RU2585733C1 - Device for fixation of at least part of thoracic and/or lumbar of person to pelvis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Device for fixation of at least part of thoracic and/or lumbar of person to pelvis involves assembly of multiple fixing elements arranged one above other, and at least one rod or wire connecting said fixing elements, as well as device for attachment of assembly to pelvis. Device for attachment of assembly to pelvis includes at least one support locking element, which represents an extended body having a recess extending along length of elongated body, support(s) fixing element(s) are made on basis of previously made three-dimensional model of pelvis and lumbosacral spine based on computed tomography. Contact surface of recess is intended for contact with at least part of outer and inner surfaces of wing of ilium and at least part of iliac crest.

EFFECT: invention provides high efficiency of spinal pelvic fixation in various pathological conditions (decompensation balance body at neurogenic spinal deformations with pelvic obliquity and spinal pelvic instability and support function of a sacral bone and pelvis at various congenital anomalies, tumour and tumour-like diseases or after various surgeries).

9 cl, 30 dwg

Description

The invention relates to medicine and can be used in orthopedics, neurosurgery, including neuroorthopedics, traumatology and vertebrology.

It is intended for operations performed from the dorsal (posterior) access, mainly for performing spinal-pelvic fixation under the condition of maximum safety and ensuring maximum stability of the spinal-pelvic fixation. The use is shown, first of all, in violation of spinal-pelvic stability, pelvic support, including neurogenic scoliosis, deformity in neurofibromatosis, congenital scoliosis, tumors and abnormalities of the spine and pelvis.

Two main types of vertebral-pelvic fixation are known.

The first type is in which the fixing elements installed on the spine (hooks, wire, screws) are fixed to the wings of the pelvis using specially curved contoured rods that can either be inserted into the wings of the pelvis or rest on top of them (Khaled M. Kebaish Sacropelvic Fixation Techniques and Complications // Spine 2010 Vol35, N25, pp 2245-2251; Michael W. Peelle, Lawrence G. Lenke, Keith H. Bridwell, Brenda Sides Comparison of Pelvic Fixation Techniques in Neuromuscular Spinal Deformity Correction: Galveston Rod Versus lliac and Lumbosacral Screws // Spine 2006 Vol31, N20, pp. 2392-2398; RF patent No. 2271165, priority 05/12/2003).

The second type - in which screws are installed in the pelvic bone that connect through the rods to the fixing elements (hooks, wire, screws) mounted on the spine (Khaled M. Kebaish Sacropelvic Fixation Techniques and Complications // Spine 2010 Vol35, N25, pp 2245-2251 ; Michael W. Peelle, Lawrence G. Lenke, Keith H. Bridwell, Brenda Sides Comparison of Pelvic Fixation Techniques in Neuromuscular Spinal Deformity Correction: Galveston Rod Versus lliac and Lumbosacral Screws // Spine 2006 Vol31, N20, pp. 2392-2398; RF patent No. 2271165, priority 05/12/2003).

The disadvantage of the first type of fixation is the lack of sufficient stability of fixation to the pelvis, micromotion. In both types of fixation, there is a high risk of developing bone tissue failure at the abutment site of the device due to the small contact area and large load (it can simply push it), which is why there is a high risk of displacement of the fixing elements, and insufficient axial fixation. In addition, rod fractures are possible due to the large load applied to it.

The closest analogue is a device for fixing at least part of the human thoracic and / or lumbar spine to the pelvis, including an assembly of many fixing elements located one above the other, and at least one rod or wire connecting these fixing elements and also a fixture for attaching the assembly to the pelvis (Allen B. Jr., Ferguson R. The Galveston Technique of Pelvic Fixation with L-Rod Instrumentation of The Spine // Spine 1984 Vol.9 N4 pp. 388-394).

The advantage of the method is the relative ease of installation, the use of standard fixing elements, widely used in modern spinal surgery.

Its disadvantage is the lack of sufficient stability of fixation to the pelvis, micromotion, the possibility of development of bone tissue failure at the point of abutment of the device due to the small contact area and heavy load (it can simply push it), high risk of displacement of the fixing elements, and insufficient axial fixation. In addition, rod fractures are possible due to the large load applied to it.

