JP2007185481A - Tracheotomic tube - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a tracheotomic tube in which a balloon surely swells while inhaling, air is sent into the lung without leaking, exhalation reaches the vocal cord when a patient desires vocalization, and the saliva does not travel into the trachea when exhaling without desiring vocalization. <P>SOLUTION: The balloon 22 maintains a swollen shape at normal pressure, and the balloon maintains approximately the state stuck to the trachea 10 when a ventilator device 16 sends out air into the balloon 22 via a hole 24 provided in an internal tube section. The swollen shape is maintained under the pressure of exhalation not aiming at vocalization, and the swollen shape is reduced under the pressure of exhalation aiming at vocalization. Exhalation is sent out toward the vocal cord via the gap between the balloon 22 of reduced shape and the trachea wall. The film thickness of the balloon 22 is 0.01-0.7 mm. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

The present invention relates to a tracheostomy tube. More specifically, the present invention relates to a tracheostomy tube that can be uttered when exhaling air even when the tracheostomy tube is tracheostomized and inserted into the body.

Normal ventilation with a tracheostomy tube is performed by incising the trachea in the neck, placing a tube with a balloon in the trachea and connecting it to the ventilator. It is used in such a way that oxygen or air is sent to the lungs with a ventilator, while the balloon is pressed against the inner wall of the trachea so that oxygen or air does not flow toward the mouth.

In this method, the balloon is always inflated so that the gap between the trachea and the tube is blocked so that the air to be respired only passes between the ventilator and the lungs. Otherwise, when air is sent in, a lot of air does not reach the lungs, but leaks out from the mouth, making effective artificial respiration impossible.

On the other hand, since the vocal cords are located between the trachea and mouth, using a conventional tracheostomy tube,
Unable to send air to the vocal cords and the patient cannot speak. In order to solve this problem, the applicant of the present application has proposed a tracheostomy tube that can be generated even if a tracheostomy tube with a balloon is inserted into the trachea (Japanese Patent Laid-Open No. 2003-210585). The tracheostomy tube includes an inner tube portion disposed in the trachea, an outer tube portion connected to the ventilator, and a balloon disposed around the entire outer periphery of the inner tube portion. The inner tube portion is attached to the outer side of the balloon so that the inner side and the outer side of the balloon cannot communicate with each other, and the inner tube portion has a hole that allows the inner side of the inner tube portion to communicate with the inner side of the balloon. It is characterized by this.

According to this tracheostomy tube, when inhalation, that is, when the ventilator sends air, the air from the ventilator is sent to the inside of the balloon through the hole provided in the inner tube portion, and the balloon is inflated. The gap between the trachea and the tube can be blocked so that the air sent by the ventilator does not leak and flows into the lungs. When exhaling, that is, exhaling, the air inside the balloon returns to the inside of the inner tube portion through the hole provided in the inner tube portion, and the balloon shrinks to the original size so as to contact the outer wall of the inner tube portion. A gap is created between the tube and trachea, and part of the exhaled breath flows out of the body through the vocal cords. This allows the patient to speak.
Japanese Patent Laid-Open No. 2003-210585

In the conventional tracheostomy tube, if the balloon is not completely inflated during inspiration, the air sent from the ventilator leaks from the gap between the balloon and the tracheal wall, and effective ventilation cannot be performed, and expiration occurs. Each time the patient's vocal cords are exposed to air, there is a risk of placing a burden on the patient, and when exhalation occurs, saliva may reach the area beyond the balloon through the trachea and the contracted balloon There is.

Therefore, in order to solve such problems, the present invention ensures that the balloon is inflated during inspiration, the air is sent to the lung without leaking, and when the patient wants to speak, exhalation reaches the vocal cords, It is another object of the present invention to provide a tracheostomy tube that prevents saliva from entering the trachea during exhalation when speech is not desired.

To achieve the above object, the present invention comprises an inner tube portion disposed in a trachea, an outer tube portion connected to a ventilator, and a balloon disposed on the entire outer periphery of the inner tube portion. Equipped,
The balloon is attached to the outside of the inner tube portion so that the inside and outside of the balloon cannot communicate, and the inner tube portion communicates the inside of the inner tube portion with the inside of the balloon. In the tracheostomy tube having a hole, the balloon maintains an inflated shape at normal pressure, and when the ventilator sends air to the balloon through the hole provided in the inner tube portion, the balloon Since the balloon is almost in close contact with the trachea and the pressure of the balloon is further increased, the balloon is tightly attached to the tracheal wall, so that air is sent to the lungs without leakage and exhalation pressure not intended for vocalization Then, while maintaining the inflated shape, the inflated shape is reduced by the exhalation pressure for the purpose of vocalization, and through the gap between the reduced-shaped balloon and the tracheal wall. Exhalation configured to be sent towards the vocal cords, the thickness of the balloon is characterized in that it is 0.01～0.7Mm.

