WO2016028239A1

WO2016028239A1 - An intubation tube used in tracheostomy practices

Info

Publication number: WO2016028239A1
Application number: PCT/TR2014/000290
Authority: WO
Inventors: Mehmet Akif YAŞAR
Original assignee: Yaşar Mehmet Akif
Priority date: 2014-08-20
Filing date: 2014-08-20
Publication date: 2016-02-25

Abstract

The invention relates to an intubation tube (10) comprising a protective sheet (20) with C shaped cross section in the trachea end (80) of said intubation tube (10) used during tracheostomy operation in order to reduce complications that are likely to arise during the practice, a fiber optic light (40), a camera (30) and a shortened cuff (50).

Description

An Intubation Tube Used in Tracheostomy Practices DESCRIPTION Technical Field

The invention relates to an intubation tube used in tracheostomy practices.

The invention particularly relates to preventing complications that are likely to occur during tracheostomy process as intubation tube comprises a protective sheet, a fiber optic light, a camera and a shortened cuff.

Prior Art Tracheostomy is the process of forming a hole in front of the main trachea and providing a path for breathing or providing respiration support to the patient via a tube placed within this hole. By virtue of tracheostomy process, it is possible to protect the structures in the upper respiratory tract, remove secretions, and supply more air and oxygen to the lungs. This process also assists in providing means of caring patients outside the intensive care unit. In tracheostomy practices, it is possible to implement Surgical or Percutaneous dilatational tracheostomy (PDT). In Surgical or PDT practices, anesthesia is applied to the patient during the process through preliminary preparations and monitorization.

Today, PDT techniques are rather more preferred particularly in intensive care units. The primary reasons for preferring PDT are minimal invasivity, cost-effectiveness, shorter process duration and no need for transferring the patient to the surgical room (reduced transport complications). Although PDT process provides advantages, the principal problems experienced by all PTD processes defined until today are identification of the insertion site just at the beginning of the process, placement of needles or dilatators when applying the method and causing injuries in the esophagus by penetrating the posterior wall of the trachea or further during dilatation.

Sometimes, various undesirable complications might occur during/after tracheostomy. Their probability of occurrence is around 1%. Said complications are conditions such as hemorrhage, rupture between trachea and esophagus, damages in the peripheral veins, fistula formation between trachea and vital veins, nerve injuries and hoarseness. Surgical operations at larger scale might be necessary in case such complications develop. Moreover, infectious conditions such as infection, mediastina, etc. can also be observed at the wound site. At the late period, a soft tissue that will constrict the trachea might also develop at the end of the tube. In addition to the foregoing, temporary or permanent hoarseness, and loss of function associated with facial, eyebrow, hearing, swallowing, eye and eye movements and some problems might develop depending on medication/medical substance use.

The risk of mortality is extremely low (<1 %).

In order to minimize said surgical complications, some operations (one or several) are applied to the patient simultaneously by a second person in order to verify the site of the installed cannula when performing PDT. These operations are fiber optic bronchoscope, capnography, radiology or confirmation of spontaneous respiration.

The most common additional practice implemented during tracheostomy process is the fiber optic bronchoscopy. This operation has some advantages and disadvantages. The advantages are confirmation of needle procedure, prevention of postoperative wall damages and prevention of accidental extubation. The disadvantages, on the other hand, are reduced ventilation/oxygenation, additional personnel requirement and increased cost/time.

During tracheostomy process; first the trachea of the patient and the interval where the operation will be applied is identified and said site is incised until subcutaneous tissue for approximately 1.5-2 cm. However, some challenges can be encountered in identification of the location where the process will be performed. Therefore, loss of time and failure can be experienced. After the incision, the endotracheal tube cuff is deflated and the tube is retracted in order to avoid prevention of needle insertion. Aspiration is performed with the help of the injector installed to the needle. The aspired air, on the other hand, is an indication of penetration into trachea. Another operation that enables site identification is visualization of the needle in the anterior wall of the trachea with the fiber optic bronchoscope performed by a second person during air aspiration. The reason for choosing fiber optic bronchoscope in the practice is to prevent possible damages by observing approach of the needle or the dilators to the posterior wall of the trachea. However fiber optic bronchoscope is a challenging practice which needs time to prepare and implement. Moreover, one more person to perform this practice is required in addition to the person performing tracheostomy.

