Method for the stepped multimodal treatment of children with cleft lip and palate
The staged comprehensive treatment method for children with cleft lip and palate addresses the comprehensive needs of these children, achieving complete restoration of physiological functions and aesthetic rehabilitation, thereby ensuring they can lead a full life in society.
Patent Information
- Application Number
- PCT/RU2024/050311
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-06
- Filing Date
- 2024-12-04
- Publication Date
- 2025-06-12
AI Technical Summary
Current methods for treating children with cleft lip and palate do not provide comprehensive restoration of symmetrical, functionally complete, and aesthetically attractive facial contours, nor do they ensure complete restoration of physiological functions and aesthetic rehabilitation.
A staged comprehensive treatment method involving examination, surgical and orthodontic treatment, speech therapy, hearing correction, dispensary dynamic observation, and cosmetic procedures to address the complex needs of children with cleft lip and palate.
The method achieves complete restoration of physiological functions, aesthetic rehabilitation, and ensures children can lead a full life in society, with improved speech, swallowing, and facial appearance.
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Abstract
Description
[0001]METHOD OF STAGED COMPREHENSIVE TREATMENT OF CHILDREN WITH CLEFT LIP AND PALATE The invention relates to medicine and is intended for complex treatment of sick children with congenital cleft lip and palate, with speech disorders, swallowing. Congenital cleft lip and palate are one of the common developmental defects (1:500), in some areas (1:250). Newborns are born with severe anatomical and functional disorders - severe respiratory and feeding disorders, severe deformation of the midface. From the prior art, patent No. 2278708 with priority from 08.02.2005, a method of complex staged treatment of herniated intervertebral discs of the lumbar and lumbosacral spine is known, including hardware traction and ultrasound exposure.The treatment is carried out sequentially without interruption in four stages, while the first stage includes therapeutic gymnastics with positional correction of discogenic disorders, the second stage includes classical therapeutic segmental paravertebral massage using a gentle technique, the third stage includes paravertebral ultrasound with chondroprotectors on the lumbosacral spine, in the presence of radicular syndrome, ultrasound with hydrocortisone and vitamin B12 is additionally carried out on the projection of the affected root with an intensity of 0.4-0.6 W / cm2 in pulse mode, the treatment is completed with hardware traction, while the treatment is carried out 2-3 times a week, in a course of 7-12 procedures. After the traction procedure, rigid corseting is carried out for 2 hours. But this complex is not intended for the treatment of children with cleft lip and palate. From the prior art, patent No. 2435537 with priority from 12.05.2010.A method for eliminating extensive defects of the upper jaw in congenital through clefts of the upper lip and palate is known. An extensive defect of the hard palate and alveolar process of the upper jaw is eliminated by dissecting the mucous-periosteal membranes of the hard palate and plastic surgery with free revascularized skin-fascial radial and congruently modeled according to the defect free bone mandibular autografts. This method allows eliminating a through defect of the hard palate and alveolar process of the upper jaw, improving speech, chewing and swallowing, reducing the number of inflammatory phenomena from the ENT organs, and reducing the number of congestion in the nasopharynx. But this method does not provide for the entire complex of treatment of the child, and also does not provide for the restoration of symmetrical functionally complete and aesthetically attractive contours of the upper lip and nose, as well as an aesthetically attractive facial profile.In addition, this method does not allow for the complete restoration of the child's physiological functions and does not provide for its aesthetic rehabilitation. The closest in its technical essence is the method for treating congenital unilateral cleft lip, described in patent No. 2151562 with priority from 23.02.1999.A method for treating a congenital unilateral cleft lip by determining standard points, a through arcuate incision, forming and moving two flaps together with subsequent layer-by-layer suturing of the mucous membrane, orbicularis muscle, skin and vermilion border, characterized in that a through arcuate incision is made with a length equal to the height of the column of the healthy side of the lip, a triangular flap with a base facing the nasal septum is transformed by means of an incision