RU2285483C2 - Device for performing stabilizing operation on spinal column (versions) and method of performing of stabilizing operation on spinal column - Google Patents

Device for performing stabilizing operation on spinal column (versions) and method of performing of stabilizing operation on spinal column Download PDF

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Publication number
RU2285483C2
RU2285483C2 RU2004134385/14A RU2004134385A RU2285483C2 RU 2285483 C2 RU2285483 C2 RU 2285483C2 RU 2004134385/14 A RU2004134385/14 A RU 2004134385/14A RU 2004134385 A RU2004134385 A RU 2004134385A RU 2285483 C2 RU2285483 C2 RU 2285483C2
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Russia
Prior art keywords
screw
cavity
characterized
device according
bone cement
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RU2004134385/14A
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Russian (ru)
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RU2004134385A (en
Inventor
Дмитрий Николаевич Дзукаев (RU)
Дмитрий Николаевич Дзукаев
Виталий Игоревич Семченко (RU)
Виталий Игоревич Семченко
Леонид Алексеевич Крашенинников (RU)
Леонид Алексеевич Крашенинников
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Общество с ограниченной ответственностью "КОНМЕТ" (ООО "КОНМЕТ")
Дмитрий Николаевич Дзукаев
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Priority to RU2004134385/14A priority Critical patent/RU2285483C2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7041Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A61B17/7098Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7049Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
    • A61B17/864Threaded wires, pins or screws; Nuts therefor hollow, e.g. with socket or cannulated

Abstract

FIELD: medicine; traumatology.
SUBSTANCE: according to the first version, device has transpedicular fixation system screws introduced into vertebra. Heads of screws are connected with longitudinal rods by means of locks. Device also has osseous cement. Any screw is made with at least one cavity fit for pumping osseous cement in. One side of cavity goes to screw's head, and the other its side goes through at least one additional channel to external surface of screw's rod. Plug is disposed inside cavity to prevent pollution of cavity with osseous chips; plug is made for removal. According to the other version, device has transpedicular fixation system screws introduced into vertebra, and osseous cement. Heads of screws are connected with longitudinal rods by means of locks. Any screw is made with at least one cavity fit for pumping osseous cement in. The cavity is made through and it goes to sharpened end of screw's rod. Plug is disposed inside cavity to prevent pollution of cavity with osseous chips; plug is made for removal. Method provides access to back surface of vertebrae subject to treatment and to healthy adjacent vertebra, which are not subject to treatment. Screws of transpedicular fixation system are introduced into those lower and higher vertebrae in such a way that screws goes through leg of vertebrae inside its body. Rest part of transpedicular fixation system is mounted onto heads of screws. Main units of transpedicular fixation system are mounted finally after spinal column is reclined. Both versions can be used for treatment. Osseous cement is pumped into vertebrae's bodies. Broken vertebrae is reclined due to spatial shift of screws relatively axis of longitudinal rods of device.
EFFECT: reliable fixation of vertebrae-moving segment; prevention of screw migration; partial reconstruction of damaged osseous structure.
30 cl, 10 dwg

Description

The invention relates to medicine, in particular to spinal surgery. More specifically, it relates to the treatment of pathological fractures of the spine, aggravated by a pathologically altered structure of bone tissue, and to the treatment of diseases of the spine, aggravated by a pathologically altered structure of bone tissue. In other words, the invention is intended to stabilize damaged vertebral-motor segments of the thoracolumbar spine against a pathologically altered bone structure.

NOTE: the term “spinal” is a generally accepted term in medicine, meaning “referring to the spine” [1].

In recent years, the interest of neurosurgeons and traumatologists in the problem of treating spinal injuries, in particular fractures, burdened by a pathologically altered bone structure, has increased.

Although as a result of advances in science, it was possible to effectively treat spinal fractures using a transpedicular fixation system [2], however, at present, it is not possible to effectively treat spinal fractures, which are characterized by increased friability of bone tissue. Increased bone tissue friability can occur either in the event of a bone fracture, or due to a change in the structure of bone tissue caused by spondylolisthesis. In bone tissue with increased friability, it is difficult to firmly fix the transpedicular screws of the transpedicular fixation system due to its friability. In addition, over time, the screws become loose (migrate) and the connection loosens.

To prevent this, there are currently several ways to go. For example, use eight instead of four transpedicular screws for fixation, or increase the diameter of the screws, or their length, or combine these techniques. However, all of the above does not guarantee the exclusion of subsequent screw migration, which delays the timing of fracture fusion and activation of patients. In addition, each of these methods has its drawbacks. For example, an increase in the number of screws leads to greater trauma to bone tissue. An increase in the diameter of the screws, for example, up to 8 mm, in addition to increasing trauma to the bone tissue, is simply not applicable in some cases, since the size of the sections of the vertebrae into which they must be inserted can be as little as 6 mm, i.e., have a smaller diameter. An increase in the length of the screw is injurious, as it can damage adjacent organs.

In order to more stable fixation of the spine against the background of osteoporosis, a method of fixation and stabilization has recently been used with the use of so-called “tabular” screws, each of which contains a main screw with a cavity and slots in the front part and an inner shaft corresponding to the size of the internal cavity, the introduction of which the front parts of the screw under the influence of the end of the inner rod are moved apart in different directions in the form of "petals" and are firmly embedded in the osteoporotic vertebral body [3]. All parts of the screw are made of durable bioinert material, such as titanium.

Specifically, the method of performing a stabilizing operation on the spine in this case consists of the following steps:

- access to the back surface of the vertebra to be treated and to adjacent whole unsuitable treatment of the overlying and underlying vertebrae, each of which has an upper and lower contact plate;

- in the overlying and underlying whole untreated vertebrae, screws of the transpedicular fixation system are inserted from both sides at the point lying at the intersection of the transverse and articular processes of the vertebra, so that the screw passes through the leg of the vertebra into its body,

- with the provision of additional anchoring of each screw in the vertebrae, the rest of the transpedicular fixation system of locks, nuts and longitudinal rods is mounted on the screw heads;

- and carry out the final fixation of the main nodes of the transpedicular fixation system.

The reduced transpedicular fixation using the "tabular" screws is carried out according to the following standard method. After access to the posterior surface of the spine in the area of damage, typical points for the insertion of transpedicular screws, which are usually located at the intersection of the transverse and superior articular processes of the vertebra, are noted. Each such point is the beginning of the leg of the vertebra - the formation through which the screw passes before it enters the body of the vertebra.

The method described above for performing a stabilizing operation on the spine using a “tabular” screw and a device for performing a stabilizing operation on the spine, including the screws of the transpedicular fixation system inserted into the vertebrae, the heads of which are connected with longitudinal rods by locks, are accepted as the closest analogue (prototype) of the claimed inventions, since they are closest to them in the aggregate of common essential features and the achieved result.

Compared with the technical solutions described at the beginning of this description, the use of a “tabular” screw provides a more stable fixation of the spine against osteoporosis.

However, when performing an operation using “tabular” screws, a problem may arise as a result of a mismatch between the dimensions of the vertebrae leg and the diameter of the screw shaft. The fact is that in this case it is necessary to use screws of large diameter up to 7-8 mm, which is due to the requirement to increase the strength characteristics of the screw.

In addition, over time, bone resorption around the “petals” of the screw can occur, which will inevitably lead to its migration.

Finally, with a pronounced lesion of the vertebral body, an additional effect in the form of a discrepancy between the “petals” of the screw can lead to additional trauma, which will also worsen the prognosis and treatment results of this category of patients.

