RU2765777C2 - T-shaped silicone radiocontrast endotracheal and tracheostomy tube - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely, to a T-shaped silicone radiocontrast endotracheal and tracheostomy tube intended for forming a lumen of the larynx or trachea in chronic stenoses localised below the tracheostome and providing pulmonary ventilation. The tube consists of medical silicone, barium sulphate powder in the amount of 20% wt. is introduced into the silicone, absorbable by X-rays, with the possibility of X-ray monitoring of the position of the tube in the lumen of the respiratory tract. The T-shaped silicone radiocontrast endotracheal and tracheostomy tube is configured to shorten the proximal elbow up to 1.5 cm. The length of the distal elbow is configured to be installed in accordance with the length and localisation of the stenotic area so that the distal end of the tube is placed 1 cm below the stenosis.

EFFECT: occurring radiocontrast property of the T-shaped endotracheal and tracheostomy tube, creating the possibility of objective X-ray monitoring of the position of the tube in the lumen of the respiratory tract in prolonged prosthetics thereof, by routine methods: computed tomography, tomosynthesis, analogue and digital radiography.

1 cl, 8 dwg

Description

SUBSTANCE: invention relates to medicine, in particular to otorhinolaryngology, for carrying out prosthetics of the reconstructed lumen of the larynx and trachea after laryngotracheoplastic surgery and for performing X-ray monitoring of the condition of the operated organs and the standing of the prosthesis (tube).

Currently, rational prosthetics of the lumen of the larynx and/or trachea after the elimination of cicatricial stenosis is an urgent task. According to the National Guidelines for Otorhinolaryngology (2016), cicatricial stenosis of the larynx / trachea is a pathological process, which is based on the replacement of normal structures of the larynx / trachea wall with connective tissue, leading to a narrowing of the lumen with the development of respiratory failure and, as a rule, requiring surgical correction. The effectiveness of postoperative treatment is largely achieved through the use of optimally sized tracheostomy tubes, stents, and protectors, which makes it possible to achieve stable expansion of the lumen within 6-8 months and proceed to the next stage of reconstruction. In this regard, of particular relevance is the need to use such a tube that could be easily removed and installed by the patient himself through the tracheostomy opening, would provide natural breathing and phonation, would not have the risk of dislocation, and control over its standing in the lumen of the larynx and/or trachea could would be carried out without resorting to complex, invasive, expensive, diagnostic techniques in the form of video laryngotracheobronchoscopy or computed tomography.

For prosthetics of the larynx and / or trachea after the elimination of cicatricial stenosis, many options have been proposed: the use of tracheostomy tubes with a fixed finger obturator (Zenger V.G. et al., 2007), T-shaped tubes from various manufacturers (Shulutko AM et al., 2006), Dumon tracheal stents (Dumon JF, 1989).

A known method of tracheal prosthesis with tracheostomy tubes made of transparent biocompatible polyvinyl chloride, including radiopaque, for example Blue Line Ultra Suctionaid Portex tracheostomy tube (Smiths Medical, UK) or Shiley tube (Covidien, Ireland). In these tracheostomy tubes, X-ray contrast is achieved by an X-ray contrast strip running through the body of the tube, which allows the silhouette of the tube to be identified in the lumen of the trachea on X-ray examination. The disadvantages of using these tubes include the impossibility of prosthetic replacement of the proximal trachea and / or larynx (subglottic section), as well as the inability to clearly assess all the contours of the tracheal mucosa adjacent to the tube, with the exception of the area where the X-ray contrast strip is applied.

A known method of prosthetics of the trachea distal to the tracheostomy opening using the so-called split endotracheal tube, which is an elongated tracheostomy tube made from a conventional tube for orotracheal intubation with X-ray contrast strip (Zenger VG, 1988). Such a tube, having shortened it to the desired length, is partially cut along the proximal end and inserted into the tracheostomy to the incision line. Having made holes in the walls of the cut part of the tube, they are pulled apart and fixed with a bandage around the neck. The method is simple, cheap and can be used for stenosis of any localization (from tracheostomy to tracheal bifurcation), but it does not allow breathing through the nose and free phonation, changing the tube, as a rule, requires the participation of a doctor, there is no possibility of prosthetic replacement of the proximal trachea, and as in In the case of using X-ray contrast tracheostomy tubes, there is no information about the contours of the mucous membrane except for the area where the X-ray contrast strip is applied.

There is a known method of stenting the trachea with self-fixing stents held in the lumen of the respiratory tract due to either protrusions on the outer surface (Dumon J.-F., 1989), or pressure from the inside on the walls of the trachea - the Polyflex stent (Rusch, Germany), or its Y-shape (Cooper JD et al., 1989; Freitag L. et al., 1997). Currently, the most widely used in endoscopic surgery of the trachea and bronchi are X-ray contrast silicone stents "Endoxane" (Dumont stents) ("Novotech", - France) - and their domestic counterparts manufactured by CJSC "Medsil" (Russia), thin-walled silicone stents "Polyflex" ("Rusch", - Germany) and expandable metal stents with silicone coating "Ultraflex" and "Wallstent" ("Boston Scientific Corporation", - USA). Their advantages are sufficiently reliable fixation, a well-established technique of administration, the possibility of using in the trachea and large bronchi, and relative neutrality with respect to the mucous membrane of the respiratory tract. At the same time, they are not used in the presence of a tracheostomy, installation and removal require general anesthesia, bronchoscopy, a special instrument, the impossibility of prosthetics of the larynx, the risk of dislocation in the trachea.