A guide wire is introduced within the needle after aspiration process. The guide wire is determinant for further processes. If the ventilation is applied under high pressure by means of a tube with its cuff air being deflated or especially ventilator (PEEP >10 CmH20), it affects treatment process in the lungs. In the prior art, on the other hand, preservation of ventilation and oxygenation cannot be achieved soundly.

The guide wire inserted through advancement within the needle then acts as a guide for the dilatation and tracheostomy cannula. The needle is removed after insertion of the guide wire. In all kinds of said dilatation process; posterior/lateral walls of the trachea, even the esophagus can be punctured, injured. After dilatation process, the operation is finalized by installing the tracheostomy cannula. Another disadvantage of the prior art is that the intubation tube fails to cover the trachea completely as the cuff of the intubation tube is deflated and the tube is retracted. Therefore, the air directed to the lungs by the ventilator returns and is exhaled from the mouth, especially in the pressure ventilation practices. Sufficient volume of air cannot be supplied to the lungs due to the air exhaled from the mouth. The alveoli kept open with pressure in the lungs are closed. The pressure applied with the ventilator during the process almost dissipates thus deteriorating the ventilation of the lungs. In order to ensure oxygenation, this type of tracheostomy is not applied to the patients who require high pressure.

The size of the cuffs available in the intubation tubes of the prior art varies in the range of 3.5-4.5 cm. However, this fact narrows the area desired to be used for tracheotomy. Moreover, aspiration of the intraoral fluid first to the trachea then to the lungs can be performed due to lowering of the cuff. This fact, on the other hand, increases the risk of infection in the lungs. One of the patents available in the literature on this subject matter is the application No. US2010300448A1. In said application, the camera is positioned on the tracheostomy cannula of the invention. The purpose of using camera here is to observe the damage that is likely to occur in the trachea wall as the cannula remains on the trachea for long time. This situation will only prevent the damages after tracheostomy and fails to prevent the damages that are likely to occur during said operation. Because, as the tracheostomy cannula is a cannula that remains installed on the trachea after the operation; the intubation tube of the invention is used during tracheostomy operation.

The patent application No. US20120088971A1 , on the other hand, relates to a device containing a camera and used at the orotracheal intubation procedure and fixed to the mouth by means of teeth. Said device is used for observation of the throat section of the patient. In conclusion, an improvement is necessary in the respective technical field due to aforementioned disadvantages and due to inadequacy of the available solutions on the subject matter. Objective of the invention

The present invention relates to an intubation tube used in the tracheostomy practices, which fulfills aforementioned requirements, eliminates all disadvantages and brings some additional advantages.

The primary objective of the invention is to obtain an intubation tube comprising a protective sheet on the lower and lateral walls of which a metal layer is placed after the cuff and has cross-section in the form of C. In this manner, the protective sheet acts as a barrier in front of the posterior wall and lateral walls of the trachea during tracheostomy operation when installing the needle and the dilatator, thus preventing possible damages. In this manner, said complications do not occur.

Another objective of the invention is to ensure safe identification of the application zone in the trachea by virtue of the detachable fiber optic light and camera available on the device. In this manner, tracheostomy operation is performed more securely, in shorter period and with lower cost.

An objective of the invention is to ensure elimination of the need for fiber optic bronchoscope practice, which is performed simultaneously with the tracheostomy operation by virtue of the elements such as light and camera comprised thereon. In this manner, tracheostomy operation can be performed by only one person, without any need for an additional person to perform fiber optic bronchoscope operation.

