WO2021017662A1 - Nerve monitoring endotracheal cannula - Google Patents

Abstract

Provided in the present invention is a nerve monitoring endotracheal cannula, the endotracheal cannula comprising: an endotracheal guide tube; an annular balloon, used for sealing the gap between the endotracheal guide tube and the trachea of the patient, the annular balloon being disposed annularly on the outer wall of the endotracheal guide tube; a support balloon, used for positioning the endotracheal cannula, the support balloon being arranged on the side of the endotracheal guide tube facing the glottis, and the support balloon adapting to the shape of the glottis after inflation and expansion; and a first inflation assembly and a second inflation assembly for inflating the annular balloon and the support balloon respectively.

Description

Nerve monitoring tracheal intubation Technical field

The invention belongs to the technical field of medical devices, and specifically relates to a nerve monitoring tracheal intubation.

Background technique

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. At present, 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. However, because the recurrent laryngeal nerve runs in the tracheoesophageal groove on the left and right sides, 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. Despite the rapid development of modern basic medicine and clinical medicine, the accumulation of relevant knowledge and experience during the operation Various preventive measures have been taken, but the recurrent laryngeal nerve injury during thyroid surgery still occurs from time to time. Real-time nerve function monitoring during the operation can accurately locate the nerve and determine the state of nerve function, and can provide a reliable prognosis for the damaged nerve function The objective indicators of this, thereby reducing iatrogenic nerve damage. At present, the incidence of this adverse effect is about 10%. The adverse rate is relatively high. After injury, it will cause adverse events such as hoarseness, loss of voice, coughing after drinking, breathing difficulties or suffocation, so avoiding recurrent laryngeal nerve injury is very important in this type of surgery. thing. Therefore, since the 1970s, 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. However, although there are 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.

technical problem

In view of the above technical problems, 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.

Technical solutions

In order to achieve the above-mentioned purpose of the invention, the present invention adopts the following technical solutions:

A nerve monitoring tracheal intubation, which includes:

Tracheal tube

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.

In some embodiments, 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.

In some embodiments, 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.

In some embodiments, both the monitoring electrode A and the monitoring electrode B are made of silver, copper or gold materials.

In some embodiments, 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.

In some embodiments, the first inflation component and the second inflation component both include an inflation tube, an inflation balloon, and an inflation valve. In some embodiments, a nylon wire is arranged inside the monitoring electrode A and the monitoring electrode B.

In some embodiments, the number of the monitoring electrodes A is two.

In some embodiments, the number of the monitoring electrodes B is two.

In some embodiments, the cross section of the arc-shaped airbag is fan-shaped.

In some embodiments, the endotracheal tube is a visual endotracheal tube.

In some embodiments, the endotracheal tube is a disposable product.

Beneficial effect

Compared with the prior art, 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 The phenomenon that the nerves are not in contact with the monitoring results. Solve the current clinical problems that the electrodes cannot be monitored, the monitoring signal is unstable, and the monitoring fails.

Description of the drawings

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.

Tracheal tube 1, annular balloon 2, supporting balloon 3, inflation tube 41, inflation tube 42, inflation balloon 51, inflation balloon 52, monitoring electrode A 61, monitoring electrode A62, monitoring electrode B 63, monitoring electrode B 64, conductive Connector 71, conductive connector 72, conductive connector 73, conductive connector 74, inflation valve 81, inflation valve 82, vent connector 9, glottis 10.

Embodiments of the invention

The embodiments of the present invention are described in detail below. The embodiments described by referring to the accompanying drawings are exemplary, and are only used to explain the present invention, but cannot be construed as limiting the present invention.

In the description of the invention, it should be understood that the directions or positional relationships indicated by the terms "inner", "outer", "left", "right", "front", "rear", etc. are based on the drawings shown The orientation or positional relationship is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the pointed device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention.

In the description of the present invention, it should be noted that, unless otherwise specified and limited, the terms "installation" and "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. For those of ordinary skill in the art, the specific meaning of the above terms can be understood according to specific circumstances.

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.

Example 1

The present invention provides an improved tracheal intubation based on the prior art and combined with nerve monitoring function. As shown in Figure 1, Figure 2 and Figure 3, the intubation structure includes:

The tracheal tube 1 is used for the ventilation channel. See Figure 4 for details. When the tracheal tube is inserted into the trachea through the glottis 10, 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. For nerve signals, 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. Therefore, whether 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.

Further, 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. In this embodiment, 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.

Taking into account the phenomenon of the intubation falling down after insertion, 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 purpose of this consideration is that if the supporting balloon is arranged in a ring-shaped balloon, It will cause pulling damage to the vocal cords on both sides; in addition, 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.

In this embodiment, 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. As shown in Fig. 3, 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;

In addition, 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.

Further, 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 monitoring electrode A and the monitoring motor B 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.

In one embodiment of the present invention, 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.

Further, 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; Specifically, 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.

Furthermore, 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:

Before the tracheal intubation tube is inserted into the trachea, the annular airbag and the supporting airbag are in an uninflated state. After the intubation, 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 ; Then through the second inflation component (inflation valve 82 and inflation tube 42) to 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.

Claims (10)

1. A nerve monitoring tracheal intubation, which is characterized in that the tracheal intubation includes:

   Tracheal tube (1);

   An annular balloon (2), 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 (3) is used for positioning 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.
2. The nerve monitoring tracheal intubation according to claim 1, wherein the supporting balloon is an arc-shaped balloon, and the size of the arc-shaped balloon allows it to abut against the glottis when it bulges.
3. The nerve monitoring tracheal intubation according to claim 1, wherein 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.
4. The nerve monitoring tracheal intubation according to claim 1, wherein the monitoring electrode A and the monitoring electrode B are made of silver, copper, gold or stainless steel.
5. The nerve monitoring tracheal intubation according to claim 1, wherein the monitoring electrode A and the monitoring electrode B extend along the length of the tracheal tube, and have an exposed section corresponding to the position of the vocal cords relative to the tracheal tube, and Deviation from the inner block of the vocal cords.
6. The nerve monitoring tracheal intubation tube according to claim 1, wherein the first inflation component and the second inflation component both comprise an inflation tube, an inflation balloon, and an inflation valve.
7. The nerve monitoring tracheal intubation according to claim 1, wherein a nylon wire is arranged inside the monitoring electrode A and the monitoring electrode B.
8. The nerve monitoring tracheal intubation according to claim 1, wherein the number of monitoring electrodes A is two and/or the number of monitoring electrodes B is two.
9. The nerve monitoring tracheal intubation according to claim 2, wherein the cross section of the arc-shaped balloon is fan-shaped.
10. The nerve monitoring tracheal intubation according to any one of claims 1-9, wherein the tracheal intubation is a visual tracheal intubation.