Device for surgically correcting spinal deformities
The device enhances spinal deformity correction by allowing independent three-plane manipulation and distraction from the concave side, addressing limitations of existing devices and reducing surgical complexity and complications.
Patent Information
- Application Number
- PCT/RU2024/000297
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-05
- Filing Date
- 2024-09-26
- Publication Date
- 2026-02-12
AI Technical Summary
Existing spinal deformity correction devices are limited in their ability to effectively correct severe deformities, particularly due to the lack of distraction capabilities from the concave side, requiring additional surgical stages and increased blood loss, and are restricted to simultaneous three-plane manipulations.
A device with a base rod and levers mounted on additional transverse rods allowing for independent three-plane manipulation, including distraction from the concave side, facilitated by means for transverse movement and rotation of the levers relative to each other, enhancing the device's spatial manipulation capabilities.
The device enables more effective correction of spinal deformities by increasing distraction and spatial repositioning of spinal segments, reducing the need for additional surgical stages, minimizing blood loss, and lowering the risk of complications.
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Figure RU2024000297_12022026_PF_FP_ABST
Abstract
Description
[0001] Device for surgical correction
[0002] Field of technology
[0003] The invention relates to medicine and can be used for surgical correction of spinal deformities, in particular, in the surgical treatment of scoliosis of various etiologies and severity.
[0004] Prior art
[0005] A device is known for surgical correction of spinal deformities, including a base rod intended for placement along the spine with a gap, and at least a pair of levers mounted on it, one end of each of which is intended for connection with temporary shortened rods intended for connection with vertebrae, and the other is equipped with a handle for mechanical action on the spine in three planes (1).
[0006] This technical solution is accepted as a prototype of the claimed invention, since it is the closest to it in terms of a set of common essential features.
[0007] The known device is intended to provide auxiliary mechanical action on the spinal column during operations to correct scoliotic spinal deformities using a classic dorsal approach with the use of metal structures consisting of transpedicular screws and connecting rods.
[0008] This device increases spatial manipulation capabilities for various sections of the spinal column involved in the surgical site in the axial, coronal, and sagittal planes. During surgery, the manipulation arms are attached to temporary shortened rods, which are in turn secured to individual spinal motion segments in a standard manner, secured to the heads of transpedicular screws with locking screws (nuts).
[0009] Manipulating levers are used for simultaneous correction of deformities in three planes. Using this device, the spinal deformity is corrected according to the optimal position of the spine in space. The device and spine assembly are then rigidly fixed in space, and a permanent fixation rod is installed on the contralateral (opposite) side of the spine. At the final stage, the device and short temporary rods that secure it to the spine are removed, and a second permanent fixation rod is installed on the ipsilateral (same) side, finalizing the spinal column.
[0010] There are three main spinal manipulations with the known device:
[0011] The first manipulation is the rotation (axial displacement) of the spinal sections in conjunction with the rib cage relative to each other for the purpose of derotation (axial correction of the spine). This is performed by rotating the manipulating levers relative to each other in opposite directions around the base rod.
[0012] The second manipulation involves compression of two sections of the spine toward the apex of the curve on its convex side, with the goal of correction in the frontal (coronal) plane. This is accomplished by bringing the manipulating levers toward each other.
[0013] The third manipulation is sagittal correction, aimed at restoring or reducing thoracic kyphosis. It is accomplished by simultaneously rotating the manipulating levers around a horizontal axis perpendicular to the base rod. The advantages of this well-known device for surgical correction of scoliotic spinal deformities include the following.
[0014] The device allows you to:
[0015] • improve the degree and accuracy of correction of spinal deformity;
[0016] • facilitate the operation and the efforts applied by the surgeon during its implementation;
[0017] • control the correction of severe sagittal, frontal and axial deformities of the spine;
[0018] • perform additional local corrective maneuvers at the apex of the deformation;
[0019] • Maintain and support the corrected spinal position during placement of the permanent fixation rod;
[0020] • reduce the time of surgery compared to traditional correction methods.
