RU2609777C1 - Method for postoperative prosthetics of vocal part of larynx after laryngoplasty and stent for its realisation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of the inventions relate to medicine, namely to otorhinolaryngology, and can be applied for postoperative prosthetics of larynx after laryngoplasty. Stand contains hemostatic oxycellulose tampon, made with possibility of radial extension by silicon hydroballoon, fastened inside tampon by means of synthetic ligature. Hydroballoon has channels for blowing hydroballoon cavity and for instillation of medications. Channels are made with possibility of connection to sources of overpressure and are equipped with clips. Output of channel for medication instillation is located in butt end wall of tampon at distance 1-2 mm from external wall surface. Method includes stenting of vocal part of larynx by means of developed stent. Stent is placed in such a way, that its upper end is 2-3 mm higher than level of vocal folds. Blown part of hydroballoon is placed in zone of mobilised larynx flap, which covers defect of tissues in area of ablated arytenoid cartilage. After introduction of stent hydroballoon is blown through channel, fixing mobilised flap of larynx. Then through the channel for medication instillation antiseptic solution is introduced in quantity, sufficient for saturation of hemostatic tampon. Tracheostomal tube is installed into tracheostoma lumen, creating barrier for stent shifting. Antiseptic, anti-inflammatory preparations, and preparations, which improve tissue regeneration, are daily introduced into postoperative area through the channel for medications instillation. Stenting is carried out for not less than 5 days.

EFFECT: group of the inventions ensures creation of conditions for fast healing of soft tissues in operation zone, formation of lumen of vocal part of larynx sufficient for breathing, which makes it possible to reduce quantity of postoperative complications, as well as reduce duration of patients' rehabilitation due to application of developed stent.

4 cl, 1 ex, 1 dwg

Description

The group of inventions relates to the field of medicine, namely to otorhinolaryngology. The technology developed by us is effective for prosthetics of the larynx after laryngoplasty in patients with a prolonged and complicated course of bilateral laryngeal paralysis, with ankylosis of the cricoid cartilage, an accompanying aggravating pathology, which have technical difficulties during the isolation of the arytenoid cartilage in the formation of the extensive postoperative operation, with the formation of extensive tissue surgery .

Currently, laryngeal paralysis takes the 2nd place in frequency in the structure of chronic diseases of the vocal apparatus (29.9%). Bilateral laryngeal paralysis - a condition that is one of the causes of stenosis of the upper respiratory tract, is characterized by a bilateral disorder of the motor function of the larynx in the form of a violation or complete absence of voluntary movements of the vocal folds due to a violation of the innervation of the corresponding muscles, ankylosis of the cricoid joints.

Surgical treatment of patients is a long and complicated process, sometimes it consists of several stages and reaches several years, and the duration of prosthetics of the voice section of the larynx reaches 6 months. Numerous methods of surgical treatment of this pathology and postoperative prosthesis of the larynx have one goal - the expansion of the glottis and the restoration of adequate breathing. One of the common methods of surgical treatment is laryngoplasty with submucosal removal of the arytenoid cartilage from the articular bag on one side, followed by excision of the muscle mass of the vocal fold, while the anterior folds are preserved in the area of the elastic cone to preserve phonation. The soft tissue defect in the area of the removed arytenoid cartilage is covered by a flap of the mucous membrane from the vestibular part of the larynx and is fixed by an atraumatic U-shaped suture to the perichondrium of the thyroid cartilage.

For patients with a long course of the disease, chronic cannula carriers, with the presence of ankylosis of the cricillary joints and aggravating concomitant somatic pathology (diabetes mellitus, hypothyroidism, hypoparathyroidism), the formation of large wound surfaces, high tension of the sutures, fixing the flap of the mucous membrane in the area of the removed scapular cartilage reactive events and fibrin plaque. All this complicates the healing process of soft tissues, increases the number of postoperative complications, slows down the restoration of respiratory function, increases the length of inpatient treatment, rehabilitation period and the period of patients' disability. In some cases, poor tissue healing can lead to restenosis of the lumen of the larynx and the need for repeated surgical treatment, which can lead to permanent disability, up to disability.

