RU2599373C1 - Method of manufacturing of orthopaedic apparatus for preoperative early orthodontic treatment of children with congenital single- and double-sided complete cleft of upper lip and palate - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to orthodontics, and is applicable for using in orthopaedic rehabilitation of children with congenital complete single- and double-sided cleft of upper lip and palate. Cast of the upper jaw is obtained by forming thermoplastic mass in the form of truncated cone with subsequent fixation of its base to aluminium strip with rounded ends, 2/3 of which firstly bend at an angle 135°, closing one of the ends of aluminium strip by edges of the base of truncated cone if the thermoplastic mass. In the thermoplastic mass is formed a recesses for doctor's middle finger. Cast of the upper jaw is obtained by pressing a truncated cone with attached to its base of aluminium strip to all surfaces of the alveolar processes of the upper jaw and holding of not more than 6 seconds with further immersion of the obtained cast into water at temperature 15-20 °C. Further, the three-dimensional laser scanning of the obtained cast of upper jaw is conducted, as a result of which a digital model of congenital defect of the upper jaw is obtained. Than carry out the construction of a computer drawing of the orthopaedic apparatus at digital model of congenital defect by the way of whole duplication and subsequent transfer on the individual surface of the congenital defect of the upper jaw on the surface of orthopaedic apparatus. After digital three-dimensional simulation of treatment stages an orthopaedic apparatus is made with the help of three-coordinate milling machine with programmed numerical control by digital model of orthopaedic apparatus of solid standardized workpiece of cubic shape made of plastic "StomAkril".

EFFECT: method provides reliable retention and comfortable finding of orthopaedic apparatus in the oral cavity, reduce the length of early orthodontic treatment and reducing the time of manufacturing orthopaedic apparatus.

1 cl, 12 dwg, 2 ex

Description

The invention relates to medicine, namely to orthodontics, and can be used for orthopedic rehabilitation and early orthodontic treatment of children with congenital complete one- and two-sided congenital cleft lip and palate in order to improve the quality of preoperative preparation of newborns for the first stage of surgical treatment - primary chelorinoplasty .

Congenital single and bilateral cleft of the upper lip and palate are severe and common malformations of the maxillofacial region, accompanied by gross anatomical and functional disorders. From birth, these patients have violated vital functions: breathing, sucking, and swallowing, so from the first hours of life, the newborn should be given orthopedic rehabilitation at the earliest opportunity and early orthodontic treatment subsequently. Orthopedic care for children with single and bilateral congenital clefts involves the manufacture of an individual prosthesis of the palate, which separates the oral cavity and nose, ensuring normal feeding of the newborn and restoration of the functions of sucking and breathing. The task of early orthodontic treatment is to correct the congenital deformation of the alveolar processes and, thus, achieve the correct shape of the upper jaw, as a result of which the most favorable conditions are created in the defect area for timely and high-quality successful chelorinoplasty both during the operation and in the distant period [1 -3].

Known are traditional methods for the manufacture of orthopedic devices with congenital complete one- and two-sided cleft of the upper lip and palate, combining the steps of obtaining an impression of the upper jaw and manufacturing, using the obtained impression of the upper jaw, a gypsum model by which the wax pattern of the future apparatus is modeled, after which it is gypsum in the cuvette and a gypsum stamp is obtained, according to which the orthopedic apparatus is finally modeled from liquid plastic and the plastic is polymerized for it, at the final stage manufacturing carry out grinding and polishing of the finished orthopedic apparatus [4-13].

According to the closest technical essence, as a prototype, we have chosen a method of manufacturing an orthopedic apparatus with bilateral full congenital cleft of the upper lip and palate, which consists in first receiving a mold of the upper jaw, and then making a plaster model of it from the upper jaw that is scanned with using a three-dimensional laser scanner with an accuracy of <0.2 mm (Vivid 910, Konica Minolta Holdings) with the resulting three-dimensional image resolution of 640 × 480 pixels. The resulting digital model of a congenital maxillary defect for analysis is loaded into a computer program (Polygon Editing Tool 2.0), then into the Rapid Form computer program for digital three-dimensional modeling of treatment steps, in which the model of the maxilla is virtually divided into three segments: two alveolar processes and a segment with intermaxillary bone. After modeling the design of the orthopedic apparatus, it is manufactured using the additive technology of rapid prototyping, which consists in layer-by-layer addition or synthesis of model material under the action of the energy of a directed light beam. The finished orthopedic device is a plate made of plastic 2 mm thick, as well as two retention buttons extending from it, elongated in the form of a mustache, which extend from the intraoral plate and ensure its retention in the oral cavity using extraoral elastic elements. Holding the device in the oral cavity also requires the application of several additional fixing elements in the form of dressings, plasters and ribbons. Two metal wires extend from the orthopedic apparatus, at the ends of which there are plastic balls that are located in the nasal passages. Metal wires extending from the buttons of the intraoral apparatus are made manually by bending steel wire after receiving the finished orthopedic apparatus. At each end of the metal wires are plastic balls in the form of a kidney, which serve to raise the skin-cartilaginous frame of the nose. Plastic balls, which are also made manually after the manufacture of the finished orthopedic apparatus, fully enter the nasal passages, leaving no clearance for the patient's free nasal breathing. They also need, in conjunction with the orthopedic apparatus, additional fixation with plasters and tapes. Ready orthopedic apparatus is presented in the form of a set consisting of several, on average 12-16, orthopedic apparatuses, the manufacture of which is a prerequisite for the operation of the orthopedic apparatus. Parents of the patient need to independently perform weekly replacement and placement of the orthopedic apparatus in the patient’s oral cavity [14].