The technical task of the claimed invention is to increase the efficiency of performing spinal-pelvic fixation in various pathological conditions (decompensation of the balance of the body with neurogenic deformities of the spine with a skew of the pelvis and spinal-pelvic instability, violation of the support function of the sacrum and pelvis in various congenital anomalies, tumor and tumor-like diseases , or after various surgical interventions). With congenital malformations of the spine and pelvis, neurogenic scoliosis, neurofibromatosis and other diseases (pathological processes), the pelvic bones are often thinned and do not allow fixation with screws, rods or other methods.

The technical result is achieved by the fact that in the device for fixing at least part of the thoracic and / or lumbar spine of the person to the pelvis, including an assembly of many locking elements located one above the other, and at least one rod or wire, connecting these locking elements, as well as the device for attaching the assembly to the pelvis, according to the invention, the device for attaching the assembly to the pelvis includes at least one supporting fixing element, which is a a laden body having a recess extended along the length of the extended body, supporting (s) fixing (s) element (s) are made on the basis of a previously performed three-dimensional model of the pelvis and lumbosacral spine based on computed tomography, and the contact surface of the recess is intended for contact with at least a portion of the outer and inner surfaces of the iliac wing; and at least a portion of the ilium crest.

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

Such a technical solution has the following advantages compared to the prototype:

- High stability of fixation to the pelvis,

- a large area of support on the pelvic bones and, as a result, the ability to withstand large loads without the development of instability and destruction of bone tissue;

- the ability to use for various anomalies of the pelvis and lumbosacral;

- the possibility of using in case of insolvency of previously performed surgical spinal-pelvic fixation.

In addition, in relation to the claimed device, the applicant considers it necessary to highlight the following development and / or refinement of its essential features related to particular cases of implementation or use.

In the general case, a single support fixing member may be used.

However, the applicant decided to illustrate the claimed invention by the example of two supporting fixing elements as the most optimal and most common.

Supporting locking elements may be provided with at least one locking means, in a locking position extending into the space formed by the contact surface of the concavity. This additional device allows you to increase the stability of the supporting locking elements on the wing of the ilium. There may be two, three, etc.

The design of the fixing means may be different and the applicant has developed several options for it.

However, it is preferable that the fixing means comprise a screw and a through hole formed therein in the support fixing element. This option is easy to install.

An additional through hole can be made in the support fixing element on the opposite side of the through hole, and in the locking position, the screw passes through both holes. Given the passage of the screw through two cortical layers of the bone, this gives additional stability.

The screw may have additional threads under the head, and the through hole through which it is screwed may also have threads. In this case, when the screw is screwed into the fixing position, it is fixed not only in the bone tissue, but also with the supporting fixing element, which gives additional stability to the fixation of the whole structure as a whole.

The applicant notes that the number of supporting fixing elements may be different. At least one, but optimally two for the most frequently performed operations, when the device must be fixed on two wings of the ilium. In this modification, a pair of supporting locking elements are interconnected and relative to the assembly with the possibility of rotation and shear. This makes it easier to install the structure on the basin and connect it to the overlying assembly. In addition, this design is characterized by more stable fixation due to the optimal load distribution.

Applicant has developed many variations of this design.

It is preferable, according to the applicant, that on each supporting fixing element there are tie clamps, and the extended element is a cylinder, the ends of which are mounted in the holes of the clamps with the possibility of tightening, and the Central part through additional connecting parts connected to the assembly. In this case, it is desirable that each additional connecting part contains a clamp with a possibility of tightening, the opening of which would cover the cylinder, and a recess for mounting the end of the rod or assembly wire, across which a threaded hole is made in the additional connecting part, into which a screw is screwed with a stop butt in the cylinder.

This design is characterized by simplicity and a minimum number of parts, which simplifies the operation.

Supporting fixing elements can be made on the basis of a pre-made three-dimensional model of the pelvis and lumbosacral spine based on computed tomography. This makes it possible to manufacture the most accurate anatomically comparable support elements and the device as a whole, which, in turn, allows to achieve the maximum degree of fixation stability, preoperative planning, facilitate the course of the operation, reduce the time and invasiveness of the operation.

It is desirable that the claimed device would be made of titanium, which has a unique biocompatibility and allows studies using magnetic resonance imaging (MRI).

