An intubation tube with at least two air outlet ports providing a balanced flow-pressure relationship

Abstract

The present invention relates to an intubation tube (1) developed to provide a more balanced and homogeneous distribution of air to the lungs for use in the field of medicine and to provide a better airflow, where tracheal damage, post-extubating complications and tracheomalacia are further reduced.

Description

[0001] DESCRIPTION

[0002] AN INTUBATION TUBE WITH AT LEAST TWO AIR OUTLET PORTS PROVIDING A BALANCED FLOW-PRESSURE RELATIONSHIP

[0003] Technical Field

[0004] The present invention relates to an intubation tube developed to provide a more balanced and homogeneous airflow, where the distribution of air to the lungs for use in the field of medicine is more balanced and homogeneous, and the possibility of tracheal damage, postextubating complications and tracheomalacia and tracheal stenosis is further reduced.

[0005] State of the Art

[0006] Although various improvements have been made to the intubation tubes, some serious problems in the trachea and major airways, and in the remaining lungs may still occur in the patient who is intubated tracheally with the intubation tubes in the known state of the art and connected to the mechanical ventilator. Serious problems or damage may occur with the flow and / or pressure mechanism in the trachea and subsequent airways. Figure 1 shows the shape and sections of an intubation tube used in the state of the art. In addition, the way the air progresses as a result of the placement of the intubation tube in the patient's lungs, that is, in the trachea, is given in Figure 2. In particular, the shape of the tip (bevel) is important in terms of the flow pattern and the complications and improvements that develop accordingly.

[0007] There are difficulties and complications in the intubation tubes used in the previous art, especially due to the structure of the tip of the tubes (bevel), and accordingly, there may be a decrease in patient satisfaction, an increase in morbidity and mortality during the surgery and intensive care or after intubation or after leaving the ventilator and removing the intubation tube.

[0008] During the delivery of air, that is, the air coming out of the tip of the intubation tube due to positive pressure during ventilation, may damage the inner surface of the airway, the entire airway structure and the lung structures it is adjacent to. In addition to the occurrence of at least one of the known problems as a result of the use of existing intubation tubes, it has been observed that problems arise due to the unbalanced distribution of air to the lungs to the lung bronchi. With the emergence of these problems, the need to improve intubation tubes has arisen.

[0009] The most common harms of conditions that occur during positive-pressure ventilation with the current endotracheal tube (currently in use) are the following: a) Positive pressure air creates turbulence in the trachea and due to turbulence, the forward delivery of air is delayed and there is an increase in pressure in the area of turbulence, b) Due to the tip design of the tube, the air coming out of the tip of the tube causes local pressure (Murphy eye area) and current trauma in the tracheal wall in the upper right area of the trachea and damage to the cells in the trauma area, especially the inner surface of the trachea (Figure 2-3, Table 1), c) Due to the tip design of the tube, the airflow towards the upper lobe of the right lung is low, resulting in decreased ventilation in the right upper lobe (Figure 4, Table 1), d) Due to the tip design of the tube, the air coming out of the tip of the tube causes local pressure and flow trauma, especially on the right lateral of the carina, where the trachea is divided into two, and damage to the cells in the area of trauma, especially the inner surface lining epithelium of the trachea (Figure 4-6, Table 1), e) Due to the tip design of the tube, the airflow towards the lower lobe of the right lung is increased, resulting in increased bronchial secretion carried with the air and increased tendency for pneumonia in the right lower bronchus (Figure 4-6, Table 1), f) Pulmonary collapse called atelectasis in the lower left lobe due to lack of airflow to the left lung, g) Increased cough and sputum for approximately 1-2 weeks until the inner surface cells are regenerated due to tracheal damage, h) Loosening or bulging or ballooning of the tracheal structure called tracheomalacia in the trachea with damage, stretching, loosening of the tracheal cartilage rings, especially in the right outer region where local pressure / flow trauma in the trachea occurs, i) Narrowing and shortness of breath due to inflammation in the trachea, j) After swelling (edema) occurs on the inner surface as a result of insertion into the tracheal wall due to the sharp tip of the tube, difficulties occur in the inlet and outlet of the air due to the temporary narrowing of the inner lumen of the trachea, and breathing difficulties occur due to this reason, k) Local trauma due to sinking and damage to the tracheal wall due to the pointed tip of the tube, which may cause external bulging or permanent narrowing as a result of local trauma, l) Damage to the tracheal wall and / or esophagus due to the sharp tip of the tube can cause rupture of one or both structures, mediastinitis, pneumothorax and similar conditions.