Another objective of the invention is to avoid deterioration of oxygenation by ensuring continuity of ventilation as the intubation tube comprises shortened cuff. By virtue of the cuff contained in the intubation tube of the invention, pressure can still be applied although the cuff is shortened. Moreover, aspiration in the stomach and mouth is prevented by virtue of the inflated cuff, thereby minimizing the risk of infections. Moreover, hypoxia or hypercarbia and complications that are likely to arise due to the same are also prevented.

In order to fulfill the aforementioned objectives, the intubation tube used during tracheostomy operation comprises a protective sheet with C shaped cross section in the trachea end of said intubation tube, fiber optic light, camera and cuff with reduced diameter in order to diminish the complications that are likely to arise during the practice.

The structural and characteristic properties and all advantages of the invention will be understood more clearly by means of the figures provided hereunder and the detailed description written with reference to these figures and therefore the assessment should be performed taking into consideration said figures and detailed description.

Figures To Facilitate Understanding of the Invention

Figure-1 is the perspective view of intubation tube comprising the protective sheet.

Figure-2 is the view of the section of the intubation tube that enters into trachea.

Figure-3 is the general view of the camera-display system.

Figure-4 is the general view of the fiber optic light system.

Figure-5 is the general perspective view of the intubation tube.

Figure-6 is the view of the fiber optic and camera system comprising stop plate.

Figure-7 is the view of the fiber optic and camera system comprising stop gasket.

Figure-8 is the view of the cables passing through and entering into the intubation tube. The drawings are not necessarily drawn to be scaled and details not necessary for understanding the present invention may have been neglected. Moreover, elements that are either substantially identical or have substantially identical functions are illustrated with identical numbers.

Description of Part References

10. Intubation Tube 44. Adapter

20. Protective sheet 45. Power source

21. Metal layer 46. Light source

22. Coating 47. Fiber optic cable

30. Camera 50. Cuff

31. Transfer cable 60. Air cable

32. Stop plate 61. Air cable port

33. Transfer cable port 62. Pilot balloon

40. Fiber optic light 70. Display 42. Stop gasket 71. Jack

43. Fiber optic cable port 80. Trachea end

Detailed description of the invention In this detailed description, preferred embodiments of the intubation tube (10) of the invention are disclosed only for a better understanding of the subject matter without any limiting effect.

As illustrated in Figures 1 and 2, the invention comprises a protective sheet (20) with C shaped cross section in the trachea end (80) of said intubation tube (10) used during tracheostomy operation in order to reduce complications that are likely to arise during the practice. The open end of said protective sheet (20) with C shaped cross section is positioned in such manner to face the anterior wall where needle will be inserted. In this manner; the damages that are likely to occur in the posterior and lateral walls during insertion of the substances such as needle, dilatator used when opening a hole in the anterior wall of the trachea, are prevented. There is a metal layer (21) available in order to form a sound structure within the protective sheet (20). The periphery of said metal layer (21) is coated with a coating (22) made of a plastic material, thus forming the protective sheet (20). It can be used in both adult and pediatric patient group. As illustrated in Figure-2, there is a detachable fiber optic light (40) and a camera (30) extending up to the trachea end (80) of the intubation tube (10) of the invention. Said detachable fiber optic light (40) and camera (30) system can be reassembled to the disposable intubation tubes (10), after sterilization. The cables (31 , 47) of said systems advance within the intubation tube (10) and are fixed in the intubation tube (10) trachea end (80).

Figure 3 illustrates a general view of the camera (30)-display (70) system. The camera (30) is connected to a transfer cable (31) that transfers the displayed data. Said transfer cable (31) enters into the intubation tube (10) from the transfer cable port (33) and extends within the intubation tube (10) (Figure 8). The end of the transfer cable (30) extending from the intubation tube (10) is connected to the display (70) by means of a jack (71). In this manner, imaging is ensured on the display (70) by means of the camera (30) during tracheostomy operation. The display (70) to which the image captured by means of the fiber optic light (40) and camera (30) is transferred, provides guidance to the person performing the tracheostomy operation in identification of the anterior wall of the trachea, in advancement of the needle, in insertion of the guide wire and during dilatation.