The purpose of the claimed invention is the intention to find a technical solution characterized by stable fixation of the spinal motor segment in the presence of a pathologically altered vertebral structure.

The first object of our invention is a device for carrying out a stabilizing operation on the spine, including screws of the transpedicular fixation system inserted into the vertebrae, the heads of which are connected by means of locks to the longitudinal rods, according to the invention it is equipped with bone cement, and each screw is made adapted for pumping bone cement, at least one cavity extending on one side to the screw head and the other through at least one additional channel to the outer erhnost rod screws, wherein arranged within the cavity of the plug to prevent clogging of the cavity with bone chips, adapted to extract.

Such a technical solution has the following advantages compared to the closest analogue (prototype):

1. In the prototype, a problem may arise as a result of a mismatch between the dimensions of the vertebral leg and the diameter of the screw shaft (using large diameter screws up to 7-8 mm, which is necessary to increase the strength characteristics of the screw). In the claimed device, as a result of hardening with bone cement of the vertebra, the possibility of using larger diameter screws is provided.

2. In the prototype over time, bone resorption around the "petals" of the screw can occur, which will inevitably lead to its migration. On the contrary, in the claimed device, with the same damage, reliable anchoring of the screws in the vertebrae is ensured without resorption and migration with stable fixation of the vertebral-motor segment in the presence of a pathologically altered vertebral structure.

3. In the prototype, with a pronounced lesion of the vertebral body, an additional effect in the form of a discrepancy between the “petals” of the screw can lead to additional trauma, which will also worsen the prognosis and treatment results of this category of patients. In the inventive device, while providing improved screw anchoring, there is generally no discrepancy between the “petals” and the injuries caused by them. In addition, in relation to the device, we consider it necessary to highlight the following development and / or refinement of its essential features related to particular cases of implementation or use.

One of them relates to the design of the plug. It may be different. However, the most simple to manufacture and use a plug, which is an additional rod, which for convenience to take with your fingers can be equipped with a washer mounted on one side of it.

The number of additional channels, their shape and location may be different. Let us consider this issue in more detail.

Although the cavity of the screw can be connected to one additional channel, however, there can be a different number of such channels. However, the most practical and sufficient for most operations will be to perform a screw with a pair of additional channels directed oppositely and facing the outer surface of the screw shaft. In addition, this design is easy to use during the operation, in the manufacture. It is easily sterilized.

An additional advantage of this design, which provides injection of bone cement in these directions, is that the upper and lower end plates of the vertebra are located on the path of filtration of bone cement, which prevents the penetration of bone cement outside the vertebral body, which is extremely undesirable.

As was repeatedly noted above, the number of additional channels can be different. Moreover, the openings of the additional channels on the outer surface of the screw shaft can be located at different distances along the length of the screw from its pointed end. The described ability to change the number of additional channels, their location and the direction of the holes on the outer surface of the screw shaft allows, for example, to provide selective injection of bone cement into the individual required areas of the vertebra, which expands the possibilities of surgical operation.

Selective injection of bone cement can be provided by other constructive solutions. For example, as a result of changes in the pressure of the current bone cement inside the cavity. This can be achieved, in particular, as a result of the fact that the cavity of the screw is conical in shape with the base facing the side of the screw head. Another constructive technique is to increase the area of the additional channel on the outer surface of the screw shaft, through which bone cement is injected into the vertebral body. This can be done, for example, as a result of the fact that the cavity of the screw is connected to the longitudinal groove extending to the outer surface of the screw shaft.

It should be noted that in all of the above examples, the screw has one cavity. However, in the General case, the screw may have several cavities, each of which has its own additional channels for pumping fluid. In this case, bone glue with one setting of hardening time and viscosity can be injected through one cavity, and with other parameters through another cavity, or one fluid (bone glue) can be injected through one cavity, and another (anesthetic composition) through another cavity. .

Above we considered the features of the cavity and additional channels on a part of the length from the side of the pointed end of the screw.

However, there are features of the cavity from the opposite side.

In particular, to ensure the convenience of supplying bone cement into the cavity, it is advisable that the cavity, on a part of the length from the end of the screw head, be conical in shape with the base facing the screw head. This will facilitate the insertion into it of an adapter designed to pump the prepared and fluid fluid bone cement into the cavity.

Since the screw shaft with the holes of the additional channels on its outer surface is located in the vertebra and is not visible to the surgeon, it is desirable to provide the device with a tool that allows the surgeon to accurately determine the location of the holes of the additional channels on the outer surface of the screw during the operation. This, for example, will allow to stop screwing in at the moment when the indicated openings of the additional channels are directed towards the upper and lower end plates of the vertebra and provide bone cement filtration in these directions. As such means, it is preferable to use a mark formed on the screw head, the position of which corresponds to the location of the holes of the additional channels on the outer surface of the screw shaft. This mark can be used to determine the location of the holes of the additional channels on the outer surface of the screw, not only for the case of a pair of additional channels, but also to locate any number of holes of the additional channels on the outer surface of the screw.

Now consider the design of the adapter. There can be many modifications. However, the most preferred design, according to which the adapter is a cylinder with a through cavity of a conical shape from one end and formed on the other end of a conical protrusion with the possibility of installation in the cavity of the screw, moreover, at the junction of the cylinder and the conical protrusion, an annular protrusion is formed for easy holding by fingers in the process conducting an operation. As the material of the adapter, it is desirable to use the plastic from which it is turned or molded.

For a successful operation, it is advisable that the parameters of the prepared bone cement, namely the solidification time and viscosity, meet the following requirements.

It is desirable that bone cement have a solidification time at which it is filtered through the vertebral body to a depth sufficient to reliably fix the screw, without going beyond the outer surface of the body of this vertebra. Under this condition, an undesirable rapid hardening of the initially supplied bone cement in the vertebral body near the screw will not occur, which will become an obstacle for the bone cement supplied so that the full intended volume of the vertebral body does not filter.

Preferably, bone cement would also be characterized in that it has a viscosity at which its filtration through the vertebral body does not exceed the external surface of the body of this vertebra. This condition is very important, since the penetration of bone cement beyond the outer surface of the vertebral body can have negative consequences for the patient, in particular, it can lead to the formation of an emboli, damage to the spinal cord, other important tissues, organs and blood vessels.

In general, with such a device for carrying out a stabilizing operation on the spine, reconstruction of damaged bone structures of the spine against the background of a pathologically changed structure of bone tissue is provided.

A variant of the technical solution described above is a device for carrying out a stabilizing operation on the spine, including screws of the transpedicular fixation system inserted into the vertebrae, the heads of which are connected by means of locks to the longitudinal rods, according to the invention it is equipped with bone cement, and each screw is made with bone cement adapted to pump bone cement at least one cavity made through and facing the pointed end of the screw shaft, and inside the cavity meschena plug to prevent clogging of the cavity with bone chips, adapted to extract.

For convenience of distinction, the device described in the previous paragraph will hereinafter be called the second variant of the claimed device, and the device described before it will be called the first variant of the claimed device.

The reason for the protection of the claimed device in the form of two options is due to the fact that the considered technical solutions cannot be stated in one paragraph of the claims, since the signs characterizing the means of injecting bone cement from the inside of the screw to its surface are not technical equivalents.

