A new intubation tube used during the percutaneous dilatational tracheostomy procedure and monitored by ultrasonography (USG)

Abstract

The invention relates to an intubation tube for use during percutaneous dilatational tracheostomy procedure, which provides safe ventilation of the patient, prevents damage to the esophagus under the trachea during the process, and has an area through which the bronchoscope device can pass easily.

Description

[0001] A NEW INTUBATION TUBE USED DURING THE PERCUTANEOUS DIEATATIONAE TRACHEOSTOMY PROCEDURE AND MONITORED BY UETRASONOGRAPHY (USG)

[0002] Technical Field

[0003] The invention relates to an intubation tube for use during percutaneous dilatational tracheostomy procedure, which provides safe ventilation of the patient, prevents damage to the esophagus under the trachea during the process, and has an area through which the bronchoscope device can pass easily.

[0004] The invention also relates to an intubation tube, the position of which can be accurately and precisely determined, and the rate of errors and complications in the application is minimized since it can be visualized by ultrasonography (USG) technique due to the characteristics of the material from which it is manufactured.

[0005] Prior Art

[0006] Percutaneous dilatational tracheostomy is necessary for patients requiring prolonged mechanical ventilation and prolonged intubation, especially in patients requiring prolonged respiratory support due to underlying problems such as head and neck cancers, swallowing disorders, or tracheal damage. In short, all patients who need to stay in intensive care for more than 14 days have a tracheostomy, this is a medical necessity. During the percutaneous dilatational tracheostomy procedure, the existing intubation tube is tried to be removed from the procedure area by pulling it out of the trachea thoroughly, but at the same time, since the patient needs to be ventilated, the procedure is completed by holding it manually at the entrance of the airway.

[0007] Several difficulties are encountered during the percutaneous dilatational tracheostomy process. These include perforation of the esophagus, inadequate withdrawal of the intubation tube and fixation of the intubation tube by passing a needle through it, perforation of the fiberoptic bronchoscopy device with a needle and making it unusable, and difficulties in passing bronchoscopy through the narrow endotracheal tube and trying to ventilate the patient at the same time.

[0008] Perforation of the esophagus: the esophagus is located just behind the trachea, and only a thin muscular wall separates the two organs from each other. Perforation of this wall separating these two structures leads to a condition called tracheoesophageal fistula. Although tracheoesophageal fistula occurs in 0.8% of cases, it is highly fatal. In addition, in our clinical observations during the Covid- 19 pandemic, it was observed that the tissues became very sensitive and this rupture rate was much higher. The tracheostomy procedure is performed under bronchoscopy to protect the posterior wall. However, since the tracheal space is very narrow, it is almost impossible not to touch the posterior wall.

[0009] The intubation tube cannot be pulled out sufficiently, and the needle is passed through it and fixed. During the procedure, the patient cannot breathe in and out because he / she is unconscious. The patient's breathing is provided by mechanical ventilators connected to the patient by an intubation tube. However, since the tracheostomy will be opened where the tube is normally located, the tube will be withdrawn during the procedure, and the patient will be both ventilated and the procedure will be performed. During the opening of the tracheostomy, the healthcare professional's task is to withdraw this intubation tube and try to hold it in a stable position with his / her hand.

[0010] If there is a specialized tube for tracheostomy, the airway safety of the patient encountered during the procedure will be better ensured.

[0011] A fiberoptic bronchoscopy device can be punctured with a needle and become unusable; a fibreoptic bronchoscopy device is sent through the tube and used to monitor the inside of the lumen during the procedure. However, since the person performing the procedure and the person holding the bronchoscope are different, sometimes the bronchoscope can be pierced with a needle. Repairing a bronchoscopy is costly, and another tracheostomy cannot be opened until the repair is completed. Difficulties in passing bronchoscopy and ventilating the patient through the narrow endotracheal tube: The intubation tube is selected according to the patient's trachea, but it must be of a certain width (at least 7.5 inches) for fiber optic bronchoscopy to pass. Since the tracheostomy tube will be used without entering the trachea, it is important that it is wide enough for the fiberoptic bronchoscope to pass through and that the air given to the patient can easily pass through.

