WO2021017662A1 - Canule endotrachéale de surveillance des nerfs - Google Patents

Canule endotrachéale de surveillance des nerfs Download PDF

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Publication number
WO2021017662A1
WO2021017662A1 PCT/CN2020/095767 CN2020095767W WO2021017662A1 WO 2021017662 A1 WO2021017662 A1 WO 2021017662A1 CN 2020095767 W CN2020095767 W CN 2020095767W WO 2021017662 A1 WO2021017662 A1 WO 2021017662A1
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WO
WIPO (PCT)
Prior art keywords
monitoring
tracheal
balloon
nerve
tracheal intubation
Prior art date
Application number
PCT/CN2020/095767
Other languages
English (en)
Chinese (zh)
Inventor
崔德荣
熊雪锐
李宏博
杨本全
王卫南
王卫东
王桃红
张家智
夏帮凑
龚青明
李卫平
Original Assignee
浙江优亿医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 浙江优亿医疗器械有限公司 filed Critical 浙江优亿医疗器械有限公司
Publication of WO2021017662A1 publication Critical patent/WO2021017662A1/fr

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Classifications

    • 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 invention belongs to the technical field of medical devices, and specifically relates to a nerve monitoring tracheal intubation.
  • Tracheal intubation is a kind of supraglottic airway management device. It creates a temporary artificial airway to ventilate the patient when the patient is unable to breathe spontaneously during emergency and anesthesia.
  • the recurrent laryngeal nerve injury in clinical thyroid surgery is the neck A common complication of surgery, when the anatomy is relatively normal, the laryngeal nerves along the neck are usually discernible. However, the presence of abnormal tissues, such as tumors, inflammation or trauma, may make neuroanatomy almost impossible without injury. Therefore, clinically there is a tracheal intubation for recurrent laryngeal nerve monitoring, which is used to monitor the recurrent laryngeal nerve during thyroid surgery.
  • each nerve controls a group of laryngeal muscles. Including the vocal cords, slight traction or direct contact can cause paralysis, or poor contact, lack of contact can lead to intraoperative clamping, excessive traction, sutures or even cuts and other direct mechanical operations. Failure to detect in time may cause the recurrent laryngeal nerve Injury, the current recurrent laryngeal nerve injury is a serious complication of thyroid surgery. After the recurrent laryngeal nerve injury, the patient’s vocal cord paralysis will affect the patient’s quality of life.
  • the electromyography was used for the first time to monitor and identify the recurrent laryngeal nerve. It is an electrode that monitors the electromyography signal of the laryngeal muscles and is installed on the tracheal intubation tube.
  • nerve detection equipment used to detect the recurrent laryngeal nerve, the detection often fails and undetectable situations occur because the structure of the vocal cords is similar to a triangle. After the tracheal intubation is inserted, it will fall down and cause the electrodes to contact If not, or the electrode conductivity is not good, this will cause the test to fail.
  • CN207493036U discloses a sac-shaped electrode nerve monitoring double-lumen tracheal intubation device, which can effectively monitor nerve signals during surgery and avoid neurological injury and its sequelae.
  • Its structure includes bronchial airbags, tracheal airbags and electrode airbags
  • the electrode balloon described therein surrounds the annular balloon around the tracheal intubation after inflation, and the electrode wire is exposed outside the inflated annular balloon. As can be seen from the figure, it is arranged in a similar oval shape. It can ensure that the electrode wire is in full contact with the circumferentially inflated airbag, but its structural design still cannot avoid the defect that it is easy to fall off, and the expansion of the annular airbag will cause pressure and damage to the vocal cords.
  • the purpose of the present invention is to provide a nerve monitoring tracheal intubation, which has good positioning effect and will not fall off, and effectively solves the phenomenon of electrode failure and monitoring failure caused by the falling of the tracheal intubation.
  • a nerve monitoring tracheal intubation which includes:
  • An annular balloon which is used to seal the gap between the tracheal tube and the patient's tracheal wall, and the annular balloon is arranged around the outer wall of the tracheal tube;
  • the first group of monitoring components is used to monitor the nerve signals of the left vocal cord.
  • the first group of monitoring components includes at least two monitoring electrodes A.
  • the two monitoring electrodes A at least corresponding to the left vocal cord are arranged in the tracheal tube And the two monitoring electrodes A are arranged along the extension direction of the left vocal cord;
  • the second group of monitoring components is used to monitor the nerve signals of the right vocal cord.
  • the second group of monitoring components includes at least two monitoring electrodes B.
  • the two monitoring electrodes B at least corresponding to the right vocal cord are arranged in the tracheal tube On the outer wall of, and the two monitoring electrodes B are arranged along the extension direction of the right vocal cord;
  • the supporting balloon is used to locate the tracheal intubation, the supporting balloon is arranged on the side of the tracheal tube facing the glottis, and the supporting balloon is inflated and expanded to fit the shape of the glottis;
  • the first inflatable component and the second inflatable component are respectively used for inflating the annular airbag and the supporting airbag.
