RU2738169C1 - Method for prevention of posterior naris restenosis after surgical correction of their congenital atresia - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely otorhinolaryngology. Protector is placed within the formed posterior naris lumen. Protector used is an elongate flexible tubular part from plastic, which has head and tail parts. Head part has expansion in form of funnel, part of which is cut parallel to axial plane of tubular part at a distance exceeding its diameter. Protector is introduced, starting from tail part, through oral cavity, oropharynx, nasopharynx in half of nose on side of former atresia in such a way that expansion in form of funnel is located in area of formed posterior naris, cut part of funnel is located laterally, and part of funnel with preserved wall is medially in area of resected vomer. Further, in the transverse direction through the diametrical opening of the tail part, spaced from the expanded part of the protector at a distance equal to the distance from the formed posterior naris to the vestibule of the nose, a flexible tube with a thread is made in its lumen. End of the tail part of the protector protruding from the nose cavity is cut off from the diametrical hole by 2–3 mm. Ends of the suture are tied around the patient's head, providing fixation of the protector funnel in the formed posterior naris area for 2–3 months. On completion of the treatment, the tube with the suture is cut off from the protector and unfolded so that the cut part of the funnel is in the area of the vomer, and the protector is removed. In bilateral atresia, the posterior naris protector is delivered in each half of the nose.

EFFECT: method provides higher reliability of protector fixation in nasal cavity in any form of congenital atrophy posterior naris in children of different ages, reducing intraoperative injuries, providing possibility of protector removal from nasal cavity without traumatization of mucosa without general anaesthesia.

4 cl, 2 ex, 6 dwg

Description

The invention relates to medicine, namely otorhinolaryngology, and can be used to prevent restenosis of the choanal lumen with their atresia in children, both in unilateral and bilateral forms.

Congenital choanal atresia is a unilateral or bilateral formation of a bony or membranous septum between the nose and the pharynx with complete closure or sharp narrowing of one or both halves of the nose and is one of the most common congenital anomalies leading to impaired nasal breathing. Treatment of congenital choanal atresia is only surgical. Timely operation for the formation of choanas in the early stages is one of the necessary conditions for the correct psychophysical development of the child and the prevention of concomitant and concomitant diseases of the ENT organs in children. Despite progress in various surgical methods for the treatment of congenital choanal atresia, the incidence of restenosis is still high. The most effective and widespread method of surgical correction of congenital choanal atresia is transnasal endoscopic choanotomy.

It is traditionally believed that, regardless of the method of surgical intervention, all children, after surgery with the aim of re-epithelialization of the neochoana, prevention of re-infection of the choanalis (restenosis) and persistent formation of the choanostoma, must be inserted into the newly formed openings of different types of protectors or stents, and now many surgeons are adherents of this technique (Yunusov A.S. "Modern aspects of surgical treatment of congenital choanal atresia in children", Russian otorhinolaryngology, 2005, No. 3 pp. 31-33; National Medical Association of Otorhinolaryngologists. Choanal atresia in children. Clinical guidelines, 2016, 20 p. .).

A stent is a tube of elastic material. The inner edge of the stent should protrude into the nasopharynx only a few millimeters so as not to injure the surrounding soft tissues, and the outer diameter of the protector should strictly correspond to the lumen of the formed posterior nasal opening and not exert pressure on the walls of the nasal cavity.

Many surgeons, as a protector to prevent cicatricial infection of the choanas in children, use endotracheal tubes, which are selected according to the diameter of the formed opening and model them along the length (Yunusov A.S., Rybalkin S.V., Saidulaeva A.I. “Transeptal access for the formation of choanas with their congenital atresia. "Pediatric otorhinolaryngology", 2011, No. 1, pp. 38-40).

A device for postoperative treatment of the choanal lumen is known - a dilator (thermoplastic tube), the diameter of which corresponds as much as possible to the formed hole. The inner end of the tube is installed in the choanae, and the outer end, which should protrude from the nose by 1.5-2 cm, is fixed on the skin with ligatures and adhesive plaster (RU 2157664, 20.10.2000). The disadvantage of this device is the unreliability of its attachment in the nasal cavity, which does not allow installing the device for a long time for the final formation of the choanal lumen in the postoperative period.