[0012] During the percutaneous dilatational tracheostomy procedure, airway problems may occur during or after tracheostomy tube placement. These may include tube dislodgement, obstruction, or misplacement of the tube. These situations may require urgent intervention. Incorrect tube placement or damage to the esophagus during dilatation is a rare complication. If symptoms of oesophageal injury (difficulty swallowing, pain, bleeding, etc.) occur, medical attention should be sought. Injury to the trachea can occur during incorrect dilatation or tube placement. This can be a serious complication and may require urgent surgical intervention. The tracheostomy tube may move or become blocked. This can cause breathing difficulties, and the tube may need to be straightened or replaced. The intubation tube may not be pulled out sufficiently, and a needle may be passed through it. In this case, the fiberoptic bronchoscopy device may be punctured with a needle and become unusable.

[0013] EP4197578A1 discloses an endotracheal tube.

[0014] US2013047992A1 discloses an endotracheal tube comprising a corrugated cuff.

[0015] When the existing studies in the prior art were analyzed, it was necessary to develop an intubation tube to be used during percutaneous dilatational tracheostomy procedure that provides safe ventilation of the patient, prevents damage to the esophagus under the trachea during the procedure, and an area where the bronchoscope device can pass easily. Objectives of the Invention

[0016] The object of the present invention is to develop an intubation tube to be used during percutaneous dilatational tracheostomy procedure, which provides safe patient ventilation and prevents damage to the esophagus under the trachea during the procedure.

[0017] Another object of the present invention is to develop an intubation tube, the position of which can be accurately and precisely determined, and the rate of error and complication in the application is minimized since it can be visualized by ultrasonography (USG) technique due to the material properties of which it is made.

[0018] The object of the present invention is to develop an intubation tube with a space through which the bronchoscope device can pass easily.

[0019] A further object of the present invention is to develop an intubation tube that allows the procedure to be performed more comfortably during percutaneous dilatational tracheostomy procedure.

[0020] Detailed Description of the Invention

[0021] The intubation tube provided to achieve the objects of the present invention is shown in the attached figures.

[0022] Figures;

[0023] Figure 1: A view of the intubation tube of the invention.

[0024] Figure 2: A view of the intubation tube of the invention in an exemplary embodiment.

[0025] The parts in the figures are numbered individually, and the corresponding descriptions are given below. 1. Body

[0026] 2. Tongue piece

[0027] 3. Cuff balloon I

[0028] 4. Ventilation connection

[0029] 5. Inflation line

[0030] 6. Air hole

[0031] 7. Ultrasonography (USG) monitoring strip

[0032] 8. Cuff balloon II

[0033] The invention relates to an intubation tube for use during percutaneous dilatational tracheostomy procedure, which provides safe ventilation of the patient and prevents damage to the esophagus under the trachea during the procedure, comprising;

[0034] - Body (1),

[0035] - Open-top tongue piece (2) at the end of the body ( 1 ) , which prevents damage to the esophagus under the trachea during the procedure,

[0036] - Cuff balloon I (3) positioned at the entrance of the tongue piece (2) and ensuring that the air given to the patient during the procedure does not escape backward,

[0037] Ventilation connection (4) located at the inlet of the body (1) and providing the connection between the intubation tube and the mechanical ventilator or ambu,

[0038] Inflation line (5) positioned in the body (1) for inflating the cuff balloon I (3),

[0039] - Air hole (6) positioned between the cuff balloon I (3) and the tongue piece (2),

[0040] - Ultrasonography (USG) monitoring strip (7) made of PVC matrix composite (PMK) material filled with calcite (CaCOs) and positioned between the inner and outer layer of the tongue piece (2),

[0041] Cuff balloon II (8) connected to the cuff balloon I (3) and controlling how much the cuff balloon I (3) is inflated. The intubation tube of the invention comprises a tongue piece (2) which has 1 cm width and 8-10 cm length, extending towards the end of the body (1). The diameter of the body (1) of the inventive intubation tube is large so that sufficient air can be supplied to the patient when the bronchoscope is passed through it. The cuff balloon I (3) remains above the vocal cords, after which the tongue piece (2) extends. In the intubation tube according to the invention, the tongue piece (2) is obtained by top- cutting the tube section into a (U) shape. In addition, a composite strip with CaCCh and Ag filled PVC matrix was added to this part as an intermediate layer by co- extrusion method and its traceability in USG was ensured. In this way, complications occurring during the procedure to the patient were prevented. For example, needle puncture from above when the tip is not visible, damage to the pipe end.