Besides said camera (30) is the fiber optic light (40) enabling illumination of the medium. Said fiber optic light (40) protrudes from the trachea end (80) of the intubation tube (10) and illuminates trachea. As illustrated in Figure 4, illumination is ensured by means of a light source (46) available on the fiber optic cable (47). Moreover, as illustrated in Figure 5, the fiber optic cable (47) comprises thereon a power source (45) and one adapter (44). The fiber optic cable (47) enters into the intubation tube (10) from fiber optic cable port (43) (Figure 8).

Figure 6 and 7 illustrates a view of the fiber optic and camera (30) system comprising a stop plate (32) and a stop gasket (42). Camera (30) and fiber optic light (40) system comprises stop plate (32) which enables fixation of the intubation tube (10) in the trachea end (80); is positioned on both the camera (30) and the fiber optic light (40). Moreover, it further comprises stop gasket (42) for fixation. These elements ensure fixation of the camera (30) and the fiber optic light (40).

Said camera (30) and fiber optic light (40) can be used for multiple times, if sterilized, as this system is detachable. However, as said camera (30) and fiber optic light (40) systems will constrict the inner diameter of the intubation tube (10), it is not preferred for children aged 12 and below.

Said intubation tube (10) comprises a cuff (50). The length of said cuff (50) is reduced. The length of the cuff (50), which is shortened, is 0.4-0.7 cm. In this manner, no air leaks occur when cuff is inflated and a large space for tracheostomy is provided. Moreover, the upper and lateral walls of the tube are removed starting from the bottom end of the cuff (50). That is to say, the intubation tube (10) does not pass through the cuff (50) and the intubation tube (10) is terminated at the point where cuff (50) starts. The protective sheet (20), on the other hand, is extended through the cuff (50) up to the intubation tube (10) and is fixed thereto.

The intubation tube (10) of the invention further comprises a pilot balloon (62). There is an air cable (60) supplying air to said pilot balloon (62) and an air cable port (61 ) where said air cable enters into the intubation tube (10) (Figure 8).

Claims

1. An intubation tube (10) used during the tracheostomy operation, characterized in comprising a protective sheet (20) with C shaped cross section in the trachea end (80) of said intubation tube (10) in order to reduce complications that are likely to arise during the practice.

2. The intubation tube (10) according to Claim 1, characterized in comprising a metal layer (21) in the inner section of said protective sheet (20) and coating (22) made of plastic material, coated to the top and bottom part of said metal layer (21).

3. The intubation tube (10) according to Claim 1 , characterized in comprising fiber optic light (40) illuminating the trachea and camera (30) capturing images within the trachea, which are installed in the trachea end (80) of said intubation tube (10) and detachable.

4. The intubation tube (10) according to Claim 3, characterized in comprising at least one stop plate (32) fixing said fiber optic light (40) and camera (30) to the trachea end (80).

5. The intubation tube (10) according to Claim 3 or 4, characterized in comprising at least one stop gasket (42) that fixes said fiber optic light (40) and camera (30) to the trachea end

(80).

6. The intubation tube (10) according to Claim 3, characterized in comprising a display (70) that enables transfer of the images received via said camera (30) and fiber optic light (40).

7. The intubation tube (10) according to Claim 3 or 6, characterized in comprising a transfer cable (31) that transfers the images received from said camera (30) to the display (70) by means of a jack (71).

8. The intubation tube (10) according to Claim 3, characterized in comprising adapter (44), power source (45) and light source (46) supplying light and power to said fiber optic light (40).

9. The intubation tube (10) according to Claim 1 , 3 or 6, characterized in that; said intubation tube (10) comprises a cuff (50) with a size of 0.4-0.7 cm.

10. The intubation tube (10) according to any of the foregoing claims, characterized in comprising a pilot balloon (62) extending within said intubation tube (10) via an air cable (60).