[0021] The disadvantage of the known technical solution is the limited possibilities of deformation correction, which consists of the following:
[0022] • Considering the exclusively manual impact on the deformation due to the existing levers, the device is applicable only in conditions of relative mobility of the deformation (requires radical surgical mobilization of the spine in case of severe rigid deformations);
[0023] • Lack of the possibility of distraction action (not manual) on the concave side of the deformity, which causes low possibilities of correction of severe deformities (the possibilities of sagittal, axial and frontal correction are sharply reduced with an increase in the degree of the scoliotic arc of the deformity due to the convergence and lateral displacement of the vertebral elements on the concave side); • Insignificant possibilities of translation (medial displacement) at the apex of the deformity;
[0024] • The inability to move the base rod lateral to the surgical wound, which can complicate the installation of transpedicular screws on the side where the device is installed by blocking access to the posterior elements of the vertebrae with the base rod;
[0025] • The impossibility of performing manipulations in different planes independently of each other (manipulations in all three planes are possible only simultaneously, by relaxing a single connecting node of the device).
[0026] Disclosure of invention
[0027] The technical objective of the claimed device is to increase the capabilities of intraoperative distraction (stretching) of the spinal column from the concave side of the deformity and change the position of its individual parts in space (in three planes) regardless of the distraction effect, which radically increases the possibilities of deformity correction.
[0028] Thus, in accordance with the stated technical task, the technical result achieved through the use of the claimed device in the surgical correction of spinal deformities is:
[0029] • More effective correction of spinal deformities by increasing and facilitating the possibilities of local and global intraoperative distraction of the spinal column and three-plane spatial change in the position of its individual parts;
[0030] • Reducing the need for an additional surgical stage (ventral release) and / or radical surgical mobilization of the spinal column, necessary to achieve effective correction of spinal deformities in the absence of pronounced distraction effects from the concave side of the deformity;
[0031] • Reduction in the duration of surgery and the volume of intraoperative blood loss;
[0032] • Reducing the risk of intraoperative and postoperative complications;
[0033] • As well as expanding the arsenal of tools when carrying out this type of operation.
[0034] The stated technical task and the specified technical result are achieved by the claimed device for the surgical correction of spinal deformities, including a base rod intended for placement along the spine with a gap, and at least a pair of levers mounted thereon, one end of each of which is intended for connection with temporary shortened rods intended for connection with the vertebrae of the spine, and the other is provided with a handle for mechanical action on the spine in three planes, and, according to the invention, each lever is mounted on the base rod by means of an additional transverse rod, one end portion of which is connected to the base rod by means of a means for connecting the base rod to the additional transverse rod, ensuring the possibility, during installation,a fixed rotation of the additional transverse rod around the longitudinal axis of the base rod and its longitudinal movement along the axis of the additional transverse rod, the other end of which is transversely connected to the lever by means of a means for connecting the additional transverse rod to the lever, ensuring the possibility of their transverse movement relative to each other and rotation relative to each other. The given set of general essential features represents the essence of the claimed invention. It is necessary and sufficient in all cases of its implementation.
[0035] Thus, as noted above, in accordance with the stated technical task, the technical result achieved by the claimed device is:
[0036] • More effective correction of spinal deformities by increasing the possibilities of local and global intraoperative distraction of the spinal column and three-plane spatial change in the position of its individual parts;
[0037] • Reducing the need for an additional surgical stage (ventral release) and / or radical surgical mobilization of the spinal column, necessary to achieve effective correction of spinal deformities in the absence of pronounced distraction effects from the concave side of the deformity;
[0038] • Reduction in the duration of surgery and the volume of intraoperative blood loss;
[0039] • Reducing the risk of intraoperative and postoperative complications,
[0040] • As well as expanding the arsenal of tools when carrying out this type of operation.
[0041] In addition, with regard to the claimed invention, the applicant considers it necessary to highlight the following developments and / or clarifications of the totality of its essential features, relating to particular cases of implementation or use.
[0042] The means for connecting an additional transverse rod to a lever, ensuring the possibility of their transverse movement relative to each other and rotation relative to each other, can have various designs (see, for example, the connections of rods with clamps, given in the following source https: / / pmg.su / article / / homutovye-lesa-svojstva-i-harakteristiki, 20.06.2024).