[0042] The tongue piece (2) in the intubation tube of the invention consists of 3 layers, the inner and outer layers of which are made of transparent PVC and the USG monitoring strip (7) is made of PVC matrix composite (PMK) material filled with calcite (CaCOs). Co-extruded USG monitoring strip (7) is developed for imaging the position of the tongue piece (2) with an ultrasound device and is produced by adapting the polymer (usually polyvinyl chloride - PVC) matrix composite material containing 0.1-60 wt% CaCOs homogeneously mixed filler as a thin (0.1 -8mm wide) strip on the outside of the inner layer of the tube so as not to separate from the tube during the production of the tube by co-extrusion method. Then the outer polymer (PVC) layer is coated with the 3rd co-extruder during production. In this way, since the CaCOs- filled PMK material is positioned as an intermediate layer, the particles are prevented from breaking off, deforming and escaping into the respiratory system in case of any unfavourable situation (needle stick, etc.) during the operation. Calcium carbonate is frequently used as biomaterial due to its good biocompatibility, bioactivity and bioabsorbability. Calcium carbonate particles loaded with silver nanoparticles (Ag-CaCOs) can also be used for filling, thus providing antibacterial properties to the composite material visible on USG. Here, instead of silver nanoparticles, additives with different antibacterial properties can also be used. In the traditional method, the end of the tube is closed in the form of a pipe. Since it is made of transparent PVC material, it cannot be located by USG.

[0043] In the application of the intubation tube according to the invention, the tube is inserted into the trachea so that the tongue piece (2) remains in the trachea and the cuff balloon II (8) is outside the vocal cords. The patient will be connected to the mechanical ventilator by inflating the cuff balloon I (3). The tongue piece (2) of the tube will be visualised in the trachea by ultrasound and the tracheostomy needle will be inserted between the second and third tracheal rings. In the meantime, since the tongue piece (2) of the tube is under the entrance site of the needle, excessive advancement of the needle will be prevented. The guide wire will be advanced through the needle, the needle will be withdrawn and the trachea will be dilated with dilators over the guide wire. During this process, the tongue piece (2) will protect the posterior wall. After the trachea is sufficiently dilated, the tracheostomy cannula will be placed and the mechanical ventilator will be connected to the tracheostomy cannula. The tube will be removed from the patient and the procedure will be finalised.

[0044] The intubation tube according to the invention is designed for use during tracheostomy and also provides airway safety during the procedure. The inventive intubation tube does not remain in the patient for a long time like the endotracheal tube, but is used only during the procedure and prevents unwanted events and makes the procedure more comfortable.

Claims

CLAIMS1. An intubation tube for use during percutaneous dilatational tracheostomy procedure, which provides safe ventilation of the patient and prevents damage to the esophagus under the trachea during the procedure, characterized by, comprising;- Body (1),- Open-top tongue piece (2) at the end of the body (1), which prevents damage to the esophagus under the trachea during the procedure,- Cuff balloon I (3) positioned at the entrance of the tongue piece (2) and ensuring that the air given to the patient during the procedure does not escape backward,- Ultrasonography (USG) monitoring strip (7) made of PVC matrix composite (PMK) material filled with calcite (CaCOs) and positioned between the inner and outer layer of the tongue piece (2).

2. An intubation tube according to claim 1 , characterized by the inner and outer layer of the tongue piece (2) is made of transparent PVC material.

3. An intubation tube according to claim 2, characterized by it comprises ventilation connection (4) located at the inlet of the body (1) and providing the connection between the intubation tube and the mechanical ventilator or ambu.

4. An intubation tube according to claim 3, characterized by it comprises an inflation line (5) positioned in the body (1) for inflating the cuff balloon I (3).

5. An intubation tube according to claim 4, characterized by it comprises an air hole (6) positioned between the cuff balloon I (3) and the tongue piece (2).

6. An intubation tube according to claim 5, characterized by the ultrasonography monitoring strip (7) comprises 0,1-60 wt% CaCCh.

7. An intubation tube according to claim 6, characterized by the ultrasonography monitoring strip (7) comprises calcium carbonate particles loaded with silver nanoparticles (Ag-CaCCh) instead of calcite filler.

8. An intubation tube according to claim 7, characterized by it comprises a cuff balloon II (8) connected to the cuff balloon I (3) and controlling how much the cuff balloon I (3) is inflated.

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