A tracheostomy cannula system comprising at least two air outlet ports balanced airflow distribution

Abstract

This invention relates to a tracheostomy cannula system (1) placed in the trachea, which is necessary and essential for securing the patient's airway and providing adequate breathing in the field of medicine, where air inlet and outlet are more comfortable, reducing tracheal damage, cannulation and decannulation complications, tracheomalacia and tracheal stenosis, as well as carina damage, and providing lower pressure and balanced airflow. The invention aims to realize a tracheostomy cannula system (1) wherein the tip provides more comfortable ventilation compared to conventional cannulas, wherein less damage is caused to the trachea during air entry, wherein the air in the cannula moves more in accordance with the anatomy of the structures in question during the movement of air to structures such as trachea and main bronchus, and wherein air is delivered more effectively with lower pressure compared to conventional cannulas.

Description

[0001] A TRACHEOSTOMY CANNULA SYSTEM COMPRISING AT LEAST TWO AIR OUTLET PORTS BALANCED AIRFLOW DISTRIBUTION

[0002] Technical Field

[0003] This invention relates to a tracheostomy cannula system placed in the trachea, which is necessary and essential for securing the patient's airway and providing adequate breathing in the field of medicine, where air inlets and outlets are more comfortable, reducing tracheal damage, cannulation and decannulation complications, tracheomalacia and tracheal stenosis, as well as carina damage, and providing lower pressure and balanced airflow.

[0004] State of the Art

[0005] The trachea begins at cervical C6 and divides into the right and left main bronchus at thoracic T4, a place named the carina. The Turkish Thoracic Society defines tracheotomy as a surgical procedure in which a hole is made in the front of the patient's neck, between the trachea's second and third cartilage rings, and a tube is inserted to ensure continuous airway patency. This tube is called a "tracheostomy cannula". A tracheostomy is a temporary or permanent opening of the trachea's anterior wall to provide an airway. A hole (tracheostomy) is made in the trachea when orotracheal airway patency cannot be guaranteed (in an emergency), to ensure respiratory work or airway patency, or when a mechanical respiratory support device is required for an extended period.

[0006] Tracheostomy cannulas are commonly used to secure a patient's breathing and airway. Some changes may occur in the trachea, large airways, and lungs of a patient who is connected to a mechanical ventilator via the tracheal route using a tracheostomy cannula. Changes or damage to the trachea and its airways, carina, and right and left main bronchi may occur due to flow and / or pressure mechanisms. Specifically, the bevel shape is important in terms of flow pattern, complications, and healing. Due to the bevel structure of the cannula tip, there is intense airflow from the cannula tip to the area of the trachea known as the carina, where the right and left main bronchus are divided. The high pressure in the airflow causes difficulties and complications, resulting in unstable airflow in the patients' trachea and other airways (Figure 1). Due to these difficulties, patient satisfaction may decrease, morbidity and mortality may increase during the intensive care unit (ICU) period, as well as when the patient is connected to the ventilator and the tracheostomy cannula is removed.

[0007] Through the negative intrathoracic pressure generated during breathing in normal respiration, air passes through the upper respiratory tract and reaches the trachea and bronchial system and then to the areas of the lung where gas exchange will occur. The air travels through the airways under negative pressure, and the airways are not subjected to positive pressure applied from within. During mechanical respiration, the tracheostomy cannula, an endotracheal tube inserted into the trachea, provides air into and out of the lungs, while positive pressure is generated by a machine or other manual device. During ventilation, positive pressure from the tip of the tracheostomy cannula can damage the inner surface of the airway, the entire airway structure, and the adjacent lung structures.