Also previously described was a device that was a thermoplastic tube that was secured with a silk thread that was tied around the child's head. (Kovshenkova Yu.D., Chumicheva I.V. Experience in the treatment of congenital choanal atresia in children. Russian otorhinolaryngology: II Plenum of the Board of the Russian Society of Otorhinolaryngologists "100 years of Russian otorhinolaryngology: achievements and prospects" (23-24 April 2008. , St. Petersburg) - 2008 - Appendix No. 2 - P. 55-58). This device is installed for a period of at least 2.5 months, which made it possible to finally form the choanal lumen after the elimination of atresia. The disadvantage of this protector was that the threads that were tied around the child's head to fix the stent constantly rubbed and even cut through the wings of the nose, which contributed to inflammation and deformation of the wings of the nose. In addition, this fixation was not strong, which often led to spontaneous loss of the tread or its accidental removal in domestic conditions.

Foley's silicone probes were used as a protector or, in case of bilateral atresia, a fenestrated U-shaped stent fixed due to an olive-shaped expansion in the vestibule of the nose, the period of wearing stents was 1-12 weeks, which depended on the type of atresia and anatomy of the choanal region, longer - with bone forms (Rodriguez, N., Cuestas, G., & Passali, D. Experiencia de 20 anos en el tratamiento microquirurgico de la atresia de coanas. Acta Otorrinolaringologica Espafiola, 65 (2), 85-92.). This fixation option does not injure the structure of the external nose, but does not prevent its displacement into the nasopharynx and oropharynx.

Similar design, U-shaped protectors modified from endotracheal tubes with various fixation methods were used by other surgeons, including for unilateral atresia (Riepl R, Scheithauer M, Hoffmann TK, Rotter N. Transnasal endoscopic treatment of bilateral choanal atresia in newborns using a balloon dilatation: own results and review of literature Int J Pediatr Otorhinolaryngol. 2014; 78 (3): 459-464.)

So in the ENT clinic MONIKI a device (stent) was developed to prevent cicatricial infection of the restored choanal lumen in children with bilateral atresia (RU 2213585 dated 10.10.2003). The device consists of a thermoplastic tube (Wili Rusch AG, or PORTEX, Germany) with an outer diameter of 5 mm and an inner diameter of 3 mm with an initial length of 20 cm. Before insertion into the choanae, a part of the tube is cut in the central part of the three times its diameter, leaving the wall height equal to 1/3 of the circumference. Then a bend is made in the middle of the cut, after which a conductor (strong thread) is fixed to the ends of the tube, with the help of which the device is inserted through the mouth into the choanal lumen until it touches the opener. Retaining rings are put on the ends removed from the nose and held until the vestibule of the nose, after which the free ends of the protector are cut off, retreating 1-1.5 mm from the retaining rings. The retainer rings 5 mm long are a piece of silicone tube with an inner diameter 0.5 mm less than the outer diameter of the device.

This design allows you to firmly fix the device in a given position. The obliquely cut wall of the device in the area of the opener allows not to disrupt the function of the auditory tubes, to avoid complications in the form of eustachitis and otitis media, as well as the formation of granulations on the posterior wall of the nasopharynx. The device is left in the choanal lumen for 3 -3.5 months, in some cases after 1.5 months the protector is changed to a stent of a larger diameter. However, this protector and similar U-shaped protectors can only be used in case of bilateral atresia; in a unilateral process, the use of this protector is unreasonable, since part of the protector will pass through the healthy half of the nose. In addition, the stent is removed under the control of optics under general anesthesia.

A device for use in the treatment of choanal atresia and prevention of stenosis after choanotomy in children has been described (US 2003153937 (A1) - 08.14.2003). This device includes two tubes that run parallel to each other, each tube made of a plastic material approved for human use. Each tube has a metal insert built into its wall (reinforced tubes). The ends of the tubes are connected by a plastic strip, and at the other end of the tubes there is a bridge made of plastic material, which is located between the tubes and is movably attached to the ends of the tubes. The mechanism is such that the tubes pass through the nasal cavity and the formed choanal openings of the child, the plastic strip of the stent passes behind the posterior edge of the opener separating the nasal passages, and the plastic bridge is next to the columella of the nose. The device has a reliable fixation, but has the above disadvantages: it has a complex design, can be used only for bilateral atresia, in a one-sided process, the use of this protector is unreasonable, since part of the protector will pass through the healthy half of the nose, the stent is removed under the control of endoscopy under general anesthesia ...

