RU2791202C1 - Epithesis of the nose - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: it is intended for prosthetics of the nose in its absence of various origins. The epithesis of the nose consists of two parts. The first part faces the prosthetic bed with anatomical repetition of the edges in the nasolabial folds of the piriform opening. The second part forms the external shape of the nose, taking into account the anatomical features of the face. Epithesis is made of two-component platinum-based medical silicone. On the inner surface of the epithesis, two magnetic attachments 4.0-4.5 mm in diameter each are installed in the center. The location of the magnetic attachments installed on the inner surface of the epithesis corresponds to the attachments installed in the plates of the reinforcing element made as two arcual plates enabling its attachment to the bone tissue. The arcual plates of the reinforcing element are made of titanium VT 1-0, 1.0 mm thick, located across the pear-shaped hole, 10.0-30.0 mm away from each other, and are made with seven bosses with a diameter of 4.5 mm each and a thickness of 1.5 mm with through holes with a diameter of 2.5 mm each, with 8.0-12.0 mm between their centers. Bone screws are installed in the four end holes of each plate, providing fixation to the zygomatic bones. In central M2.5×0.35-threaded holes each plate has magnetic attachments. In M2.5×0.35- threaded holes to the right and left of the central screws-plugs are installed, and the magnets of the attachments of the inner surface of the epithesis and the plates of the reinforcing element are designed to be attracted to each other to fix the epithesis. Air filters are installed in the nasal openings.

EFFECT: use is characterized by an improved fixation system and an increase in the comfort of using the epithesis of the nose.

1 cl, 8 dwg

Description

The invention relates to medicine, and in particular to maxillofacial orthopedics, and is intended for prosthetics of the nose in the absence of various genesis.

Known epiprosthesis of the nose, consisting of two elements connected to each other by physical attraction of opposite-pole magnets. The first element is a nose made of medical silicone, matching the color and shape of the patient's skin. A magnetic element in the form of a truncated cylinder 2.6 mm high and 9.4 mm in diameter is rigidly fixed on the inner surface in the center. The reinforcing element is made of titanium alloy by computer milling, which provides further fixation of the nose prosthesis, presented in the form of a ring with an inner diameter of 9.7 mm and an installed magnet with a pole charge opposite to the magnet fixed in the first element of the prosthesis, which is in the form of a truncated cylinder with a height of 2 .6 mm and a diameter of 9.4 mm and externally extending from the ring, radial processes having a bend and holes in the end sections through which the structure is screwed to the abutments of implants installed in the zygomatic bone. (Patent RU No. 2618891, IPC A61F2 / 00 06/02/2016).

A disadvantage of the known design of the nasal epiprosthesis is that the reinforcing element in the form of a ring with an inner diameter of 9.7 mm with a magnet in the form of a truncated cylinder with a diameter of 9.4 mm and a height of 2.6 mm covers a significant part of the volume of 50% -90% of the respiratory passages, depending on the anatomy of the patient, which leads to difficulty breathing.

A universal epithesis fixation system is known, which includes an intermediate element equipped with fastening devices for fixing to the skull bone tissue, devices for fixing a prosthesis made of medical silicone. The intermediate element is made in the form of a lattice plate with holes with a unified thread for fastening to bone tissue with screws, installation of magnetic and mushroom attachments. The magnetic attachment is made with a neodymium magnet and installed in a titanium case with a faceted outer surface. On the inner surface of the facial epithesis, parts for magnetic attachments are made, with installed neodymium magnets.

RU No. 198364, IPC A61F2/18 A61F2/00 A61F2/14 A61F2/02

А61С8/00 06/10/2019

The disadvantage of the universal epithesis fixation system is the design, made in the form of a lattice plate with holes with a unified thread, which makes it difficult to access the cavity of the nasal defect during hygienic procedures by the patient.

The closest technical solution is the design of the nose ectoprosthesis, consisting of two parts, the first of which is made of a superelastic alloy based on titanium nickelide facing the prosthetic bed and is made with protrusions entering the nasal passages and retention points of the defect edges. The second part of the ectoprosthesis is made to simulate the external shape of the nose, nasal passages, with the edge of the prosthesis in the nasolabial folds, made of solid acrylic plastic and a wire device in the bridge of the nose is fixed to the frame of the glasses. The first part is made of a superelastic alloy based on titanium nickelide in the form of a saddle according to the anatomical shape of the bridge of the nose, the upper edge of the pear-shaped opening, the nasal septum, and also, according to the anatomical shape of the inner surface of the wings of the nose, with retention loops on the side facing the second part. The wire fixing device is made in the form of a U-shaped wire element made of titanium nickelide alloy with a diameter of 0.7-1.0 mm and fixed motionless in the thickness of the plastic of the second part. Protrusions included in the nasal passages and retention points of the edges of the defect with a thickness of 0.3 mm. (Patent RU No. 2339344 A61F2 / 50 09.03.2007).