Briefly, the essence of the differences between the options is that for the injection of bone cement

or

- the cavity may be equipped with at least one additional channel connecting the cavity with the outer surface of the screw,

or

- this cavity can itself go to the pointed end of the screw shaft (that is, the cavity is made through and does not have additional side channels).

Fundamentally, the invention in both cases is carried out in one way (injection of bone cement on the outer surface of the screw), but cannot be covered by one general claim.

Thus, the reason for filing an application containing a group of inventions that are options for solving the same problem on the device is that both solutions (devices) are implemented essentially in the same way, but cannot be covered by one a general claim, although each of them meets the requirements of the invention.

The above-described second variant of the device also allows you to achieve the previously given for the first variant advantages compared with the prototype (see above).

In addition, in relation to the second version of the device, we consider it necessary to highlight the following development and / or refinement of its essential features related to particular cases of implementation or use.

One of them, as for the first version of the device, relates to the design of the stub. It may be different. However, the most simple to manufacture and use a plug, which is an additional rod, which for convenience to take with your fingers can be equipped with a washer mounted on one side of it.

The shape of the cavity may also be different.

For example, the screw cavity may be conical in shape with the base facing the screw head, or the screw cavity may be connected to a longitudinal groove facing the outer surface of the screw shaft.

In the second embodiment, as in the first embodiment, in addition to the peculiarities of the execution of the screw cavity from the side of the pointed end of the screw, numerous design solutions from the opposite side of the cavity can be used.

In particular, to ensure the convenience of supplying bone cement into the cavity, it is advisable that the cavity, on a part of the length from the end of the screw head, be conical in shape with the base facing the screw head. This will facilitate the insertion into it of an adapter designed to pump the prepared and fluid fluid bone cement into the cavity.

Since the screw shaft with the openings of the additional channels on its outer surface is located in the vertebra and is not visible to the surgeon, it is desirable to provide the second option, like the first, with a tool that allows the surgeon to accurately determine the location of the openings of the additional channels on the outer surface of the screw. This, for example, will allow to stop screwing in at the moment when the indicated openings of the additional channels are directed towards the upper and lower end plates of the vertebra and provide bone cement filtration in these directions. As such means, it is preferable to use a mark formed on the screw head, the position of which corresponds to the location of the holes of the additional channels on the outer surface of the screw shaft. This mark can be used to determine the location of the holes of the additional channels on the outer surface of the screw, not only for the case of a pair of additional channels, but also to locate any number of holes of the additional channels on the outer surface of the screw.

As in the first embodiment, in the second embodiment, many modifications of the adapter can be used. However, the most preferred design, according to which the adapter is a cylinder with a through cavity of a conical shape from one end and formed on the other end of a conical protrusion with the possibility of installation in the cavity of the screw, moreover, at the junction of the cylinder and the conical protrusion, an annular protrusion is formed for easy holding by fingers in the process conducting an operation. As the material of the adapter, it is desirable to use the plastic from which it is turned or molded.

For a successful operation, it is advisable that the parameters of the prepared bone cement, namely the solidification time and viscosity, meet the following requirements.

It is desirable that bone cement have a solidification time at which it is filtered through the vertebral body to a depth sufficient to reliably fix the screw, without going beyond the outer surface of the body of this vertebra. Under this condition, an undesirable rapid hardening of the initially supplied bone cement in the vertebral body near the screw will not occur, which will become an obstacle for the bone cement supplied so that the full intended volume of the vertebral body does not filter.

Preferably, bone cement would be characterized in that it has a viscosity at which its filtration through the vertebral body does not exceed the external surface of the body of this vertebra. This condition is very important, since the penetration of bone cement beyond the outer surface of the vertebral body can have negative consequences for the patient, in particular, it can lead to the formation of an emboli, damage to the spinal cord, other important tissues, organs and blood vessels.

In general, the second variant of the device, like the first variant, provides the opportunity to reconstruct damaged bone structures of the spine against the background of a pathologically altered structure of bone tissue.

A third object of the invention is a method of performing a stabilizing operation on the spine, in which access is made to the back surface of the vertebra to be treated and to the adjacent whole, not subject to treatment, overlying and underlying vertebrae, each of which has an upper and lower contact plate, into the overlying and underlying whole untreated vertebrae are inserted from both sides with screws of the transpedicular fixation system so that the screw passes through the leg of the vertebra into its body, I mount on the screw heads, the rest of the transpedicular fixation system, final fixation of the main nodes of the transpedicular fixation system after the spinal reclination is performed, moreover, according to the invention, devices according to claim 1 and any of the dependent points 2-14, and according to claim 15 and any from points 16-25 dependent on it, bone cement is injected into the vertebral bodies, the fracture of the broken vertebra is carried out by spatial displacement of the screws relative to the axis of the longitudinal rods of the device used.

This technical solution allows you to achieve all the previously mentioned advantages for the first and second versions of the device compared to the prototype (see above).

In addition, with regard to the method, we consider it necessary to highlight the following development and / or refinement of its essential features related to particular cases of implementation or use.

In particular, various methods of introducing bone cement into the vertebral bodies are possible.

For example, bone cement can be injected after each screw is inserted to its full depth. However, in practice, it is much preferable to first introduce all the screws to full depth, and pump the bone cement after the completion of the introduction of all screws.

But other tricks are possible. For example, it is possible to introduce each screw in stages to a part of the depth, and to inject bone cement after each partial stage-by-stage insertion of the screw to a part of the depth.

If there is a need and opportunity, then after mounting the transpedicular fixation system, it is advisable to recline the broken vertebra by spatial displacement of the screws relative to the axis of the longitudinal rods.

The injection of bone cement into the vertebral bodies can be carried out in various ways. For example, before, after or during the insertion of screws into the vertebral bodies, to strengthen them, use a needle for bone biopsy and infusion 10-15 cm long. For this, it is inserted into the vertebral body to a certain required depth. Then, bone cement is injected into the vertebral body through it, strengthening the vertebral body.

However, it is preferable to carry out this operation, that is, to inject bone cement into the body of the vertebra, instead of using a separate needle to inject bone cement, use for this purpose a screw with at least one cavity extending from one side to the end of the screw and the other through at least one additional channel to the outer surface of the screw shaft, equipped with a plug installed with the possibility of extraction, and before the introduction of bone cement, remove the plug through the cavity into the vertebral body pump bone cement. This combination of functions greatly simplifies and speeds up the operation. At the same time, a plug is necessary to prevent bone chips from entering the screw cavity, which is formed when the screw is screwed into the vertebral body and can “clog” the cavity so much that it makes it impossible to inject bone cement into the vertebral body.

In this case, it is desirable that a screw with a pair of oppositely directed additional channels be used, and injection would be carried out with the location of additional channels in the direction of the upper and lower end plates of the vertebra. This is due to the fact that during injection of bone cement in these directions, the upper and lower end plates of the vertebra appear on the path of filtration of bone cement, which prevents the penetration of bone cement outside the vertebral body, which is extremely undesirable.

In general, the claimed device (its variants) and the method allow not only to provide more stable fixation of the spine against osteoporosis, but also to avoid bone resorption around the screw, which inevitably leads to its migration, to prevent the application of additional trauma from the impact of the "petals" of the screw, which worsens prognosis and treatment outcomes of this category of patients.

The applicant also considers it necessary to note that although the claimed group of inventions, so interconnected that they form a single common inventive concept, are intended primarily to stabilize the damaged vertebral-motor segments of the thoracolumbar spine against a pathologically altered bone structure, however, they can be used to treat other pathological fractures of the spine, both accompanied by damage to the spinal cord, and not accompanied I tend to cause severe pain.