Known stent containing two curved hollow tubes connected by a flexible transverse bridge, to which is attached a thread passing through the lumen of the tubes (US 6606995 (B1) - 19.08.2003). These tubes are installed in the desired position due to two thin guides, which are preliminarily passed through the nose and out through the choanae into the oral cavity. Further movements of the stent are impossible due to the transverse tube, which is located in the region of the nasal septum and is attached to two movable short connected tubes attached to two long hollow tubes. Fixation is provided by an adjustable fastening mechanism. Excess pipe is cut off. The stent is removed without the use of general anesthesia by cutting off the suture in one of the long tubes This device has a reliable fixation, but has the above disadvantages: it has a complex design, can only be used for bilateral atresia; in a unilateral process, the use of this protector is unreasonable, since part of the protector will pass through the healthy half of the nose.

The closest to the proposed device is a device for preventing cicatricial overgrowth of the choanal lumen in newborns, made of a tube with a complete dissection into two identical parts, located in parallel and provided with a bridge in the form of a rectangle, at the distal ends of the tube there are fixators. The tubes are made with a bend of 140-170 degrees in the middle (RU 2614936 C1, 03/30/2016). EFFECT: invention allows for reliable fixation, avoiding the germination of granulations into its lumen, and also forming the distal part of the device individually according to the shape and size of the nasopharynx. However, the device can only be used for bilateral atresia. In a unilateral process, the use of this protector is impractical, since part of the protector will pass through the healthy half of the nose, it is intended for a specific age category - newborns, and the stent is removed under the control of endoscopy under general anesthesia.

In addition, all of the above protectors have a shape that does not provide full contact over the relief of the wound surface.

The present invention is aimed at solving the problem of reliable fixation of the protector, preventing spontaneous prolapse both from the nasal cavity outward and into the oropharynx, applicable in different forms of congenital choanal atresia, both bilateral and unilateral, in children of different ages.

The technical result achieved by the implementation of the invention consists in:

- increasing the reliability of fixation of the protector in the nasal cavity in any form of congenital choanal atresia in children of different ages due to the conformity of the protector shape to the relief of the wound surface in the area of the formed choanas;

- reducing the invasiveness of the intervention, ensuring the possibility of removing the protector without traumatizing the mucous membrane without general anesthesia due to the simplicity of the design features of the protector, matching the shape of the protector to the relief of the wound surface in the area of the formed choanas.

The essence of the invention is as follows.

To prevent choanal restenosis after surgical correction of its congenital atresia in children, a protector is installed in the area of the formed choanal lumen. In this case, an elongated flexible tubular plastic part, which has a head and a tail, is used as a protector. The head part has a funnel-shaped expansion, part of which is cut parallel to the axial plane of the tubular part at a distance exceeding its outer diameter.

The protector is inserted, starting from the tail part, through the oral cavity, oropharynx, nasopharynx into the half of the nose on the side of the former atresia so that the funnel-shaped expansion is located in the area of the formed choana, the cut part of the funnel is located laterally, and the part of the funnel with the preserved wall is medial , in the area of the resected opener.

Further, in the transverse direction, a flexible catheter with a thread in its lumen is passed through the diametrical opening of the tail part, which is spaced from the expanded part of the protector at a distance equal to the distance from the formed choana to the vestibule of the nose. The end of the tail part of the protector protruding from the nasal cavity is cut off, departing from the diametral hole by 2-3 mm. The ends of the thread located in the lumen of the flexible catheter are tied around the patient's head, ensuring the fixation of the funnel of the protector in the area of the formed choana for 2-3 months. After that, a flexible catheter with a thread is cut off from the protector and unfolded so that the cut part of the funnel is in the area of the opener and the protector is removed.

In bilateral choanal atresia, the protector is inserted into each half of the nose.