The disadvantages of the method selected as a prototype are:

- Insufficiently reliable retention and comfortable placement of the orthopedic apparatus in the oral cavity, both at rest and during feeding the patient, which is associated with insufficient accuracy in obtaining an individual anatomical form of a congenital defect of the upper jaw as a result of obtaining an impression of the upper jaw and, as a consequence, insufficient accuracy obtaining a digital model of a birth defect.

- The need to obtain a gypsum model of the upper jaw at the stages of manufacturing an orthopedic apparatus, which increases the duration of its manufacture, and also reduces the accuracy of its manufacture as a result of the inevitable shrinkage of gypsum, and also increases the cost of treatment.

- The use of numerous fixing extraoral elements to hold the orthopedic apparatus in the oral cavity in the form of buttons, plasters, ribbons, dressings and hooks requiring repeated replacement during the day, which is an increased risk of irritation, inflammation and trauma to the surrounding soft tissues of the patient’s face, which, in in turn, significantly increases the risk of abandoning the use of the orthopedic apparatus, which increases the time required to prepare and wait for the operation of chelorinoplasty, which is 5-6 months.

- The presence in the nasal passages of plastic balls designed to raise the skin and cartilage of the nose, does not provide free nasal breathing for newborn patients and also requires additional fixing elements, which overloads the design of the orthopedic apparatus, making it difficult to adapt to it, especially during sleep and feeding a newborn, and also requires additional time and material costs for their manufacture. In addition, manual bending of a metal wire, as well as manual manufacturing of plastic balls after the manufacture of an orthopedic apparatus, creates a delay for its functioning to begin.

- Production of a kit, including 12-16 orthopedic devices, and the absence, if necessary, the possibility of instant correction using any standard dental instruments and materials (cold and / or hot polymerisation plastic) available in any dental department.

Immediate correction when using standard dental instruments and using cold and / or hot polymerization plastic due to insufficient adhesive properties of the light-cured material from which the orthopedic apparatus is made is a high risk of sudden cleavage or tearing of the plastic from the surface of the orthopedic apparatus, which can lead to its re-manufacturing , which will undoubtedly increase the cost and duration of treatment.

- The inability to dynamically monitor changes in the shape of the upper jaw and the relative position of its processes with subsequent correction of the orthopedic apparatus taking into account the individual growth and development of this category of patients and, therefore, the need for the patient’s parents to independently replace the orthopedic apparatus weekly, which is a risk of incorrect placement of the orthopedic apparatus in the patient’s oral cavity, as a result of which the duration of treatment increases, and its quality decreases.

- The duration of the manufacture of an orthopedic apparatus, which, according to the literature and according to our own data, averages more than 8-10 hours [15, 16, 17].

- The need to use expensive foreign highly specialized consumables and equipment requiring licensing, staff training, which will inevitably lead to an increase in the cost of treatment.

The objective of the invention is:

- ensuring reliable retention and comfortable placement of the orthopedic apparatus in the oral cavity, both at rest and during feeding the patient, eliminating the risk of irritation and trauma to the surrounding soft tissues of the patient's face;

- reducing the time of early orthodontic treatment, that is, reducing the time of preparation and waiting for the operation of chelorinoplasty;

- improving the accuracy of the method of manufacturing an orthopedic apparatus and its simplification, as well as reducing material and time costs for the manufacture of an orthopedic apparatus and, accordingly, reducing the total cost of early orthodontic treatment.

The technical result of the invention is:

- improving the accuracy of obtaining an individual anatomical form of a congenital defect in the upper jaw and, as a result, improving the accuracy of obtaining a digital model of a congenital defect;

- eliminating the need to manufacture a gypsum model of the upper jaw at the stages of manufacturing an orthopedic apparatus;

- eliminating the need to use any locking extraoral elements, such as dressings, bandages, buttons or hooks;

- eliminating the need for manufacturing additional elements extending from the orthopedic apparatus in the form of a mustache with plastic balls at the ends intended for correction of the skin-cartilaginous frame of the nose;

- the exception of the incorrect placement of the orthopedic apparatus in the patient's oral cavity;

- the possibility of instant correction, if necessary, of the finished orthopedic apparatus using any standard dental instruments, as well as plastic cold and hot polymerization;

- the possibility of dynamic monitoring of changes in the shape of the upper jaw and the relative position of its processes and orthopedic apparatus during the growth of this category of patients, which eliminates the risk of improper placement in the patient’s oral cavity.