A known method of prosthetics of the larynx and/or trachea T-shaped rubber stent Montgomery (Montgomery W.-W., 1965). The stent has a horizontal (intratracheal) part and a vertical (outer) knee. The advantages of this stent are the preservation of natural breathing through the nose, phonation, secure fixation in the trachea and the ability to aspirate the contents of the trachea through its external knee. The T-shaped stent can be used for stenosis of the larynx (the level of the cricoid cartilage), the upper and middle thirds of the trachea, located both below and above the tracheostomy. Its disadvantages include the lack of x-ray contrast.

T-shaped silicone endoprostheses, analogues of the Montgomery stent, endotracheal-tracheostomy T-shaped silicone disposable TETsK and TETsO tubes manufactured by CJSC MedSil (Russia), TU 9398-018-18037666-00 (Fig. one). Medical silicone is a mixture of silicone rubber, the structure of which is most inert to solutions, most acids and alkalis. It is resistant to the accumulation of bacteria, does not cause allergic reactions, has no smell, its structure is homogeneous. The fragility, service life, transparency, purity and other characteristics of medical silicone depend on the additives introduced. Made from more tissue-neutral silicone, the tube has a vertical (intratracheal) section and a horizontal (outer) elbow. Available in various sizes, the tube can be fitted to almost any anatomical size of the trachea (Fig. 2).

It ensures the preservation of natural breathing through the nose or mouth, phonation, is securely fixed in the trachea without the risk of dislocation, provides the ability to aspirate the contents of the trachea and bronchi through its external knee. The T-tube can be used for stenosis of the larynx, upper and middle third of the trachea, located both below and above the tracheostomy. After training, patients independently install and remove the tube, without depending on the doctor, without resorting to anesthesia. Its disadvantages include the lack of x-ray contrast.

The objective of this invention was to develop an X-ray contrast device (product) for effective prosthetics of the larynx and / or trachea after reconstructive surgery and objective monitoring of the consistency, position of the device (product) in the lumen of the respiratory tract, based on the use of available radiological imaging methods.

The essence of the invention lies in the fact that the proposed device (product) tube endotracheal-tracheostomy T-shaped silicone x-ray contrast (Fig. 3). Types of tubes and their sizes correspond to silicone non-X-ray contrast. (Fig. 2). The X-ray contrast properties of the T-shaped silicone tube are obtained by introducing into the composition of silicone a fine powder of barium sulfate in an amount of 20 wt. %, which is well absorbed by x-rays. The introduction process is carried out according to well-known technology on mixing rollers.

The technical essence and principle of operation of the proposed tool are illustrated by drawings, in which:

Fig. 1 - General view of the endotracheal-tracheostomy T-shaped silicone tube;

Fig. 2 - types of tubes, tube sizes;

Fig. 3 - General view of the endotracheal-tracheostomy T-shaped silicone tube X-ray contrast;

Fig. 4 - view of the anterior surface of the patient's neck with an installed endotracheal-tracheostomy T-shaped silicone tube;

Fig. 5 - multislice computed tomography a, b - 3D reconstruction; c - MPR in the oblique plane; d - MPR in the axial plane; e - MPR in the frontal plane;

Fig. 6 - analog radiography, a - radiograph of the lower parts of the neck and chest organs in direct projection; b - X-ray of the chest organs in the lateral projection; c - radiograph of the lower parts of the neck in the lateral projection;

Fig. 7 - digital radiography, a - radiograph of the lower parts of the neck and chest organs in direct projection; b - X-ray of the lower parts of the neck in the lateral projection.

Fig. 8 - tomosynthesis, a, b, c - digital tomosynthesis images of the neck and upper chest in the lateral projection.

The technical result of the invention is the emerging X-ray contrast property of the endotracheal-tracheostomy T-tube, which makes it possible to objectively control the position of the tube in the lumen of the respiratory tract during long-term prosthetics, using routine methods: computed tomography, tomosynthesis, analog and digital radiography.

The device (product) is used as follows. - The procedure for installing the tube is performed under local application anesthesia, for example, an aqueous solution of 2-4% lidocaine, instilling the latter into the lumen of the trachea through a tracheostomy. The diameter of the tube and the length of the proximal (cranial) and distal (caudal) knees of the horizontal part are selected according to bronchoscopy and computed tomography. If the stenosis is localized below the tracheostomy, the proximal elbow of the tube is shortened to 1.5-2 cm, and the length of the distal elbow is set in accordance with the length and location of the stenotic zone so that the distal end of the tube is 1.0-1.5 cm below the stenosis. When the stenosis is localized above the tracheostomy, the length of the proximal knee is determined by the distance from the tracheostomy to the vocal cords so that the end of the tube does not touch them.