There are various methods for prosthetics of the larynx in the postoperative period.

Known "New Intra-Laryngeal Endoprosthesis", which is used in patients with laryngeal dysfunction to restore breathing, swallowing and phonation. The device includes a valve designed for installation in the lumen of the larynx to form a sealing of its structures and prevent leakage of saliva, mucus and food masses [1].

The well-known "Method of stenting with laryngoplasty in children" using autologous costal cartilage. Form the lumen of the larynx with a stent. A silicone stent is placed in the larynx so that the upper end of the stent is 0.3-0.5 cm above the vocal folds, the lower 0.5 cm below the stenosis area. The stent is stitched with a through U-shaped suture through the walls of the larynx for a long time with absorbable material. The outer diameter of the stent should exceed the lumen of the larynx by 1-2 mm. A tracheostomy cannula is located below the stent without fixation to it. The method allows to completely restore the lumen of the larynx, to carry out treatment in one stage [2].

A known method is “LT-Mold ™ airway prosthetics with a stent for patients with chronic stenosis of the larynx and trachea, violation of the dividing function of the larynx”. Used silicone LT-Mold ™ stents of anatomical structure and various sizes, which were selected individually for the patient. The dimensions of the mold varied: the outer diameter was from 6 to 14 mm (average 8 mm), the length was from 10 to 36 mm (average 20 mm). The silicone material and the round shape of both its ends prevented the formation of erosion and granulation growths of the mucous membrane of the restored airway lumen. The distal stent abduction was covered with a silicone cap. A stent was inserted into the lumen of the larynx and trachea and was sutured for fixation to the lateral walls without fixing to the tracheostomy tube. The duration of stenting averaged 3 months (from 1 to 12 months). In 3 cases, the loss of the silicone cap was noted, in 1 case the stent was displaced, and in 1 case the growth of the granulation visor along the upper edge of the tracheostomy in a patient with a lost cap was noted. The results of the study showed that long-term stenting is effective when the prosthesis is used with its distal cap. A prerequisite for preventing stent displacement in the lumen of the larynx and trachea is its adequate fixation [6].

The known method "Method of selecting length of t-shaped tube in treatment of chronic larynx stenoses". With this method, after surgical treatment of bilateral laryngeal paralysis, the larynx is prosthetized with a T-shaped tube with preliminary correction of its leads taking into account anthropometric parameters. The method is atraumatic due to the absence of the need to remove and shorten the tube in the early postoperative period, does not violate the protective function of the larynx due to the optimal position of the upper end of the tube and the lack of pressure on the base of the epiglottis. The method allows to achieve a reduction in the multiplicity of operations and increases the percentage of rehabilitation of patients [3].

Also known is the “Method of restoring scarred larynx and upper trachea”, including laryngotracheofissure, excision of scars in the lumen of the respiratory tract and placing a laryngeal tracheal prosthesis with a dilator in the form of a hollow latex balloon filled with water, starting from 6-7 days after placing the laryngeal-tracheal prosthesis, 1/3 of the water volume is pumped out of the latex balloon for 7-8 seconds and this procedure is repeated for 20 minutes daily 2 times a day until the epithelization is completed and damaged part of the respiratory tract [4].

For prosthetics of the laryngeal lumen in patients with bilateral laryngeal paralysis in the postoperative period, a hemostatic swab is also used - a large-pore PVA sponge (oxycellulose) Merocel® soaked in an antiseptic solution. The sponge has a good absorbent ability and does not exert excessive pressure on the mucous membrane of the larynx. Prosthetics of the lumen of the larynx is carried out within 3-5 days, if necessary, change the tampon [7].