The technical result is achieved by the fact that the method of manufacturing an orthopedic apparatus for preoperative early orthodontic treatment of children with congenital one- and two-sided complete cleft upper lip and palate consists in obtaining an impression of the upper jaw by forming a thermoplastic mass in the form of a truncated cone with subsequent attachment of its base to an aluminum strip with rounded ends, 2/3 of which are previously bent at an angle of 135 °, while closing one of the ends of the aluminum strip to Ayami base of the truncated cone of the thermoplastic mass. At the same time, a recess is formed in the thermoplastic mass for the doctor’s middle finger, after which an impression of the upper jaw is obtained, pressing a truncated cone with an aluminum strip attached to its base to all surfaces of the alveolar processes of the upper jaw and holding it for no more than 6 seconds, followed by immersion of the obtained impression in water with temperature 15-20 ° C. Next, a three-dimensional laser scan of the obtained impression of the upper jaw is carried out, as a result of which a digital model of a congenital defect of the upper jaw is obtained. After that, the computer drawing of the orthopedic apparatus is carried out according to the digital model of the birth defect by the complete duplication and subsequent transfer of the entire individual surface of the congenital defect of the upper jaw to the surface of the orthopedic apparatus. After digital three-dimensional modeling of the treatment stages, an orthopedic apparatus is manufactured using a three-coordinate milling machine with numerical control according to a digital model of the orthopedic apparatus from a solid array of standardized cubic billet made of plastic "StomAkril".

The method is as follows.

) осуществляют построение чертежа ортопедического аппарата с учетом всех индивидуальных анатомических особенностей одно- или двустороннего дефекта. Построение компьютерного чертежа ортопедического аппарата начинают с очерчивания границ и определения размеров будущего изделия. Затем проводят полное дублирование всей индивидуальной поверхности врожденного дефекта и осуществляют ее виртуальный перенос на поверхность ортопедического аппарата. В результате переноса индивидуальной поверхности дефекта на внутреннюю поверхность ортопедического аппарата при односторонней полной врожденной расщелине верхней губы и нёба на стороне ортопедического аппарата, отражающего здоровую область верхней челюсти, получается участок, имеющий вид крючка, а на стороне, отражающей врожденную расщелину, - участок в виде гребня. Далее проводят цифровое трехмерное моделирование этапов лечения, т.е. моделирование этапов взаимного перемещения большего и меньшего альвеолярных отростков верхней челюсти в динамике лечения. При этом при одностороннем врожденном дефекте виртуально удаляют участок ортопедического аппарата за большим альвеолярным отростком, что необходимо для образования свободного пространства в ортопедическом аппарате для дальнейшего дистального перемещения большего отростка в процессе лечения. Кроме того, кпереди от меньшего альвеолярного отростка верхней челюсти виртуально удаляют участок ортопедического аппарата для возможности его последующего перемещения вперед в процессе лечения, согласно проведенному цифровому трехмерному моделированию этапов лечения. На Фиг. 5 изображена цифровая модель ортопедического аппарата при одностороннем полном врожденном дефекте верхней челюсти.The Masster thermoplastic impression mass is heated by adding boiled water at a temperature of 100 ° C for 2 minutes in a plastic heat-resistant bowl until a soft plastic consistency is obtained, which is checked with a spatula. A heated portion of the thermoplastic mass is formed in the form of a cone with a truncated apex, the base of the cone of thermoplastic mass is attached to one of the ends of an aluminum strip with rounded ends, 2/3 of which are previously bent at an angle of 135 °. One of the ends of the aluminum strip is closed by the edges of the base of the truncated cone, thus forming a recess for the doctor’s middle finger in the thermoplastic mass. By the time it is introduced into the oral cavity, the thermoplastic mass acquires a temperature of not more than 50 ° C, which provides sufficient softness and suppleness of the impression thermoplastic mass, which is necessary for accurate casting, and is comfortable for a patient who experiences sensations similar to a warm moist compress. After the thermoplastic mass is formed in the form of a truncated cone on an aluminum strip, it is inserted into the oral cavity, holding the aluminum strip with the right hand, while the doctor places the middle finger in the recess for it from the thermoplastic mass, and the index finger of his left hand is in the corner of the patient’s mouth between the upper and lower jaws, thereby ensuring the condition of the child’s open mouth in the process of obtaining an impression of the upper jaw. After introducing the thermoplastic mass on an aluminum strip into the patient’s oral cavity, the thermoplastic mass is actively pressed to all surfaces of the alveolar processes of the upper jaw and hold for no more than 6 seconds, thus obtaining an individual anatomical form of the birth defect. The resulting impression of the upper jaw is removed from the oral cavity and immersed in water at a temperature of 15-20 ° C for 2 minutes for final hardening. After final hardening, the obtained cast is removed from the water and carefully inspected, checking its integrity and quality of the anatomical surface displayed on it. At the slightest visible deformation or defects on the surface of the obtained impression, it is recommended to repeat it. In FIG. 1 and FIG. Figure 2 shows the obtained casts of a single and bilateral full congenital cleft of the upper lip and palate on an aluminum strip after final hardening. To obtain a digital three-dimensional model of a congenital defect in the upper jaw, a non-contact surface laser scanning of the obtained impression of the upper jaw is carried out with a laser accuracy of 0.56 ± 0.25 mm. As a result of three-dimensional laser scanning of the impression of the upper jaw, a three-dimensional polygonal mesh model of a congenital single or bilateral congenital defect of the upper jaw is obtained (Fig. 3 and Fig. 4). The digital three-dimensional model of the birth defect, if necessary, is digitally modified to eliminate the possible noise that arose during the three-dimensional laser scanning and to select the optimal resolution. At the stage of testing a digital three-dimensional model of a birth defect, all polygonal objects obtained as a result of scanning of its surface are checked, which must have the correct normals, as well as the correct joining of the triangles of the grid, which will ensure the greatest accuracy of the future apparatus after milling. Next, a digital model of a birth defect using the CATIA V5 computer program (Dassault