To conclude this section of the description, it should be noted that, in general, the advantage of the present invention is to expand the possibility of surgical care for patients with severe spinal deformities and spinal-pelvic instability, including against the background of neuromuscular diseases, abnormalities of the spine and pelvis, bone tissue weakness defects after previous operations.

The device according to the invention allows for spinal-pelvic fixation by combining with standard generally accepted modern metal structures for fixing the spine.

An important advantage of the invention is also that the details of the device can be prefabricated on conventional processing equipment used in the medical industry.

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

These and numerous other variations of the invention are covered by the following claims.

The invention is illustrated by drawings.

In FIG. 1 shows the claimed device assembly with an installation option on the pelvis, axonometry;

In FIG. 2 shows the claimed device assembly, a perspective view;

In FIG. 3 shows the claimed device assembly in rear view;

In FIG. 4 is the same section along AA in FIG. 3, assembled with a coupling clamp, cylinder and screw;

In FIG. 5 is the same section along BB in FIG. 3, in an assembly with an additional connecting part, a clamp screw, a screw securing the assembly rod or wire, and the assembly rod or wire;

In FIG. 6 is the same side view along arrow B in FIG. 3, axonometry;

In FIG. 7 is the same, section along G-D in FIG. 3, in an assembly with an additional connecting part, a screw and a rod, or an assembly wire;

In FIG. 8 shows a left support fixing element, a top view, a perspective view;

In FIG. 9 is the same, view along arrow D in FIG. 8, axonometry;

In FIG. 10 is the same, view along arrow E in FIG. 8, axonometry;

In FIG. 11 is the same, front view along arrow G in FIG. 8, axonometry;

In FIG. 12 is the same, section along II in FIG. 8;

In FIG. 13 is the same, section along KK in FIG. 9;

In FIG. 14 shows a cylinder, a longitudinal view;

In FIG. 15 is the same side view along arrow L in FIG. fourteen;

In FIG. 16 - shows a cylinder, a perspective view;

In FIG. 17 shows an additional connecting part, side view;

In FIG. 18 is the same, view along arrow M in FIG. 17;

In FIG. 19 is the same, section along H-H in FIG. 17;

In FIG. 20 depicts a screw for fixing a rod or wire assembly;

In FIG. 21 shows an additional connecting part, side view;

In FIG. 22 is the same, view along arrow O in FIG. 21;

In FIG. 23 is the same, a section along PP in FIG. 21;

In FIG. 24 shows a screw for fixing the rod or wire assembly, a perspective view;

In FIG. 25 shows a clamp screw;

In FIG. 26 is the same, view along arrow P in FIG. 25;

In FIG. 27 shows a clamp screw on the side with a partial tear-out along the CC section in FIG. 26;

In FIG. 28 depicts a clamp screw, a perspective view;

In FIG. 29 shows a screw, a perspective view;

In FIG. 30 shows a support fixing element mounted on a ridge with a fixing screw (cross section).

The claimed device 1 for fixing at least part of the thoracic and / or lumbar spine of the person to the pelvis includes an assembly of many fixing elements located one above the other (not shown in the figures, because it is not the subject of the invention) and, according to at least one rod 2 or wire connecting these locking elements (Fig. 1-Fig. 6). In addition, the claimed device includes a device 3 for attaching the assembly to the pelvis. The device 3 for attaching the assembly to the pelvis contains supporting locking elements 4 (Fig. 1-Fig. 3, Fig. 6, Fig. 8-Fig. 11). Each supporting fixing element 4 is an extended body 5, having one recess 6 in cross section, extended over the entire length of the body 5 (Fig. 6). The contact surface 7 of the recess 6 is intended for contact with at least part of the outer 8, inner 9 and upper 10 surfaces of the crest 11 of the wing 12 of the ilium 13 (Fig. 1).

The supporting fixing element 4 is provided with at least one fixing means in a locking position extending into the space 14 formed by the contact surface of the recess (Fig. 6).

The applicant has developed many such designs. The most optimal design of the fixing means comprises a screw 34 (Fig. 29) and a through hole 15 made in the supporting fixing element 4 through it (Fig. 1, Fig. 6). For additional fixation of the supporting fixing element 4 on the ilium, it is enough to insert a screw into the hole 15 and screw it into the bone.