In conclusion of this section of the description, it should be noted that in General, the advantage of the present invention is as follows:

1. The possibility of using in the treatment to stabilize the damaged vertebral-motor segments of the thoracolumbar spine against the background of pathologically altered bone structure.

2. A large number of bone cement supply points provides the ability to fix any area of the vertebral body and securely anchor a screw in it with the possibility of subsequent recline of the broken vertebra by spatial displacement of the screws relative to the axis of the longitudinal rods of the transpedicular fixation system.

3. The combination of a screw with a means for injecting bone cement significantly reduces the time of surgery.

An important advantage of the invention is also that the device for performing a stabilizing operation on the spine can be prefabricated on technological equipment already used in the medical industry. The treatment method, which is based on the claimed device, also does not require special tools or devices.

NOTE: the term “screw” in this application means any element screwed into the bone, for example, the “pedicle screw” repeatedly indicated above, that is, a screw characterized by certain thread parameters that provide reliable anchoring in the bone, and used for this reason to transpedicular stabilization of the spine . However, according to the invention, the term “screw” means, in addition to transpedicular screws, other bone anchored elements that can be used in the context of the claimed invention, for example, a pointed rod with a hook at the end made with an external screw thread, etc.

The invention is illustrated by drawings.

Figure 1 shows a separate transpedicular fixation system assembly, axonometry (the spine on which the transpedicular fixation system is fixed, as well as holes for pumping cement at the end of the screws, are not shown so as not to overload the figure).

Figure 2 shows the transpedicular fixation system during the assembly process, axonometry (holes for pumping cement at the end of the screw are not shown, so as not to overload the figure).

Figure 3 shows a screw made with one cavity and a pair of additional channels directed oppositely and facing the outer surface of the screw shaft, side view.

Note to figure 3: the screw is shown after breaking the "technological" tip (see description below).

Figure 4 is the same, section aa of figure 3.

Figure 5 is the same, the cross-section BB of figure 4, a breakout, is increased.

Figure 6 shows schematically a screw made with one cavity and several pairs of additional channels, and the holes of the additional channels on the outer surface of the screw shaft are located at different distances along the length of the screw from its pointed end, a longitudinal section.

Figure 7 shows schematically a screw, the cavity of which is made cone-shaped with the base facing towards the screw head, a longitudinal section.

Fig. 8 shows schematically a screw, the cavity of which is connected with a longitudinal groove facing the outer surface of the screw shaft, a longitudinal section.

Figure 9 shows a plug, side view.

Figure 10 shows the adapter, a longitudinal section.

The following are descriptions of the first and second variants of the device, as well as the method of performing the stabilizing operation on the spine, the method being illustrated using the variants of the device for performing the stabilizing operation on the spine, shown in the drawings.

The device 1 for carrying out stabilizing operations on the spine includes longitudinal rods 2, nuts 3, screws 4 and locks 5, which together, when assembled, form a transpedicular fixation system 6, as well as bone cement (not shown).

To obtain a general idea of the installation location of the device 1 for carrying out the stabilizing operation and the nature of its operation, Fig. 1 shows an assembled transpedicular fixation system 6 without an image of bone cement, which is pumped through screws 4 (see below for more details). The transpedicular fixation system 6 is a spatial structure, the main element of which, as noted above, are screws 4 that are inserted into the vertebrae of the vertebrae, which are inserted into the bodies of the fixed vertebrae at the back, through the legs of the vertebral arches, which are the connecting link between the vertebral bodies and their posterior divisions (on 1 vertebrae are not shown).

During the operation, the screws 4 screwed into the bones first anchor into the healthy vertebrae adjacent to the damaged vertebrae. As a result, two rows of screws 4 are screwed into the bone, the longitudinal axes of which extend at different angles, that is, in each row, the axes of the screws 4 screwed into the bone are formed in different positions in space. At the stage of correction of spinal deformity (reclamation or wedging), damaged vertebrae can be moved by a surgeon by moving screws 4 screwed into the bone, anchored into them. As a result of this, the multidirectionality of the axes of the screws 4 screwed into the bone in each row relative to each other is enhanced. To stabilize the transpedicular fixation system 6, the heads 7 of the screws 4 screwed into the bone 4 of each row are connected to each other by a longitudinal rod 2 with a tightening of all joints. Two longitudinal rods 2 are mounted. The entire transpedicular fixation system 6 is stabilized by means of at least one cross member 8 connecting two longitudinal rods 2 to each other. Typically, one cross member 8 is used when there are four to six screws 4 screwed into the bone. If the transpedicular fixation system 6 includes a larger number of screws 4 screwed into the vertebrae, for example eight or ten, then two cross members 8 are installed.

Each longitudinal bar 2 can be curved in the shape of the spine. As noted above, the transpedicular fixation system 6 fixes the vertebrae of the spine until they merge and monopolize. Specific methods for using the transpedicular fixation system are different. However, they do not apply to the claimed method and device and therefore are not described.

The applicant considers it necessary to pay attention to the fact that in each row of screws 4 screwed into the bone, the longitudinal rod 2 must be connected to all the heads 7 of the screws 4 screwed into the bone, the axes of which occupy different positions in space. Therefore, the locks 5 connecting the heads 7 of the screws 4 screwed into the bone of one row with the longitudinal rod 2 of this row should provide rotation relative to the three spatial coordinate axes.

Next, we consider the specific design of the claimed device 1 for carrying out stabilizing surgery on the spine and its individual elements.

As noted above, the device 1 for carrying out stabilizing surgery on the spine consists of two parts: a transpedicular fixation system 6, including longitudinal rods 2, nuts 3, screws 4 and locks 5, and bone cement.

In turn, the screw 4 screwed into the bone includes a screw rod 4 directly screwed into the bone 4, which is separated from the head 7 equipped with an external thread 10 of the protrusion 11, having a polygonal shape in plan with the convex part 12 facing towards the head 7 with the possibility of providing the support foot function. In this case, the convex toward the head 7 part 12 of the protrusion 11 of the screw 4 screwed into the bone is made spherical. Equipped with an external thread 10, the head 7 of the screw 4 screwed into the bone can be made with an external annular groove 13, which is designed to facilitate the separation of a part of the screw 4 screwed into the bone after corrective actions (see below). It should be noted that the protrusion 11 of the head 7 forms a polyhedron under the tool, for example a wrench, for inserting a screw 4 into the vertebra into the vertebra.

The lock 5 contains a pair of branches 14 and 15 with through holes 16 and 17, respectively, in each branch, which are formed opposite each other. The branches 14 and 15 are connected by a connecting segment 18, covering a longitudinal rod 2 in the area of the bend 19. One of the features of the claimed device 1 for performing a stabilizing operation on the spine is that the surface 20 facing the nut 3 of the branch 14 of the lock 5 is convex, for example spherical , with the ability to perform the function of the supporting heel. One of the features of the claimed device is that the through holes 16 and 17 of each branch 14 or 15 of the capture 5 are made conical in shape, with their vertices facing each other. Thanks to this surgeon, when installing the transpedicular fixation system 6, it is not necessary to pay attention to which side to turn the lock 5.