) carry out the construction of the drawing of the orthopedic apparatus, taking into account all the individual anatomical features of a single or bilateral defect. The construction of a computer drawing of an orthopedic apparatus begins with the outline of the boundaries and the determination of the dimensions of the future product. Then complete duplication of the entire individual surface of the birth defect is carried out and its virtual transfer to the surface of the orthopedic apparatus is carried out. As a result of the transfer of the individual surface of the defect to the inner surface of the orthopedic apparatus with unilateral full congenital cleft of the upper lip and palate on the side of the orthopedic apparatus, which reflects the healthy region of the upper jaw, a section is obtained that looks like a hook, and on the side that reflects the congenital cleft, a section in the form crest. Next, digital three-dimensional modeling of the stages of treatment, i.e. modeling of the stages of mutual displacement of the larger and smaller alveolar processes of the upper jaw in the dynamics of treatment. In this case, with a unilateral congenital defect, the area of the orthopedic apparatus behind the large alveolar process is virtually removed, which is necessary for the formation of free space in the orthopedic apparatus for further distal movement of the larger process during treatment. In addition, an area of the orthopedic apparatus is virtually removed anterior to the smaller alveolar process of the upper jaw so that it can be further moved forward during treatment, according to a digital three-dimensional modeling of the treatment steps. In FIG. 5 shows a digital model of an orthopedic apparatus with a one-sided complete congenital defect in the upper jaw.

With bilateral congenital cleft of the upper lip and palate, as a result of complete duplication of the individual surface of the congenital defect, areas in the form of ridges are obtained on the surface of the orthopedic apparatus. Next, digital three-dimensional modeling of the stages of treatment, i.e. simulation of the stages of mutual movement of the alveolar processes and intermaxillary bone in the dynamics of treatment. In this case, with a bilateral congenital defect of the upper jaw, the area of the orthopedic apparatus behind the intermaxillary bone is removed. The area to be removed is equal to the distance between the most protruding and distant points of the intermaxillary bone and is necessary to create space in the orthopedic apparatus in order to establish the previously displaced intermaxillary bone in its original position, according to a digital three-dimensional modeling of the treatment stages. In FIG. Figure 6 shows a digital model of a congenital complete bilateral maxillary defect.

The length, thickness, height, slope of the retention sites in the form of a hook and ridges depend on the individual anatomical shape of a single and bilateral complete birth defect.

After building a computer drawing of the orthopedic apparatus, it is prepared for milling on a machine with numerical control. The milling process is made from a solid array of cubic-shaped plastic billets, which are pre-made from domestically produced plastic "StomAkril", a manufacturer of "StomaDent", intended for the production of orthopedic devices and recommended by the Committee on New Medical Equipment of the Ministry of Health of Russia. Obtaining a standardized plastic blank for an orthopedic apparatus is carried out by mixing the plastic components, according to the instructions recommended by the manufacturer, followed by polymerization of the plastic in cubic form in a polymerization dental pan under a pressure of 2 atmospheres and for 25 minutes. Before milling the orthopedic apparatus, its digital model is loaded into the control program for the three-coordinate milling machine, in which the exact size of the future product along the X, Y and Z axes is first determined, after which the appropriate type and size of the cutter are selected. The thickness range in the future orthopedic device is determined according to its digital model.

The milling process is performed on a program-controlled three-coordinate milling and engraving machine with milling accuracy in the range from 0.05-0.1 mm. The processing of the plastic blank of the future orthopedic apparatus is carried out according to the given coordinates of the digital model of the orthopedic apparatus according to the X, Y, Z axes. In FIG. 7 shows the process of milling an orthopedic apparatus from a standardized plastic blank. The milling process can be conditionally divided into two stages. Initial “rough” milling - a rougher milling process occurs at a speed of 2100 mm / min using a spherical milling cutter with a diameter of 6 mm. The parameters of the control program specify the milling depth per pass, which for the initial milling is 0.5 mm. At the second stage of milling, a plastic preform is machined with a mill of a smaller diameter over the entire processing depth at the same speed. The required surface cleanliness of the future orthopedic apparatus is achieved by processing the surface relief from all sides of the product. In FIG. 8 shows a finished orthopedic apparatus after milling.

Distinctive essential features of the invention and a causal relationship between them and the achieved result:

- An impression of the upper jaw is obtained by forming a thermoplastic mass in the form of a truncated cone.

