RU2672282C2 - Method for forming endoprosthesis of vertebral body and endoprosthesis of vertebral body - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: group of inventions relates to medicine. Method of forming the endoprosthesis of the vertebral body includes the formation of an endoprosthesis from the plate with holes in the final form by twisting from one edge to several turns in a spiral of the required diameter with turns of the spiral inside. Spiral turns are formed with free cavities between the walls of the turns to be filled with osteogenic material through openings distributed throughout the plate. Endoprosthesis of the vertebral body is an endoprosthesis of the vertebral body in the form of a releasable part with holes on the surface. Endoprosthesis is formed from a plate with holes by twisting from one side of the edge into several turns along a spiral and has spiral turns inside with free cavities between the walls of the turns to be filled with osteogenic material through openings distributed throughout the plate.EFFECT: inventions allow to improve the result of treatment by preventing migration of the endoprosthesis under axial and rotational loads.8 cl, 7 dwg

Description

The invention relates to medicine, namely to traumatology and neurosurgery, and can be used to stabilize the vertebral-motor segments during operations of the anterolateral spinal fusion in the surgical treatment of fractures and pathological processes of the cervical and thoracic vertebrae in critical conditions in the absence of generally accepted standard implants of the required size.

The invention allows to form during the operation implants of a cylindrical and other acceptable shape, various diameters and lengths, which have significant resistance to axial and rotational loads.

The multilayer nature of the implant enhances its strength characteristics, and the presence of a free cavity and a hole in the walls allows the implant to be filled with osteosubstituting material.

The invention in the particular case of execution improves the treatment result due to the unity of the fixation and support parts of the implant.

To perform anterior spinal fusion, isolated use of bone grafts, most often taken from the iliac crest, is known, which requires additional surgery to take them, a long time to install bone autografts, as well as long bed rest due to the risk of fracture or displacement.

There are frequent cases of ligation of autografts with the loss of the achieved correction of the spinal column.

It is known to use monolithic titanium and monolithic plastic implants. The fixation of such implants is not reliable, since the implant is integrated due to the surrounding scar tissue. The monolithicity of the structures does not imply the formation of a bone-metal block.

The use of mesh metal endoprostheses of vertebral bodies is known. For example, mesh - pyramesh titanium block gratings - firms Medtronic, Titanmed, Medbiotech, etc. However, their installation requires additional stabilization with a second implant - a titanium plate of a strictly defined size.

The use of mesh metal endoprostheses of vertebral bodies is known. Patent US 5702451 A was published on December 30, 1997 (Space holder, in particular for a vertebra or an intervertebral disk), and Patent US 20120029638 A1 was published on 02.02.2012, (Vertebral body replacement device configured to deliver a therapeutic substance). (www.uspto.gov/).

The disadvantage of these patents is that during installation they require additional stabilization by a second implant - a titanium plate of a strictly defined size.

The patent for utility model BY 7659 U “vertebral body prosthesis” is also known. It is a cylindrical endoprosthesis of the vertebral body made in the form of a hollow mesh cylinder with the possibility of filling it with osteogenic material.

The disadvantage of this solution is that this endoprosthesis has strictly defined dimensions and is selected by diameter and adjusted in length, i.e. during the operation, the surgeon’s arsenal must have a whole set of such products or it is necessary to specially order the necessary implant. In addition, the hollow structure is rather weak. Another disadvantage is that this endoprosthesis requires additional fixation with a separate implant in the form of a titanium plate of a strictly defined size (http://bypatents.com/).

Also known is the solution “Telescopic body-replacing implant” which includes a support part and a stabilization part in the form of L-shaped elements attached to the side surfaces and, due to the presence of holes, are attached to the vertebral bodies with screws.

The disadvantage of this solution is that this endoprosthesis has a complex structure, as well as a 4th type of size from 13 to 65 mm, which requires the presence of all options for the size of the product in the surgeon's arsenal. In addition, the stabilizing L-shaped elements are located on the bases of the endoprosthesis and do not have a (unified) front-lateral surface, while one of the elements is mounted on a twisting element of the supporting part, which makes stabilization not effective under axial and rotational loads (http: // cmomed .ru / index.php? module = catalog & aid = 133 & cid = 180)

Disclosure of the invention.