[0043] In the applicant's opinion, it is most preferable that the means for connecting one additional transverse rod to the lever would contain a three-dimensional body, on one lateral flat face of which, near the adjacent face, an opening is made in which a screw rod with a screw thread is fixed, on the opposite side of this lateral flat face, near the other adjacent face, a projection with a transverse through opening with an axis placed in it is made, and between them a transverse tapering recess is made along the full width of this face of the three-dimensional body, and a plate for fixing an additional transverse rod with a through opening is pivotally fixed on the axis, in which the end part of the screw rod with a screw thread is placed with a gap, onto which a nut with a means for rotating by hand is screwed (note: any means for facilitating rotation by hand can be used in the device, of which there can be a plurality, for example, from special keys, to, in the general case,using any available device, in particular pliers, for this reason the applicant does not consider it necessary to provide them), and on the plate for fixing the additional transverse rod opposite the transverse tapering recess, a projection facing into it is made, while on the lateral flat face of the volumetric body, located opposite to the lateral flat face on which the plate for fixing the additional transverse rod is fixed, a rectilinear groove is made along the entire height of the volumetric body, and on one face of the volumetric body adjacent to it, a projection is made flush with it with a through hole oriented across the rectilinear groove, in which the rod of the screw with a screw thread is fixed, on the opposite face of the volumetric body adjacent to it, a projection is formed with a transverse through hole parallel to the rectilinear groove in which the axis is placed, parallel to this adjacent face,wherein a plate for fixing the lever is pivotally fixed on the axis with a recess on the side, in which the end part of the screw rod with a screw thread is placed, onto which a nut with a means for rotating by hand is screwed, and on the plate for fixing the lever opposite the rectilinear groove a protrusion is made facing into it.
[0044] This means of connecting an additional transverse rod to a lever is small in size and easy to use during surgery, does not block access to the posterior elements of the spine, and allows for rotation.
[0045] For ease of installation of the lever, it is desirable that it be made with transverse annular grooves along its length.
[0046] In this case, it is preferable that the transverse annular grooves be made to the full height of each lever.
[0047] This makes it possible to increase the height of the base rod relative to the spine, thereby changing the vector of the transverse traction force in the vertical direction, ensuring a greater degree of derotation of the apex of the spinal deformity. Let us explain this in more detail: some spines have very severe curvatures. In this case, the vertebrae at the apex of the deformity on the concave side are subject to pronounced rotation (that is, rotation around the longitudinal axis of the spine) and increased anterior deflection of the concave side at the apex of the deformity. Increasing the height of the base rod relative to the spine allows for greater lateral and posterior extension of the apex of the deformity (correction in the frontal and sagittal planes). Furthermore, this allows for a more convenient configuration of the entire device for different vertical depths of different sections of the spine.
[0048] It is advisable for each additional crossbar to be mounted on the base bar on its underside (i.e., positioned below the base bar). This increases the distance between the base bar and the additional crossbar, resulting in increased distance between the base bar and the chest surface. PC17RU2024 / 000297
[0049] 9 cells, preventing the chest surface from resting on the base rod, facilitating the operation in that the chest surface does not rest on the base rod.
[0050] It is preferable for the base rod to come in different lengths (standard sizes). This allows for the treatment of patients with different anthropometric measurements.
[0051] It's advisable for each lever to have a guard on the handle side. This guard prevents the lever from slipping out of the body when the body reaches the limit of the lever's length. This is especially helpful if the lever is short.
[0052] In order to expand the possibilities of changing the position of the sections of the spine in space, it is advisable that at least one transverse traction (located perpendicular to the base rod) be mounted on the base rod between the additional transverse rods, one end of which is provided with a grip for grasping a temporary shortened rod intended for fastening on the vertebrae of the spine, fixed with locking screws (nuts) in the heads of transpedicular screws installed on the concave side of the apex of the deformation, and the end part on the other side of the traction is provided with a means for connecting the traction to the base rod with the possibility of transverse movement relative to the base rod, and the means for connecting the transverse traction to the base rod with the possibility of transverse movement relative to the base rod contains a tube placed on the transverse traction with the possibility of free movement along it,with a hook on the outer side designed to grip the base rod, with the end facing the transverse traction rod formed at the other end in the form of a hook for gripping a temporary shortened rod, designed for fixation in two or more vertebrae on the concave side of the apex of the spinal deformity, wherein the transverse traction rod is provided with a screw thread, onto which, from the side of the tube, on the opposite side from the location of the hook for gripping the temporary shortened rod, a nut with a means for rotation by hand, in the form of plates on the nut, is screwed. The presence of such a transverse traction makes it possible to quickly and freely install it in the most advantageous position, relative to the apex of the arc of deformity, and to carry out a translational corrective maneuver, ensuring radical correction of the deformity in the frontal and sagittal (depending on the location of the base rod) planes. It is important to note,that under significant loads on the base rod during strong distraction of severe scoliotic deformities, its moderate outward bending occurs, and the use of transverse traction levels out this bending.
