RU2766795C1 - Implant as an auditory bone prosthesis to replace damaged parts of the middle ear (options) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine, namely to implants of auditory ossicles. According to the first version of the invention, the implant includes a shaped body containing a transformable conical twisted spring for installing it under a neotimpanal membrane, the extreme turn of the larger base of which is pressed to an adjacent coil so that most of its outer surface is located at the right angle to the longitudinal axis of the conical twisted spring to form a support surface, a straight rod into which the extreme turn of the smaller spring base passes and is made entirely with a spring, and a part for mounting on the footplate of the stirrup, made entirely with a rod in the form of tightly wound coils of a spring. The second version of the invention differs in that the part for mounting on the footplate of the stirrup is made in the form of a body connected to the end of the rod with an outward-facing recess.

EFFECT: expansion of the functional capabilities of the prosthesis is achieved for the restoration and replacement of damaged parts of the middle ear when the chain of auditory bones is interrupted, increasing and simplifying the manufacturability of the implant and its installation during hearing-improving operations, as well as expanding the range of implants for ossicular reconstruction.

5 cl, 3 dwg

Description

The invention relates to the field of medicine and specifically relates to implants for replacing damaged parts of the human middle ear for ossicular reconstruction. It can be used for repair and prosthesis in case of interruption of the ossicular chain during hearing-improving operations, and specifically for ossicular chain prostheses for reconstructive middle ear surgery.

Known prosthesis of the auditory ossicles used for restoration and prosthetics in case of interruption of the auditory ossicles during hearing-improving operations (1). The prosthesis of the auditory ossicles (implant) contains a flat support platform in the form of a frame, on one side of which there is a rod perpendicular to it, and a means for fixing the prosthesis in the tympanic plane. Means for fixing the prosthesis is made in the form of two coaxial semi-axes made of elastic wire with U-shaped knees and pointed ends.

Known prosthesis provides the possibility of prosthetics of the destroyed chain of the auditory ossicles while maintaining optimal operating conditions. However, the disadvantage of the prosthesis is its rather complicated and lengthy installation, which is associated with its design features: to install the prosthesis, the knees of the semiaxes are elastically bent so that the distance between the pointed ends becomes less than the distance between the walls of the tympanic cavity; then the ends of the semi-axes are inserted into the space between the walls and the knees are allowed to straighten; at the same time, the pointed ends penetrate into the bone walls of the tympanic cavity and are held there by the forces of elastically deformed knees. The points of penetration of the ends of the semiaxes are chosen by the surgeon so that the end of the rod rests against the middle of the footplate of the stirrup perpendicular to it.

Known for the prosthesis of the auditory ossicles "KURTS" made of titanium with a variable length for partial or complete reconstruction of the chain of the auditory ossicles with a round head or asymmetric head (options), and a rod with a shoe. During the operation, the length of the prosthesis can be adjusted using a trimmer. Functional length of the prosthesis for partial reconstruction from 0.75 mm, for complete reconstruction from 3.0 mm; when installing the prosthesis with a trimmer, the prosthesis shaft is cut to obtain a rod of the required length (2).

The main advantage of the KURZ ossicular prostheses of this model is an unlimited choice of length, but at the same time, in order to adjust it to size, a preliminary preparatory fitting technique with the help of additional tools (measuring template for universal titanium prostheses, trimmer for cutting the rod) is necessary, which complicates the use it during installation. Its disadvantage is also the difficulty in capturing the prosthesis and holding it by the oval surface,

Known prosthesis of the auditory ossicles (all-metal implant of the middle ear), which can be used to restore hearing when the chain of the auditory ossicles is interrupted during hearing-improving operations (3). This technical solution is accepted as the closest analogue (prototype). The implant contains a shaped body in the form of an S-shaped curved plate with the formation of parallel parts and a means of fixation: the first part (support platform) of the shaped body is intended for installation under the neotympanic membrane and has an oval window, the second part of the plate is made integral, and the third is equipped with fixation means in the form of four bent petals, made with the possibility of covering the elements of the ossicular chain. The first and second parts of the plate are connected by a radially bent jumper made with the possibility of changing the distance between the parallel first and second parts.

A disadvantage of the known prosthesis of the auditory ossicles (implant) is the lack of flexibility of the S-shaped plate when compressed and stretched along the axis when fitting it and modeling the appropriate length of the prosthesis, taking into account the anatomical features of the patient.