  • the supporting airbag is an arc-shaped airbag, and the arc-shaped air size allows the supporting airbag to abut against the glottis when it bulges.
  • the first group of monitoring components and the second group of monitoring components are respectively combined on both sides of the tracheal tube facing the vocal cords.
  • both the monitoring electrode A and the monitoring electrode B are made of silver, copper or gold materials.
  • the monitoring electrode A and the monitoring electrode B extend along the length extension direction of the tracheal tube, and have an exposed section corresponding to the position of the vocal cords and an inner block deviated from the vocal cords relative to the tracheal tube.
  • the first inflation component and the second inflation component both include an inflation tube, an inflation balloon, and an inflation valve.
  • a nylon wire is arranged inside the monitoring electrode A and the monitoring electrode B.
  • the number of the monitoring electrodes A is two.
  • the number of the monitoring electrodes B is two.
  • the cross section of the arc-shaped airbag is fan-shaped.
  • the endotracheal tube is a visual endotracheal tube.
  • the endotracheal tube is a disposable product.
  • the present invention has the following beneficial effects:
  • the present invention provides a supporting balloon, and the supporting balloon adopts a glottal-like structure design, which is the same as the glottal structure, plays the role of supporting the tracheal intubation, and prevents the tracheal intubation from falling under the glottis, causing the electrode to contact
  • FIG. 1 and 2 are schematic diagrams of the structure of the tracheal intubation provided by the present invention.
  • Figure 3 is a cross-sectional view of the tracheal intubation provided by the present invention.
  • Fig. 4 is a simplified diagram of the cooperation between the tracheal intubation tube and the glottis provided by the present invention.
  • connection should be understood in a broad sense. For example, they may be mechanically or electrically connected, or they may be internal to two components.
  • the connection may be a direct connection or an indirect connection through an intermediary.
  • the prior art provides a nerve monitoring tracheal intubation.
  • the tracheal intubation is inserted into the trachea through the glottis.
  • the front side of the trachea is provided with a circular air bag. In this way, after the intubation is placed in the trachea, the inflated and inflated circular air bag can be sealed.
  • the gap between the tracheal tube and the patient’s tracheal wall prevents oxygen leakage and establishes a passage.
  • the present invention provides an improved tracheal intubation based on the prior art and combined with nerve monitoring function.
  • the intubation structure includes:
  • the tracheal tube 1 is used for the ventilation channel. See Figure 4 for details.
  • the vocal cords on both sides are located in the larynx, the area between the vocal cords is the glottis, and the glottis opens upside down "V" shape, the following descriptions are based on the open state of the glottis when the tracheal intubation is inserted into the trachea.
  • the annular balloon 2 as shown in Fig. 1, is arranged around the outer wall of the tracheal tube. This annular balloon is located on the front side of the tracheal tube. When entering the glottis position, it is inflated and expanded to seal the gap between the tracheal tube and the patient's tracheal wall.
  • the first group of monitoring components is used to monitor the nerve signals of the left vocal cord.
  • the first group of monitoring components includes at least two monitoring electrodes A (61, 62).
  • the second group of monitoring components is used to monitor the right vocal cord.
  • the second group of monitoring components includes at least two monitoring electrodes B (63, 64); when a voltage is applied to the laryngeal nerve or its accessories, electrical impulses are transmitted to the relevant set of laryngeal muscles through the nerve.
  • the electrodes on the tracheal intubation can detect electrical impulses entering the relevant laryngeal muscles; the surgeon can locate the nerves by electrically stimulating various parts of the neck during the operation, and pay attention to whether the reaction is detected by touching the electrode wires of the relevant laryngeal.
  • the electrodes are in contact with the laryngeal nerve is very important; therefore, in order to allow the monitoring electrodes to fully contact the vocal cords, at least the part corresponding to the left vocal cords is arranged on the outer wall of the tracheal tube, and the two monitoring electrodes A
  • the left vocal cords are arranged in the extending direction; and the two monitoring electrodes B at least corresponding to the right vocal cords are arranged on the outer wall of the tracheal tube, and the two monitoring electrodes B are arranged along the extending direction of the right vocal cords; Realize the contact between the vocal cords and the electrodes, and monitor the contact stimulation of the recurrent laryngeal nerve.
  • the monitoring electrode A and the monitoring electrode B extend along the length of the tracheal tube.
  • the monitoring electrodes are exposed on the outer wall of the tracheal tube 1.
  • the monitoring electrodes will also contact other tissues of the larynx when they are in contact with the vocal cords.
  • the electrode wire is insulated from other tissues.
  • the monitoring electrode A and the monitoring electrode B are designed as exposed segments and inner blocks.