The nut 3 contains a skirt 21 in contact with the convex surface of the lock 5, and for this the bottom surface of the skirt 21 can be made, for example, conical or spherical in shape. In addition, the nut 3 can be made with an outer annular groove 22, and inside smooth from the transverse plane of this annular groove to one of its ends, ensuring that the upper part of the nut is cut off no higher than the annular groove 13 on the screw 4 screwed into the bone. the cross section of the nut 3 passing through the annular groove 22 is designed so that the part of the nut 3 located above the annular groove 22 and not in contact with the external thread 10 of the head 7 of the screw 4 screwed into the bone comes off while ensuring the necessary tightening force of the longitudinal rod 2. In practice, during the operation, this occurs as follows. First, the surgeon with a tool to tighten the nut, for example with a wrench, covers the entire nut 3 in height and tightens it. After that, it lifts the wrench up along the axis so that the wrench covers only part of the nut 3 opposite the smooth inner surface of its hole between the transverse plane passing through the outer annular groove 22 and the corresponding end face of the nut 3. Then, it applies force to the wrench and rotates until the top of the nut is cut, which is then removed. The end part of the head 7, called the "technological" tip, which then breaks off along the outer annular groove 13 is exposed.

As follows from figure 2, the mounted transpedicular fixation system 6 is characterized in that the head 7 of the screw 4 screwed into the bone equipped with an external thread 10 is passed through the through holes 16 and 17 of the branches 14 and 15 of the lock 5 until it stops in the branch 15 of the lock 5 convex facing side of the head 7 of the upper part 12 of the protrusion 11 and a nut 3 is screwed onto it to provide compression of the branches 14 and 15 of the lock 5. Since the surface 20 of the lock 5 facing the nut 3 is convex with the possibility of performing the function of a supporting heel, and the nut 3 is equipped with a contact 20 s with the skirt surface 21, there is a possibility of mutual rotation of the lock nut 5 and 3 when mounting transpedicular fixation system 6. By rotating the nut 3 comes elastic deformation lock 5, wherein the locking surface 5 of its covers a longitudinal rod 2 and holds it against displacement.

This is one of the possible specific designs of the transpedicular fixation system 6, with the use of which the claimed invention can be used. Of course, lock 5, nut 3 may have other designs.

Let us consider in more detail the other individual elements of the device 1 for performing a stabilizing operation on the spine according to the claimed invention.

Figure 3 shows the screw 4, which contains the head 7 of the screw 4 with an external thread 10. This figure 3 shows the design of the screw 4, shown after it was broken off along the outer annular groove 13, the end part of the head 7, called "technological" tip. In addition, as noted above, the screw 4 contains a screw thread 4 of a screw 4 with an external thread that is directly screwed into the bone and is separated from the head 7 equipped with an external thread 10 by a protrusion 11 having a polygonal shape with a convex part 12 facing the head 7 with the possibility support foot function. While facing the head 7, part 12 of the protrusion 11 of the screw 4 screwed into the bone is made spherical. It should be noted that the protrusion 11 of the head 7 forms a polyhedron under the tool, for example a wrench, for inserting a screw 4 into the vertebra into the vertebra.

To facilitate the insertion of a screw 4 screwed into the bone, screw 4 has the following design features. The rod 9 of the screw 4 directly screwed into the bone is equipped with a screw thread. Moreover, it is made on the main section 23 of its length of a cylindrical shape, passing in the final section 24 into a conical shape, ending with a pointed end 25. Thus, the lower part of the shaft 9 of the screw 4 screwed into the bone has a thread, the entrance part of which has a smaller diameter, than the inner thread of the thread. In addition, a pair of ledges can be formed in the end section 24 of the conical shape, made obliquely to the longitudinal axis of the screw 4 screwed into the bone, and the lower part of both ledges does not reach the axis of the element 4 screwed into the bone with the formation of a pair of lead cutting edges located at an angle to each other.

The screw 4 is made with a cavity 26 adapted for injection of bone cement, one side extending to the head 7 of the screw 4, and the other through additional channels 27 and 28 to the outer surface of the shaft 9 of the screw 4.

The diameter of the cavity 26 is usually about 2 mm. This is because the cavity 26 is technically difficult to drill with a diameter of 1 mm to the required depth of the screw 4, and if the cavity 26 is made with a diameter of more than 2 mm, the screw 4 is too weak.

The diameter of the additional channels 27 and 28 is approximately equal to the diameter of the cavity 26. If their diameter is very small, it will be difficult to pump bone cement. If their diameter is too large, then screw 4 may become so loose that its end in the vertebra will disappear, which is unacceptable.

The outlets of the additional channels 27 and 28 should be close enough to the pointed end 25 of the screw 4, so that when pumping the bone cement does not go out through the thread, which leads to the inability to completely monolith the bone tissue of the vertebral body.

A plug 29 can be placed inside the cavity 26 with the possibility of extraction (in FIG. 3 - FIG. 8, the plug is not shown so as not to overload the drawings). Another name for the stub: mandraine.

Separately, the stub 29 is shown in Fig.9. The cap 29 is an additional rod 30 that is inserted into the cavity 26 of the screw 4. For convenience, the additional rod 30 is equipped with a washer 31 mounted on one side of it, which is convenient for the surgeon to take with his fingers during the operation. The purpose of the stub 29 is as follows. When screw 4 is screwed in, it is necessary to block the access of the resulting bone particles (bone chips) into the cavity 26 of the screw 4. This is achieved by installing a plug (mandrel) 29 in the cavity 26 of the screw 4. Thus, the plug 29 is necessary to prevent bone chips from entering the cavity 26 of the screw 4 , which is formed during the screwing of screw 4 into the vertebral body and can “clog” the cavity 26 so much that it makes it impossible to inject bone cement into the vertebral body. The cap 29 is a piece of a pin (wire) made of titanium. The outer diameter of the plug 29 is determined by the internal diameter of the cavity 26. The outer diameter of the plug 29 must be slightly smaller than the internal diameter of the cavity 26 of the screw 4 so that the plug 29 does not jam inside the cavity 26. However, if the plug 29 is made too thin, bone chips may clog into the cavity 26 screw 4. The cap 29 with its lower end should reach the end of the cavity 26 and overlap additional channels 27 and 28. As noted above, the washer 31 at the end of the cap 29 is welded for ease of removal from the cavity of the screw 4.

In Fig.3 - Fig.5 screw 4 is made with a pair of additional channels 27 and 28, directed opposite and facing the outer surface of the shaft of the screw 4. This design is the most practical and sufficient for most operations. In addition, it is easy to manufacture and easily sterilized. As noted above, an additional advantage of this design, which provides injection of bone cement in two mutually opposite directions, is that the screw 4 can be oriented so that the upper and lower end plates are located on the path of filtering bone cement from additional channels 27 and 28 vertebra, which prevents the penetration of bone cement outside the body of the vertebra, which is extremely undesirable.

Since the shaft of the screw 4 with the outlets of the additional channels 27 and 28 on its outer surface is in the vertebra and is not visible to the surgeon, it is desirable to provide the screw 4 with a means that allows the surgeon to accurately determine the location of the outlets of the additional channels on the outer surface of the screw during the operation. This, for example, will allow stopping screw screwing in exactly at the moment when the indicated outlet openings of additional channels 27 and 28 will be directed towards the upper and lower end plates of the vertebra and to ensure bone cement is filtered in these directions. As such a means, it is preferable to use a mark formed on the screw head, the position of which corresponds to the location of the outlet openings of the additional channels on the outer surface of the screw shaft, for example, a dot set by paint. This mark can be used to determine the location of the outlet openings of additional channels on the outer surface of the screw, not only for the case of a pair of additional channels, but also to locate any number of openings of the additional channels on the outer surface of the screw.

