RU194916U1 - DEVICE FOR STENTING SHARE BRONCH - Google Patents

Abstract

The utility model relates to medicine, namely to endoscopy, and can be used in operative surgical bronchoscopy for stenting of the lobar bronchus with strictures of various origins, in particular in patients with stenosis of the lobar bronchi, formed, for example, as a result of postoperative ischemia of the mucous membrane after lung transplantation . The device for stenting the lobar bronchus is made in the form of a tubular length of a polymer material having supporting projections on the outer surface and radiopaque marks, while the tubular segment is made with the possibility of tight placement at the distal end of the bronchoscope and is equipped with a jumper of polypropylene filament located in diameter in the middle of the tube. The inventive device can be used for diagnostic bronchoscopy under local anesthesia, which greatly simplifies the stenting process, reduces the time the patient’s stay in the hospital and avoids recurrent stenosis of the lobar bronchi.

Description

FIELD OF THE INVENTION

The utility model relates to medicine, namely to endoscopy, and can be used in surgical operative bronchoscopy for stenting of the lobar bronchus with strictures of various origins, in particular in patients with lobar stenosis formed, for example, as a result of postoperative ischemia of the mucous membrane after lung transplantation .

State of the art

It is known from the prior art to treat stenosis of the trachea and main bronchi with endoprosthetics using silicone self-fixing stents, which are installed in the lumen of the bronchus to stabilize the lumen of the bronchus and maintain its lumen in order to prevent complete closure of the bronchus with subsequent respiratory failure.

During lung transplantation, blood supply to the bronchial mucosa is due to retrograde blood flow. All of these patients in the postoperative period have ischemia of the transplant bronchial mucosa, which can lead to anastomotic and non-anastomotic stenosis. Anastomosis of the bronchi is superimposed on the upper edge of the mouth of the upper lobe and lower lobe bronchi. When an anastomosis of the left main bronchus is formed, the mouths of the lobar bronchi of the left lung are stenotic, with an anastomotic stenosis of the right bronchial anastomosis, the upper lobe of the right lung is stenotic. With standard stenting by known silicone endoprostheses of the anastomoses of the main bronchus in the postoperative period, granulation growths form at the level of the mouths of the lobar bronchi, which leads to restenosis. To solve this problem, repeated operations using general anesthesia are necessary. The proposed technical solution allows to solve this problem with diagnostic bronchoscopy under local anesthesia, which greatly simplifies the stenting process, reduces the length of the patient’s hospital stay and avoids recurrent stenosis of the lobar bronchi. To remove the stent from the lumen of the bronchus, surgical and general anesthesia are also not required; the device is removed during diagnostic bronchoscopy.

Various self-locking stents for treating bronchial stenosis that are held in the lumen of the airways due to protrusions on the outer surface are known in the art. Currently, Endoxane silicone stents (Dumont stents), manufactured by the French company Novatech, and their domestic counterparts manufactured by Medsil CJSC, thin-walled Polyflex silicone stents by Polyflex, are widely used in endoscopic surgery of the trachea and bronchi. Rusch "(Germany) and expandable metal stents with silicone coating" U1-traflex "and" Wallstent "of the company" Boston Scientific Corporation)) (USA). Their advantages are a fairly reliable fixation, a well-established introduction technique, the possibility of use in the trachea and large bronchi and relative neutrality with respect to the mucous membrane of the respiratory tract. However, the known stents are intended for stenting the trachea and large (main) bronchi, and cannot be used to treat stenosis localized in the mouths of the lobar bronchi.

In particular, the silicone tracheal stent "Dumont", selected as a prototype, is known from the prior art (Alezov A. A. Endoscopic prosthetics in the treatment of patients with cicatricial stenosis of the trachea. Abstract of Candidate of Medical Science Moscow 2004. 23 pp.) It is a tube made of medical silicone with spikes (protrusions) located on the outer surface and installed in the lumen of the trachea through the tube of an operating bronchoscope. However, the installation of such a stent requires an operating room equipped with a high-frequency ventilation device, as well as a set of tubes of a rigid bronchoscope. The operation is performed under general anesthesia.

The claimed solution allows you to install a stent in the lumen of the lobar bronchus after preliminary balloon dilatation of cicatricial narrowing during diagnostic bronchoscopy under local anesthesia with a solution of lidocaine. Also, to remove the stent from the lumen of the bronchus, special conditions are not required.

The technical problem, the solution of which is provided by the developed device, is the possibility of stenting the mouth of the lobar bronchus, as well as the removal of the stent (if necessary) from the lumen of the bronchus during diagnostic bronchoscopy under local anesthesia (without using operating and general anesthesia).