passing through the apex of the cleft along the bottom of the nasal passage into a quadrangular flap, which is moved upward by the difference in the heights of the nasal septum on the healthy and cleft sides, and a triangular flap formed by an incision along the edge of the cleft and a continuation of the incision in the bottom of the nasal passage is moved into its place, forming a lip without cutting off the wing of the nose.But this method does not provide for the entire complex of treatment of the child, and also does not provide for the restoration of symmetrical functionally complete and aesthetically attractive contours of the upper lip and nose, as well as an aesthetically attractive facial profile. In addition, this method does not allow for the complete restoration of the physiological functions of the child and does not provide for his aesthetic rehabilitation. The technical problem of the claimed invention is the restoration of symmetrical functionally complete and aesthetically attractive contours of the upper lip and nose, adequate to the age of speech development, prevention of hearing and speech disorders and a harmonious bite and facial profile. The technical result of the claimed invention is the complete restoration of the physiological functions of the child and his aesthetic rehabilitation, which ensures further full life in society.The stated technical result is achieved due to the fact that the method of staged complex treatment of children with cleft lip and palate includes the following stages: examination, surgical and orthodontic treatment, speech therapy training, hearing correction, dispensary dynamic observation with a certain frequency of examinations by a pediatrician, neurologist, maxillofacial surgeon, orthodontist, speech therapist, audiologist, otolaryngologist, geneticist, psychologist, and the final stage of cosmetology procedures. The examination stage begins from the moment of birth of the child, while an examination is performed to exclude concomitant pathology, verification of the diagnosis, a plan for staged complex treatment is drawn up and the child is prepared for early surgical treatment.In order to completely eliminate functional disorders, cosmetic defects and create optimal conditions for the formation of speech and bite of the child, surgical treatment is carried out in several stages, with primary cheilorhinoplasty performed at the age of 1-3 months, cleft soft palate eliminated at the age of 6-8 months, and congenital defect of the hard palate eliminated at the age of up to 12 months. A comprehensive assessment of the results of surgical treatment is carried out at the age of 2-3 years through speech therapy testing and examination, if necessary, reconstructive operations are carried out at preschool age 5-6 years with support and contour plastic surgery of large cartilages of the wings of the nose and complete restoration of all muscle and cartilaginous structures of the nasolabial region. If velopharyngeal insufficiency is detected, it is eliminated surgically at the age of 5-6 years, and when the child reaches 7-11 years of age, bone grafting of the alveolar process of the upper jaw is performed.Throughout the entire stage of surgical treatment, the hearing status is monitored by means of an audiological examination at least once every 6 months, followed by conservative elimination of the dysfunction of the auditory tube and / or, in the presence of uncorrectable exudative otitis, a meatotympanostomy is performed. In addition, a speech therapy rehabilitation stage is carried out, including an examination using speech therapy testing, and from the age of 2-3 years, if there are indications for nasopharyngoscopy, cyclic stages of speech therapy training are carried out.Based on the results of speech therapy training, a sample of patients with clinical signs of persistent velopharyngeal insufficiency is selected, in the presence of which a surgical intervention is performed that combines mobilization of the soft palate tissues, the use of a mucomuscular flap from the back wall of the pharynx on the upper pedicle, dosed narrowing of the pharyngeal ring and complete reconstruction of the muscular structures of the soft palate. After the formation of baby teeth, orthodontic treatment is started, including an orthodontic examination with the selection of removable and non-removable orthodontic equipment at the age of 2-3 years, and, depending on the indications, preparation for bone autoplasty of the alveolar process of the upper jaw and reconstruction of the defect of the dental arch in the cleft area.At the end of the comprehensive treatment, at the age of 14-18, a stage of aesthetic rehabilitation is carried out, including the elimination of anatomical and cicatricial deformations of the operated tissues using cosmetic procedures. The declared