The prototype of our invention was "Bioresorbable laryngotracheal stent and methods of treatment". Use a biological self-absorbable stent, which allows you to maintain airway clearance after laryngeal and laryngotracheal reconstruction due to the radial strength of its effect. Also, stent is used in patients with tracheomallation, with neoplasms of the trachea to maintain airway clearance. The stent has a self-absorbable body that has a shape that anatomically matches the shape of the airway lumen. The radial strength of stents decreases over time due to bioresorption. Thus, with prolonged prosthetics, surgery is not required to remove the stent. The plateau phase is distinguished, in which the radial force decreases slightly over time, then the second stage follows - a quick loss of strength. The plateau phase lasts at least 1 week, which exceeds the period required for prosthetics of the larynx after laryngoplasty with unilateral myoartenoidchordectomy. The stent is anatomical, mainly used for laryngotracheal reconstruction and cannot always be used to remove elements of the larynx and laryngoplasty, when maintaining the formed lumen of the larynx is carried out mainly due to the adequate fixation of the displaced tissues. This stent is saturated with anti-inflammatory drugs and drugs that improve tissue regeneration, however, their number is dosed and there is no possibility of adjusting the amount of the active drug during prosthetics individually for each patient depending on the course of the healing process [5].

The problem to be solved in the present invention is the development of a method and device that can improve the effectiveness of surgical treatment of patients with bilateral laryngeal paralysis with the help of postoperative prosthetics of the laryngeal lumen.

Achievable technical result is the creation of conditions for the rapid healing of soft tissues in the area of the operation, the formation of a lumen of the vocal section of the larynx sufficient for breathing, which generally reduces the number of postoperative complications (granulation, prolonged edema, plaque of fibrin, cicatricial changes in soft tissues), ensuring a decrease in duration rehabilitation of patients.

The main advantage of the stent we developed is the possibility of a complex effect on soft tissues: the mechanical fixing effect of the hydroballon in the operation area, the hemostatic effect, the absorption of blood and productive fluid in the operation area, the delivery of drugs to the area of the transferred intervention.

We have developed a stent for prosthetics of the lumen of the voice section of the larynx after laryngoplasty. The developed stent consists of:

1. hemostatic oxycellulose swab with an internal channel;

2. silicone hydroballon with two channels designed: the first - to inflate the balloon; the second is for administering drugs and installing them directly in the zone of the transferred intervention.

Moreover, the silicone hydroballon is installed in the channel of the hemostatic tampon and fixed to the sponge using synthetic suture material. A hemostatic oxycellulose swab is impregnated with an antiseptic solution. Gidroballon is made of 100% silicone. Max cylinder volume 2 ml. The diameter of the balloon in the most inflated state is about 8 mm.

Silicone balloon is inflated by introducing into it through the channel a NaCl solution of 0.9% room temperature in a volume of 1.5 ml. Every day, through the channel for the introduction of drugs, they install a postoperative area. Antiseptic, anti-inflammatory and drugs that improve tissue regeneration are used. Prosthetics are performed within 5 days.

The structural implementation of the stent is shown in the drawing, on which the following elements are indicated:

1. silicone hydroballon;

2. hemostatic oxycellulose swab;

3. channel for balloon inflating;

4. channel for the instillation of drugs;

5. hole for the instillation of drugs;

6. clips.

The invention consists in the following.

1. Our stent for postoperative prosthetics of the voice section of the larynx after laryngoplasty contains a hemostatic oxycellulose tampon made with the possibility of radial expansion by a silicone hydroballon fixed inside the tampon by means of a synthetic ligature. Moreover, the silicone hydroballon has channels for inflating the cavity of the hydroballon and for the instillation of drugs, the channels are made with the possibility of connecting to sources of overpressure and are equipped with clamps, and the outlet of the channel for the instillation of drugs is located in the end wall of the tampon at a distance of 1-2 mm from the outer surface of the wall .