Disclosure of the invention

The technical result consists in simplifying the process of stenting of the lobar bronchus without the use of general anesthesia while reducing the patient’s stay in the hospital, as well as reducing the risk of recurrent stenosis of the lobar bronchi. The stent of the claimed design is made with the possibility of its installation in the lumen of the mouth of the lobar bronchus, previously bougie balloon dilator, with diagnostic bronchoscopy under local anesthesia.

The claimed technical result is achieved by using a stent made in the form of a tubular segment (tube) of polymer material having supporting projections and radiopaque marks on the outer surface (in the form of strips or protrusions), while the tubular segment is made with the possibility of tight placement at the distal end of the bronchoscope and equipped with a jumper of polypropylene yarn located in diameter in the middle of the tube.

To ensure the possibility of tight placement at the distal end of the bronchoscope, the inner surface of the tubular segment from the placement side at the distal end of the bronchoscope on a length of 4-8 mm is made in the form of a mounting surface (for example, repeating the shape of the outer surface of the distal end of the bronchoscope at the location of the stent).

Polypropylene yarn in a specific embodiment has a thickness of 0.2 mm. A jumper made of polypropylene thread can be formed by injecting an atraumatic needle with a thread from the side of the inner surface of the tube, removing the needle from the side of the outer surface of the tube and then injecting the needle from the opposite side towards the first injection with fixing the ends of the thread with a knotted suture with a thread tension without deformation of the tube and subsequent displacement of the nodal seam to the tube wall.

As a tubular segment (tube) made of a polymeric material with supporting protrusions and radiopaque marks, an Endoxane silicone stent (Dumont stents) manufactured by the French company Novatech or its domestic counterpart manufactured by Medsil CJSC, which has an external surface, can be used supporting protrusions and radiopaque marks, as well as a thin-walled silicone stent "Polyflex" company "Rusch" (Germany).

For atraumatic insertion of the stent of the claimed design at the mouth of the lobar bronchus, the tubular segment is made with a beveled (or rounded) outer edge from the distal and proximal ends.

In one embodiment of the stent, the tubular section is made with an external diameter without protrusions D = 6-7 mm, and an external diameter with protrusions D1 = 8-10 mm, an inner diameter d = 4-5 mm, length L = 10-12 mm

Thus, this technical result is ensured by a device for stenting the lobar bronchi, which, in essence, is a transparent silicone tubular (cylindrical) nozzle (stent) on the distal edge of the bronchoscope with a locking jumper in the middle part, represented by a ligature stitched through the tubular walls nozzles, with which a stent is installed in the lumen of the lobar bronchus and is removed from it. In this case, the jumper allows you to hold the stent at the distal end of the bronchoscope with forceps inserted into the endoscope channel and install it into the lumen of the lobar bronchus. Removing the endoscope, the stent is pulled together from the distal end of the bronchoscope and fixed in the lumen of the bronchus. Using a jumper from a polypropylene filament located in diameter in the middle of the stent, it is also easy to remove using forceps, while the endoscope is inserted into the stent lumen, the jumper is grasped with a forceps and the stent is removed without risk of respiratory failure in the patient. The stent is made of a silicone mixture with a resistance to radial compression of 2-4 N, which allows atraumatic delivery of a stent fixed at the distal end of the bronchoscope into the lumen of the trachea and lobar bronchus, and also ensures its tight placement on the distal end of the bronchoscope during delivery of the stent to the installation site and removal from the distal end (with little effort without the risk of trauma to the surrounding structures) at the time of installation of the stent in the stenosis at the mouth of the lobar bronchus.

Brief Description of the Drawings

The design of the claimed device is illustrated by drawings, where in FIG. 1 shows a general view of a stent mounted on the distal end of a bronchoscope; in FIG. 2 - general view of the stent; in FIG. 3 is a diagram of the formation of a jumper from a polypropylene thread; in FIG. 4 - stent with a jumper, top view, in FIG. 5 is an embodiment of a particular implementation of the inventive stent; in FIG. 6 is a diagram of the installation of the stent at the mouth of the lobar bronchus; in FIG. 7 - intraoperative photographs with examples of the installation of the stent of the claimed design: a) stenotic upper lobar bronchus of the left lung; b), c), d) the process of installing the stent in the lobar bronchus, monitoring the position of the stent; d) stenosis of the lower lobe bronchus; e) a stent in the lumen of the lower lobe bronchus; g) the position of the stent in the upper lobe bronchus of the left lung; h) the condition after stenting of the lobar bronchi and the left main bronchus at the level of bronchial anastomosis.

The positions in the figures indicate: 1 - stent (nozzle or tubular section or tube), 2 - distal end of the bronchoscope, 3 - protrusions on the outer surface of the stent, 4 - jumper in the middle of the stent, 5 - trachea, 6 - main bronchi, 7 - lobar bronchi, 8 - anastomosis.

