厌等组织的嵌入，同时降低了导入部封闭的第一侧的管壁的硬度，进一步地增加导入部的柔软度，使其遇阻时可以变形。
在本发明的一些实施方式中，所述气管导管还包括设置于所述管体上且临近于所述导入部一侧的气囊，所述气囊的前缘至所述第一侧的末端的距离小于35mm。
在本发明的一些实施方式中，所述气囊的前缘至所述墨菲氏孔后缘的距离小于8mm。
在本发明的一些实施方式中，所述的气管导管还包括沿所述管体长度方向设置的标记线A以及在所述管体中段沿其周向设置的标记线B。
上述标记线A4作为插管时辨别管体1背面向前(上)或向后(下)的指示标记。上述标记线B5作为经喉罩插管时辨别导入部2所处位置的指示标记。
有益效果：
1、本发明提供的气管导管的导入部设计成半个子弹头的流线型并具有变形能力。安装管芯时，管体背侧向前(上)，管芯尖端抵达墨菲氏孔后缘，当导入部进入声门后，把持管芯不动继续向前推进管体，当导入部抵到气管前壁后，导入部易于向后弯曲，流线型的导入部继续滑入气管，此时退出管芯并调整管体至合适深度。
2、本发明提供的气管导管的导入部始终位于整个气管导管的中心线上，当借助探条或视频软镜引导插管时导入部与探条或镜体紧密贴合成流线型，便于辅助气管导管进入声门。
3、本发明提供提供的气管导管的导入部较为柔软，有利于克服常规气管导管的缺点，便于经喉罩、以及经鼻插管，达到提高插管成功率和降低气道损伤 的目的。
附图说明
图1为本发明的气管导管的整体结构示意图；
图2为本发明的气管导管的导入部的侧视图；
图3为本发明的气管导管的导入部的正视图；
图4为本发明的气管导管的导入部的后视图；
图5为本发明的气管导管的导入部的仰视图；
图6为现有技术中的气管导管的导入部的示意图；
其中，1-管体，2-导入部，3-尾端，4-标记线A，5-标记线B，6-气囊，7-第二侧，71-第一开放区域，7-第二开放区域，8-第二侧，81-墨菲氏孔，9-指示气囊。
具体实施方式
下面结合具体实施方式，进一步阐述本发明。
图1和图2，所示为本发明一实施例提供的气管导管，所述气管导管主要包括管体1、导入部2和尾端3，管体1的两侧分别与导入部2、尾端3联通。导入部2为中空的子弹头形状，靠近前端的部分管壁被切除。具体为子弹头状的导入部2沿一定的切割轨迹切除部分管壁后形成的半个子弹头形状，切除后形成的切割曲面将导入部2分割为具有弧形表面的封闭的第一侧8和邻接于所述第一侧8的开放的第二侧7。
第二侧7分为两个开放区域，第一开放区域71从最头端开始，并且是沿所述导入部2的中心轴线布置。第二开放区域72是沿所述导入部2的中心轴线倾斜布置(向着导入部2的后端径向向外)。第一开放区域71和第二开放区域72 连续地形成。所述第一开放区域71终止于位于所述导入部2的中心轴线上的所述第一侧8的末端。
基于此，本实施例提供的气管导管的第一侧8的末端位于导入部2中心(如图5所示)，导入部2整体呈流线型，无论导入部2的第一侧8或第二侧7旋转到哪个方向，封闭的第一侧8的末端都位于导入部2的中心轴线上，其有利于从正中位置打开和进入声门。另外，由于第一侧8的管壁为圆润的弧面设计，有效避免了在进入声门时对声门和气管黏膜的损伤。
更具体地，第一开放区域71和第二开放区域72相接处平滑过渡，二者所处平面的夹角成105～135°的钝角。由此，构成了半个子弹头形状且较为柔软的导入部2。
进一步地，所述第一开放区域71沿所述导入部2的中心轴线方向(如图2所示的竖向)与所述管体1内径的比设计为1.5-2:1。
进一步地，第二开放区域72的后缘在所述导入部2的中心轴线上的投影，至所述第一开放区域71的前缘的距离小于20mm。
结合图3和图4所示，更进一步地，上述的导入部2包括了形成于所述第一侧8的长度方向中线上的墨菲氏孔81。
由于在封闭的第一侧8上设置了墨菲氏孔81，因此使得导入部2变得更为柔软，当导入部2进入声门内稍遇阻力便易于变形，减少了导入部2对气道的损伤，也提高了插管操作的准确性。
更具体地，上述的墨菲氏孔81为经过圆角处理的矩形盲孔。所述墨菲氏孔81的长宽比为2～2.5:1；所述墨菲氏孔81的宽度与所述管体1内径的比为1:1.5～2。
基于此，这种细长形的墨菲氏孔81的面积超过了管体1内截面积的80％， 能防止会厌等组织的嵌入，同时降低了导入部2封闭的第一侧8的管壁的硬度，进一步地增加导入部2的柔软度，使其遇阻时可以变形。