The technical problem solved by the claimed group of inventions is to expand the functionality of the auditory ossicle prosthesis as an implant for restoring or replacing damaged parts of the human middle ear, depending on and taking into account the anatomical features and age of the patient (for children and adults), providing the possibility of precise selection and length adjustment implant, ensuring its fast and accurate installation, simplifying its manufacture and installation during surgery, expanding the arsenal of means for restoring and prosthetics of parts of the middle ear.

In accordance with the set technical task, the technical result achieved by the claimed group of inventions is the expansion of the functionality of the prosthesis (implant) for the restoration and replacement of damaged parts of the middle ear when the ossicular chain is interrupted, the increase and simplification of the manufacturability of the implant and its installation during hearing-improving operations , as well as expanding the range of implants for ossicular reconstruction.

The set technical task and the specified technical result are achieved by the claimed group of inventions, which includes, as options, prostheses (implants) of the auditory ossicles (parts of the human middle ear).

One variant of the invention is an implant as a prosthesis of the auditory ossicles to replace damaged parts of the middle ear, including a shaped body containing a transformable part in the form of a conical twisted spring intended for installation under the neotympanic membrane of the ear, the extreme coil of the larger base of which is pressed against the adjacent coil so that a large part of its outer surface is located at right angles to the longitudinal axis of the conical coiled spring with the formation of a supporting surface, the intermediate part, which is a straight rod, into which the extreme coil of the smaller base of the conical coiled spring passes, and is made integral with a conical coiled spring, and a part intended for installation on the foot plate of the stirrup, made in one piece with a straight rod of the intermediate part in the form of tightly wound coils of a spring.

NOTE: during the course of the disease, perforations of various sizes form in the eardrum, which are closed during the operation (restored with the help of own tissues, fascia or cartilage). Sometimes perforation occupies almost the entire area of the tympanic membrane, then as a result of the surgical operation, a “new” tympanic membrane is practically created. After repair, the "new" tympanic membrane is called neotympanic membrane, therefore, in this application, the term neotympanic membrane is used, as the most appropriate.

The above set of common essential features is the essence of the claimed invention according to the first variant. It is necessary and sufficient in all cases of its implementation.

This technical solution has the following advantages compared to the prototype: expanding the functionality of the prosthesis (implant) for restoring and replacing damaged parts of the middle ear when the auditory ossicles chain is interrupted, increasing and simplifying the manufacturability of the implant and its installation during hearing-improving operations, as well as expanding the range implants for ossicular reconstruction.

In addition, in relation to the claimed first version, the applicant considers it necessary to highlight the following developments and / or clarifications of the totality of its essential features related to particular cases of implementation or use.

It is desirable that the extreme turn of the larger base of the conical coiled spring of the transformable part be ground from the outside to form an expanded flat bearing surface.

It is also preferable that the outermost coil of the closely wound coils of the spring of the part intended for installation on the foot plate of the stirrup be ground off from the outside to form an expanded flat bearing surface.

Another variant of the invention of the claimed group is an implant as a prosthesis of the auditory ossicles to replace damaged parts of the middle ear, including a shaped body containing a transformable part in the form of a conical twisted spring intended for installation under the neotympanic membrane, in which the outermost coil of the larger base is pressed against the adjacent coil so that most of its outer surface is located at right angles to the longitudinal axis of the conical coiled spring with the formation of a supporting surface, the intermediate part, which is a straight rod, into which the extreme coil of the smaller base of the conical coiled spring passes, and is made integral with the conical coiled spring, and a part intended for installation on the foot plate of the stirrup, made in the form of a body connected to the end of a straight rod, for example, by microwelding, with a recess facing outward.

This set of common essential features is the essence of the claimed invention according to the second option. It is necessary and sufficient in all cases of its implementation.

This technical solution has the following advantages compared to the prototype: expanding the functionality of the prosthesis (implant) for restoring and replacing damaged parts of the middle ear when the auditory ossicles chain is interrupted, increasing and simplifying the manufacturability of the implant and its installation during hearing-improving operations, as well as expanding the range implants for ossicular reconstruction.

In addition, in relation to the claimed second option, the applicant considers it necessary to highlight the following developments and / or clarifications of the totality of its essential features related to particular cases of implementation or use.

It is desirable that the extreme turn of the larger base of the conical coiled spring of the transformable part be ground from the outside to form an expanded flat bearing surface.

The claimed technical solution in the form of a group of inventions in comparison with the prior art and the closest analogue (prototype) has a great advantage, which consists in simplifying the technology of its manufacture, as well as when using it when performing hearing-improving operations.

An important advantage of the invention is also that the devices according to both variants can be manufactured on technological equipment already used in the medical industry.