As noted above, the applicant illustrates the invention using an example of the use of a pair of support fixing elements 4 (see the following paragraph and below).

The device depicted in the figures contains a pair of supporting locking elements 4, namely the left supporting fixing element 16 and the right supporting fixing element 17, interconnected by an extended element 18. There can be two or more two extended elements, depending on the design of the attachment device assembly to the pelvis.

A pair of supporting locking elements 16 and 17 are interconnected for rotation and shear. The applicant has developed several options for this design.

The most optimal, according to the applicant, is the following.

On each supporting fixing element 4 there are coupling clamps 19, and the extended element 18 is a cylinder 20, the ends 21 (Fig. 16) of which are mounted in the holes 22 (Fig. 10) of the coupling clamps 19 (Fig. 4) with the possibility of tightening, and the central part 23 (Fig. 14) by means of additional connecting parts 24 is connected to the assembly 2.

Each additional connecting part 24 contains a clamp 25 (Fig. 5, Fig. 18) with a possibility of a tightening, the hole 26 of which covers the cylinder 20, and a recess 27 for installing the end of the rod or wire 28 of the assembly 2, across which a hole is made in the additional connecting part 24 29 with a thread 30, into which a screw 31 is screwed with the possibility of abutment with the end face 32 into the wire or assembly rod (Fig. 7, Fig. 24).

The final fixation of the claimed device 1 for fixing after its installation is carried out using screws 33 (Fig. 1, Fig. 3, Fig. 28), with which tightening the coupling clamps 19 and clamps 25 of additional connecting parts 24.

The applicant considers it necessary to dwell in more detail on the fixing means (Fig. 29, Fig. 30). As noted above, it comprises a screw 34 with a head 35 and a through hole 15 formed therein in the support fixing element 4. The through hole 15 is made with a thread 36, and the screw 34 has an additional thread 37 under the head 35. An additional through hole 38 is made in the supporting fixing element 4 on the opposite side from the through hole 15, and in the locking position, the screw 34 passes through both holes 15 and 38. At the final fixation, the screw 34 is connected to the supporting fixing element by means of a thread 37 under the screw head and a thread 36 in the through hole 15. Also, during installation, the screw 34 passes through the iliac crest and is connected stays with bone tissue by the main threaded part 39.

Supporting fixing elements can be made on the basis of a pre-made three-dimensional model of the pelvis and lumbosacral spine based on computed tomography.

The proposed technical solution to the problem is illustrated by the example of using it for the operation: "Correction of spinal deformity with the help of metal structures and performing spinal-pelvic fixation."

1. In preparation for surgery, the patient performs computed tomography (hereinafter referred to as CT) of the lumbosacral spine and pelvis.

2. According to CT data, a three-dimensional model of the lumbosacral spine and pelvis of the patient is performed.

3. Based on this model, a device 1 is modeled (designed) and manufactured for fixing at least part of the human thoracic and / or lumbar spine to the pelvis.

4. During the operation, the patient under anesthesia is given a supine position.

5. After processing the skin, a longitudinal skin incision is made along the line of the spinous processes to the required length.

6. The upper point from the side of the head of the beginning of the incision is determined depending on the pathology, and the lower part of the incision is made to the level of the second or lower sacral vertebrae.

7. Dissect sequentially subcutaneous fat, fascia, muscles.

8. Bone tissue of the posterior vertebrae is exposed (skeletonized).

9. Fixing elements (screws, hooks, wire, tapes made of polymer materials, etc.) are installed on the vertebrae (not shown in the figures, since it is well known and is not the subject of the invention).

10. The locking elements are installed on both sides.

11. The installation level of the fixing elements from the head, their number and installation order depends on the pathology.

12. Bone tissue of the posterior sacral surface is exposed (skeletonized) to the level of the second sacral vertebra (and, if necessary, lower).

13. Bone tissue of the posterior and middle third of the iliac crests on both sides is exposed (skeletonized), and the outer and inner surfaces of the iliac wings are partially skeletonized over this length.

14. Pre-assemble the device 1 for fixing at least part of the thoracic and / or lumbar spine of the person to the pelvis.