  • the exposed and embedded means that relative to the tracheal tube, the exposed means that the monitoring electrode is exposed On the outer wall of the tracheal tube, the embedded means that the monitoring electrode is hidden on the inner wall of the tracheal tube or arranged inside the tracheal tube.
  • the present invention provides a positioning structure for positioning the tracheal intubation; specifically, the present invention provides a supporting balloon 3 for fixing and supporting the tracheal intubation to avoid intubation Falling makes the electrode inaccessible and the monitoring fails.
  • the supporting balloon is arranged on the side of the tracheal tube facing the glottis, and the supporting balloon is inflated and expanded to fit the shape of the glottis, as shown in Figure 2 and As shown in 4, the circumferential side of the tracheal tube corresponding to the glottis position is not uniformly provided with a supporting balloon 3, and the supporting balloon is only combined on the side facing the glottis.
  • the airbag provided by the present invention is an inflatable positioning body, so compared with other positioning bodies, it is small and controllable to avoid discomfort caused by excessive volume.
  • the doctor can use inflation
  • the action change supports the fullness of the airbag to adapt to different sizes of glottis, which is extremely practical.
  • the supporting airbag is an arc-shaped airbag, and the arc-shaped air size allows the supporting airbag to press against the glottic position when it bulges.
  • the arc-shaped airbag is a fan-shaped airbag.
  • the shape of the fan-shaped airbag It is adapted to the size and shape of the glottis, is designed according to the human glottis structure, and adopts a bionic design, which will not cause discomfort to the patient;
  • the first group of monitoring components and the second group of monitoring components are respectively combined on both sides of the tracheal tube facing the vocal cords, that is, the monitoring electrodes are not in contact with the fan-shaped balloon, and they are directly connected to the outer wall of the tracheal tube instead of being arranged on the support.
  • the outer wall of the balloon in this way, the monitoring electrode will not be pulled by the fan-shaped balloon after expansion, and it is stably combined with the outer wall of the tracheal tube, and it will not generate pressure on the vocal cords while monitoring the nerves.
  • the present invention provides a first inflatable component and a second inflatable component, which are used to inflate the annular airbag and the supporting airbag, respectively.
  • the first and second inflatable components each include an inflation tube, an inflation balloon, and an inflation valve;
  • Ground, the first inflation assembly includes an inflation tube 41, an inflation balloon 51 and an inflation valve 81;
  • the first inflation assembly includes an inflation tube 42, an inflation balloon 52 and an inflation valve 82;
  • the materials are all silver, with good conductivity, and there will be no bad contact with nerves and unstable contact signals;
  • the inner core of the monitoring wire is also made of silver to ensure the conductivity and stability of the conductivity, the monitoring electrode A and the monitoring motor B has nylon wire, which increases the tensile performance of monitoring wire products to ensure the overall quality performance of the product.
  • the tracheal tube can be made of plastic material or silicone material; there is also a ventilation connector 9 for connecting to the ventilator on the back of the tube.
  • the tube contains 4 monitoring electrodes, which are sub-installed in the tube. Left and right.
  • the tracheal intubation provided in this embodiment is a disposable product.
  • the four monitoring electrodes are respectively connected to the monitor through conductive joints (71, 72, 73, 74), which play the role of signal transmission.
  • the tracheal intubation provided in this embodiment is a visual tracheal intubation, which enables a clear observation of the glottis and epiglottis during the clinical intubation process, and timely understands the position and fixation effect of the catheter through the visual function;
  • the visual device is a camera, and the camera is fixed in the lumen of the cannula at a distance from the proximal end of the oblique port at the head end.
  • the annular airbag 2 and the supporting airbag 3 provided in this embodiment are equipped with pressure devices, which can monitor the pressure in the balloon at any time. If the pressure in the balloon is too high, it can automatically deflate to a natural state. Automatically inflate a certain amount of air into the balloon to prevent the balloon from being too large to compress human tissues and cause damage, and to avoid undesirable phenomena such as falling due to insufficient air volume.
  • the present invention also provides a method for using the above-mentioned tracheal intubation:
  • the annular airbag and the supporting airbag are in an uninflated state.
  • the annular airbag is inflated through the first inflation component (the inflation valve 81 and the inflation tube 41), so that the airbag is inflated and sealed ;
  • the second inflation component inflation valve 82 and inflation tube 42
  • inflate into the support balloon so that the support balloon expands to support the tracheal intubation, to prevent the tracheal intubation from falling and causing the electrode wire to be out of contact with the nerve, This leads to poor monitoring and affects the surgeon’s judgment.
  • the supporting effect is shown in Figure 4.