2. A method of postoperative prosthetics of the voice section of the larynx after laryngoplasty with removal of the larynx elements that we developed includes stenting of the voice section of the larynx using the stent developed by us. Moreover, the stent is positioned so that its upper end is 2-3 mm higher than the level of the vocal folds, and the inflated part of the hydroballon is located in the area of the mobilized flap of the larynx, covering the tissue defect in the area of the removed arytenoid cartilage. After the introduction of the stent, the hydroballon is inflated through the canal, fixing the mobilized flap of the larynx. Next, an antiseptic solution in an amount sufficient to soak a hemostatic oxycellulose swab is introduced through the channel for the instillation of drugs. A tracheostomy tube is placed in the lumen of the tracheostomy, creating an obstacle to the mixing of the stent. Antiseptic, anti-inflammatory and tissue regeneration agents are injected repeatedly (optimally - 3 times a day) every day through the channel for drug instillation of drugs, which, when impregnated with an oxycellulose swab, affect soft tissues in the operation area for a long time. The choice of drugs for administration is carried out taking into account the healing process and the presence of reactive changes in the soft tissues of the larynx, if necessary, the dosage, frequency of administration and replacement with the drug necessary in a particular case are increased. The hemostatic oxycellulose swab has a high absorbing ability, absorbing blood and productive fluid, the swab reduces swelling of adjacent tissues, gently squeezes them, reducing bleeding. Stenting is performed for at least 5 days. In addition, to inflate a silicone hydroballon, 1.5 ml of physiological saline solution is injected through its channel. To soak a hemostatic oxycellulose swab with drugs, 3-4 ml of the drug is administered.

Our developments are implemented as follows.

Immediately after the operation - laryngoplasty and the formation of the voice section of the larynx, a stent developed by us is installed in its lumen (see drawing). Moreover, the stent is installed in such a way that its upper end (edge) is 2-3 mm higher than the vocal folds, and the inflated part of the silicone hydroballon is 1, directly in the area of the mobilized flap covering the defect in the region of the removed arytenoid cartilage. pressure on the base of the epiglottis.

1.5 ml of physiological saline solution at room temperature is drawn into the syringe and introduced into the hydroballon through the corresponding channel - 3, thereby inflating it and fixing the mobilized flap of the vestibular part of the larynx. The channel lumen is clamped with a clip - 6.

Then, through the channel for the instillation of drugs - 4, an antiseptic solution is introduced, in an amount sufficient to soak the hemostatic sponge (mainly 3-4 ml of solution is injected) - 2, the lumen of the channel is also clamped with a clip - 6. Both channels are fixed to the side of the neck with patch. A tracheostomy tube is installed in the lumen of the tracheostomy, which prevents the device from moving.

The stent is monitored endoscopically. Prosthetics of the lumen of the larynx is carried out for five days.

Every day, 3 times a day through the channel for the instillation of drugs, antiseptic, anti-inflammatory drugs and agents that improve tissue regeneration are introduced.

Example No. 1. Patient Sh., 51 years old. I turned to the department complaining of difficulty breathing, shortness of breath during physical exertion, sometimes even insignificant. According to the anamnesis, the patient underwent thyroidectomy 17 months ago, regarding multinodular goiter. Immediately after the operation, bilateral laryngeal paresis and laryngeal stenosis of the 2nd degree were diagnosed. Conducted conservative vascular stimulating therapy without a pronounced positive effect.

After the preoperative, the diagnosis was established: Bilateral laryngeal paralysis. Laryngeal stenosis 2-3 degrees. Concomitant: Arterial hypertension. Postoperative hypothyroidism, hypoparathyroidism in the stage of compensation.

It was decided to carry out a simultaneous operation: tracheostomy, laryngoplasty under ETN.

At the first stage, the patient underwent tracheostomy under ETN with intubation with an endotracheal tube No. 6. The second stage, after re-intubation through a tracheostomy, was performed laryngoplasty, right-sided myoartenoidoid chorectomy. Ankylosis of the cricoid joints was revealed intraoperatively, which caused technical difficulties in the isolation and removal of the arytenoid cartilage, which was removed in fragments. A mobilized flap of the mucous membrane of the vestibular part of the larynx was laid in the area of soft tissue defect in the area of the removed cartilage and fixed to the perichondrium of the thyroid cartilage with a U-shaped suture. Due to an extensive tissue defect, flap tension was noted in the area of operation. As a stent for postoperative prosthetics of the voice section of the larynx, a silicone hydroballon with a hemostatic oxycellulose swab was installed. Gidroballon was inflated by the introduction of 1.5 ml of physiological saline into it. The hemostatic swab was saturated with an antiseptic solution. Monitoring the standing level of the hydroballon was carried out endoscopically. Laryngeal prosthetics was performed for 5 days. Medicinal preparations were injected daily into the hydroballon canal for better healing of soft tissues in the area of operation. Conducted systemic antibiotic therapy, general and local anti-inflammatory therapy, physiotherapy. The postoperative period was uneventful. On the 6th day after the operation, only a slight swelling of the mucous membrane in the area of the operation remained. According to the FVD study, normal indicators of pulmonary ventilation were noted, stage-by-stage de-cannulation was carried out. 2 weeks after surgery, the patient was decanulated. 3 weeks after the operation, respiratory exercises were followed by subsequent phonopedic exercises. The tracheostomy closed independently for 1 month. The patient's decanulation period was 2 weeks, the hospitalization duration was 7 days.