In a preferred embodiment of the present invention, the balloon material is maintained so that the inflated shape is maintained at the time of inhalation and exhalation pressure not intended for vocalization, and the inflated shape is reduced by the exhalation pressure intended for vocalization. At least one of size, shape, and balloon film thickness is adjusted.

A preferred method for manufacturing a tracheostomy tube according to the present invention is to use a spherical mold, a spherical mold, or an elliptical or trapezoidal mold by dipping, in which the mold is immersed several times in a liquid of a material such as silicon rubber or urethane. A film of silicon or the like is formed around the periphery, and then it is taken out to form a balloon. The mold is taken out from the openings formed at both ends of the balloon, the inner tube is inserted into the opening, and the inner tube and the balloon are Seal the joint. Conventionally, a cylindrical mold was used, but this would result in a balloon that is contracted at normal pressure. Therefore, it is desirable to use a spherical or elliptical mold.

Suitable materials for balloons include materials that can be made freely, such as silicone rubber and urethane,
A suitable film thickness is 0.01 to 0.7 mm, preferably 0.05 to 0.35 mm, more preferably 0.15 to 0.3 mm.
It is. Thereby, the state which the balloon has become spherical at normal pressure can be maintained. However, since it is a thin film made of silicon, it shrinks with a little pressure.

The shape of the balloon is almost a sphere, but its diameter is slightly larger in the direction perpendicular to the direction in which the bronchus extends (
It is preferable that the shape is an ellipse having a shape of 1/3 at most with respect to the direction in which the bronchus extends. With this shape, the balloon can maintain a spherical shape at the pressure of exhalation without normal pressure or vocalization, and at the same time, the adhesion area with the tracheal wall can be narrowed. That allows air to pass between the trachea and the balloon.

As described above, the present inventor pays attention to the difference between the exhalation pressure for the purpose of utterance and the exhalation pressure for the purpose of utterance of the patient wearing the tracheostomy tube, By providing a balloon-inspired tracheostomy tube that maintains an inflated shape with the latter pressure, exhalation reaches the vocal cords when the patient wants to speak and saliva enters the trachea during exhalation that does not want to speak This is what I did not.

FIG. 1 shows a tracheostomy tube 12 positioned in a patient's trachea 10. FIG. 1 shows an intake state. The tracheostomy tube 12 is connected to a ventilator 16 via a communication tube 14. The tracheostomy tube 12 includes an inner tube portion 18 disposed in the trachea, an outer tube portion 20 connected to the ventilator 16, and a balloon 22 disposed on the entire outer periphery of the inner tube portion. .

The balloon 22 is attached to the outer wall of the inner tube portion 18 with an adhesive or the like over the entire circumference of the inner tube portion 18 in the upper and lower portions of the balloon 22 so that the inner side and the outer side of the balloon 22 cannot communicate with each other. . The inner tube portion 18 has a hole 24 that allows communication between the inside of the inner tube portion 18 and the inside of the balloon 22. The holes 24 are configured by variously shaped holes, slits, meshes, opening portions of columnar structures, and the like.

The ventilator 16 repeats inhalation and exhalation at a predetermined cycle. When inhaling, the ventilator 16 discharges a predetermined amount of oxygen or air at a predetermined pressure, and when exhaling, the inside of the tracheostomy tube 12 and the atmosphere. To communicate with each other. When a patient wearing a tracheostomy tube exhales by himself / herself, exhales slightly more strongly for the purpose of speaking, and weakly exhales if not intended for speaking. The expiratory pressure in the former case is usually 5-10 cmHg, and the expiratory pressure in the latter case is usually 2-3 cmHg.
It is.

FIG. 2 is a partially enlarged perspective view of the inner tube portion 18 including the balloon 22. As described above, the balloon is formed from a thin film of silicon rubber and maintains a substantially spherical shape at normal pressure. When this balloon is inserted into the trachea and air is supplied from the ventilator to the balloon with a pressure of 5 to 100 mmHg, the balloon 22 is further inflated and closely contacts the tracheal wall as shown in FIG. That is, when oxygen or air is sent into the tracheostomy tube 12 by the ventilator 16 during inspiration, air is sent into the balloon 22 through the hole 24 of the inner tube portion 18, and The balloon 22 in an inflated shape is further expanded by pressure, and the outer surface of the balloon 22 is in the trachea 10.
It strongly adheres to the side of the tract and prevents communication between the lung side of the trachea and the mouth side of the trachea. This effectively allows oxygen or air to be delivered to the patient's lungs without air leakage.