However, the applicant considers it necessary to note the examination that the number of additional channels can be not only equal to two. They may not exist at all when the cavity 26 is made through and extends to the pointed end 25 of the screw 4 shaft. At this point in the description, the applicant considers it necessary to note that if the outlet is made at the screw 4 end, then the vertebral body is weak due to osteoporosis and there is a danger that bone cement can extend beyond the vertebra. On the other hand, the number of additional channels may be more than two. In addition, the shape and location of the additional channels may have various modifications.

Let us consider this issue in more detail.

As noted above, the number of additional channels may be different. While the openings of the additional channels on the outer surface of the shaft of the screw 4 can be located at different distances along the length of the screw 4 from its pointed end 25. As shown in Fig.6 and Fig.7, the openings of the additional channels 32 and 33 on the outer surface of the shaft of the screw 4 located closer to the pointed end 25 than the holes of the additional channels 34 and 35 on the outer surface of the shaft of this screw.

As also noted above, the design of the screw is possible, the cavity of which is made through and goes to the pointed end of the screw shaft. With this modification, additional channels may both be present in varying amounts, but may not exist at all. The described ability to change the number of additional channels, their location and the direction of the holes on the outer surface of the screw shaft allows, for example, to provide selective injection of bone cement into the individual required areas of the vertebra, which expands the possibilities of surgical operation.

Selective injection of bone cement can be provided by other constructive solutions.

For example, as a result of changes in the pressure of the current bone cement inside the cavity. This can be achieved, in particular, as a result of the fact that the cavity 26 of the screw 4 is conical in shape with the base 36 facing the head 7 of the screw 4. Such a structural feature of the cavity 26 is illustrated in FIG. 7.

Another constructive technique is to increase the area of the additional channel on the outer surface of the shaft of the screw 4, through which bone cement is injected into the vertebral body. This can be done, for example, as a result of the fact that the cavity 26 of the screw 4 is connected to the longitudinal groove 37 that extends to the outer surface of the shaft of the screw 4.

It should be noted that in all of the above examples, the screw 4 has one cavity 26. However, in the General case, the screw 4 may have several cavities, each of which has its own additional channels for pumping fluid into the bone tissue. In this case, bone cement (bone glue) can be injected through one cavity with one set hardening time and viscosity, and bone cement (bone glue) with other parameters through another cavity, or one fluid medium can be injected through one cavity, for example bone cement (bone glue), and through another - another (anesthetic composition).

Above we considered the features of the cavity and additional channels on a part of the length from the side of the pointed end of the screw.

However, there are features of the cavity from the opposite side.

In particular, to ensure the convenience of supplying bone cement into the cavity 26, it is advisable that the cavity 26, in part of the length from the end of the head 7 of the screw 4, be conical in shape 38 with the base 39 facing the head of the screw 7 (Fig. 3). This will facilitate the insertion into it of an adapter designed to pump the prepared and fluid fluid bone cement into the cavity 26 of the screw 4.

Let us now consider separately the design of the adapter 41 made with a cone-shaped protrusion 40 (Fig. 10), although, generally speaking, there can be many modifications of the adapters. The considered construction of the adapter 41 is a cylinder 42 with a through cavity 43 of conical shape from one end and formed on the other end of the conical protrusion 40 with the possibility of its installation in the cavity 26 of the screw 4, and at the junction of the cylinder 42 and the conical protrusion 40, an annular protrusion 44 is formed for ease of holding the adapter with 41 fingers during the operation, as well as for ease of installation and removal from the cavity of the screw. As the material of the adapter, it is desirable to use the plastic from which it is turned or molded.

For the successful operation, it is also advisable, as noted above, that the parameters of the prepared bone cement, namely the hardening time and viscosity, correspond to the following requirements.

It is desirable that bone cement have a solidification time at which it is filtered through the vertebral body to a depth sufficient to secure the screw 4 securely, without going beyond the outer surface of the vertebral body. Under this condition, an undesired rapid hardening of the initially supplied bone cement in the vertebral body near the screw will not occur, which will become an obstacle for the bone cement supplied so that the full intended volume of the vertebral body does not soak.

Preferably, bone cement would be characterized in that it has a viscosity at which its filtration through the vertebral body does not exceed the external surface of the body of this vertebra. This condition is very important, since the penetration of bone cement beyond the outer surface of the vertebral body can have negative consequences for the patient, in particular, it can lead to the formation of an emboli, damage to the spinal cord, other important tissues, organs and blood vessels.

Consider an example implementation of the invention.

During the operation, the patient is placed on his stomach. A soft tissue incision is made to the spine along the midline. Soft tissue is separated by expanders. At the bottom of the wound, a segment of the spine is exposed, which includes a broken vertebra, above and below which are healthy unbroken vertebrae. They are used to fix a broken vertebra. A broken vertebra must be stabilized for about 1 year, so that a broken vertebra grows together and bone marrow is formed. To fix a broken vertebra (with the help of healthy unbroken vertebrae located on its sides), it is necessary to insert screws 4 into the above and below unbroken vertebrae. After they are inserted into the vertebral bodies, a transpedicular fixation system is installed 6. This means that screws 4 are fastened between each other with rods 2, running along the vertebrae using locks 5.

If the fracture is clearly not stable, then the transverse fixation of the rods 2 using the cross member 8 is additionally used.

In the presence of osteoporosis, when the vertebral body is not strong and prone to fractures, the introduction of metal screws, as noted above, is a relative contraindication, since they do not stay in the porous vertebral bodies of the spine, due to their softness, and migrate. In this case, it is proposed to use the claimed invention with screws 4 made with cavities 26, which, after their introduction (screwing in), allow bone cement to be pumped into the vertebral bodies. Bone cement will strengthen the vertebral bodies, so that each screw 4 of the transpedicular fixation system 6 is firmly fixed in the body of the corresponding vertebra.

After exposure of the spinal segment, the operation in this case is as follows.

The points of insertion of screws 4 into the vertebral bodies are found. Install screws 4 with cavities 26 by screwing a pair into the unbroken vertebra located above and adjacent to the broken vertebra, as well as into the unbroken vertebra below and adjacent to the broken vertebra. In this case, each screw 4 is screwed with a cap 29 inserted into the cavity 26, which does not allow the cavity 26 of the screw 4 to become clogged with bone chips. After screwing each screw 4, the plug 29 is removed. A cone-shaped protrusion 40 of the adapter 41 is inserted into the end part of the cavity 26 from the head 7 of the screw 4. Bone cement is pumped into the vertebral body under pressure using a syringe 41 so that the bone cement in a fluid state under pressure is evenly distributed in the spongy substance of the vertebra. If there is no pressure, then bone cement will not evenly be distributed in the body of the vertebra. There are several brands of bone cement. Preferred: bone cement under the brand name "Simplex - P" company "Stryker - Howmedical" (USA); bone cement under the trademark "OSTEOPAL" company "Biomet MERCK" (Russia). After that, X-ray control is performed on the operating table to assess the degree of filling of the vertebral body with bone cement, as well as the position of the screws 4. The time is held until the bone cement solidifies. Although there is no particular need for this, since after the introduction of bone cement it is necessary to carry out preparatory work for the further operation, in particular, X-ray control, which just takes 4-7 minutes (see below for more details).

The applicant considers it necessary to note that the general procedure for conducting the operation is given above. Of course, depending on the specific features, there may be many options for the operation, for example, concerning the features of the introduction of screws, the number of which in each case is determined independently.