15. For this purpose, two additional connecting parts 24 are mounted on the cylinder 20 with holes 26, moving them to the center of the cylinder 20. The left and right ends 21 of the cylinder 20 are inserted into the holes 22 of the coupling collar 19 of the left 16 and right 17 of the supporting fixing element, respectively.

16. After that, the left supporting fixing element 16 and the right supporting fixing element 17 are installed on the ridges of the left and right iliac bones, respectively.

17. Screws 34 are inserted and screwed into the through holes on the left support fixing element 16 and the right support fixing element 17 to fix them on the ilium. The number and position of the screws can be different and are determined depending on the anatomy and characteristics of the ilium.

18. On the vertebral fixing elements installed on both sides, the modeled rods (wires) of the corresponding length are laid and fixed, and the lower ends (opposite from the head) of the rods 28 are laid in the recesses 27 of the additional connecting parts 24.

19. After this, the rods (wire) are fixed in the recesses 27 of the additional connecting parts 24 using screws 31.

20. The tightening of the coupling clamps 19 and the clamps 25 of additional connecting parts with 24 screws 33.

21. Next, the final stages of the operation are performed (flushing, hemostasis, drainage and suturing of the wound).

The invention is illustrated by clinical examples.

Example 1

Patient F., 16 years old, was admitted with a diagnosis of neurogenic paralytic left-sided thoracolumbar scoliosis of the fourth degree, decompensated. Lower paraplegia. Condition after surgical treatment.

Previously, the patient was operated on for paralytic scoliosis to correct deformity and eliminate spinal pelvic decompensation.

The deformation correction was performed by the metal structure with the implementation of the spinal-pelvic fixation by installing screws in the iliac bones and connecting them to the overlying metal structure.

1 year after surgery, the patient noted pain in the lower back and pelvis. Examination on radiographs and computed tomography revealed instability of the spinal-pelvic fixation, loosening of the screws in the iliac bones with pronounced bone resorption around them.

In connection with the instability of fixation, pain of the patient and the risk of developing inflammatory changes, the patient was shown surgical treatment.

Given the weakness of the bone tissue of the ilium and the presence of defects due to previously installed screws, the only option for performing spinal-pelvic fixation was to use the claimed device.

During the operation, the patient was removed unstable screws from the iliac bones, installed support retaining elements according to the invention, connected to an overlying metal structure.

As a result of the operation, it was possible to achieve stable spinal-pelvic fixation with relief of pain.

The long-term follow-up of the patient after surgery is one year, the spinal-pelvic fixation is stable, the patient is satisfied with the operation, does not present any special complaints.

This treatment illustrates an example of the use of the claimed invention in the absence of other options for the implementation of spinal-pelvic fixation.

Example 2

Patient Ch., 20 years old, was admitted with a diagnosis of Spinal amyotrophy. Neurogenic paralytic left-side thoracolumbar scoliosis of the IV degree, decompensated.

The patient in connection with lower paraplegia moves only in a wheelchair.

Finding a patient in a sitting position is associated with great difficulties due to weakness of the muscles of the trunk.

In this case, there is a significant increase in spinal deformity with compression of the abdominal organs and with pronounced skewness of the pelvis.

The corset used to compensate for these phenomena is not effective enough and causes a number of inconveniences.

Examination on radiographs revealed severe scoliotic deformity of the spine with pronounced distortion of the pelvis, there is a significant aggravation of deformation on the radiograph in the sitting position compared with radiographs performed in the supine position.

All of the above served as indications for the implementation of surgical treatment.

The purpose of the planned surgical treatment is to correct spinal deformity and provide the patient with the opportunity to be in a sitting position without aggravating spinal-pelvic deformity and “blocking”.

To achieve this goal, an operation was performed using the claimed device. As a result of the operation, correction of spinal deformity, a significant elimination of pelvic distortion, and stable spinal-pelvic fixation were achieved. As a result of treatment, the patient may be sitting for a long time without external fixative agents, while she does not notice “blocking”, notes improvement in the function of external respiration, and the digestive system.

The long-term follow-up of the patient after surgery is one year, the spinal-pelvic fixation is stable, the patient is satisfied with the operation, and has no complaints.

This treatment illustrates the most typical example of surgical treatment.