[0010] There is an increase in mobility and mortality in the patient due to at least one of these conditions.

[0011] An intubation tube is described in the TR 2017 / 10015 registered patent document of the inventor, which is the closest known state of the art. However, it has been seen and understood that said tube causes various negativities listed above due to the fact that it is currently used in the industry. Accordingly, it has become necessary to make various improvements that eliminate the above problems.

[0012] When the tomography of the intubated patient is obtained with the intubation tubes (or endotracheal tube, ETT) used in the state of the art, some of the above-mentioned side effects are supported by Figure 3. In other words, it is seen that the above-mentioned negative results may occur with the tomography image of the 1-week intubated patient. In the CT of the intubated patient, it is seen that the trachea is hollowed out in the trachea section opposite the Murphy eye. Figure 3 also shows the enlargement of the trachea lumen on the opposite side, where the flow through the Murphy eye is towards the trachea.

[0013] The current simulation of the current ETT in the trachea is given in Figure 4, and the current and pressure curves obtained when ANSYS is applied to the Computational Flow Dynamics program are shown in this figure. In Figure 4, it is seen that the flow is towards the trachea from the Murphy eye on the right lateral and there is an expansion in the trachea lumen on the opposite side. In addition, the Venturi effect is evident in these flow dynamics. Some intubation side effects we see in the clinic can be explained more easily with the Venturi effect. On the other hand, in order to better understand the problems caused by the intubation tubes used in the known situations of the art, computed thoracic tomography (CT) was performed on the adult patient connected to the orotracheal intubation and ventilator. The tomography images were examined in the Computational Flow Dynamics (CFD) program. Pressure and flow changes in the trachea and subsequent major airways were examined in a total of six pressure zones. It was observed that the pressures at six points on the trachea and main bronchi were different from each other (Table 1). Current characteristics in the same regions also differed. Especially in the abdomen and on the lower right outer side of the intubation tube, it was seen that the pressure at the point called "Murphy eye" was higher compared to other points (Figure 5). In particular, the pressures at points P4 and Pl are high. The reason for this is that positive pressure air only comes out of the two outlet ports and reaches the lungs. As a result, since the pressure is not homogeneously distributed, it has been clearly observed that some of the above-mentioned situations occur due to high pressure at the points where the air outlets. These data are obtained from 10 different patients within the scope of a scientific research. In the light of the data, there is a need to develop a new type of intubation tube. In Figure 5, it is seen that the current from the Murphy eye on the right lateral at P4 towards the trachea and the current in the Pl carina is also high. In addition, the graph shows the pressure-current relationship to different points of the trachea (Figure 6). It should be evaluated together with Figures 4, 5 and 6 in order to make the correct evaluation.

[0014] Table 1: Pressure values at 6 points on the trachea and main bronchi with ETT used in the present art

[0015] Damage on the trachea and subsequent damage to the airways may occur in the patient who has undergone tracheal intubation and ventilated. The damage sites are the balloon area of the intubation tube, the Murphy eye area, and the carina area. The CFD data is clinically consistent in this sense. There is a need for ventilation with a new type of intubation tube that can prevent or reduce damage to the airway in the patient due to tracheal intubation and mechanical ventilator to eliminate these negativities or damages.