The use of thermoplastic mass, in contrast to the prototype method, which uses an alginate impression mass to obtain an impression of the upper jaw, allows to achieve maximum accuracy of the displayed surface of the congenital defect of the upper jaw with the shortest time of solidification in the oral cavity (2-3 seconds), while minimizing the risk of deformation when removing the thermoplastic mass from the patient's oral cavity.

The formation of a thermoplastic mass in the form of a truncated cone contributes to its safe introduction by a truncated vertex into the region of a congenital defect in the upper jaw and its subsequent uniform distribution in the region of a single or bilateral defect.

- With subsequent attachment of the base of the truncated cone to an aluminum strip with rounded ends, 2/3 of which are bent at an angle of 135 °, closing one of the ends of the aluminum strip with the edges of the base of the truncated cone from a thermoplastic mass, forming a recess for the doctor’s middle finger.

The attachment of the base of the truncated cone to the aluminum strip contributes to the greatest reliability for holding the thermoplastic mass when receiving the impression of the upper jaw, as well as the safe, easy and comfortable removal of the thermoplastic mass on the aluminum strip from the patient’s mouth without the risk of deformation of the resulting impression of the upper jaw.

The bending of 2/3 of the aluminum strip at an angle of 135 ° contributes to the maximum achievement of the goal, namely, the safe introduction of the thermoplastic mass on the aluminum strip attached to it, and its subsequent accurate positioning in the patient's oral cavity.

A part of the indicated 2/3 parts of the aluminum strip serves as a handle for a comfortable and physiological arrangement of the doctor's hand in the process of obtaining an impression of the upper jaw. Maintaining the physiological location of the doctor’s hand when receiving an impression of the upper jaw is especially important when it is necessary to obtain an accurate impression of the upper jaw in the shortest time of exposure.

The rounded ends of the aluminum strip, as well as the closing of one of the ends of the aluminum strip with the edges of the base of the truncated cone from the thermoplastic mass, allows you to protect the mucous membrane of the patient’s oral cavity when making an impression, as well as to form an individual depression for the doctor’s middle finger, which is also obtained by forming a thermoplastic mass.

The formation of the aforementioned recess is necessary for the correct and stable location of the middle finger of the doctor’s right hand, which provides precise control of the aluminum strip with the thermoplastic mass attached to it, which, in turn, prevents the excessive amplitude of the movements of the doctor’s hand under limited visualization conditions of the patient’s oral cavity and thereby increases the accuracy of obtaining an individual anatomical form of a congenital defect of the upper jaw.

- A truncated cone with an aluminum strip attached to its base is pressed to all surfaces of the alveolar processes of the upper jaw and held for no more than 6 seconds.

The pressing and holding of the thermoplastic mass in the form of a truncated cone together with an aluminum strip attached to its base to all surfaces of the alveolar processes of the upper jaw provides a highly accurate individual anatomical form of the birth defect.

The retention time of the thermoplastic mass attached to the aluminum strip in the patient's oral cavity is no more than 6 seconds, which is optimal for the correct positioning of the aluminum strip together with the thermoplastic mass attached to it and its safe removal from the oral cavity.

The temperature regime of 15-20 ° C when immersing the obtained impression in water is selected taking into account the fact that a lower or higher temperature regime is a risk of deformation and shrinkage of the resulting impression of the upper jaw.

- Conduct a computer drawing of the orthopedic apparatus according to the digital model of the birth defect obtained as a result of three-dimensional laser scanning of the impression of the upper jaw, by complete duplication and subsequent transfer of the entire individual surface of the birth defect to the surface of the orthopedic apparatus, which allows you to get sections on the inner surface of the apparatus in the form of a hook on the healthy side and in the form of a crest on the side of the congenital cleft with unilateral complete congenital cleft ver her lip and palate and sites in the form of ridges with a bilateral complete congenital cleft lip and palate.

Carrying out a three-dimensional laser scan of the obtained impression of the upper jaw eliminates the need to obtain a gypsum model of the upper jaw at the stages of manufacturing the orthopedic apparatus and allows you to immediately get a digital model of a congenital defect of the upper jaw, which increases the accuracy of the manufacture of the orthopedic apparatus, since the inevitable shrinkage of gypsum, affecting the accuracy of manufacturing, and also reduces the time and financial costs for the manufacture of an orthopedic apparatus.

The obtained sections in the form of a hook and ridges represent retention points, which make it possible to exclude the use of any extraoral fixing elements, such as bandages, tapes, plasters and hooks, since the orthopedic apparatus is kept in the oral cavity due to the full correspondence to the anatomical characteristics and individual characteristics of the birth defect that contribute to the comfortable finding and reliable retention of the orthopedic apparatus in the oral cavity, both at rest and when feeding the patient, excluding rice irritation and trauma surrounding soft tissue of the patient face.