The width of the funnel neck in the uncut part is not less than 3.0, and its height is not less than 2.0 of the outer diameters of the tubular part.

The wall thickness of the tubular piece is 0.5 mm with an outer diameter of 3 or 4 or 5 or 6 or 7 or 8 mm.

The essence of the invention is illustrated in the drawings.

FIG. 1-3 depict side and top views of the tread.

FIG. 4 is a general view of the tread, in perspective.

FIG. 5-6 - attachment of the protector with unilateral (Fig. 5) and bilateral (Fig. 6) congenital choanal atresia.

The following positions are indicated in the figures:

1- the head of the tubular part;

2- tubular part;

3- the tail of the tubular part;

4- funnel of the head of the tubular part;

5- cut off part of the funnel 4;

6 - diametrical hole in the tail part 3;

7- the wall of the tubular part;

8- uncut part of the funnel;

9- cut off parts of funnels;

10 - a tube (thin catheter) with a thread 11 inside, passing through a diametrical opening 6;

11- a thread that is passed inside the tube 10 to fix the tubular part 2.

The method is carried out as follows.

The following protector is used to carry it into the nasal cavity.

The protector contains a tubular part 2, which includes a head 1 and a tail 3 parts. The head part 1 has a funnel-shaped expansion 4 with an opening angle of 90 °. Part 5 of the funnel 4 is cut parallel to the axial plane of part 2 at a distance exceeding the diameter d of the tubular part 2. The width m of the throat of the funnel 4 in the uncut part is at least 3 diameters of the tubular part 2, and its height h is at least 2 external diameters of tubular part 2.

The tubular part 2 is made with the possibility of passing the tail part 3 through the oral cavity, the mouth and the nasopharynx. The tail part 3 has a diametrical hole 6 in the wall for fixing the protector around the patient's head by means of a piece of tube 10 and a thread 11.

The wall thickness 7 of the tubular part 2 is 0.5 mm with an outer diameter of 3 or 4 or 5 or 6 or 7 or 8 mm. The protector can include two identical tubular parts 2, installed by the cut-off portions 9 of the funnels in opposite directions.

During the installation of the device, the distal flared end should be installed so that the made notch is located laterally, which allows not to disrupt the function of the auditory tubes, to avoid complications in the form of tubotitis and the formation of granulations on the posterior wall of the nasopharynx. In addition, such a shape of the extended end of the device, when it is removed and the tube is turned 180 degrees so that the cut part of the expansion is in the area of the coulter, makes it possible to remove the device from the nasal cavity without special efforts and traumatizing the mucous membrane outside of general anesthesia.

With bilateral atresia, it is also possible to use this device. The protector is then inserted into each half of the nose. In this case, the tube 10 (flexible catheter) with the thread 11 can be passed through the two thermoplastic tubes after they are inserted into the nasal cavity, taking into account the correct location of the enlarged zone in the nasopharynx. This view of the device is shown in FIG. 6.

The process of installing the protector is the final part of the operation - the formation of choanas during their atresia and occurs with the help of a flexible catheter, which is passed through the protector lumen.

Through the oral cavity, the oropharynx and the nasopharynx, the device is inserted into the nasal cavity so that the end with the funnel-shaped expansion is located in the nasopharynx in such a way: the trimmed part is laterally, the medial part of the expanded zone, preserved unchanged, is set towards the resected vomer. Then the end of the tail part of the protector protruding from the nasal cavity is cut off, departing from the diametrical hole by 2-3 mm. Similarly, the device is installed in case of bilateral atresia, in this case, the tube 10 with the thread 11 is passed through both tubular parts 2 after their installation in the nasal cavity, taking into account the correct location of the enlarged zone in the nasopharynx. Thread 11 is tied around the patient's head. The device is left in the choanal lumen for a period of 2 to 3 months, depending on the morphology of atresia (bone, membranous, mixed) and length. Removing the device outside of general anesthesia is performed by cutting off the tube 10 with the thread 11 and turning the protector by 180 degrees so that the cut-off part 5 of the expansion is in the area of the opener, which allows the device to be removed from the nasal cavity without much effort and trauma to the mucous membrane. After that, to assess the viability of the choanal opening, an endoscopic examination of the nasal cavity and nasopharynx is performed.