[0016] Brief Description of the Invention

[0017] The object of the present invention is to realize an intubation tube developed to provide a more balanced airflow, where the distribution of air to the lungs for use in the field of medicine is more balanced and homogeneous, and the possibility of tracheal damage, postextubating complications, and tracheomalacia and tracheal stenosis is further reduced.

[0018] The advantages of the new type of intubation tube can be listed as follows:

[0019] I. The tip provides more comfortable ventilation than traditional tubes, causes less damage to the trachea during the entry of air,

[0020] II. During the movement of air in the tube to structures such as the trachea and main bronchus, the air moves more in accordance with the anatomy of said structures and in a more balanced way,

[0021] III. Ensuring that air is delivered more effectively with lower pressure,

[0022] IV. It creates an effect that prevents the movement of air in the trachea (inspiration) or retrieval of air (expiration) or improves the airflow.

[0023] One of the above-mentioned advantages is that an ETT has been developed containing an air outlet port (Medipol eye) on one side in the bevel section, which prevents the air from moving in the trachea or retrieving the air or creates an air flow healing effect. Similarly, on the other side of the bevel section, another air outlet port (Murphy eye) was reshaped and optimized. Thus, in the preferred embodiment of the invention, at least a two-eyed intubation tube has been developed, one on the right and one on the left lateral, facing each other. Thus, it was observed that there was local pressure / flow trauma in the trachea, especially damage, stretching, loosening of the surface epithelium and tracheal cartilage rings in the right region, and the problem of loosening or bending or ballooning of the tracheal structure called tracheomalacia in the trachea was solved. Since the tip (bevel) shape of the intubation tube is important in terms of the flow pattern and the complications and improvements that develop accordingly, the development has been made by focusing on the bevel section of the intubation tube subject to the invention.

[0024] Descriptions of the Figures

[0025] Figure 1. A large-scale representation of the bevel section of an intubation tube containing the general and classical Murphy eye from the top, which is in the state of the art.

[0026] Figure 2. A representative view of the way the air advances as a result of the placement of an intubation tube in the state of the art in the patient's lungs, that is, in the trachea.

[0027] Figure 3. An appearance of the relationship between the Murphy eye and tracheal dilatation in some intubation tubes (ETT in CT) in the state of the art.

[0028] Figure 4. A view of the flow and pressure curves in the trachea of the traditional intubation tube obtained when ANSYS is applied to the Computational Flow Dynamics program.

[0029] Figure 5. A representative view for 6 separate pressure (P) points in the trachea of the traditional intubation tube obtained when ANSYS is applied to the Computational Flow Dynamics program.

[0030] Figure 6. A representative view of the flow chart of the traditional intubation tube in the trachea over time when ANSYS is applied to the Computational Flow Dynamics program.

[0031] Figure 7. A top general perspective representation of the intubation tube of the invention.

[0032] Figure 8. A large-scale perspective representation of the bevel section of the intubation tube, which is the subject of the invention, from a top angle and includes the Medipol eye.

[0033] Figure 9. Another aspect of the intubation tube subject to the invention is the large-scale perspective representation of the bevel section containing the Murphy eye, which has been given a new form from the top. Figure 10. A top perspective representative cross-sectional representation of the intubation tube of the invention.

[0034] Figure 11. A representative view of the way the air advances as a result of the placement of the intubation tube, which is the subject of the invention, in the patient's lungs, that is, in the trachea.