Ensuring the maximum residence time of the orthopedic apparatus in the patient’s oral cavity helps minimize the preparation time and wait for the chelorinoplasty operation. Due to the reduction in preparation time for chelorinoplasty by 2 times (from 5-6 months in the prototype method to 2.5-3 months in the present method), according to our data, correction of the skin-cartilaginous frame of the nose is no less effective immediately thus influencing the growth of the cartilage of the nose, as well as the aesthetics of the nasolabial region as a whole. Correction of the skin-cartilaginous frame of the nose immediately after the operation, and not before it, excludes, in contrast to the prototype method, the manufacture of additional elements extending from the orthopedic device in the form of a mustache with plastic balls at the ends that fully enter the lumen of the patient’s nasal passages , interfering with the free nasal breathing of the newborn and making it difficult for him to adapt to them during sleep and feeding, and also require additional time and material costs for their manufacture.

- An orthopedic apparatus is made using a three-coordinate milling machine with numerical control according to a digital model of an orthopedic apparatus from a solid array of standardized cubic billet made of plastic "StomAkril".

The use of a three-coordinate milling machine with numerical control allows you to use the machining method, as a result of which it is possible to obtain individual and different thicknesses in a finished orthopedic device, the range of which is 1 mm - 3.5 mm in the region of the palatine plate of the device and its sides and more than 4 mm in areas of retention ridges.

The manufacture of one orthopedic device from a solid array of standardized plastic billets, in contrast to the method of layer-by-layer synthesis of model material used in the prototype method for the manufacture of several orthopedic devices, as well as due to the strength and surface characteristics of the StomAkril plastic from which the orthopedic device is made, is possible dynamic monitoring of changes in the shape of the upper jaw and the relative position of its processes with subsequent high-precision corr tran sportation the same orthosis with individual growth and development of this group of patients, which eliminates the risk of incorrect setting of the orthopedic device in the patient's mouth, as well as reducing the duration and cost of early orthodontic treatment, ie, preparation and expectation of the operation of chelorinoplasty, compared with the prototype.

Using a standardized plastic billet allows you to speed up the manufacturing process of the orthopedic apparatus, as well as improve its quality, since the billet is obtained in advance and in accordance with all technological requirements and the mode of preparation of plastic for it.

The cubic shape is the most optimal, taking into account the smallest stock of material when milling an orthopedic apparatus from it, and, in addition, does not require long-term machining of an array of plastic.

Thus, the use of a three-coordinate milling machine with numerical control allows you to get a high-precision orthopedic apparatus, significantly reducing material and time costs, compared with the prototype, as well as analogues.

The cost of a 3D printer capable of printing a similar orthopedic apparatus consisting of plastic used in the prototype method is from 6 to 10 million rubles. The cost of a three-coordinate milling machine with numerical control used in the present method is from 50,000 to 120,000 rubles.

The manufacturing time of the orthopedic apparatus according to the prototype method, according to its own data, is on average 8-10 hours, according to traditional manufacturing methods (analogues) - 22-26 hours. According to the claimed method is not more than 4 hours.

The set of essential distinguishing features is new and allows you to:

- increase the accuracy of obtaining an individual anatomical form of a congenital defect in the upper jaw and, accordingly, the accuracy of obtaining a digital model of a congenital defect;

- exclude the receipt of a gypsum model of the upper jaw at the stages of manufacturing an orthopedic apparatus;

- exclude the use of any locking extraoral elements, such as bandages, bandages, buttons or hooks;

- to exclude the manufacture of additional elements extending from the orthopedic apparatus in the form of a mustache with plastic balls at the ends intended for correction of the skin-cartilaginous frame of the nose;

- eliminate the incorrect placement of the orthopedic apparatus in the patient's oral cavity;

- to carry out, if necessary, an instant correction of the finished orthopedic apparatus using any standard dental instruments, as well as plastic cold and hot polymerization;

- conduct dynamic monitoring of changes in the shape of the upper jaw and the relative position of its processes, as well as adjusting the orthopedic apparatus during the growth of this category of patients;

which, in turn, allows you to:

- to ensure reliable retention and comfortable placement of the orthopedic apparatus in the oral cavity, both at rest and during feeding the patient, eliminating the risk of irritation and trauma to the surrounding soft tissues of the patient's face;

- reduce the time of early orthodontic treatment, that is, reduce the time of preparation and waiting for the operation of chelorinoplasty;

- to improve the accuracy and simplify the method of manufacturing an orthopedic apparatus, as well as reduce the material and time costs of manufacturing an orthopedic apparatus and, accordingly, reduce the total cost of early orthodontic treatment.

Examples of specific performance of the method

Example 1

Patient P., 7 days. Diagnosis: "Congenital complete left-sided (unilateral) cleft of the upper lip and palate."