method of staged comprehensive treatment of children with cleft lip and palate ensures full restoration of the physiological functions of the child with speech and swallowing disorders, and also provides children with aesthetic rehabilitation and further full life in society. Treatment begins with the provision of advisory assistance to the child by a maxillofacial surgeon, pediatrician and neurologist. The pediatrician deals with solving the child's somatic problems, nutrition, preparation for surgical treatment. The neurologist deals with solving the child's neurological problems. The geneticist examines both the child and the parents. The audiologist assesses the child's hearing.An ENT specialist examines the child and establishes the absence or presence of fluid in the middle ear and, if necessary, a shunt is performed. The determining factors for specifying the age for performing surgical intervention are: the type and severity of the congenital defect of the upper lip, the presence or absence of a congenital defect of the palate, the somatic and neurological status of the child. Conducting an examination (neurogram, echocardiography, ultrasound of the abdominal cavity and kidneys, ultrasound of the hip joints) and examination allows identifying absolute (preventive) and relative (requiring preoperative preparation) contraindications for planned surgical treatment. In the presence of concomitant diseases accompanied by insufficiency of vital functions that require priority correction, surgical treatment is not performed until the main problems are resolved. The presence of multiple malformations or stigmas of dysembryogenesis in patients is the basis for referral to a geneticist for consultation.Surgical treatment of patients with congenital clefts of the upper lip for all types and degrees of defect is performed during the first 3 months of life. In case of isolated clefts of the upper lip, the timing of surgical treatment is determined by the peculiarities of feeding the child, psychological and social factors. In the absence of a congenital defect of the palate and priority choice of breastfeeding, the timing of surgical treatment is shifted to the age of 4-5 months, but their further shift is not recommended due to the increase in the child's activity and, as a consequence, the increased risk of damage to the nasolabial area in the early postoperative period. In other cases, the timing of surgical treatment was determined, in addition to a set of medical, social and psychological factors, and the need for early elimination of the palate defect in order to create optimal conditions for the formation and development of speech.Primary lip surgery (at the age of 1-3 months) – primary cheilorhinoseptoplasty, during which areas of pathological attachment and displacement of muscle fibers and cartilages of the nose are eliminated by means of subperiosteal mobilization of soft tissues of the lip and cheek along the anterior surface of the maxilla and the edges of the pyriform opening, modeling of the mobilized lateral leg of the large cartilage of the ala of the nose is performed in accordance with the position and contours of the cartilage of the opposite side and displacement to the midline of the anterior part of the quadrangular cartilage of the nasal septum.A complete reconstruction of the anatomy of the muscle bundles is performed, and in case of bilateral clefts - bilateral modeling of the lateral leg, its movement upward with a change in the projection of the arch, forming the vestibule of the nasal cavity and directed traction of the muscles by reconstructing the nasal muscles of the lateral fragment - fixing them to the connective tissue in the area of the anterior nasal spine, to the anterior part of the base of the cartilage of the nasal septum. According to the proposed method, in order to create conditions for the formation of speech in normal anatomical and physiological conditions, surgical treatment of patients with congenital clefts of the palate was performed at the age of up to 1 year.One-stage surgical intervention is performed at the age of 6-8 months in groups of patients with congenital isolated clefts of the soft palate by means of functional plastic surgery of the soft palate with narrowing of the pharyngeal ring and with isolated clefts of the soft and partially hard palate with the width of the defect within the latter no more than 5 mm. In all other cases, with congenital isolated and through clefts of the palate, a two-stage plastic surgery of the palate is performed: Stage I - functional plastic surgery of the soft palate with narrowing of the pharyngeal ring (6-8 months), Stage II - gentle plastic surgery of the hard palate (11-12 months). Restoration of anatomically correct orientation and continuity of the soft palate muscles along with dosed narrowing of the