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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)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

La présente invention concerne une canule endotrachéale de surveillance des nerfs, la canule endotrachéale comprenant : un tube de guidage endotrachéal ; un ballonnet annulaire, utilisé pour sceller l'interstice entre le tube de guidage endotrachéal et la trachée du patient, le ballonnet annulaire étant disposé de manière annulaire sur la paroi externe du tube de guidage endotrachéal ; un ballonnet support, utilisé pour positionner la canule endotrachéale, le ballonnet support étant disposé sur le côté du tube de guidage endotrachéal faisant face à la glotte et le ballonnet support s'adaptant à la forme de la glotte après gonflage et dilatation ; et un premier ensemble de gonflage et un deuxième ensemble de gonflage destinés respectivement à gonfler le ballonnet annulaire et le ballonnet support.
PCT/CN2020/095767 2019-07-31 2020-06-12 Canule endotrachéale de surveillance des nerfs WO2021017662A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201921223570.1 2019-07-31
CN201921223570.1U CN210813283U (zh) 2019-07-31 2019-07-31 一种神经监测气管插管

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WO2021017662A1 true WO2021017662A1 (fr) 2021-02-04

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CN (1) CN210813283U (fr)
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070074728A1 (en) * 2005-05-13 2007-04-05 Rea James L Endotracheal electrode and optical positioning device
US20100249639A1 (en) * 2009-01-20 2010-09-30 Samir Bhatt Airway management devices, endoscopic conduits, surgical kits, and methods of using the same
US20100317956A1 (en) * 2007-01-23 2010-12-16 Kartush Jack M Nerve monitoring device
CN204033972U (zh) * 2014-08-11 2014-12-24 中国人民解放军第四军医大学 一种电极可控的气管插管
CN104955389A (zh) * 2013-11-27 2015-09-30 美敦力施美德公司 支气管内导管装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070074728A1 (en) * 2005-05-13 2007-04-05 Rea James L Endotracheal electrode and optical positioning device
US20100317956A1 (en) * 2007-01-23 2010-12-16 Kartush Jack M Nerve monitoring device
US20100249639A1 (en) * 2009-01-20 2010-09-30 Samir Bhatt Airway management devices, endoscopic conduits, surgical kits, and methods of using the same
CN104955389A (zh) * 2013-11-27 2015-09-30 美敦力施美德公司 支气管内导管装置
CN204033972U (zh) * 2014-08-11 2014-12-24 中国人民解放军第四军医大学 一种电极可控的气管插管

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