For example, according to one embodiment, first all four screws 4 are inserted sequentially into the vertebral bodies, that is, into an unbroken vertebra overlying a relatively broken vertebra and into an underlying unbroken one. Then bone cement is pumped in, passing from one screw to another. This is convenient as it saves time. The fact is that bone cement is prepared next to the operating table by mixing the powder with a solvent to obtain the necessary consistency. They take it with a syringe and, through the adapter 41, inject it sequentially into the cavity 26 of the screws 4 under pressure. Of course, you can enter each screw 4 individually and immediately inject bone cement through its cavity, and then proceed to screw another screw 4. However, this technique takes more time to carry out the operation.

As noted above, in practice, there is no need to specifically stop the operation in order to solidify bone cement in the vertebral bodies. It is prepared with such a consistency that it quickly hardens (5-7 minutes). And this time is just necessary in order to carry out X-ray monitoring after the introduction of bone cement into the vertebrae to study the question of how far the bone cement has filtered (spread) in the body of each vertebra and in case of insufficiency to finish it. Another goal of X-ray monitoring is to control the position of the screws after they are inserted into the vertebrae. As noted above, bone cement has two characteristics: solidification time (fast, slow, medium) and viscosity (low viscosity, medium viscosity, high viscosity). The invention recommends the use of medium viscosity bone cement. If, after mixing bone cement with a solvent, the prepared bone cement has a high viscosity, then it is difficult to introduce it, if it is low viscosity, then it can quickly spread in the vertebra, go beyond its borders and reach the spinal canal and spinal cord, which is unacceptable.

After X-ray control and the end of hardening of bone cement, the transpedicular fixation system 6 is mounted as described previously. Then, drainage is installed in order for blood to flow for 1-2 days to prevent the formation of a hematoma. Carry out layer-by-layer suturing of the wound.

If necessary, if, for example, the axis of the spine is violated, a reclination is made, that is, the broken vertebra is straightened, in particular, by spatial approach of the free open parts of the screws 4 during the installation of the transpedicular fixation system 6, since the lower part of the screws is in the vertebral body, or using the operating table by bending its surface.

There are other features of the claimed invention, for example the following.

In the above example, the injection of the prepared bone cement is carried out after the introduction (screwing) of the screw 4 to the full depth into the vertebral body is completed. However, bone cement can also be introduced while screwing the screw in the following manner: the screw is inserted in stages, and bone cement is injected after each partial phased introduction of the screw to a part of the depth. Such a method, according to the applicant, is less convenient compared to the previously described at the beginning of this paragraph.

The spinal device is made of titanium alloys or other materials, such as steel.

The invention is illustrated by a clinical example.

Patient S., 75 years old, was in the City Clinical Hospital No. 67 from 03/10/2004 to 03/27/2004 with a diagnosis of an uncomplicated fracture of the body of the first lumbar vertebra (L1) against osteoporosis. The operation was performed: transpedicular fixation of the twelfth thoracic - second lumbar vertebrae (Th12 - L2). For the operation, the transpedicular system of the Closed Joint-Stock Company CONMET Incorporated was used, in which the claimed invention was used. During the operation, after installing the screws, bone cement was injected into the vertebrae.

On the second day, the patient was activated in a corset. On the twelfth day, the stitches were removed and an extract was made for outpatient treatment at the place of residence.

The invention allowed in the presence of osteoporosis to carry out a stabilizing operation on the spine with subsequent early activation after 12 days instead of one year.

Control computed tomography of the spine showed that the condition of the fixative is satisfactory, bone cement evenly fills the vertebral bodies.

In GKB No. 67, two operations were carried out using the claimed invention.

Both results are positive. The invention is intended for use:

- With osteoporosis.

- For oncological diseases.

- As an element of revision surgery. This is necessary, in particular, if the screw after insertion (screwing) into the vertebra “loosened” in it due to the fact that the leg is weak, or the leg was broken, for example, as a result of using a screw of the wrong size (oversized).

The invention is intended for use in medical institutions for the surgical treatment of patients with unstable fractures on the background of a pathologically altered vertebral structure. It allows you to reduce the complexity of the operation and increase its effectiveness.

The invention is easy to operate and use, cheap, and can be recommended for widespread use.

In addition to the above variants of the invention, numerous other modifications thereof are possible.

All of them are covered by the following claims.

Information sources

1. A modern dictionary of foreign words. Moscow, Russian Language, 1993, p. 573.

2. US Patent No. 5938663, cl. 606-61, publ. 1999.

3. "Spine", 2003, No. 3 (prototype of the method and device).

Claims (29)

1. A device for performing a stabilizing operation on the spine, including screws of the transpedicular fixation system inserted into the vertebrae, the heads of which are connected with longitudinal rods through locks, characterized in that it is equipped with bone cement, and each screw is made with at least bone cement at least one cavity extending on one side to the screw head and the other through at least one additional channel to the outer surface of the screw shaft, and inside the cavity eschena plug to prevent clogging of the cavity with bone chips, adapted to extract.
2. The device according to claim 1, characterized in that the plug is an additional rod.
3. The device according to claim 2, characterized in that the additional rod is equipped with a washer mounted on one side of it.
4. The device according to claim 1, characterized in that the screw is made with a pair of additional valves directed oppositely and facing the outer surface of the screw shaft.
5. The device according to claim 1, characterized in that the holes of the additional channels on the outer surface of the screw shaft are located at different distances along the length of the screw from its pointed end.
6. The device according to claim 1, characterized in that the screw cavity is conical in shape with the base facing the screw head.
7. The device according to claim 1, characterized in that the cavity of the screw is connected with a longitudinal groove facing the outer surface of the screw shaft.
8. The device according to claim 1, characterized in that the cavity of the screw on a part of the length from the end of the screw head is conical in shape with the base facing the screw head.
9. The device according to claim 1, characterized in that a mark is formed on the screw head, the position of which corresponds to the location of the holes of the additional channels on the outer surface of the screw shaft.
10. The device according to claim 1, characterized in that it is equipped with an adapter.
11. The device according to claim 10, characterized in that the adapter is a cylinder with a through cavity of a conical shape at one end and a conical protrusion formed at the other end with the possibility of installation in a screw cavity, and an annular protrusion is formed at the junction of the cylinder and the conical protrusion.
12. The device according to claim 11, characterized in that the adapter is made of plastic.
13. The device according to claim 1, characterized in that the bone cement is characterized by a solidification time such that it is filtered through the vertebral body to a depth sufficient to secure the screw, without going beyond the outer surface of the body of this vertebra.
14. The device according to claim 1, characterized in that the bone cement is characterized in that it has a viscosity at which its filtration through the vertebral body does not exceed the external surface of the body of this vertebra.
15. A device for carrying out a stabilizing operation on the spine, including the screws of the transpedicular fixation system inserted into the vertebrae, the heads of which are connected by means of locks to the longitudinal rods, characterized in that it is equipped with bone cement, and each screw is made with at least bone cement at least one cavity made through and going to the pointed end of the screw shaft, and a plug is placed inside the cavity to prevent bone chips from clogging the cavity, made with the possibility of extraction.
16. The device according to clause 15, wherein the plug is an additional rod.
17. The device according to clause 16, characterized in that the additional rod is equipped with a washer mounted on one side of it.
18. The device according to p. 15, characterized in that the cavity of the screw is made conical in shape with the base facing the screw head.
19. The device according to p. 15, characterized in that the cavity of the screw is connected to the longitudinal groove facing the outer surface of the screw shaft.
20. The device according to p. 15, characterized in that the screw cavity on a part of the length from the end of the screw head is made conical in shape with the base facing the screw head.
21. The device according to p. 15, characterized in that it is equipped with an adapter.
22. The device according to item 21, wherein the adapter is a cylinder with a through cavity of a conical shape at one end and a conical protrusion formed on the other end with the possibility of installation in the screw cavity, and an annular protrusion is formed at the junction of the cylinder and the conical protrusion.
23. The device according to item 22, wherein the adapter is made of plastic.
24. The device according to p. 15, characterized in that the bone cement is characterized by a solidification time such that it is filtered through the vertebral body to a depth sufficient to secure the screw, without going beyond the outer surface of the body of this vertebra.
25. The device according to clause 15, wherein the bone cement is characterized in that it has a viscosity at which its filtration through the vertebral body does not exceed the external surface of the body of this vertebra.
26. A method of performing a stabilizing operation on the spine, including access to the back surface of the vertebral column to be treated and to the adjacent whole non-treatable overlying and underlying vertebrae, each of which has an upper and lower contact plate, into the overlying and underlying whole non-treatable vertebrae the screws of the transpedicular fixation system are inserted from both sides so that the screw passes through the leg of the vertebra into his body, the rest of the transpedicular is mounted on the screw heads of the fixation system, the final fixation of the main nodes of the transpedicular fixation system after the spinal reclination is carried out, characterized in that the devices according to claim 1 and any of the dependent points 2-14 and claim 15 and any of the points dependent on it are used 16-25, bone cement is injected into the vertebral bodies, the fracture of the broken vertebra is carried out by spatial displacement of the screws relative to the axis of the longitudinal rods of the device used.
27. The method according to p, characterized in that the bone cement is injected after the screw is inserted to full depth.
28. The method according to p. 26, characterized in that the screw is introduced in stages, and bone cement is injected after each partial phased introduction of the screw to a part of the depth.
29. The method according to p. 26, characterized in that all the screws are introduced first, and bone cement is pumped after all the screws have been inserted.
RU2004134385/14A 2004-11-25 2004-11-25 Device for performing stabilizing operation on spinal column (versions) and method of performing of stabilizing operation on spinal column RU2285483C2 (en)