[0035] Figure 12. Virtual environment data of the invention and the view of the flow and pressure curves of the intubation tube in the trachea obtained by applying ANSYS to the Computational Flow Dynamics program. of References in Figures

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

[0037] 1. Intubation tube

[0038] 1.1. Body

[0039] 1.2. Connector

[0040] 1.3. Radiopaque line

[0041] 1.4. Pilot balloon

[0042] 1.4.1. Valve

[0043] 1.5. Connection tubing

[0044] 1.6. Balloon

[0045] 1.7. Outlet end

[0046] 1.7.1. First outlet port

[0047] 1.7.2. Second outlet port

[0048] Pl. Pressure value at point Pl on the trachea and main bronchi

[0049] P2. Pressure value at point P2 on the trachea and main bronchi

[0050] P3. Pressure value at point P3 on the trachea and main bronchi

[0051] P4. Pressure value at point P4 on the trachea and main bronchi

[0052] P5. Pressure value at point P5 on the trachea and main bronchi

[0053] P6. Pressure value at point P6 on the trachea and main bronchi P7. Pressure value at point P7 on the trachea and main bronchi

[0054] Detailed of the Invention

[0055] The intubation tube (1) of the invention in order to prevent or minimize all complications by providing a homogeneous distribution of positive pressure air to the lung trachea and bronchi, comprising: a) at least one cylindrical body (1.1) of a predetermined length and thickness, open at both ends, hollow inside and containing at least one length marking for the passage of air, b) at least one connector (1.2) located at one tip of said body (1.1), c) at least two radiopaque lines (1.3) preferably located on said body (1.1) near the end where said connector (1.2) is located and used to determine the position of said body (1 1), d) at least one pilot balloon (1.4) separated by means of a connection tube (1.5) through an opening in the body (1.1), e) at least one balloon (cuff) (1.6) located at the other end of the body (1.1) without connector (1.2) and f) an outlet end (1.7) (Bevel) located at the bottom of said balloon (1.6) at the other end of the body (1.1) without connector (1.2), which increases the forward as well as the lateral orientation of the inlet air (Figure 7).

[0056] Said pilot balloon (1.4) comprises at least one one-way valve (1.4.1) that allows one-way air passage.

[0057] The outlet end (1.7) of the intubation tube (1) of the invention also comprises at least one first outlet port (Medipol eye) (1.7.1) and at least one second outlet port (1.7.2) (Murphy eye) facing each other in the bevel section of the body (1.1) to prevent local pressure / current trauma in the trachea in order to transmit the air homogeneously and evenly in the preferred embodiment of the invention (Figure 7). In the preferred embodiment of the invention, the outlet end (1.7) comprises a first outlet port (1.7.1) and a second outlet port (1.7.2) with different geometric diameters and forms facing each other. The first outlet port (1.7.1) may be produced in a larger or smaller geometric diameter and form than the second outlet port (1.7.2). In other words, the outlet ports on the right and left can be of different sizes or shapes. According to the embodiments of the invention, the cutting angle of the outlet end (1.7) may be straight cut (blunt) or right lateral cut or left lateral cut or anteroposterior cut or posterior anterior cut. Thus, it was observed that local pressure / flow trauma in the trachea, damage, stretching, loosening of the tracheal cartilage rings, especially in the right region, and loosening or bulging or ballooning of the tracheal structure called tracheomalacia in the trachea were solved.

[0058] With the first outlet port and the second outlet port (1.7.1 and 1.7.2), the inner section of the body (1.1) through which the air passes is narrowed, and the air is more easily directed to the right and left from said air outlet ports on the wall of the body (1.1).

[0059] Therefore, considering the data of Figures 5 and 6, a new type of intubation tube (ETT), which is the subject of the invention, has been developed, which includes two outlet ports of mutually identical or different geometric forms and diameters (Figures 7, 8, 9, 10). In addition, the way the air progresses as a result of the placement of the intubation tube of the invention in the patient's lungs is given in Figure 11. Simulation of said intubation tube (inlet and outlet of air to the channels) was carried out by taking into account the data of Figures 5 and 6. As can be seen from Figure 7, in the preferred embodiment of the invention, there are two outlet ports (one Murphy and the other Medipol eye) at the lower tip of the ETT, that is, at bevel.