在一些实施例中，气管导管还包括了设置于所述管体1上且临近于所述导入部2一侧的气囊6，气囊6的前缘至导入部2的第一侧8的末端的距离小于35mm。所述气囊6的前缘至所述墨菲氏孔81的后缘的距离小于8mm。
基于前述结构，柔软且平滑的导入部2进入声门后能够继续顺利向前行进，直至过渡到管体1和气囊6的通过。
在一些实施例中，气管导管还包括了沿所述管体1长度方向设置的标记线A4(可以设计为沿管体1背侧中线由前端的导入部2向着尾端3延伸的直线)，以及在所述管体1中段沿其周向设置的标记线B5。上述标记线A4作为插管时辨别管体1背面向前(上)或向后(下)的指示标记。上述标记线B5作为经喉罩插管时辨别导入部2所处位置的指示标记。
进一步地，所述管体1上还具有与所述气囊6相贯通的指示气囊9。
需要说明的是，实施例中对于导入部2开口的方向、角度、弧长、宽度的限定是本发明经过长期的临床试验和不断的改进后得出的，使气管导管更易于通过喉和声门并可尖端变形以适应上下气道的S形解剖结构。
本发明提供的气管导管借助管芯改善了视频喉镜下推送导管进入气管的成功率，减轻了气管导管在气管内对气管前壁的压力和损伤，提高了探条引导插管、视频软镜或纤维支气管镜引导插管的成功率，减少了操作难度，并降低其并发症。改善经喉罩插入气管导管和经鼻插管，减少损伤，提高成功率。
《中华人民共和国医药行业标准YY 0337.1-2002气管导管》中介绍现有技术中的有套囊气管导管设置有斜切面，其斜切面是通过切刀切割形成，斜切面及墨菲氏孔的结构如图6所示，与本申请有明显的不同。
以上所述仅是本发明的优选实施方式，应当指出的是，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润 饰，这些改进和润饰也应视为本发明的保护范围。

Claims (11)

  1. 气管导管，具有管体以及连接于所述管体一端的导入部或直接形成于所述管体一端的导入部，其特征在于，所述导入部为中空的子弹头形状，靠近前端的部分管壁被切除，包括：
    由所述管壁形成的具有弧形表面的封闭的第一侧；
    邻接于所述第一侧的开放的第二侧，所述第二侧包括：
    沿所述导入部的中心轴线布置的第一开放区域，所述第一开放区域终止于位于所述导入部的中心轴线上的所述第一侧的末端，和
    与所述第二开放区域连续地形成，并相对于所述导入部的中心轴线倾斜布置的第二开放区域。
  2. 根据权利要求1所述的气管导管，其特征在于：
    所述第一开放区域和所述第二开放区域为平滑过渡，所以第一开放区域所处平面和所述第二开放区域所处平面的夹角为105～135°。
  3. 根据权利要求1所述的气管导管，其特征在于：
    所述第一开放区域沿所述导入部的中心轴线方向的长度与所述管体内径的比为1.5-2:1。
  4. 根据权利要求1所述的气管导管，其特征在于：
    所述第二开放区域的后缘在所述中心轴线上的投影，至所述第一开放区域的前缘的距离小于20mm。
  5. 根据权利要求1所述的气管导管，其特征在于，所述导入部包括：
    形成于所述第一侧的长度方向中线上的墨菲氏孔。
  6. 根据权利要求5所述的气管导管，其特征在于：
    所述墨菲氏孔为经过圆角处理的矩形盲孔。
  7. 根据权利要求5所述的气管导管，其特征在于：
    所述墨菲氏孔的长宽比为2～2.5:1；所述墨菲氏孔的宽度与所述管体内径的比为1:1.5～2。
  8. 根据权利要求5所述的气管导管，其特征在于，还包括：
    设置于所述管体上且临近于所述导入部一侧的气囊，所述气囊的前缘至所述第一侧的末端的距离小于35mm。
  9. 根据权利要求8所述的气管导管，其特征在于：
    所述气囊的前缘至所述墨菲氏孔后缘的距离小于8mm。
  10. 根据权利要求1所述的气管导管，其特征在于，还包括：
    沿所述管体长度方向设置的标记线A；以及
    在所述管体中段沿其周向设置的标记线B。
  11. 根据权利要求8所述的气管导管，其特征在于：
    所述管体上还具有与所述气囊相贯通的指示气囊。
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