[0008] The issues that arise during positive pressure breathing with the currently used tracheostomy cannulas are as follows:

[0009] • The air supplied from the respirator and exiting from the tip of the cannula creates a laminar flow in the trachea, due to the laminar flow, the air is transmitted forward in a thin segment, and high pressure is applied to every area and trachea section in front of it and damages the tracheal wall,

[0010] • The air travels in a way which is not suitable for the anatomy of the trachea and bronchi and improperly hits the walls of the tracheal structure, in other words, it exerts high pressure on the right side of the carina, that is, the right main bronchial divide,

[0011] • Local pressure in the trachea causes flow trauma, which damages the cells in the area of trauma, especially the lining epithelium of the inner surface of the trachea, • The right lung is more ventilated than the left lung because the right main bronchus has higher pressure and flow than the left main bronchus,

[0012] • Increased airflow into the middle and lower lobes of the right lung, which increases the bronchial secretion carried by the air and increases the tendency for pneumonia in the right middle and lower bronchus,

[0013] • Lung collapse known as atelectasis in the lower left lobe caused by a lack of airflow to the left lung,

[0014] • The patient complains of increased cough and sputum for about 1-2 weeks until the cells on the inner surface of the trachea regenerate due to the damage,

[0015] • Difficulty in disconnecting the ventilator due to airway damage and subsequent respiratory complications, increased rate of reinsertion of tracheostomy cannula (decannulation / cannulation),

[0016] • Narrowing and shortness of breath due to inflammation in the trachea, requiring surgical removal of the narrowed area for treatment,

[0017] • Difficulty in the inlet and outlet of air due to temporary narrowing of the internal lumen of the trachea after swelling (edema) occurs on the inner surface due to penetration of the tracheal wall due to the sharp tip of the cannula, and thus difficulty in breathing,

[0018] • The sharp tip of the cannula may result in bulging or permanent narrowing as a result of local trauma caused by penetration and damage to the tracheal wall,

[0019] • The sharp tip of the cannula can cause damage to the tracheal wall and / or esophagus, resulting in the rupture of one or both structures, mediastinitis, pneumothorax, and other similar conditions,

[0020] • Malacia (loosening and softening), granuloma, and ulcer formation at the lower tip of the cannula.

[0021] Changes in the trachea may occur as a result of varying tracheostomy cannula positions. The problems listed above may cause a prolonged illness and result in the patient's death.

[0022] A computed tomography (CT) scan of the thorax of a patient ventilated with an existing tracheostomy cannula was performed, and the pressure and flow changes in the trachea and the following large airways were examined in different areas of the trachea using ANSYS (flow simulation) in the computational fluid dynamics (CFD) program. Pressures were found to differ at various points along the trachea and main bronchi. The flow characteristics in the same areas also differed. In particular, it was discovered that a high current was applied to the separation point of the right and left main bronchus, known as the carina of the trachea, with the current primarily directed towards the right main bronchus. As a result, the pressure at the carina and the "bevel or tip" at the lower tip / side of the tracheostomy cannula was greater than at other points (Figure 1). In other words, the air entering the lung induces a strong current in the carina, which may cause carina damage. Furthermore, high pressures were observed as a result of the high current, particularly at the inner-right points of the carina where exiting air came into contact. Figure 1 supports some of the aforementioned side effects by depicting the relationship between the tracheostomy cannula, trachea, and carina damage and dilation. That is, the tomography image of a patient with a tracheostomy for 2-4 weeks demonstrates the aforementioned negative consequences. These results were obtained from tomography of 10 different tracheostomy patients as part of a scientific study.

[0023] A patient who has undergone tracheal intubation and is ventilated may suffer tracheal and airway damage. Damaged areas include the balloon area of the intubation tube, Murphy's eye, and the carina. The CFD data appear to be consistent with clinical data in this regard.

[0024] In the state of the art, utility model document numbered CN219481182U describes an improved tracheal metal sleeve. The sleeve comprises internal and external sleeves, each with two slitshaped holes in the bevel. However, the tracheal cuff in the said document does not comprise a cuff and is thus unsuitable for positive pressure ventilation. It is intended to help the patient breathe by activating their own respiratory muscles, resulting in negative pressure. Therefore, due to this and the shape of the holes, the airflow dynamics created by the cuff under consideration in this document are vastly different. Given the problems with the current technique described above and the data obtained, it is clear that a new tracheostomy cannula is required to prevent or reduce airway damage in patients connected to tracheal intubation and mechanical ventilators, as well as to provide more balanced airflow and low pressure in the trachea.