For the manufacture of an orthopedic apparatus, an impression of the upper jaw was obtained. An impression of the upper jaw was obtained by heating the Masster thermoplastic mass with boiled water at a temperature of 100 ° C for 2 minutes until a soft plastic consistency was reached. The thermoplastic mass was formed in the form of a truncated cone. Then, its base was attached to an aluminum strip with rounded ends, 2/3 of which were previously bent at an angle of 135 °, while one of the ends of the aluminum strip was closed with the edges of the base of the truncated cone made of thermoplastic mass. Formed in the thermoplastic mass recess for the middle finger of the doctor. The formed thermoplastic mass in the form of a truncated cone on an aluminum strip was inserted into the patient's oral cavity, pressed to all surfaces of the alveolar processes of the upper jaw and held for 5 seconds. After that, the obtained impression of the upper jaw was immersed in water at a temperature of 15 ° C for 2 minutes for final hardening. Next, a three-dimensional laser scan of the obtained impression of the upper jaw was made, as a result of which a digital three-dimensional model of a one-sided complete birth defect was obtained. Then, the digital three-dimensional model of a one-sided birth defect was subjected to digital refinement, which consisted of checking the presence of possible artifacts during three-dimensional laser scanning and their subsequent elimination, as well as checking the correct joining of all polygonal surfaces of the one-sided defect model. Then, in the Rapidform XOR3 computer program, an orthopedic apparatus design was designed taking into account individual anatomical boundaries and landmarks using a digital model of a birth defect. When constructing a computer drawing of an orthopedic device using a digital model of a birth defect as a result of transferring the individual surface of the defect to the surface of the orthopedic device, a hook-shaped area was obtained on the right side of the orthopedic device, and a ridge-shaped area on the left (side corresponding to a congenital cleft). The height of the retention section in the form of a hook was 2.89 mm, and the width was 2.57 mm. The retention area in the form of a hook extended from the border of the soft with the hard palate to the pharyngeal edge of the apparatus. The height of the retention site in the form of a ridge was 3.93 mm and a width of 2.80 mm, and the angle of inclination of the ridge to the plane of the base of the apparatus was 23 °. Based on the individual anatomical parameters of the patient, the retention site in the form of a crest extended from the front edge of the orthopedic apparatus to the pharyngeal edge of the apparatus. After digital three-dimensional modeling of the treatment stages, a section of the orthopedic apparatus was virtually removed by a 2.12 mm section behind the large alveolar process of the upper jaw and a section of 2.68 mm anterior to the smaller one. In FIG. 9 is a computer drawing of an orthopedic apparatus. After constructing a computer drawing of the orthopedic apparatus, the dimensions of the future product were established, amounting to 43.485 mm in width and 41.322 mm in length according to the X, Y, and Z axes in the control program for subsequent milling. The thickness of the plastic of the future orthopedic device was 1.3 mm in the area of the palatine plate and the sides of the orthopedic device, 3.19 mm and 4.53 mm in the area of the retention sections in the form of a hook and a comb. Milling was carried out on a program-controlled three-coordinate milling and engraving machine in two stages, at the beginning of the first a spherical cutter with a diameter of 6 mm was used, and at the second stage a mill of the same shape with a diameter of 1.3 mm was used. In FIG. 10 shows an orthopedic apparatus in a patient’s oral cavity.

Testing the manufactured orthopedic apparatus in this patient confirmed the reliable retention and comfortable location of the orthopedic apparatus in the oral cavity, both at rest and during feeding the patient. Not recorded irritation and trauma to the mucous membrane of the oral cavity and surrounding soft tissues and face of the patient.

The duration of early orthodontic treatment in preparation for the first surgical stage - primary chelorinoplasty in this patient was 2 months and 6 days.

Example 2

Patient A., 5 days. Diagnosis: "Congenital complete bilateral cleft of the upper lip and palate."

For the manufacture of an orthopedic apparatus, an impression of the upper jaw was obtained by heating the Masster thermoplastic mass with boiled water at a temperature of 100 ° C for 2 minutes until it reached a soft plastic consistency. The thermoplastic mass was formed in the form of a truncated cone. Then, its base was attached to an aluminum strip with rounded ends, 2/3 of which were previously bent at an angle of 135 °, while one of the ends of the aluminum strip was closed with the edges of the base of the truncated cone made of thermoplastic mass. Formed in the thermoplastic mass recess for the middle finger of the doctor. The thermoplastic mass formed on an aluminum strip in the form of a truncated cone was inserted into the patient's oral cavity, pressed to all surfaces of the alveolar processes of the upper jaw and intermaxillary bone and held for 6 seconds. The resulting impression of the upper jaw was immersed in water at a temperature of 20 ° C for 2 minutes for final hardening. After that, a three-dimensional laser scan of an impression of the upper jaw was made, as a result of which a digital three-dimensional model of a bilateral complete birth defect was obtained. Then, a digital three-dimensional model of a bilateral birth defect was checked for possible noise after scanning and subjected to their elimination; the correct fit of all polygonal surfaces of the model of a bilateral defect was checked. Then, in the Rapidform XOR3 computer program, a drawing of an orthopedic apparatus was constructed using a digital model of a birth defect. As a result of complete duplication and transfer of the individual surface of the defect to the inner surface of the orthopedic apparatus, areas in the form of ridges were obtained. The height of the retention sections in the form of ridges was 7.53 mm and 6.89 mm and with the inclination angles to the plane of the apparatus base equal to 68 ° and 89 °, based on the individual anatomical parameters of the patient, the retention sections extended uniformly and along the entire length from the front edge of the orthopedic device to pharyngeal edge of the apparatus. In FIG. 11 shows an orthopedic apparatus at the stage of its digital construction. After digital three-dimensional modeling of the treatment stages, a virtual removal of a section of the orthopedic apparatus was made equal to the distance between the most protruding and distant points of the intermaxillary bone, which was 21.3 mm. Then, the dimensions of the future product were determined, which amounted to 44.761 mm in width and 27.386 mm in length according to the X, Y and Z axes in the control program for milling. In FIG. 12 shows the sizing of a future product in a computer program. The range of thicknesses of plastic in the future orthopedic apparatus was determined, which was 1 mm in thickness along the palatine plate of both halves of the apparatus and 3.10 mm and 3.23 mm in the area of the crests. Milling was carried out in two stages, at the beginning of the first a mill of a spherical shape with a diameter of 6 mm was used, and at the second stage a mill of the same shape, but a smaller diameter of 2.5 mm, was used.