The funnel shape of the device allows achieving more complete contact along the relief of the wound surface and reliable fixation.

This device has a size range with an inner diameter (d) from 3 to 8 mm, which allows you to choose a stent that matches the anatomical dimensions of the choanal region and nasopharynx in children of different ages, wall thickness 0.5 mm.

On the opposite side of the expansion, to fix the stent through its lumen in the transverse direction, a thin thermoplastic catheter with a diameter of 1 to 3 mm is passed, inside which a thread is threaded, this catheter with a thread is tied around the patient's head. This type of fixation prevents trauma to the structures of the external nose and provides reliable fastening, preventing the device from moving into the lower respiratory tract - it makes it possible to increase the reliability of fixation of the device in the nasal cavity.

The patented method has been successfully used in 61 patients with various forms of atresia at the age from 2 months to 7 years. The results of the observation showed that this device allows it to be reliably fixed in the nasal cavity without the growth of granulations into its lumen, does not lead to trauma and deformation of the structures of the external nose, allows it to be removed outside the conditions of general anesthesia, and, most importantly, leads to persistent formation of the choanal foramen. In all patients operated on with the use of this device, no evidence of restenosis was revealed during follow-up observation for a period of 1 to 9 years.

Clinical example 1.

Boy B., 3 months

Diagnosis: Bilateral congenital complete bony choanal atresia.

Anamnesis: The child was ill from birth, at birth there was respiratory failure, resuscitation was carried out, due to the impossibility of spontaneous breathing, he was on mechanical ventilation for 3 days, then breathing was carried out using the oropharyngeal air duct, the child was tube feeding, during examination at the place of residence catheterization of the nasal cavity, bilateral choanal atresia was revealed, the child was referred for surgical treatment.

On examination: The shape of the nose is not changed, nasal breathing is absent, oral breathing in an upright position, in a horizontal position is possible only through the air duct. The nasal septum is slightly bent to the right, the mucous membrane of the nasal cavity is pale pink, in the common nasal passages there is abundant viscous mucopurulent discharge. Endoscopic examination of the nasal cavity and nasopharynx revealed bilateral complete, palpable osseous choanal atresia. CT scan of the paranasal sinuses confirmed the diagnosis.

Operation: the child underwent a transnasal endoscopic choanotomy with epipharyngoscopic control with partial resection of the posterior edge of the vomer; at the last stage of the operation, the proposed device was inserted into the newly formed choanal openings from both sides using a flexible catheter through the protector lumen in accordance with the proposed method; the width of the throat of the tread funnel in the uncut part was 3.0 outer diameters of the tubular part, and its height was 2.0 outer diameters of the tubular part, the wall thickness of the tubular part was 0.5 mm with an outer diameter of 3 mm.

The protector is inserted through the oral cavity, the oropharynx and the nasopharynx into the nasal cavity so that the ends of the tubes with funnel-shaped expansion are located in such a way: the trimmed part is laterally, the medial part of the enlarged zone, preserved unchanged, is set towards the resected vomer. Then the end of the tail part of the protector protruding from the nasal cavity was cut off, at a distance of 3 mm from the diametral hole. The thread catheter is fixed around the patient's head. The device was left in the choanal lumen for 3 months. The postoperative period was uneventful, the child's nasal breathing through the protectors was free, and he was transferred to artificial feeding. The daily sanitation of the nasal cavity and the lumen of the protector, irrigation therapy was performed. The child's parents are trained in stent care, the child is discharged for

7th day in a satisfactory condition. Upon re-admission, the correct position of the protector was noted, the device was removed outside general anesthesia in a dressing room by cutting off the catheter with a thread and turning the protector 180 degrees on each side so that the cut-off part of the expansion was in the area of the opener, which made it possible without much effort and trauma to the mucosa remove the device from the nasal cavity. During the period of wearing, there is no trauma to the structures of the external nose. After that, to assess the consistency of the choanal foramen, an endoscopic examination of the nasal cavity and nasopharynx was carried out: the consistency of the choanal foramen was revealed. The follow-up period was 6 years, data for restenosis were not revealed.

Clinical example 2.