The invention is illustrated by drawings.

1. In FIG. 1 schematically depicts one variant of the claimed implant, characterized in that the part intended for installation on the foot plate of the stirrup is made in one piece with a straight rod of the intermediate part in the form of closely wound coils of a spring

2. In FIG. 2 schematically shows another version of the claimed implant, characterized in that the part intended for installation on the foot plate of the stirrup is made in the form of a body connected to the end of a straight rod with a notch facing outward.

3. In FIG. 3 is a cross section A-A in FIG. 1 extreme coil of a conical coiled spring, which is ground from the outside.

In FIG. 1 shows one version (first version) of the claimed implant, characterized in that the part intended for installation on the foot plate of the stirrup is made entirely with a straight rod of the intermediate part in the form of closely wound coils of a spring

The claimed implant as a prosthesis of the auditory ossicles of the middle ear according to this first version, includes a figured body 1, which contains a transformable part 2 in the form of a conical twisted spring 3 intended for installation under the neotympanic membrane, the outermost coil 4 of the larger base 5 of which is pressed against the adjacent coil 6 so that most of its outer surface 7 is located at right angles to the longitudinal axis 8 of the conical coiled spring 3 with the formation of the bearing surface (Fig. 1). In addition, the figured body 1 includes an intermediate part 9, which is a straight rod 10, into which the outer coil 11 of the smaller base 12 of the conical coiled spring 3 passes, while the straight rod 10 is made integral with the conical coiled spring 3. Behind the straight rod 10 is part 13, designed to be installed on the foot plate of the stirrup.

The outer surface of the extreme coil 4 of the larger base 5 of the conical twisted spring 3 is additionally ground to form a flat support surface 14 (Fig. 3). It is intended for installation under the neotympanic ear membrane and, as a result of an increase in the area of contact, the pressure of the extreme coil 4 on the neotympanic ear membrane decreases.

As noted above, behind the straight rod 10 is a part 13 intended for installation on the foot plate of the stirrup.

This part may have various modifications, presented in the form of two variants of the claimed invention.

In FIG. 1 shows a modification, according to which the part 13, intended for installation on the foot plate of the stirrup, is made integral with the straight rod 10 of the intermediate part 9 and has a cylindrical shape of tightly wound coils 15 of the spring 16. The outermost coil 17 can be ground to form a flat supporting surface , similarly as shown earlier in FIG. 3, and with a similar purpose - to increase its area of contact with the foot plate of the stirrup and reduce the pressure of this outermost coil 17 on the foot plate of the stirrup.

The first variant of the invention described above can be immediately manufactured on a single spring winding machine, which is very technologically advanced.

In FIG. 2 shows another (second) version of the claimed implant, characterized in that the part intended for installation on the foot plate of the stirrup is made in the form of a body connected to the end of a straight rod with a notch facing outward.

The design according to this (second) variant with regard to the transformable part 2 and the intermediate part 9 completely coincides with the design of these parts in the first variant shown in Fig. one.

The peculiarity of the second option is that the part 13, intended for installation on the foot plate of the stirrup, is made differently, namely, in the form of a body 18 connected to the end of the straight rod 10 with a recess 19 facing outward. The straight rod 10 and the body 18, for example, made of titanium alloy, interconnected, for example, by microwelding 20.

This modification can be made on a machine for coiling springs, and then a body 18 with a recess 19 is welded to it by microwelding, which is also simple and technologically advanced. The recess 19 significantly reduces the weight of the body 18 and simplifies the installation of the device on the foot plate of the stirrup.

The claimed implant (ossicular prosthesis) is made of titanium or its alloys.

The implant according to the first variant is used as follows.

Vibrations of the neotympanic membrane superimposed on the flat supporting surface 14 of the extreme coil 4 of the larger base 5 of the conical twisted spring 3 of the transformable part 2 of the figured body 1 are transmitted through the straight rod 10 of the intermediate part 9 of the body 1 of the figured shape of the implant to the surface of the outermost coil 17 of the spring 16, mounted on the foot plate of the stirrup, thus simulating the operation of the ossicular chain.

Implant placement can be done in the following order.

Through the gaps (spaces) between the coils of the conical twisted spring 3, the coordinates of the head or arch of the stirrup are determined. Part 13 is put on the latter, intended for installation on the foot plate of the stirrup. After dressing, tightly coiled coils 15 of the spring 16 cover the head or arch of the stirrup. The distance between the new tympanic membrane (neotympanic flap or neotympanic membrane) and the stirrup is then determined. Further, by expanding or compressing the coils of the conical twisted spring 3 of the transformable part 2, the corresponding length of the implant is modeled. Then, on the flat supporting surface 14 of the extreme turn 4 of the larger base 5 of the conical twisted spring 3, a flap of the new eardrum is placed.