The disadvantages of the known design of the ectoprosthesis of the nose are the following:

The use of rigid acrylic plastic in this design creates discomfort when wearing the prosthesis, which causes chafing, leading to injury to the soft tissues of the face and in the nasolabial folds with active movement of the facial muscles. Protrusions in the nasal passages, which reduce the cross-sectional area of the airways, lead to difficulty in breathing for the patient. Fixation of the prosthesis to the spectacle frame using a wire fixing device does not provide for the possibility of changing glasses without removing the nose if it is necessary to change glasses.

The objective of the invention is to improve the fixation system and increase the comfort of using the epithesis of the nose.

The task is achieved by the fact that in the epithesis of the nose, consisting of two parts, the first part, facing the prosthetic bed with anatomical repetition of the edges in the nasolabial folds of the piriform opening, the second part in the form of the outer shape of the nose, taking into account the anatomical features of the face, the new is that the epithesis is made of two-component medical silicone with a platinum base, on the inner surface of the epithesis, two magnetic attachments with a diameter of 4.0-4.5 mm each are installed in the center, while the reinforcing element is in the form of two arcuate plates made of titanium VT 1-0, 1 thick, 0 mm, located across the pear-shaped hole at a distance between them of 10.0-30.0 mm and made with seven bosses with a diameter of 4.5 mm each and a thickness of 1.5 mm with through holes with a diameter of 2.5 mm each at a distance between centers 8 0-12.0 mm, bone screws are installed in the four extreme holes of each plate, providing fixation to the zygomatic bones, and in the central holes with M thread 2.5×0.35, magnetic attachments are installed in each plate, plug screws are installed in the M2.5×0.35 threaded holes to the right and left of the central ones, while air filters are installed in the nose holes.

The epithesis of the nose from two-component medical silicone with a platinum base ensures the appearance of the prosthesis corresponding in color and texture to the skin. Epithesis does not cause allergies and partially repeats the facial movements of the patient's facial muscles. The prosthesis does not rub the soft tissues of the prosthetic bed and does not cause tissue irritation, it is resistant to ultraviolet light. In the process of manufacturing a prosthesis, an important step is the selection of a color shade that should match the skin of the patient's face.

For reliable fixation, magnetic attachments are used, consisting of two parts. 2 magnetic attachments are installed in the titanium plate, each attachment has a neodymium magnet inside. Two magnetic attachments are installed on the inner surface of the prosthesis, the location of which corresponds to the attachments installed in the titanium plate, so that the magnets of the attachments are attracted to each other, thereby ensuring the fixation of the epithesis. On the lower part of each attachment, there is a leg with a M2.5 × 0.35 thread, a counter thread in a titanium plate for reliable fixation of the attachment.

A reinforcing element of an arcuate shape is necessary to fix it to the bone tissue and reduce the load on the bone tissue of the edges of the piriform opening.

The titanium plate is made of VT 1-0 grade titanium because this material is used in implantology and has a minimal chance of rejection by the patient's body.

The use of two plates makes it possible to choose places with the most dense bone structure for fixation, which is important for the patient after cancer treatment and provides good access for hygiene procedures.

Plug screws prevent overgrowth of holes with M2.5×0.35 thread and accumulation of bacteria in them, protect the holes from deformation during the installation of the reinforcing element and the operation of the prosthesis.

Nasal airway filters clean the air of dust and various allergens, protecting the patient from respiratory allergies.

Epithesis of the nose consists of the inner part 1 facing the prosthetic bed 2 and the outer part 3, made in the form of an outer shape of the nose. On the inner surface 1, two magnetic attachments 4, 5 are installed in the center on legs with a M2.5x0.35 thread 6, 7. The reinforcing element is in the form of two arcuate plates 8, 9 1.0 mm thick with seven holes 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, with a diameter of 2.5 mm, made in bosses with a diameter of 4.5 mm and a thickness of 1.5 mm at a distance between centers of 8.0 - 12 .0 mm in each plate. The plates are installed across the pear-shaped hole 6 at a distance of 10.0-30.0 mm, depending on the anatomical features of the patient. In each plate 8, 9, in four extreme holes 10, 11, 15, 16, 17, 18, 22, 23, bone screws 24, 25, 28, 29, 30, 31, 34, 35 are installed, fixing the plates to the zygomatic bones. Magnetic attachments 4, 5 are installed in the central holes 13, 20 with a M2.5 × 0.35 thread of each plate 8, 9, and plug screws 26 are installed in adjacent holes 12, 14, 19, 21 with a M2.5x0.35 thread , 27, 32, 33. Air filters 38 and 39 are installed in the nasal openings 36 and 37.