[0025] Brief Description of the Invention The present invention is to realize a tracheostomy cannula inserted into the trachea, which is necessary and essential in the field of medicine to administer general anesthesia to the patient or to ensure adequate breathing by securing the airway, and which provides a lower pressure and balanced airflow, reducing complications and tracheal damage that occur with the tracheostomy cannula or after the tracheostomy cannula is removed.

[0026] A further object of the invention is to create a tracheostomy cannula whose tip provides more comfortable ventilation than conventional cannulas and causes less damage to the tracheas during air entry.

[0027] A further object of the invention is to create a tracheostomy cannula in which the movement of air in the cannula to structures such as the trachea and main bronchus is more in line with the anatomy of the structures.

[0028] The invention also aims to provide a tracheostomy cannula that delivers air more efficiently and at a lower pressure than conventional cannulas.

[0029] Description of The Figures

[0030] Figure 1: A view of the flow and pressure curves inside the trachea of a conventional tracheostomy cannula in the known state of the art, obtained using ANSYS and the Computational Fluid Dynamics program.

[0031] Figure 2: A view of the flow and pressure curves of the novel tracheostomy cannula system in the trachea, obtained using ANSYS and the Computational Fluid Dynamics program.

[0032] Figure 3: A schematic representation of the inventive tracheostomy cannula system.

[0033] Figure 4: A schematic representation of the external cannula in the inventive tracheostomy cannula system. Figure 5: A schematic view of the internal cannula in the inventive tracheostomy cannula system.

[0034] Figure 6: A representative perspective schematic view of the first and second outlet ports of the external cannula of the invention's tracheostomy cannula system.

[0035] Description of the References in the Figures

[0036] For a better understanding of the invention, the parts in the figures are individually numbered, and the corresponding numbers are listed below:

[0037] 1. Tracheostomy cannula system

[0038] 1.1. External cannula

[0039] 1.1.1. Body

[0040] 1.1.2. Connection hose

[0041] 1.1.3. Cuff

[0042] 1.1.4. Pilot balloon

[0043] 1.1.5. Air inlet tip

[0044] 1.1.6. Air outlet tip

[0045] 1.1.7. First outlet port

[0046] 1.1.8. Second outlet port

[0047] 1.2. Internal cannula

[0048] 1.2.1. Body

[0049] 1.2.2. Holding tip

[0050] 1.2.3. Outlet tip

[0051] 1.2.4. First protrusion

[0052] 1.2.5. Second protrusion

[0053] Detailed Description of the Invention The inventive tracheostomy cannula system (1) comprises at least one external cannula (1.1) and at least one internal cannula (1.2) which is inserted into the body (1.1.1) of the external cannula

[0054] (1.1) and which allows the internal cannula (1.1) to be easily inserted into the patient's trachea by giving direction to the external cannula (1.1), and which is removed from the external cannula

[0055] (1.1) by spinning (rotating) the external cannula (1.1) after the external cannula (1.1) is inserted into the trachea. The external cannula (1.1) comprises at least one cylindrical body (1.1.1) of a predetermined length and thickness, hollow, open at both tips for air passage, and at least one connection hose (1.1.2) on the body (1.1.1), which can be inserted and removed from the outside after the external cannula (1.1) has been inserted into the patient's trachea, at least one cuff (1.1.3) on the body (1.1.1) which, when inflated, prevents air from escaping between the external cannula (1.1.1) and the trachea, at least one pilot balloon (1.1.4) connected to the external cannula (1.1.1) by the said connection hose (1.1.2) and allowing the head (1.1.3) to be inflated by inflating it with air, the tip of the external cannula (1.1.1) remaining outside the external cannula

[0056] (1.1.1), after the external cannula (1.1.1) is inserted into the patient's trachea, an air inlet tip