The implementation of the invention

Below is a more detailed description of the claimed utility model.

The inventive device is a stent in the form of a tubular nozzle 1 on the distal end of the bronchoscope 2 (Fig. 1, Fig. 2) made of a silicone mixture with resistance to radial compression from 2-4 N. The stent has a length L = 8-12 mm, inner diameter d = 4-5 mm, wall thickness h = 0.5-1.0 mm (Fig. 5). Stent 1 due to friction is tightly located at the distal end of the bronchoscope 2.

In a specific embodiment, the nozzle may be made of a transparent silicone rubber mixture, for example, STP MS No. 1-93, with the shape and dimensions shown in FIG. 5: D = 6-7 mm, d = 4-5 mm, h-0.5-1.0 mm, L = 10-12 mm, D1 = 8-10 mm. The proximal and distal sections of the stent (the end edge of the proximal and distal parts of the stent) are made beveled or rounded from its outer surface to the inner one, for example, with a radius of curvature R = 0.5 mm (Fig. 5). The material from which the stent is made is characterized by resistance to radial compression from 2 to 4 N. Using a material with certain values (interval) of resistance to radial compression provides the necessary stiffness and, at the same time, elasticity of the stent, which allows the stent to be installed in the lobar bronchus without traumatic impact on the walls of the trachea and bronchi, fixing it by a jumper with forceps of the bronchoscope ensures reliability during installation and delivery of the stent.

At the same time, the set of essential features, including, in addition to the stent material, its geometry, increases the efficiency of the manipulations, preventing traumatic damage to the walls of the trachea and bronchi when holding a bronchoscope in the lumen of the tracheobronchial tree.

The device operates as follows.

A silicone alloy stent is pre-flashed with a 0.2 mm thick polypropylene thread to form a jumper in the middle part formed by an atraumatic needle with a thread on the inner surface of the tube (Fig. 3, step 1), removing the needle from the outer surface of the tube and then injecting it needles from the opposite side in the direction of the first injection (Fig. 3 step 2) with fixing the ends of the thread with a knotted suture (at least 5 knots) with tension of the thread without deformation of the tube, and the subsequent displacement of the knotted seam to the tube wall (Fig. 3). A stent 1 is put on the distal edge of the bronchoscope 2 so that the distal edge of the stent is located distal to the edge of the bronchoscope exactly to the jumper fixation point. Nippers are inserted through the channel of the bronchoscope, with the help of which the stent is fixed at the distal end for the jumper. A bronchoscope with a stent is inserted through the nasal passage into the lumen of the larynx, then, if necessary, into the trachea 5 and lobar bronchus 7 (Fig. 6). After the edge of the stent 1 is inserted into the lobar bronchus 7, the latter is pulled from the bronchoscope using a jumper and forceps, removing the bronchoscope, the stent is fixed in the lumen of the bronchus.

The inventive design of the stent can be used:

- when stenting cicatricial-narrowed lobar bronchi of various etiologies, including in patients after lung transplantation;

- when stenting the lobar bronchi in patients with tumor stenosis in the area of the mouths of the lobar bronchi;

Example 1

Patient E., 49 years old, was admitted to the department of thoracoabdominal surgery with complaints of shortness of breath. From the anamnesis: lung transplantation from August 2018. X-ray examination indicates hypoventilation of the upper lobe of the left lung. When bronchoscopy was diagnosed with cicatricial-granulation narrowing of the lumen of the upper lobe bronchus of the left lung to 0.3 cm in diameter. The patient underwent balloon dilatation of the lumen of the narrowed bronchus, after dilatation, the lumen of the bronchus is about 0.7 cm in diameter, however, its progressive narrowing within 3 minutes is noted. To prevent re-stenosis using the inventive device - a stent worn on the distal end of the bronchoscope, with a resistance to radial compression of 3 N, an outer diameter without protrusions D = 6 mm, and an outer diameter with protrusions D1 = 8 mm, inner diameter d = 5 mm, length L = 10 mm, stenting of the upper lobe bronchus of the left lung was performed. The patient was discharged from the hospital on the 3rd day.

After 3 months, a control bronchoscopy was performed under local anesthesia, in which the stent lumen was free, no granulation tissue growth was observed at the proximal and distal edges of the stent. The stent is captured by forceps carried through the bronchoscope channel for a jumper, removed from the lumen of the bronchus without technical difficulties. The inventive device during its installation and removal excluded trauma to the walls of the trachea and bronchi. At the control examination, the mucous membrane of the bronchus is completely epithelized, its lumen is 0.7 cm in diameter, there are no signs of progressive narrowing. The use of this stent prevented narrowing of the upper lobar bronchus after its dilatation, and the stent narrowing for 3 months ensured the formation of a stable bronchial lumen with complete epithelization of the mucous membrane.