The objectives of the claimed invention are:

To develop an endoprosthesis of the vertebral body and a method allowing it to form the required size, shape and diameter, both in advance and during the operation. At the same time, the developed endoprosthesis should have a simple design, and in the formed form should have reinforcement and at the same time be able to fill it with osteogenic material, creating optimal conditions for the formation of a full-fledged bone block, and also in design options have the constructive ability to prevent migration of the installed endoprosthesis during axial and rotational loads. Improve the result of treatment. In addition, the developed method of formation and the developed endoprosthesis should be applicable for stabilization of the vertebral-motor segments during operations of anterolateral spinal fusion in critical conditions in the absence of generally accepted standard implants of the required size.

A constructive solution to the problems lies in the fact that the claimed endoprosthesis of FIG. 1-3, option 1 is a plate (2) of FIG. 1, 2 with holes (perforated) made of medical titanium or its alloys which are formed into the final form of the endoprosthesis (1) of FIG. 3, either in advance or during the operation, taking into account the required dimensions, by twisting from one edge (2.1.1) of FIG. 1 in a few turns in a spiral forming the endoprosthesis (1) of FIG. 3 with spiral turns inside and with free cavities (1.1.2) of FIG. 3 between the walls of the turns (1.1.1) of FIG. 3. It should be noted that, if necessary, at the beginning of the formation, a rectangular element of the required size is cut from the plate (2), depending on the required size of the endoprosthesis.

The claimed endoprosthesis option 2 of FIG. 4-7 also represents a plate (2) with holes (perforated) made of medical titanium or its alloys, which are formed into the final form of the endoprosthesis (1) of FIG. 7, either in advance or during the operation, taking into account the required dimensions by cutting out of it a T-shaped element (3) of FIG. 4, 5, then the longest part (3.1) of the T-shaped element, twist the twists from the side of the free edge (3.1.1) several turns in a spiral, capturing the short part (3.2) of the T-shaped element of FIG. 5, 6, 7, form a cylindrical endoprosthesis (1) with spiral turns inside and with free cavities (1.1.2) between the walls of the turns (1.1.1), while the short part (3.2) of the T-shaped element (3) fits snugly to the supporting part (1.1) of the endoprosthesis and becomes its anterolateral surface - the stabilization part (1.2).

It should be noted that the antero-lateral surface (1.2) in the claimed endoprosthesis of option 2 serves as a fixing plate, through the holes of which the screws of the corresponding diameter of the endoprosthesis of option 2 are fixed to the bodies of neighboring vertebrae preventing the migration of the installed endoprosthesis under axial and rotational loads ,,

The supporting part (1.1) of the endoprosthesis replaces the vertebral body, and the stabilization part (1.2) performs the stabilization function. In analogues, the stabilization function is performed either by a separate implatant in the form of a plate or by elements not connected to each other, as well as monolithically not connected with the supporting part. This feature of the monolithic joint in the endoprosthesis of the support and stabilization parts enhances the reliability of the installed endoprosthesis under axial and rotational loads and, accordingly, improves the treatment result.

The resulting turns of the plate of FIG. 3, 7 (top view) inside the endoprosthesis (1) in all versions, reinforce its design, and the formed cavities (1.1.2) between the walls of the spiral turns (1.1.1) and the holes in the walls of the turns allow the endoprosthesis to be filled with osteogenic material, which subsequently, a bone-metal block can be formed, which further enhances the fixation of the endoprosthesis and accordingly improves the treatment result.

It should be noted that in special cases of execution, the number of turns of the spiral can be from 1 to 5. The preferred number of turns of the spiral is from 2-3, Also, the axis of the spiral can pass along the edge from which the spiral is formed (1.1.1), (3.1.1) or be away from it, it should be noted that this does not affect the resulting technical result,

Variations in the lengths, diameters and number of turns of the endoprosthesis are determined in each particular clinical situation separately or in advance, for example, if there is time for preparation or directly during the operation, for example, in emergency cases.