pharyngeal ring, from the point of view of normal velopharyngeal sufficiency, are the main goals of functional plastic surgery of the soft palate.In patients with congenital isolated clefts of the palate of the third degree and congenital penetrating clefts of the palate, performing veloplasty is the main stage of treatment of patients, creating conditions for performing gentle plastic surgery of the hard palate. The consequence of performing plastic surgery of the soft palate at this age is a rapid (within 6 months) reduction in the transverse dimensions of the residual defect of the hard palate against the background of a corresponding increase in the linear dimensions of the maxillary fragments. The determining factor in choosing the method of gentle plastic surgery of the palate at the second stage of treatment are the transverse dimensions of the residual cleft of the hard palate in the projection of the distal edge of the tubercles of the upper jaw. Method I (with a cleft width in this area of no more than 2-3 mm) is mobilization, convergence and fixation of the released edges of the oral mucosa and periosteum.Method II is used in patients with transverse cleft dimensions from 3 to 5 mm and consists of forming one or two narrow (6-7 mm wide) mucoperiosteal flaps on two feeding pedicles. When the width of the defect in the projection of the distal edge of the tubercles of the upper jaw is from 5 to 8 mm, method III is used, based on the mobilization of one mucoperiosteal flap from the side of the large maxillary fragment, retreating 2-3 mm from the base of the alveolar process of the upper jaw, and up to the palatine opening with the release of the vascular-nerve bundle from it. During the surgical intervention, the flap is moved in the medial direction and fixed to the released edge of the oral mucosa from the side of the small fragment of the upper jaw. Method IV is used when the width of the residual defect of the hard palate is more than 8 mm by mobilizing, moving and suturing the mucoperiosteal flaps of both fragments of the upper jaw.The method of rehabilitation of children with congenital clefts of the palate, in addition to surgical treatment, includes the need for dynamic control, starting from the neonatal period and, if necessary, correction of the hearing condition by conservative elimination of the dysfunction of the auditory tube or, in the presence of uncorrectable exudative otitis, by meatotympanostomy. A comprehensive assessment of the results of surgical treatment of patients with clefts of the palate is carried out at the age of 2-3 years through speech therapy testing and examination aimed at assessing the type of physiological breathing, the presence or absence of a correctly formed phonation exhalation, voice function, position of the tongue in the oral cavity, the correct method and place of sound formation, the presence or absence of hypernasalization, nasal emission, compensatory mechanisms of articulation. At the age of 2-3 years, examination, testing and speech therapy training are carried out.Cycles of intensive speech therapy training by speech therapists highly qualified in the problem of rhinolalia have proven to be particularly effective. Based on the results of the first cycle of speech therapy training, a sample of patients with clinical signs of persistent velopharyngeal insufficiency is formed. However, verification of the diagnosis was always carried out by performing fiberoptic nasopharyngoscopy using a set of words containing a number of sounds, the pronunciation of which required complete closure. During the study, the type of closure is determined, the work of the soft palate and other structures of the velopharyngeal ring, the size and shape of the residual opening, indicating the degree of expression of the velopharyngeal insufficiency / dysfunction are assessed. The presence of complete closure has always been an indication for continuing speech therapy training.In the presence of persistent velopharyngeal insufficiency according to the results of repeated nasopharyngoscopy in functional conditions, surgical treatment was performed. The surgical approach used to eliminate velopharyngeal insufficiency combines the features of soft palate tissue mobilization, the use of a mucomuscular flap from the posterior pharyngeal wall on the upper pedicle, dosed narrowing of the pharyngeal ring and complete reconstruction of the muscle structures of the soft palate and is performed at the age of 5-6 years. The described method of primary cheilorhinoseptoplasty solves most of the patients' problems, however, a number of problems caused by anatomical problems of the large cartilage of the wing of the nose and all its components are designed to be solved by reconstructive surgery.During its implementation at the age of 5-6 years, the main stage is septoplasty and