[0053] In general, a transverse traction device is designed to pull the central axis of the spine laterally and shift the spine posteriorly to increase kyphosis or decrease lordosis at the affected level (or, in other words, increase posterior curvature of the spine or decrease anterior curvature). As noted previously, multiple transverse traction devices can be used if necessary, for example, if three or more curves are present.
[0054] In order to further expand the possibilities of changing the position of sections of the spinal column in space, it is desirable that the device be equipped with a device for adjustable parallel movement along the base rod of one additional transverse rod rigidly connected to the base rod relative to another additional transverse rod rigidly connected to the base rod, which contains a movable additional transverse rod made with a thickening on one side, in which a through transverse hole is formed with an end projection on one side, in the wall of which on one side an additional through hole is made, the axis of which is located transversely to the longitudinal axis of the movable additional transverse rod and transversely to the longitudinal axis of the through transverse hole in the thickening with a partial intersection of the through transverse hole with the end projection on one side,wherein an intermediate tube with a cavity and a through hole in the wall is rigidly fixed in the through transverse hole with an end projection on one side, in which a tube with an internal screw thread and an annular recess on the outer surface is pivotally mounted on one side, and which on the other side has a pair of transverse projections on the outside, and wherein a screw is screwed into the thickening of the movable additional transverse rod, passing through the additional through hole in the wall of the thickening and through the through hole of the intermediate tube and the rod of which is also located in the annular recess on the outer surface of the tube with an internal screw thread, and wherein the base rod on one side is made with a screw thread and is placed inside the tube with an internal screw thread with an annular recess on the outer surface of the thickening of the movable additional transverse rod,and on the other side, the base rod is made with a smooth (or rough) surface, to which an additional transverse rod is attached.
[0055] Numerous other modifications of the declared device are possible.
[0056] The invention is intended primarily for the surgical correction of human spinal deformities, but it can also be effectively used to treat the spine of animals, such as giant dogs and cats.
[0057] Figures and photographs
[0058] The invention is explained by a drawing.
[0059] Fig. 1 / 53 shows the claimed device for surgical correction of spinal deformity, installed on a model of a spine with scoliotic deformity from its concave side, general view, axonometry; Fig. 2 / 53 shows a base rod and a pair of additional transverse rods fixed to it at the initial stages of installation, axonometry;
[0060] Fig. 3 / 53 shows a base rod and a pair of additional cross rods fixed to it, on each of which a means for connecting the additional rod to the lever is installed, axonometry;
[0061] Fig. 4 / 53 shows a base rod and a pair of additional cross rods secured to it, on each of which a means for connecting the additional rod to the lever is installed, as well as a lever, axonometry;
[0062] Fig. 5 / 53 shows a base rod and a pair of additional cross rods secured to it, on each of which a means for connecting the additional rod to a lever is installed, as well as a lever with a handle, axonometry;
[0063] Fig. 6 / 53 shows a separate additional crossbar with a clamp at the end and a screw for tightening the clamp, axonometry;
[0064] Fig. 7 / 53 shows a separate screw for tightening the clamp, axonometry;
[0065] Fig. 8 / 53 shows temporary shortened rods fixed to the vertebrae in the region of the cranial and caudal poles of the deformity and on the concave side of the apex of the main arch of the deformity using transpedicular screws, with the temporary shortened rods located in the heads of the transpedicular screws and fixed with locking screws (nuts), axonometry;
[0066] Fig. 9 / 53 - the same, on an enlarged scale, axonometry;
[0067] Fig. 10 / 53 shows temporary shortened rods secured to the vertebrae of the spine using transpedicular screws, with a longitudinal section of the temporary shortened rod located in the head of the transpedicular screw and secured with a locking screw (nut); Fig. 11 / 53 shows a lever, axonometry;
[0068] Fig. 12 / 53 - the same, side view, on an enlarged scale, axonometry;
[0069] Fig. 13 / 53 shows the connection unit of the lever with a temporary shortened rod, cross-section;
[0070] Fig. 14 / 53 shows the connection unit of the lever with the handle, axonometry;
[0071] Note: For ease of reading, individual parts are shown transparent.
[0072] Fig. 15 / 53 - the same, longitudinal section;
[0073] Fig. 16 / 53 shows a three-dimensional body of the means for connecting an additional transverse rod to a lever from the side of the attachment point of the additional transverse rod, axonometry (as a separate milled part of the device);
[0074] Fig. 17 / 53 shows a three-dimensional body of a means for connecting an additional transverse rod to a lever in which the rods of screws with screw threads are fixed, axonometry;
[0075] Note: For ease of reading, individual parts are shown transparent.