With a short proximal elbow of the tube, the end of the distal elbow is grasped with a curved clamp (without teeth) and inserted through the tracheostomy towards the bifurcation of the trachea until the end of the shortened proximal knee, folded together with the outer knee, is hidden in the tracheostomy. At the same time, a second safety clip is applied to the edge of the outer elbow of the tube. Once the end of the proximal knee is in the lumen of the trachea, it is straightened in the trachea by gentle traction.

The correct position of the tube is controlled for the first time using video laryngotracheoscopy, and subsequently radiographically.

Removal of the T-shaped tube in all cases is carried out without anesthesia by sufficiently quickly pulling up the vertical elbow of the tube.

The possibility of carrying out the claimed invention is shown by the following examples.

Tube endotracheal-tracheostomy T-shaped silicone x-ray contrast installed to the patient after laryngotracheoplasty to eliminate stenosis of the larynx and cervical trachea.

X-ray visualization of the position of the tube, its patency was studied: when performing multislice computed tomography (Fig. 5), radiography (Fig. 6, Fig. 7), tomosynthesis (Fig. 8).

- Multislice computed tomography. Dose: 4.5 mSv. Area of study: lower neck, chest organs.

The study was performed in a spiral scanning mode, without intravenous contrast enhancement, followed by image reconstruction.

On a series of tomograms of the lower parts of the neck and chest in the lumen of the trachea at the level of C VI - Th P vertebrae, an X-ray contrast T-shaped tracheostomy tube is visualized with dimensions of 76.7 × 52.9 mm, diameter 15.0 mm (outer), 9.0 mm (internal). The tube is anatomically correct, its upper part is visualized at the level of the lower edge of the thyroid cartilage, the lower one is at the level of the sternoclavicular joint. The transverse part opens on the skin of the anterior surface of the neck, closed with a plug, the rest of the tube is passable. The tube is elastic, the cross section takes an oval shape in some places, its walls are about 2.5 mm thick, the density varies in the range of 870-1357 HU, there are no significant artifacts.

Conclusion: Consequences of installing an X-ray contrast T-shaped tracheostomy tube - an adequate position.

- Radiography. Dose: 0.9 mSv

Area of study: lower neck, chest organs.

On radiographs of the neck with the capture of the organs of the chest in frontal and lateral projections (3 images) in the lumen of the trachea at the level of C VI - Th P vertebrae

an x-ray contrast T-shaped tracheostomy tube with a diameter of about 12 mm is visualized, installed anatomically correctly, reaching its distal end to the level of the sternoclavicular joint. The transverse part is located at the level of C VI - C VII vertebrae, its diameter is about 25 mm. All departments of the tube are visualized qualitatively, have clear, even contours, its lumen appears to be passable throughout.

Conclusion: Consequences of installing an X-ray contrast T-shaped tracheostomy tube - an adequate position.

- Tomosynthesis. Dose: 2.0 mSv.

Area of study: lower neck, chest organs. An X-ray contrast T-shaped tracheostomy tube with a diameter of about 12 mm, installed anatomically correct reaching its distal end to the level of the sternum-clavicular joint. The transverse part is located at the level of C VI - C VII vertebrae, its diameter is about 25 mm. All departments of the tube are visualized qualitatively, have clear, even contours, its lumen appears to be passable throughout.

Conclusion: Consequences of installing an X-ray contrast T-shaped tracheostomy tube - an adequate position.

Based on the analysis of analog and digital radiographs in frontal and lateral projections and digital tomosynthesis data in the lateral projection of the lower zone of the face, neck with chest organs, it can be concluded that the used X-ray contrast T-shaped tracheostomy tube is visualized by all routine methods of X-ray examination. The best quality of determining the details of the tube, as well as the surrounding anatomical objects (to determine the position of the object under study) was achieved with digital radiography and tomosynthesis. The verification method was multislice computed tomography, which allows a detailed assessment of almost any objects that differ in density by more than 3-4%.

Claims (1)

Tube endotracheal-tracheostomy T-shaped silicone x-ray contrast is designed to form the lumen of the larynx or trachea in chronic stenosis, localized below the tracheostomy, and to provide ventilation of the lungs, consisting of medical silicone, the silicone contains barium sulfate powder in the amount of 20 wt. %, absorbed by X-rays, with the possibility of X-ray control of the position of the tube in the lumen of the respiratory tract, while the endotracheal-tracheostomy tube T-shaped silicone X-ray contrast is made with the possibility of shortening the proximal knee to 1.5 cm, while the length of the distal knee is made with the possibility installation in accordance with the length and localization of the stenotic zone, so that the distal end of the tube is 1 cm below the stenosis.

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