FIG. 3 shows a state of exhalation that is not intended for vocalization. At this time, since the pressure of the exhalation is relatively weak, the inflated shape of the balloon 22 is maintained almost the original shape without being reduced by the exhalation pressure. Since the balloon is in contact with the inner wall of the trachea 10, exhalation 300 enters the inner tube 18 without forming a gap between the balloon and the inner wall of the trachea. Since the balloon 22 is in contact with the inner wall of the trachea, the saliva 302 does not enter the lung side of the trachea.

On the other hand, FIG. 4 shows a state of exhalation intended for utterance. At this time, since the pressure of exhalation becomes relatively high, the inflated shape of the balloon is reduced by exhalation, and a gap through which exhalation can pass is formed between the balloon 22 and the trachea 10. When the exhalation 400 passes through this gap and reaches the vocal cords, speech can be made. Furthermore, at the time of vocalization, saliva stored on the mouth side of the balloon is discharged to the mouth side due to the high pressure generated at that time.

When the balloon is exhaled for vocalization, the circular shape at normal pressure is reduced. In exhalation not intended for vocalization, maintaining the circular shape without reducing the shape is the material, shape, and membrane of the balloon. This can be realized by appropriately adjusting at least one of thickness and size.

An example of the material of the balloon is silicon rubber. Silicone rubber has a hardness of JIS K630
1 (Type A) is preferably 20-60, and the elongation is 200-1500 in JIS K6301 (Type 3)
% Is preferred. Further, silicon rubber is preferable if it has high tear strength and self-adhesiveness.

Weigh 60g of commercially available band-like silicone rubber, put it in a 500cc beaker, slowly add toluene while gradually adding toluene to make a toluene dispersion, and then apply a release agent in advance and air dry 100m
A uniform coating film was prepared by immersing mΦ aluminum round bar mold several times above and below. The coating film is sufficiently air-dried and then heated and cured in an oven at 150 ° C. for 10 to 15 minutes. Next, the balloon is peeled off from the mold and washed with water. A balloon was attached to an endotracheal tube (outer diameter 10.4 mm) made of silicon rubber to form the tracheostomy tube of the present invention. The balloon thickness was 0.2 mm.

The tracheostomy tube was then applied to cases requiring artificial respiration. There were 3 cases, 80-year-old male (COPD), 71-year-old male (sequelae of tuberculosis), and 83-year-old male (COPD), all of whom were under artificial respiration management at home.

Two ventilator modes were performed with pressure control and one with volume control.
Previously, since they were managed by a conventional tracheostomy tube, all three people could not talk, but when they were replaced with the tracheostomy tube of the present invention, all three cases were able to talk during exhalation. After exchanging with the tracheostomy tube of the present invention, three people can talk and the quality of life has improved dramatically. In all three cases, aspiration pneumonia did not occur during follow-up for about one month.

According to the embodiment described above, silicon rubber is used as the material of the balloon, but materials such as urethane and vinyl chloride can also be used. It is also possible to form the balloon integrally with the inner tube. Furthermore, in the said embodiment, although the balloon was manufactured with the dipping method, it is also possible to shape | mold a balloon using a metal split mold, and to adhere this to a tube, and to obtain the tracheostomy tube concerning this invention. Furthermore, the balloon and the tube can be molded integrally.

FIG. 3 shows a schematic diagram of a tracheostomy tube placed in a patient's trachea. FIG. 2 is a partially enlarged perspective view of an inner tube portion provided with a balloon. FIG. 3 is a schematic view of a tracheostomy tube showing a state of exhalation not intended for vocalization. FIG. 4 is a schematic diagram of a tracheostomy tube showing a state of exhalation intended for vocalization.

Explanation of symbols

Patient trachea: 10, tracheostomy tube: 12, communication tube: 14, ventilator: 16, inner tube portion placed in the trachea: 18, outer tube portion: 20, and balloon: 22.

Claims (1)

An inner tube portion disposed in the trachea, an outer tube portion connected to the ventilator, and a balloon disposed around the entire circumference of the inner tube portion, the balloon being disposed on the inner side of the balloon It is attached to the outside of the inner tube portion so that it cannot communicate with the outside, and the inner tube portion is
In a tracheostomy tube having a hole that allows communication between the inside of the inner tube portion and the inside of the balloon,
The balloon maintains an inflated shape at normal pressure, and when the ventilator sends air to the balloon through the hole provided in the inner tube portion, the balloon is in a state of being in close contact with the trachea. The expansion shape is maintained at an exhalation pressure not intended for vocalization, and the expansion shape is reduced at an exhalation pressure for the purpose of vocalization, and the reduced shape of the balloon and tracheal wall is reduced. A tracheostomy tube, wherein exhaled breath is delivered toward the vocal cords through a gap therebetween, and the film thickness of the balloon is 0.01 to 0.7 mm.

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