The holes located on the surface of the plate can be staggered and / or randomly and of the same and / or different size. Preferred hole sizes are from 3 mm to 4.5 mm.

The optimal wall thickness of the claimed endoprosthesis in all cases can be performed in the range of 0.6-1.5 mm.

It should be noted that in particular cases of execution, the claimed plate can be made of mesh material (mesh), as an equivalent element of a perforated plate,

The claimed endoprosthesis in all variants of execution can be made of medical titanium or its alloys, as well as from materials having similar properties, including those capable of bending and approved for use in prosthetics in traumatology and neurosurgery. The minimum sheet sheet size is 50 mm × 70 mm.

In addition, the formed endoprosthesis may have an external shape based on a cylinder, or on the basis of a polygonal prism, three, four, five, etc.

It should be noted that both methods of forming the endoprosthesis can be applied to plates specially made for the formation of endoprostheses of the vertebral bodies in accordance with the stated solution, and can also be applied in the absence of those that are suitable for the characteristics (material, thickness, presence of holes, size and etc.), for example, can be applied to cranioplasty plates, which allows stabilization of the vertebral-motor segments during antero-lateral fusion operations under critical conditions x in the absence of conventional standard required size of implants.

As a result, the claimed methods allow the formation of an endoprosthesis of the vertebral body of an unnecessary size, shape and diameter, both in advance and during the operation. Moreover, the methods can be applied to form an endoprosthesis both to specially manufactured plates and to plates of similar qualities, properties and sizes, that allows you to use the claimed methods and endoprostheses when stabilizing the vertebral motor segments during operations of the anterolateral fusion in critical conditions in the absence of general Answered standard implants required size. It should be noted that the claimed variants of the endoprosthesis have a simple design in the form of platinum with holes (perforations) and in the formed form have reinforcement due to spiral revolutions and at the same time have the ability to fill it with osteogenic material due to the cavities between the walls of the spiral turns. Also, in embodiment 2 of the claimed endoprosthesis, it has a structural possibility in the form of an antero-lateral surface that acts as a fixing plate, through the holes of which the screws of option 2 endoprosthesis are fixed to adjacent vertebral bodies by preventing the migration of the installed endoprosthesis under axial and rotational loads. The claimed methods and endoprostheses can improve the result of treatment.

Brief description of the images:

Note: All images show a particular case of the claimed solution, where all the holes are equal in diameter and staggered.

FIG. 1 is a schematic representation of an unformed endoprosthesis option 1;

FIG. 2 is a schematic illustration of the beginning of the formation of an endoprosthesis option 1;

FIG. 3 is a schematic representation of the formed endoprosthesis option 1 front view and top view;

FIG. 4 is a schematic representation in an unformed endoprosthesis version 2 indicating the outline of a T-shaped element with a schematic indication "cut";

FIG. 5 is a schematic illustration of a T-shaped endoprosthesis element option 2;

FIG. 6 is a schematic representation in the process of formation of a variant 2 from a T-shaped endoprosthesis element;

FIG. 7 is a schematic representation of the formed endoprosthesis option 2 front view and top view;

Description of structural elements:

1 - endoprosthesis of the vertebral body;

1.1 - supporting part of the endoprosthesis;

1.1.1 - walls of the turns of the endoprosthesis;

1.1.2 - cavity;

1.2 - the front-side surface of the endoprosthesis;

2 - plate;

2.1.1 - the edge of the plate from which the formation of the endoprosthesis begins;

2.1.2 - the edge of the plate;

3 - T-shaped element;

3.1 - the long part of the T-shaped element;

3.1.1 - the free edge of the long part of the T-shaped element;

3.2 - a short part of the T-shaped element;

3.2.1 - the free edge of the short part of the T-shaped element;

4 - axis.

Implementation of the claimed decision:

The method of forming an endoprosthesis of the vertebral body option 1 of FIG. 1-3.