elimination of the bony ridge of the nasal septum, observed in the vast majority of patients with a history of unilateral clefts of the upper lip, which allows for complete normalization of nasal breathing in cases of difficulty. The resected part of the lower curved part of the cartilage of the nasal septum is an excellent source of plastic material, allowing for leveling the flattening of the arch of the large cartilage of the ala of the nose and the displacement of the medial crus. By means of support-contour plastic surgery of the large cartilages of the nasal wings, it is possible to achieve complete elimination of the deformation of the nose in preschool age with the receipt of stable functional and cosmetic results.In the treatment of patients with residual bilateral deformations of the upper lip and nose, a differentiated approach to the choice of tactics is used: along with the use of surgical techniques aimed at lengthening the columella, reconstructive rhinoseptoplasty is increasingly used, based on the principles of functional surgery of the nasolabial region, support and contour plastic surgery of the nasal cartilages. The use of cartilaginous septum transplants allows changing the projection of the tip of the nose, the direction of growth of the nasal cartilages and creating a stable shape of the nose. For the treatment of patients with clefts of the alveolar process of the upper jaw, a technique of bone grafting of the alveolar process of the upper jaw with an autograft from the iliac crest at the age of 7-11 years has been introduced in order to complete the orthodontic stage of treatment in the most optimal way.When planning bone grafting of the alveolar process of the upper jaw, a differentiated approach to the choice of autograft has been developed taking into account the period of bite formation, the state of the dental arch, the severity of the deformation of the midface and the planned method for eliminating the defect of the dentition. For patients with edentia and significant mobility of the upper jaw fragments during planned orthopedic treatment or implantation, a method of support-contour grafting of the alveolar process of the upper jaw and the edges of the pyriform opening with split autografts from the parietal bone has been developed. At the end of the comprehensive treatment, anatomical and cicatricial deformations of the operated tissues are eliminated using cosmetic procedures at the age of 14-18 years. An example of using the claimed method of staged comprehensive treatment of children with cleft lip and palate. The parents of a newborn girl with a cleft lip and palate (Fig. 1) consulted a doctor.A maxillofacial surgeon, pediatrician, and neurologist conducted an examination, which established that the child had a congenital bilateral complete cleft lip, alveolar process of the upper jaw, hard and soft palate with protrusion of the intermaxillary fragment. There were no contraindications for surgery in terms of somatic status (Fig. 2). The pediatrician dealt with the child's somatic problems, nutrition, and preparation for surgery. The neurologist dealt with the child's neurological problems. A geneticist examined both the child and the parents. An audiologist assessed the child's hearing. An ENT specialist examined the child and concluded that the child has dysfunction of the auditory tube on both sides against the background of a cleft palate. This child underwent a staged comprehensive treatment. The following stages of treatment were carried out: at the age of 3 months, primary bilateral cheilorhinoseptoplasty was performed (Fig.3), as a result of the surgical intervention, the contours of the Cupid's bow, the shape and symmetry of the red border and the upper lip and nose were restored (Fig. 4). At the age of 6 months, in order to create conditions for the formation of speech (Fig. 5), functional plastic surgery of the soft palate with a dosed narrowing of the pharyngeal ring was performed (the result in Fig. 6), at the age of 1 year, the cleft of the hard palate was eliminated in a gentle way (Fig. 7). At the age of 8 years, bone grafting of the alveolar process of the upper jaw was performed with an autograft from the iliac crest (Fig. 8) CT before surgery, bone tissue was restored along the entire length (Fig. 9) CT one year after surgery. At the age of 12, residual deformation of the upper lip and nose was observed (Fig. 10); the child underwent complete mobilization and reconstruction of all muscular and cartilaginous components of the nasolabial region (Fig. 11), which made it possible to achieve a good cosmetic and functional treatment result (Fig. 12).Upon reaching the age of 14, the child will undergo a stage of aesthetic rehabilitation, including the elimination of anatomical and cicatricial deformations of the operated tissues using cosmetic procedures.