Thus, the proposed method can reliably reduce the number of postoperative complications in patients with bilateral laryngeal paralysis after laryngoplasty, reduce the time of inpatient treatment, the duration of the rehabilitation period and minimize the likelihood of the need for repeated surgical intervention of this group of patients.

Information sources

1. Patent No. US 2014/0288648 AL of 09.25.2014. New Intra-Laryngeal Endoprosthesis.

Authors: Walder; Andre Michel Charles; et al.

2. Patent No. RU No. 2251986 dated 05.25.2005. A method of stenting with laryngoplasty in children.

Authors: Razumovsky A.Yu., Rachkov V.E., Mitupov Z.B.

3. Patent No. RU 2432969 (C1) dated 11/10/2011. Method of selecting length of t-shaped tube in treatment of chronic larynx stenoses.

Authors: Starostina S.V .; Mareev O.V .; Nikolenko V.N.

4. Patent No. RU (11) 99103826 dated 10.12.2000. A method of restoring scarred overgrown larynx and upper trachea.

Authors: Bystenin A.V.

5. Patent No. US 2015/0045882 AL dated February 12, 2015. Bioresorbable Laryngotracheal Stent And Methods Of Treatment.

Authors: Fox; Julia C .; et al.

6. Jaber Alshammari, Philippe Monnier Airway. Stenting with the LT-Mold ™ for severe glotto-subglottic stenosis or intractable aspiration: experience in 65 cases. Eur Arch Otorhinolaryngol. 2012 Dec; 269 (12): 2531-2538.

7. Rezakov P.A. Pathogenetic substantiation of an integrated approach to the treatment of patients with stenosis of the larynx and trachea of glaucoma // Dis. Cand. honey. sciences. - 2014. - M. - 158 p.

Claims (4)

1. A stent for postoperative prosthetics of the voice of the larynx after laryngoplasty, containing a hemostatic oxycellulose swab made with the possibility of radial expansion by a hydroballon fixed inside the swab by means of synthetic ligature, moreover, the silicone hydroballon has channels for inflating the cavity of the hydroballon and for the installation of drugs, the channels are configured to connections to sources of excess pressure and are equipped with clamps, and the output of the channel for installation ekarstvennyh drugs located in the end wall of the tampon in the region of 1-2 mm from the outer wall surface. 2. A method of postoperative prosthetics of the voice section of the larynx after laryngoplasty, in which stenting of the voice section of the larynx is performed using the stent according to claim 1, positioning the latter so that its upper end is 2-3 mm higher than the level of the vocal folds, and the inflated part of the silicone hydro balloon - in the area of the mobilized flap of the larynx, covering the defect in the tissue in the area of the removed arytenoid cartilage; after the introduction of the stent, the hydroballon is inflated through the canal, fixing the mobilized flap of the larynx; then, through the channel for the instillation of drugs, an antiseptic solution is introduced in an amount sufficient to soak the hemostatic swab; a tracheostomy tube is installed in the lumen of the tracheostomy, creating an obstacle to the mixing of the stent; daily many times through the channel for the instillation of drugs, antiseptic, anti-inflammatory drugs and agents that improve tissue regeneration are introduced into the postoperative region; stenting is performed for at least 5 days. 3. The method according to p. 2, characterized in that in order to inflate the hydroballon through its channel, 1.5 ml of physiological solution of room temperature is introduced. 4. The method according to p. 2, characterized in that for the impregnation of a hemostatic swab, 3-4 ml of the drug are administered.

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