Testing of the manufactured orthopedic apparatus in this patient confirmed the reliable retention and comfortable finding of the orthopedic apparatus in the oral cavity, both at rest and during feeding. Not recorded irritation and trauma to the surrounding soft tissue of the patient's face.

The duration of early orthodontic treatment in preparation for the first surgical stage - primary chelorinoplasty in this patient was 2 months and 17 days.

The inventive method has successfully passed clinical testing in 86 children with positive results.

All children confirmed the reliable retention and comfortable finding of the orthopedic apparatus in the oral cavity, both at rest and during feeding. Irritations and traumatization of the oral mucosa and surrounding soft tissues of the patients' faces were not recorded.

The preparation time and waiting for the operation of chelorinoplasty in the present method is not more than 2.5-3 months, and in the prototype method - 5-6 months.

The time spent on the manufacture of an orthopedic apparatus according to the claimed method is not more than 4 hours, and according to the prototype method - on average 8-10 hours.

Material costs for the manufacture of one orthopedic apparatus, taking into account the cost of consumables at all technological stages according to the claimed method, are no more than 2450 rubles, and according to the prototype method - more than 26000 rubles, according to our own data. In addition, the cost of a 3D printer capable of printing a plastic orthopedic apparatus used in the prototype method is from 6 to 10 million rubles. The cost of a three-coordinate milling machine with numerical control used in the present method is from 50,000 to 120,000 rubles.

Thus, the claimed method of manufacturing an orthopedic apparatus with single and bilateral congenital complete cleft of the upper lip and palate is new and allows, in comparison with the prototype method:

- increase the accuracy of obtaining an individual anatomical form of a congenital defect in the upper jaw and, accordingly, the accuracy of obtaining a digital model of a congenital defect;

- exclude the receipt of a gypsum model of the upper jaw at the stages of manufacturing an orthopedic apparatus;

- exclude the use of any locking extraoral elements, such as bandages, bandages, buttons or hooks;

- to exclude the manufacture of additional elements extending from the orthopedic apparatus in the form of a mustache with plastic balls at the ends intended for correction of the skin-cartilaginous frame of the nose;

- eliminate the incorrect placement of the orthopedic apparatus in the patient's oral cavity;

- to carry out, if necessary, instant correction of the finished orthopedic apparatus using any standard rotating dental instruments, as well as cold and hot polymerization plastics;

- conduct dynamic monitoring of changes in the shape of the upper jaw and the relative position of its processes, as well as adjusting the orthopedic apparatus during the growth of this category of patients;

which in turn allows you to:

- to ensure reliable retention and comfortable placement of the orthopedic apparatus in the oral cavity, both at rest and during feeding the patient, eliminating the risk of irritation and trauma to the surrounding soft tissues of the patient's face;

- reduce the time of early orthodontic treatment, that is, reduce the time of preparation and waiting for the operation of chelorinoplasty;

- to improve the accuracy and simplify the method of manufacturing an orthopedic apparatus, as well as reduce the material and time costs of manufacturing an orthopedic apparatus and, accordingly, reduce the total cost of early orthodontic treatment.

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Claims (1)

A method of manufacturing an orthopedic apparatus for preoperative early orthodontic treatment of children with congenital one- and two-sided complete cleft of the upper lip and palate, including obtaining an impression of the upper jaw, obtaining a digital model of a congenital defect of the upper jaw, digital three-dimensional modeling of the stages of treatment, characterized in that the cast of the upper jaw obtained by forming a thermoplastic mass in the form of a truncated cone, followed by attaching its base to an aluminum strip with rounded ends, 2/3 of which are pre-bent at an angle of 135 °, closing one of the ends of the aluminum strip with the edges of the base of the truncated cone from the thermoplastic mass and forming a recess in the thermoplastic mass for the middle finger of the doctor, after which the truncated cone with aluminum attached to its base a strip is pressed to all surfaces of the alveolar processes of the upper jaw and held for no more than 6 seconds, followed by immersion of the obtained impression in water at a temperature of 15-20 ° C; constructing a computer drawing of the orthopedic apparatus according to the digital model of the birth defect obtained by three-dimensional laser scanning of the impression of the upper jaw, by completely duplicating and then transferring the entire individual surface of the birth defect of the upper jaw to the surface of the orthopedic apparatus; an orthopedic apparatus is manufactured using a three-coordinate milling machine with numerical control according to a digital model of an orthopedic apparatus from a solid array of standardized cubic billet made of plastic "StomAkril".

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