Girl T., 3 years old

Diagnosis: Right-sided congenital complete bony choanal atresia.

Anamnesis: Complaints of prolonged difficulty in nasal breathing, constant discharge from the right half of the nasal cavity from the first months of life, repeatedly underwent courses of conservative therapy. During endoscopy of the nasal cavity and nasopharynx at 3 years of age, due to suspicion of adenoid hypertrophy at the place of residence, complete bony atresia of the right choana was revealed, the diagnosis was confirmed by CT data of the nasal cavity and nasopharynx, the child was referred for surgical treatment.

On examination: The shape of the nose is not changed, nasal breathing is absent on the right, free on the left. The nasal septum is slightly bent to the right, the mucous membrane of the nasal cavity is pale pink, in the general nasal passage on the right there is abundant viscous mucopurulent discharge. Endoscopic examination of the nasal cavity and nasopharynx revealed unilateral complete, palpable osseous choanal atresia.

Operation: the child underwent a right-sided transnasal endoscopic choanotomy with epipharyngoscopic control with partial resection of the posterior edge of the vomer, at the last stage of the operation, the device described by us was inserted into the newly formed choanal opening in accordance with the proposed method using a flexible catheter through the protector lumen, with an external diameter of 8 mm. so that the end of the tube with a funnel-shaped expansion with the cut part is located laterally, the medial part of the expanded zone, preserved unchanged, is set towards the resected vomer. Then the end of the tail part of the protector protruding from the nasal cavity was cut off, 2 mm away from the diametral hole. The thread catheter is fixed around the patient's head. The device was left in the choanal lumen for 2 months. The postoperative period was uneventful, the child's nasal breathing through the protector was free. The daily sanitation of the nasal cavity and the lumen of the protector, irrigation therapy was performed. The child's parents were trained to care for the stent, the child was discharged on the 5th day in satisfactory condition. Upon repeated admission, the correct position of the protector was noted, the device was removed outside the conditions of general anesthesia in a dressing room by cutting off the catheter with a thread and turning the protector by 180 degrees so that the cut part of the expanded part was in the area of the coulter, which made it possible to remove the device without much effort and trauma to the mucous membrane from the nasal cavity. During the period of wearing, there is no trauma to the structures of the external nose. After that, to assess the consistency of the choanal foramen, an endoscopic examination of the nasal cavity and nasopharynx was carried out: the consistency of the choanal foramen was revealed. The follow-up period was 3 years, data for restenosis were not revealed.

Claims (4)

1. A method for the prevention of choanal restenosis after surgical correction of its congenital atresia in children, including the installation of a protector in the area of the formed choanal lumen, characterized in that an elongated flexible tubular part made of plastic is used as a protector, which has a head and tail parts, while the head part has an expansion in the form of a funnel, part of which is cut parallel to the axial plane of the tubular part at a distance exceeding its outer diameter, the protector is inserted, starting from the tail, through the oral cavity, oropharynx, nasopharynx into the half of the nose on the side of the former atresia so that the expansion in the funnel shape was located in the area of the formed choana, the cut part of the funnel - laterally, and the part of the funnel with the preserved wall - medially, in the area of the resected opener; further in the transverse direction through the diametrical opening of the tail part, spaced from the expanded part of the tread at a distance equal to the distance from the formed choana to the vestibule of the nose, pass a flexible tube with a thread in its lumen; then the end of the tail part of the protector protruding from the nasal cavity is cut off, departing from the diametral hole by 2-3 mm; the ends of the thread are tied around the patient's head, ensuring the fixation of the funnel of the protector in the area of the formed choana for 2-3 months, at the end of the treatment, the flexible tube with the thread is cut off from the protector and unfolded so that the cut part of the funnel is in the area of the opener, and the protector is removed. 2. The method according to claim 1, characterized in that in case of bilateral choanal atresia, the protector is passed into each half of the nose. 3. A method according to claim 1, characterized in that the width of the funnel neck in the uncut part is at least 3.0, and its height is at least 2.0 of the outer diameters of the tubular part. 4. A method according to claim 1, characterized in that the wall thickness of the tubular part is 0.5 mm with an external diameter of 3, or 4, or 5, or 6, or 7, or 8 mm.

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