According to preliminary calculations according to computed tomography or data determined directly during surgery, the plate (2) of FIG. 1, 2 with openings (perforations) made of medical titanium or its alloys or from a mesh material form the endoprosthesis (1) of the FIG. 3, and if necessary, cut out a rectangular element from it according to the dimensions previously determined or during the operation and twist from one edge (2.1.1) several turns in a spiral to form the endoprosthesis (1) of FIG. 3 with spiral coils inside and with free cavities (1.1.2) between the walls of the coils (1.1.1). Next, the endoprosthesis (1) is installed between two adjacent intact (healthy) vertebrae in any known manner.

The method of forming an endoprosthesis of the vertebral body option 2 of FIG. 4-7.

According to preliminary calculations according to computed tomography or data determined directly during surgery, the plate (2) of FIG. 4 with holes (perforations) made of medical titanium or its alloys or from a mesh material is formed into the final form of the endoprosthesis (1) of FIG. 7, and either in advance or during the operation, taking into account the required dimensions, a T-shaped element (3) of FIG. 4, 5, then the longest part (3.1) of the T-shaped element is rolled up by twisting from the side of the free edge (3.1.1) several times in a spiral, capturing the short part (3.2.1) of the T-shaped element, form the endoprosthesis (1) of FIG. . 7 with spiral turns inside and with free cavities (1.1.2) between the walls of the turns (1.1.1), while the short part (3.2) of the T-shaped element fits snugly against the supporting part (1.1) of FIG. 7 of the endoprosthesis and becomes its antero-lateral surface (1.2) of FIG. 7. Next, the endoprosthesis is filled between the turns, with any osteosubstituting material and installed between two adjacent intact (healthy) vertebrae by any known method and, using the antero-lateral surface (1.2), are screwed through holes to the bodies of adjacent vertebrae preventing migration of the established endoprosthesis during axial and rotational loads.

Claims (8)

1. The method of forming an endoprosthesis of the vertebral body, including the formation of an endoprosthesis from a plate with holes in the final view by twisting from one edge a few turns in a spiral of the required diameter with spiral turns inside, characterized in that the spiral turns are formed with free cavities between the walls of the turns to fill osteogenic material through openings distributed throughout the plate. 2. The method according to p. 1, characterized in that when the plate is formed into the final form of the endoprosthesis, either in advance or during the operation, taking into account the required dimensions, a T-shaped element is cut out of it, then the longest part of the T-shaped element is rolled up, twisting with the sides of the free edge in several turns in a spiral, capturing the short part of the T-shaped element, form an endoprosthesis with spiral turns inside and with free cavities between the walls of the turns to fill with osteogenic material through holes, distributed the entire plate, while the short part of the T-shaped element fits snugly to the supporting part of the endoprosthesis and becomes its antero-lateral surface - the stabilization part for fixing to neighboring vertebral bodies. 3. The method according to p. 1 or 2, characterized in that at first the rectangular element is cut from the plate according to the dimensions previously determined or during the operation. 4. The method according to p. 1 or 2, characterized in that the plate is made of mesh material. 5. The endoprosthesis of the vertebral body is an endoprosthesis of the vertebral body in the form of a support part with holes on the surface, characterized in that it is formed from a plate with holes by twisting from the side of one edge in several turns in a spiral and has spiral turns inside with free cavities between the walls turns for filling with osteogenic material through openings distributed throughout the plate; 6. The endoprosthesis according to claim 5, characterized in that it is formed of a plate with T-shaped holes by twisting from the side of the free edge of the longest part of the T-shaped element in several turns in a spiral with the capture of a short part of the T-shaped element, has in the supporting part, the coils of the spiral inside with free cavities between the walls of the coils for filling with osteogenic material through openings distributed throughout the plate, and has a single stabilization part monolithically connected to the supporting part A fixation to the adjacent vertebral bodies. 7. An endoprosthesis according to claim 5 or 6, characterized in that the plate is made of mesh material; 8. An endoprosthesis according to claim 5 or 6, characterized in that the holes on the plate are staggered in different sizes, or staggered in the same and different sizes, or in a random order of the same size, or in a random order of different sizes, or in a random in the order of the same and different size, either in a staggered and chaotic order of the same size, or in a staggered and chaotic order of different sizes, or in a staggered and chaotic order of the same and different size.

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