Example 3

Patient O., 8 years old, was admitted with a diagnosis of Neurofibromatosis, secondary deformity of the sacrum.

In the patient, the parents noted pelvic deformity, gait disturbance, periodic complaints of lower back pain.

Examination according to x-ray and computed tomography revealed a pronounced deformity of the sacrum with its partial underdevelopment, secondary genesis against the background of pressure of neurofibromas.

In this case, there was an extremely high risk of developing a sacral fracture and impaired pelvic support, aggravated pelvic distortion and scoliotic deformity.

The patient underwent surgery using the claimed invention. As a result, the distortion of the pelvis was eliminated and the threat of the development of a fracture of the sacrum and vertebral-pelvic instability was prevented.

Observation of the child for 1 year after surgery showed stable fixation.

In total, in the group of FSBI “CITO named after N.N. Priorova "of the Ministry of Health of the Russian Federation 6 patients were operated using the above invention with a good treatment result.

The use of the claimed device made it possible to perform stable spinal-pelvic fixation in patients with extremely severe deformities, including when other types of spinal-pelvic fixation were not possible.

Thus, the use of the claimed invention allows for stable vertebral-pelvic fixation, even in the case of abnormalities in the development of the sacrum and pelvis, bone weakness and the presence of defects after previous operations.

The device according to the invention allows for spinal-pelvic fixation by combining with standard generally accepted modern metal structures for fixing the spine.

An important advantage of the invention is that the device can be used by orthopedic traumatologists and neurosurgeons without additional long special training and using standard equipment in operating rooms designed to perform operations on the spine. As a result of using this device, due to the achievement of stable spinal-pelvic fixation, it is possible to exclude the need for a long bed period and conduct early rehabilitation of patients.

These and numerous other variations of the invention are covered by the following claims.

Claims (9)

1. Device (1) for fixing at least part of the human thoracic and / or lumbar spine to the pelvis, comprising an assembly (2) of a plurality of fixing elements (4) located one above the other, and at least one a rod or wire (28) connecting these fixing elements, as well as a device (3) for attaching the assembly to the pelvis, characterized in that the device (3) for attaching the assembly to the pelvis includes at least one supporting fixing element (4) , which is an extended body (5) having ang basting (6), extended along the length of the extended body (5), supporting (s) fixing (s) element (s) (4) are made on the basis of a previously performed three-dimensional model of the pelvis and lumbosacral spine based on computed tomography, and contact the surface (14) of the recess (6) is intended to be in contact with at least a portion of the outer and inner surfaces of the iliac wing and at least a portion of the iliac crest. 2. The device according to claim 1, characterized in that the supporting fixing element (4) is provided with at least one fixing means, in a fixing position extending into the space formed by the contact surface (14) of the recess (6). 3. The device according to claim 2, characterized in that the fixing means comprises a screw (34) with a head (35) and a through hole (15) made in the support fixing element (4) under it. 4. The device according to p. 3, characterized in that the through hole (15) is threaded (36), and the screw (34) has an additional thread (37) under the head (35). 5. The device according to claim 3, characterized in that an additional through hole (38) is made in the supporting fixing element (4) on the opposite side from the through hole (15) and in the locking position the screw (34) passes through both holes. 6. The device according to p. 1, characterized in that it contains a pair of supporting locking elements (16) and (17) connected to each other by at least one extended element (18). 7. The device according to p. 6, characterized in that the pair of supporting locking elements (16) and (17) are interconnected with the possibility of rotation and shift. 8. The device according to claim 7, characterized in that on each supporting fixing element there are coupling clamps (19), and the extended element (18) is a cylinder (20), the ends (21) of which are mounted in the holes of the coupling clamps (19) with the possibility of tightening, while the Central part (23) by means of additional connecting parts (24) is connected to the assembly (2). 9. The device according to p. 8, characterized in that each additional connecting part (24) contains a clamp (25) with a possibility of tightening, the hole (26) of which covers the cylinder (20), and a recess (27) for installing the end of the rod or wire (28) of the assembly (2), across which a hole (29) with a thread (30) is made in the additional connecting part (24), into which a screw (31) is screwed with the possibility of abutment with the end face (32) in the rod or wire (28) of the assembly (2).

Images