[0057] (1.1.5), which allows air to enter the external cannula (1.1), and at least one air outlet tip (1.1.6) at the other tip of the external cannula (1.1), which allows air to exit the external cannula (1.1) and enter the trachea, at least one first outlet port (1.1.7) and at least one second outlet port (1.1.8), each with an opening of a predetermined size positioned opposite each other between the head (1.1.3) and the air outlet tip (1.1.6), which ensure a balanced progression of the air through the housing (1.1.1) and a balanced distribution of the air as it exits. The first outlet port (1.1.7) and the second outlet port (1.1.8) are round-shaped, preferably oval-shaped.

[0058] The internal cannula (1.2) comprises at least one body (1.2.1) with a size and shape that allows insertion into the body (1.1.1) of the external cannula (1.1.1), a handle (1.2.2) that allows the user (physician, etc.) inserting the external cannula (1.1.1) into the trachea to guide and insert the external cannula (1.1.1) by holding it and that remains outside when the external cannula (1.1.1) is inserted into the trachea, at least one first projection (1.2.4) and at least one second projection

[0059] (1.2.5) located on the body (1.2.1), at least one outlet tip (1.2.3) corresponding to the air outlet tip

[0060] (1.1.6) when inserted into the external cannula (1.1), which is designed in such a way that is designed in such a way that when the internal cannula (1.2) inserted into the external cannula (1.1.1), it enters and obstructs the first outlet port (1.1.7) and the second outlet port (1.1.8), and preventing tracheal tissue from penetrating the first outlet port (1.1.7) and second outlet port (1.1.8) of the external cannula (1.1) when the external cannula (1.1) is inserted into the trachea, and preventing this tissue from being transported from the outside to the inside, i.e. into the trachea. The internal cannula (1.2) comprises as many protrusions as the outlet port of the external cannula (1.1).

[0061] Considering the simulation data in Figure 1, the simulation in Figure 2 was performed. A simulation of the inventive tracheostomy cannula system (1) is shown in Figure 2. The flow and pressure curves inside the trachea of the inventive tracheostomy cannula system (1) obtained by applying ANSYS to the computational flow dynamics program are shown. Due to the first and second outlet ports (1.1.7, 1.1.8), the airflow is directed towards the trachea and forward. Compared to Figure 1, the flow pattern obtained in Figure 2 is more evenly distributed with respect to the flows to the right and left main bronchi and lung lobes. It can be observed that the problems with the current technique mentioned above may be minimized when the Figure 2 data are considered. When ANSYS is applied to the said fluid dynamics program, the program has a high accuracy of 97%.

[0062] In the state of the art, the air flow from the cannulas directly hits the carina and may cause the side effects or harmful conditions mentioned above. However, as can be seen, in the inventive tracheostomy cannula system (1), the above-mentioned problems can be minimized by a more even distribution of the air coming out of the first outlet port (1.1.7), the second outlet port (1.1.8) and the air outlet tip (1.1.6).

[0063] The advantages of the inventive system (1) can be listed as follows:

[0064] • Minimizing damage to the tracheal wall, carina, and bronchi by providing a more balanced distribution of airflow in the trachea with lower pressure,

[0065] • Balanced ventilation of both lungs thanks to balanced airflow into the left and right main bronchi,

[0066] • Reducing bronchial secretion and the tendency to pneumonia, • Preventing lung collapse that may occur in the left lower lobe due to imbalanced airflow to the left lung,

[0067] • Minimizing the patient's cough and sputum complaints until the cells of the inner surface of the trachea regenerate due to the damage,

[0068] • Preventing the temporary narrowing of the inner lumen of the trachea due to swelling (edema) on the inner surface as a result of sinking into the tracheal wall due to the sharp tip of the cannula, thus facilitating the entry and exit of air and preventing breathing difficulties,

[0069] • Minimizing difficulty in disconnecting the ventilator due to airway damage and subsequent complications related to the respiratory system, reduction in the rate of reinsertion of tracheostomy cannula (decannulation / recannulation).