The implant according to the second variant is used as follows.

Vibrations of the neotympanic membrane superimposed on the flat supporting surface 14 of the extreme turn 4 of the larger base 5 of the conical coiled spring 3 of the transformable part 2 of the figured body 1 are transmitted through the straight rod 10 of the intermediate part 9 of the body 1 of the figured shape of the implant to the surface of the body 18 mounted on the foot plate stirrup, thus simulating the work of the ossicular chain.

Implant placement can be done in the following order.

Through the gaps (spaces) between the coils of the conical twisted spring 3, the coordinates of the head or arch of the stirrup are determined. A recess 19 is put on the latter, designed for installation on the foot plate of the stirrup. After dressing the surface of the recess 19 of the body 18 cover the head or arch of the stirrup. The distance between the new tympanic membrane (neotympanic flap or neotympanic membrane) and the stirrup is then determined. Further, by expanding or compressing the coils of the conical twisted spring 3 of the transformable part 2, the corresponding length of the implant is modeled. Then, on the flat supporting surface 14 of the extreme turn 4 of the larger base 5 of the conical twisted spring 3, a flap of the new eardrum is placed.

Since the change in the length of the implant as a result of expanding or compressing the coils of the conical coiled spring 3 is relatively small, and the distance between the new tympanic membrane (neotympanic flap or neotympanic membrane) and the stirrup differs in children and adults, then implants of several standard sizes in length for children and several standard sizes are produced length for adults.

The implant provides the possibility of accurate selection of the length of the implant at the place of installation and the universal use of one type of implant for different anatomical features of people with rapid adaptation in place. This is ensured by the fact that the implant has a deformable element in the form of a conical spring, which allows you to change the overall length of the implant by compressing or stretching the coils, which greatly simplifies the operation, since the implant is small, which makes it difficult to reconfigure.

The design ensures that the implant can be placed quickly and accurately, which reduces the duration of the operation and reduces the intensity of patient suffering, as well as the duration of the effect of anesthesia on the patient.

The design of the implant is manufacturable and easy to manufacture, install and operate and provide the possibility of serial production of implants.

Sources of information taken into account:

1. Utility model patent No. 95507, U1, 12/30/2009, A61F 2/18;

2. Model VARIO|Gelios - Medical (HELIOS ME DIKAL) , MIDDLE EAR INTELLIGENCE, Heinz Kurz GmbH, 03/2018- M9600320, www.kunzmed.com);

3. Utility model patent No. 183105, U1, 02/06/2018, A61F 2/00 (closest analogue).

Claims (5)

1. An implant for use as a prosthesis of the auditory ossicles to replace damaged auditory ossicles, comprising a shaped body containing a transformable part in the form of a conical twisted spring intended for installation under the neotympanic membrane, the outermost coil of the larger base of which is pressed against the adjacent coil so that most of the its outer surface is located at right angles to the longitudinal axis of the conical coiled spring with the formation of a supporting surface, the intermediate part, which is a straight rod, into which the extreme coil of the smaller base of the conical coiled spring passes and is made integral with the conical coiled spring, and the part intended for installation on the foot plate of the stirrup, made in one piece with a straight rod of the intermediate part in the form of closely wound coils of a spring. 2. The implant according to claim 1, characterized in that the outermost coil of the larger base of the conical twisted spring of the transformable part is ground off to form an expanded flat support surface. 3. The implant of claim 1, characterized in that the outermost coil of tightly wound coils of the spring of the part intended for installation on the footplate of the stirrup is ground from the outside to form an expanded flat supporting surface. 4. An implant for use as a prosthesis of the auditory ossicles to replace damaged auditory ossicles, comprising a shaped body containing a transformable part in the form of a conical twisted spring intended for installation under the neotympanic membrane, the extreme coil of the larger base of which is pressed against the adjacent coil so that most of the its outer surface is located at right angles to the longitudinal axis of the conical coiled spring with the formation of a supporting surface, the intermediate part, which is a straight rod, into which the extreme coil of the smaller base of the conical coiled spring passes and is made integral with the conical coiled spring, and the part intended for installation on the foot plate of the stirrup, made in the form of a body connected to the end of a straight rod with a notch facing outward. 5. The implant according to claim. 4, characterized in that the outermost coil of the larger base of the conical twisted spring is ground off to form an expanded flat support surface.

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