Device operation

The patient is given anesthesia, on the operating table under anesthesia, an incision is made in the soft tissues on the face to gain access to the bone tissue at the attachment points along the edges of the piriform opening. According to the surgical template, holes are drilled in the zygomatic bone to install 8 bone screws 24, 25, 28, 29, 30, 31, 34, 35. Screws are installed in the through holes with thread M2.5 × 0.35 12, 14, 19, 21 - plugs 26, 27, 32, 33. Plates 8 and 9 are placed in place of the nose defect and fixed with bone screws 24, 25, 28, 29, 30, 31, 34, 35 to the bone tissue along the edges of the defect, sutured at the incisions and sew up. Prosthetics is carried out 30-90 days after the operation. Before taking an impression of the defect site, 2 plug screws 40, 41 are unscrewed from holes 13, 20 into which 2 magnetic attachments 4 and 5 are installed. defect by filling the cast with plaster. A model of a nose is created from modeling wax and a wax model of a nose is tried on a patient. The wax model of the nose is fixed on a plaster cast of the defect site and poured with plaster to obtain a prosthesis matrix, after the plaster has hardened, the resulting matrix is disassembled and the wax is removed from it. The matrix is covered with an insulating varnish, parts of the magnetic attachments 4 and 5 are fixed to the models of attachments displayed on the plaster model of the defect site, which are fixed in the silicone of the epithesis.

Two-component silicone is kneaded, adding dyes corresponding to the patient's skin tone, creating a minimum of 4 shades. The painted silicone is laid out in a plaster matrix. The matrix with silicone is placed in a polymerizer at a temperature of 115-125°C for 2 hours. After the gypsum matrix has cooled, the silicone epithesis is removed from it, processed and tried on on the patient.

The alleged invention is illustrated by drawings, where:

In FIG. 1 shows patient 1 before rehabilitation;

In FIG. 2 shows patient 1 after rehabilitation;

In FIG. 3 shows patient 2 before rehabilitation;

In FIG. 4 shows patient 2 after rehabilitation;

In FIG. 5 epithesis of the nose mounted on a mannequin;

In FIG. 6 shows a diagram of an epithesis;

In FIG. 7 shows a diagram of the installed reinforcing element;

In FIG. 8 shows a magnetic attachment.

The technical result of the proposed invention is:

An epithesis with high aesthetic and functional properties, securely fixed on the patient’s face, returns the patient’s self-confidence, makes it possible to return to their previous job, freely communicate with people, and visit various institutions. Thanks to the nasal filters installed in the respiratory tract, the patient can breathe freely in case of respiratory allergies.

In the Epithetika Medical Production Center in Krasnoyarsk, 17 high-tech rehabilitations of patients with the installation of nasal epitheses were carried out in the period 2019-2021. During the control examination after 1, 3, 6 months and 1 year, patients do not complain, the design is consistent.

Claims (1)

Epithesis of the nose, consisting of two parts, the first part facing the prosthetic bed with anatomical repetition of the edges in the nasolabial folds of the piriform opening, the second part in the form of an external shape of the nose, taking into account the anatomical features of the face, characterized in that the epithesis is made of two-component medical silicone with platinum base, on the inner surface of the epithesis, two magnetic attachments with a diameter of 4.0-4.5 mm each are installed in the center, while the location of the magnetic attachments installed on the inner surface of the epithesis corresponds to the attachments installed in the plates of the reinforcing element, made in the form of two arcuate plates with the possibility of fixing it to the bone tissue, and the arcuate plates of the reinforcing element are made of titanium VT 1-0, 1.0 mm thick, located across the pear-shaped hole at a distance of 10.0-30.0 mm between them and are made with seven bosses each with a diameter 4.5mm and 1.5mm thick with through holes dia. rum each 2.5 mm at a distance between the centers of 8.0-12.0 mm, bone screws are installed in the four extreme holes of each plate, providing fixation to the zygomatic bones, and in the central holes with a M2.5 × 0.35 thread in each the plate is equipped with magnetic attachments, plug screws are installed in the holes with M2.5 × 0.35 thread to the right and left of the central ones, and the magnets of the attachments of the inner surface of the epithesis and the plates of the reinforcing element are made with the ability to attract each other to fix the epithesis, while in nasal openings are equipped with air filters.

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