[0060] At the bevel, it is seen that the air flow moves to the trachea and forward with the intubation tube (1) containing the first outlet port and the second outlet port (1.7.1 and 1.7.2) on the right and left laterals. The flow pattern obtained in Figure 12 is more evenly distributed when considering the flows to the right and left main bronchi and lung lobes compared to Figure 4 and 5. Considering the data in Figure 12, it is seen that the above-mentioned side effects are minimized.

[0061] Thanks to the first outlet port and the second outlet port (1.7.1 and 1.7.2) of the intubation tube (1), the turbulence of the air given from the breathing apparatus and coming out of the tip of the intubation tube (1) is minimized and even eliminated. In addition, the air in the intubation tube (1) moves to the tips in accordance with the trachea and bronchial anatomy. With the first outlet port and the second outlet port (1.7.1 and 1.7.2), the air coming out of the tip of the tube (1) is directed to the right and left main bronchi in proportion to their size by hitting the carina area where the bronchi are divided into two as it moves through the trachea. In addition, the air coming out of the first outlet port and the second outlet port (1.7.1 and 1.7.2) does not cause local pressure or current trauma in the tracheal wall in the left anterior upper area of the trachea, so there is no damage to the cells in the relevant regions, especially the inner surface of the trachea. Since there is no damage, there is no increase in cough and sputum, and therefore, the complaints of the patient who is separated from the ventilator and whose intubation tube is removed due to intubation are reduced. In addition, with the intubation tube (1) of the invention, damage, stretching, loosening, or bending or ballooning of the trachea, which is called tracheomalacia, does not occur in the trachea cartilage rings, especially in the left anterior upper region, where there is trauma with local pressure or current trauma in the trachea in the prior art.

[0062] Industrial Applicability

[0063] The invention relates to an intubation tube developed to provide a better airflow, in which the distribution of air to the lungs for use in the field of medicine is more balanced and homogeneous, and tracheal damage, post-extubating complications and tracheomalacia are further reduced, and it is applicable to the industry.

[0064] The invention is not limited to the above explanations; however, a person skilled in the art can easily present different embodiments of the invention. They must be assessed within the scope of the protection claimed by the claims of the invention.

Claims

CLAIMS1. An intubation tube (1) to prevent or minimize all complications, especially by ensuring homogeneous distribution of positive pressure air to the lung trachea and bronchi, comprising a) at least one cylindrical body (1.1) of a predetermined length and thickness, open at both ends, hollow inside and containing at least one length marking for the passage of air, b) at least one connector (1.2) located at one tip of said body (1.1), c) at least two radiopaque lines (1.3) preferably located on said body (1.1) near the end where said connector (1.2) is located and used to determine the position of said body (1-1), d) at least one pilot balloon (1.4) separated by means of a connection tube (1.5) through an opening in the body (1.1), e) at least one balloon (cuff) (1.6) located at the other end of the body (1.1) without connector (1.2) and f) an outlet end (1.7) located at the bottom of said balloon (1.6) at the other end of the body (1.1) without connector (1.2), which increases the forward as well as the lateral orientation of the inlet air; characterized by having at least one first outlet port (1.7.1) and at least one second outlet port (1.7.2) facing each other at the bevel of the body (1.1) in order to deliver air homogeneously and evenly and thus prevent local pressure / current trauma to the trachea.

2. An intubation tube (1) according to claim 1, characterized by an outlet end (1.7) comprising a first outlet port (1.7.1) and a second outlet port (1.7.2) of different geometric diameter and form facing each other.

3. An intubation tube (1) according to claim 2, characterized by a first exit port (1.7.1) which can be manufactured with a larger or smaller geometric diameter and shape relative to the second exit port (1.7.2).

4. An intubation tube (1) according to claim 3, characterized by an outlet end (1.7), the angle of cut of which may be a straight cut (blunt) or a right lateral cut or a left lateral cut or an anteroposterior cut or a posterior anterior cut.An intubation tube (1) according to claim 4, characterized in that it comprises a pilot balloon (1.4) containing at least one one-way valve (1.4.1) allowing unidirectional passage of air.

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