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WO2016024888A1 (en) * 2014-08-14 2016-02-18 Общество С Ограниченной Ответственностью "Институт Медицинской Информатики" (Ооо "Ими") Method for percutaneous transpedicular spine stabilization in thoracic and lumbar regions
RU2611885C1 (en) * 2015-12-16 2017-03-01 Федеральное государственное бюджетное учреждение "Российский ордена Трудового Красного Знамени научно-исследовательский институт травматологии и ортопедии им. Р.Р. Вредена" Министерства здравоохранения Российской Федерации (ФГБУ "РНИИТО им. Р.Р. Вредена" Минздрава России) Method for recovery of supportability of spine in carrying out revision operations after development of instability of earlier installed transpedicular constructions
RU2615904C2 (en) * 2012-01-09 2017-04-11 Апификс Лтд. Ratchet spinal device (versions)
RU2618898C2 (en) * 2011-10-21 2017-05-11 Инновейтив Сёрджикал Дизайнс, Инк. Surgical implants for endermal vertebral leg extension during spinal stenosis elimination
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RU2444316C2 (en) * 2010-03-09 2012-03-10 ГОУ ВПО Кубанский государственный медицинский университет Федерального агентства по здравоохранению и социальному развитию Method of intra-operative reduction of sliding-off vertebra
RU2452424C1 (en) * 2010-10-01 2012-06-10 Валерий Аркадьевич Нигай Transpedicular screw for carrying out stabilising operations on spine in case of insufficient mineral density of bone tissue
RU2462206C2 (en) * 2010-11-24 2012-09-27 Федеральное государственное бюджетное учреждение "Российский ордена Трудового Красного Знамени научно-исследовательский институт травматологии и ортопедии им. Р.Р. Вредена" Министерства здравоохранения и социального развития Российской Федерации (ФГБУ "РНИИТО им. Р.Р. Вредена" Минздравсоцразвития Ро Method of vertebroplasty in case of vertebra body fractures
RU2475205C2 (en) * 2010-12-08 2013-02-20 Федеральное государственное учреждение "Новосибирский научно-исследовательский институт травматологии и ортопедии" Министерства здравоохранения и социального развития Российской Федерации (ФГУ "ННИИТО" Минздравсоцразвития России) Transpedicular screw for spinal fixation
RU2462203C1 (en) * 2011-05-13 2012-09-27 Федеральное государственное учреждение "Нижегородский научно-исследовательский институт травматологии и ортопедии" Министерства здравоохранения и социального развития Российской Федерации Method of surgical treatment of spinal stenosis of lumbar spine and device for its realisation
RU2467715C1 (en) * 2011-10-07 2012-11-27 Федеральное государственное бюджетное учреждение "Уральский научно-исследовательский институт травматологии и ортопедии имени В.Д. Чаклина" Министерства здравоохранения и социального развития Российской Федерации Method for stabilising vertebral body fractures complicated by osteoporosis
RU2618898C2 (en) * 2011-10-21 2017-05-11 Инновейтив Сёрджикал Дизайнс, Инк. Surgical implants for endermal vertebral leg extension during spinal stenosis elimination
RU2479274C1 (en) * 2011-12-23 2013-04-20 Федеральное государственное бюджетное учреждение "Российский ордена Трудового Красного Знамени научно-исследовательский институт травматологии и ортопедии им. Р.Р. Вредена" Министерства здравоохранения и социального развития Российской Федерации (ФГБУ "РНИИТО им. Р.Р. Вредена" Минздравсоцразвития Ро Method for percutaneous transpedicular spinal fixation after puncture vertebroplastic repair in treating patients suffering extensive osteoporosis and multiple metastatic spinal injuries
RU2615904C2 (en) * 2012-01-09 2017-04-11 Апификс Лтд. Ratchet spinal device (versions)
WO2016024887A1 (en) * 2014-08-14 2016-02-18 Общество С Ограниченной Ответственностью "Институт Медицинской Информатики" (Ооо "Ими") Device for percutaneous transpedicular spine stabilization
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WO2016024888A1 (en) * 2014-08-14 2016-02-18 Общество С Ограниченной Ответственностью "Институт Медицинской Информатики" (Ооо "Ими") Method for percutaneous transpedicular spine stabilization in thoracic and lumbar regions
RU2704237C2 (en) * 2014-11-04 2019-10-24 Ипревансьон Implant for stabilization of broken or unbroken bones
RU2611885C1 (en) * 2015-12-16 2017-03-01 Федеральное государственное бюджетное учреждение "Российский ордена Трудового Красного Знамени научно-исследовательский институт травматологии и ортопедии им. Р.Р. Вредена" Министерства здравоохранения Российской Федерации (ФГБУ "РНИИТО им. Р.Р. Вредена" Минздрава России) Method for recovery of supportability of spine in carrying out revision operations after development of instability of earlier installed transpedicular constructions
RU2677616C2 (en) * 2017-06-19 2019-01-17 Государственное Бюджетное Учреждение Санкт-Петербургский Научно-Исследовательский Институт Скорой Помощи Им. И.И. Джанелидзе" Method of osteosynthesis of pelvic fractures

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