[0070] Industrial Applicability of the Invention

[0071] This invention relates to a tracheostomy cannula system (1) placed in the trachea, which is necessary and essential for securing the patient's airway and providing adequate breathing in the field of medicine, where air inlet and outlet are more comfortable, reducing tracheal damage, cannulation and decannulation complications, tracheomalacia and tracheal stenosis, as well as carina damage, and providing lower pressure and balanced airflow, and it is industrially applicable.

[0072] The invention is not limited to the above description and a person skilled in the art can easily produce different applications of the invention. These should be evaluated within the scope of the protection claimed by the claims of the invention.

Claims

CLAIMS1. A tracheostomy cannula system (1) for reducing tracheal damage, complications of cannulation and decannulation, tracheomalacia and tracheal stenosis, and carina damage, for providing lower pressure and balanced airflow; comprises at least one cylindrical body (1.1.1) of a predetermined length and thickness, hollow, open at both tips for air passage, and at least one connection hose (1.1.2) on the body (1.1.1), which can be inserted and removed from the outside after the external cannula (1.1) has been inserted into the patient's trachea, at least one cuff (1.1.3) on the body (1.1.1) which, when inflated, prevents air from escaping between the external cannula (1.1.1) and the trachea, at least one pilot balloon (1.1.4) connected to the external cannula (1.1.1) by the said connection hose (1.1.2) and allowing the head (1.1.3) to be inflated by inflating it with air, the external tip of the external cannula (1.1) after the external cannula (1.1) has been inserted into the patient's trachea, at least one external cannula (1.1), including an air inlet tip (1.1.5) providing air intake into the external cannula (1.1), at least one air outlet tip ( 1.1.6) at the other end of the external cannula (1.1) allowing air to exit the external cannula (1.1) and enter the trachea, at least one body (1.2.1) having a size and shape such that it can be inserted into the body (1.1.1) of the external cannula (1.1.1), a handle (1.2.2) allowing the user inserting the external cannula (1.1) into the trachea to guide and insert the external cannula (1.1.1) by holding it and which remains outside when the external cannula (1.1.1) is inserted into the trachea, at least one outlet tip (1.2.3) corresponding to the air outlet tip (1.1.6) when inserted into the external cannula (1.1), comprising at least one internal cannula (1.2) which is inserted into the body (1.1.1) of the external cannula (1.1) and which allows easy insertion of the external cannula (1.1) into the patient's trachea by orienting the external cannula (1.1), and which is removed from the external cannula (1.1) by rotation after the external cannula (1.1) has been inserted into the trachea; characterized in that it comprises an external cannula (1.1) comprising at least one first outlet port (1.1.7) and at least one second outlet port (1.1.8), each with an opening of predetermined size positioned opposite each other between the cuff (1.1.3) and the air outlet end (1.1.6), allowing the air to travel evenly through the body (1.1.1) and to disperse evenly during the exit.

2. The tracheostomy cannula system (1) according to Claim 1, characterized in that it comprises an internal cannula (2) comprising at least one first protrusion (24) and at least one second protrusion (25) disposed on the body (21), an internal cannula (2) designed to enter and obstruct the first outlet port (7) and second outlet port (8) when inserted into the external cannula (1), preventing tracheal tissue from entering the first outlet port (7) and second outlet port (8) of the external cannula (1) when the external cannula (1) is inserted into the trachea and preventing this tissue from being carried from outside to inside, i.e. into the trachea.

3. The tracheostomy cannula system (1) according to Claim 1 or 2, characterized in that the first outlet port (1.1.7) and the second outlet port (1.1.8) are round in shape.

4. The tracheostomy cannula system (1) according to Claim 3, characterized in that the first outlet port (1.1.7) and the second outlet port (1.1.8) have an oval shape.

5. The tracheostomy cannula system (1) according to Claim 4, characterized in that it comprises an internal cannula (1.2) having as many protrusions as the outlet port contained in the external cannula (1.1).

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