Claims
CLAIMS OF THE INVENTION 1. A method for the staged comprehensive treatment of children with cleft lip and palate, in which surgical treatment is performed in several stages, namely, at the age of 1-3 months, primary cheilorhinoplasty is performed, eliminating areas of pathological attachment and displacement of muscle fibers and cartilages of the nose by means of subperiosteal mobilization of the soft tissues of the lip and cheek along the anterior surface of the upper jaw and the edges of the pyriform opening, modeling of the mobilized lateral leg of the large cartilage of the ala of the nose is performed in accordance with the position and contours of the cartilage of the opposite side - movement to the midline of the anterior part of the quadrangular cartilage of the nasal septum, while performing a complete reconstruction of the anatomy of the muscle bundles, and in the case of bilateral clefts - bilateral modeling of the lateral leg, its movement in an upward direction with a change in the projection of the arch,formation of the vestibule of the nasal cavity and directed traction of the muscles by means of reconstruction of the nasal muscles of the lateral fragment - fixation thereof to the connective tissue in the area of the anterior nasal spine to the anterior part of the base of the cartilage of the nasal septum, wherein the cleft of the soft palate is eliminated at the age of 6-8 months by means of one-stage functional plastic surgery of the soft palate with narrowing of the pharyngeal ring and in case of isolated clefts of the soft and partially hard palate with a defect width within the latter of no more than 5 mm, and a congenital defect of the hard palate is eliminated at the age of up to 12 months with an assessment of the result of the said complex surgical treatment at the age of 2-3 years by means of speech therapy testing and examination.
2. The method of staged complex treatment of children according to claim 1, characterized in that,that based on the results of the assessment of the complex surgical treatment, reconstructive operations with support-contour plastic surgery of the large cartilages of the wings of the nose and with complete restoration of all muscle and cartilaginous structures of the nasolabial region are performed at the age of 5-6 years.
3. The method of staged complex treatment of children according to paragraph 1 or 2, characterized in that additionally, the velopharyngeal insufficiency is eliminated surgically at the age of 5-6 years, and upon reaching the age of 7-11 years, bone grafting of the alveolar process of the upper jaw is performed.
4. The method of staged complex treatment of children according to paragraphs 1-3, characterized in that conservative elimination of the detected dysfunction of the auditory tube is carried out or, in the presence of uncorrectable exudative otitis, meatotympanostomy is performed, and throughout the entire stage of surgical treatment, the state of hearing is monitored,which is performed by means of an audiological examination with a frequency of at least once every 6 months.
5. The method of staged complex treatment of children according to paragraphs 1-3, characterized in that after the formation of milk teeth, orthodontic treatment is started, including an orthodontic examination with the selection of removable and non-removable orthodontic equipment, at the age of 2-3 years and, if indicated, at the age of 7-11 years, bone autografting is performed, alveolar process of the upper jaw with an autograft from the iliac crest and reconstruction of the defect of the dental arch in the cleft area.
6. The method of staged complex treatment of children according to paragraphs 1-5, characterized in that for patients with edentia and mobility of fragments of the upper jaw, support-contour plastic surgery of the alveolar process of the upper jaw and the edges of the pyriform opening is performed with split autografts from the parietal bone.
7. The method of staged complex treatment of children according to paragraphs 1-6, characterized in that upon completion of surgical treatment at the age of 14-18 years, aesthetic rehabilitation is carried out, including the elimination of anatomical and cicatricial deformations of the operated tissues using cosmetology procedures.
Citation Information
Patent Citations
Method of surgical management of prosopoanoschisis
RU2440042C1
Method of early orthodontic treatment of children with congenital double-sided cleft of upper lip and palate
RU2735063C1
Method for orthodontic preparation for cleft closure surgery in comprehensive rehabilitation of children with cleft palate and lip using computer modelling
RU2772523C1
Imaging of anatomical structures
US20090128553A1
Apparatus for use in treatment of the bilateral cleft lip and palate condition in infants
US3895624A
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