Example 2

Patient Z. 41 years old, was admitted to the department of thoracoabdominal surgery with complaints of shortness of breath when walking, respiratory failure with mild exertion. In January 2019, he underwent bilateral lung transplantation for pulmonary fibrosis. 4 months after the operation, with diagnostic bronchoscopy, granulation tissue is determined on the left side of the bronchial anastomosis, according to the lateral semicircle with foci of light fibrin, which narrows it to 0.4 cm at the mouth of the left upper lobe bronchus. The lumen of the right upper lobe bronchus is narrowed to 0.4 cm in diameter due to scarring. The patient underwent balloon dilatation of the lumen of the upper lobe bronchus of the right lung. Using the inventive device - a stent, worn on the distal end of the bronchoscope, with resistance to radial compression of 3 N, the outer diameter excluding the protrusions D = 7 mm, the outer diameter taking into account the protrusions D1 = 10 mm, the inner diameter d = 5 mm, length L = 12 mm, stenting of the lumen of the upper lobar bronchi of the right and left lungs was performed. During endoscopic observation after a day, 3-5-30 days, there are no signs of stent dislocation, growth of granulation tissue at the proximal and distal edges of the stent. The inventive device during its installation excluded trauma to the walls of the trachea and bronchi.

Example 3

Patient K., 34 years old, was admitted to the department of thoracoabdominal surgery with complaints of shortness of breath, shortness of breath at rest, periodically occurring hemoptysis. From the anamnesis he underwent lung transplantation in another state. Diagnostic bronchoscopy in the lumen of the intermediate bronchus determines a metal self-expanding stent, which is fully embedded in the wall of the bronchus, the lumen of the intermediate bronchus is narrowed to 0.3 cm in diameter, the walls of the bronchus are represented by granulations. In the lumen of the anastomosis of the left main bronchus, a metal self-expanding stent is determined. The stent is embedded in the walls of the bronchus, the lumen of the upper lobe and lower lobe bronchi of the left lung is narrowed to a point. Metal stents from the lumen of the bronchi removed with technical difficulties. Bougienage of the lumen of the bronchus was performed at the level of the anastomosis with a tube of a rigid bronchoscope with the subsequent installation of a silicone tracheal stent into the lumen of the anastomosis. However, after 3 weeks, at the level of the distal edge of the walls, massive growth of granulation tissue with narrowing of the lumen of the lobar bronchi is noted. A phased balloon dilatation of the lumen of the upper lobe and lower lobe bronchi of the left lung was performed using a balloon dilator. Stenting of the lumen of the lower lobe and upper lobe bronchi of the left lung was performed using the inventive device - a stent worn on the distal end of the bronchoscope, with a radial compression resistance of 3 N D = 6 mm, an outer diameter taking into account the protrusions D1 = 8 mm, an inner diameter of d = 4 mm , length L = 11 mm, stenting of the upper lobe and lower lobe bronchi of the left lung was performed. The protection of stent constriction is performed for 4 months. During the control examination under local anesthesia, the stents in the lumen of the bronchi are not fixed tightly, the latter are removed. When re-examined, the lumen of the bronchi is preserved, there is no granulation overgrowth, the mucous membrane is pale pink, smooth. The patient was discharged with recommendations.

Claims (6)

1. A device for stenting the lobar bronchus, made in the form of a tubular length of a silicone mixture with resistance to radial compression of 2-4 N, having on the outer surface supporting protrusions and radiopaque marks, while the tubular length is made with the possibility of tight placement at the distal end of the bronchoscope and equipped with a jumper of polypropylene yarn located in diameter in the middle of the tube. 2. The device according to claim 1, characterized in that the polypropylene thread has a thickness of 0.2 mm 3. The device according to claim 1, characterized in that the jumper of polypropylene yarn is formed by injecting an atraumatic needle with a thread from the side of the inner surface of the tube, removing the needle from the side of the outer surface of the tube and then injecting the needle from the opposite side towards the first injection and fixation the ends of the thread with a knotted seam with a thread tension without deformation of the tube, followed by a displacement of the knotted seam to the tube wall. 4. The device according to claim 1, characterized in that the inner surface of the tubular segment on the placement side at the distal end of the bronchoscope on a length of 4-8 mm is made in the form of a mounting surface that repeats the shape of the outer surface of the distal end of the bronchoscope at the location of the stent. 5. The device according to claim 1, characterized in that the tubular segment is made with a beveled outer edge from the distal and proximal ends. 6. The device according to claim 1, characterized in that the tubular segment is made with an external diameter without protrusions D = 6-7 mm, and an external diameter with protrusions D1 = 8-10 mm, inner diameter d = 4-5 mm, length L = 10-12 mm.

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