[0076] Fig. 18 / 53 shows a three-dimensional body of a means for connecting an additional transverse rod to a lever in which the rods of screws with a screw thread are secured and a plate for fixing the additional transverse rod with a through hole in which the end part of the screw with a screw thread is placed with a gap is pivotally secured on an axis, axonometry;
[0077] Note: For ease of reading, individual parts are shown transparent.
[0078] Fig. 19 / 53 shows a volumetric body of a means for connecting an additional transverse rod to a lever, in which the rods of screws with a screw thread are fixed and a plate for fixing an additional transverse rod with a through hole is pivotally fixed on an axis, in which the end part of a screw with a screw thread is placed with a gap, onto which a nut with a means for rotating by hand is screwed, axonometry;
[0079] Fig. 20 / 53 shows a three-dimensional body of the means for connecting an additional transverse rod to a lever from the side of the lever attachment point, axonometry (as a separate milled part of the device), axonometry;
[0080] Fig. 21 / 53 shows the same, with an additional depiction of a lever fixing plate with a recess on the side in which the end part of the screw with a screw thread is located, axonometry;
[0081] Note: For ease of reading, individual parts are shown transparent.
[0082] Fig. 22 / 53 - the same, from a different angle, axonometry;
[0083] Fig. 23 / 53 shows the same, with an additional depiction of a lever fixing plate with a recess on the side, in which the end part of a screw with a screw thread is placed, onto which a nut with a means for rotation by hand is screwed, axonometry;
[0084] Fig. 24 / 53 shows a plate for fixing an additional transverse rod with a through hole, axonometry;
[0085] Fig. 25 / 53 shows the plate for fixing an additional transverse rod with a through hole from a different angle, axonometry;
[0086] Fig. 26 / 53 shows a lever fixing plate, axonometry;
[0087] Fig. 27 / 53 shows the lever fixing plate from another angle, axonometry;
[0088] Fig. 28 / 53 shows a means for connecting an additional rod to a lever, enlarged scale, axonometry;
[0089] Fig. 29 / 53 is the same, side view, and for ease of reading the figure the knot is shown transparent;
[0090] Fig. 30 / 53 shows a transverse thrust, axonometry;
[0091] Fig. 31 / 53 - the same, longitudinal section; Fig. 32 / 53 shows a device for adjustable parallel movement along the base rod of one additional transverse rod rigidly connected to the base rod relative to another additional transverse rod rigidly connected to the base rod, longitudinal section;
[0092] Fig. 33 / 53 shows an additional transverse rod made with a thickening on one side, in which a through transverse hole is formed with an end projection on one side, in the wall of which an additional through hole is made, the axis of which is located transversely to the longitudinal axis of the additional transverse rod and transversely to the longitudinal axis of the hole in the wall of the thickening with a partial intersection of the through transverse hole with the end projection on one side, axonometry;
[0093] Fig. 34 / 53 shows an intermediate tube with a through hole on one side, axonometry;
[0094] Fig. 35 / 53 shows a thickening of an additional transverse rod, in the through transverse hole of which, with an end projection, an intermediate tube with a through hole on one side is rigidly fixed, axonometry;
[0095] Fig. 36 / 53 shows a tube with an internal screw thread and an annular recess on the outer surface and which has a pair of transverse projections on the other side, axonometry;
[0096] Fig. 37 / 53 shows a part with a pair of transverse projections, fixed on a tube with an internal screw thread and with an annular recess on the outer surface and which has a pair of transverse projections on the other side on the outside, axonometry;
[0097] Fig. 38 / 53 shows a tube with an internal screw thread and with an annular recess on the outer surface and which has a pair of transverse projections on the other side outside, longitudinal section, axonometry; Fig. 39 / 53 shows a tube fixed in the thickening of an additional transverse rod with an internal screw thread and with an annular recess on the outer surface and which has a pair of transverse projections on the other side outside, longitudinal section, axonometry;
[0098] Fig. 40 / 53 - the same, side view, axonometry;
[0099] Fig. 41 / 53 - the same, after screwing in the base rod, axonometry;
[0100] In Fig. 42 / 53 - the same, a longitudinal section through an additional transverse rod and through a screw passing through an additional through hole in the wall of the thickening and a through hole of the intermediate tube and which is also located in an annular recess on the outer surface of the tube with an internal thread, axonometry;
[0101] Fig. 43 / 53 shows the claimed device for surgical correction of spinal deformities at the moment when, as a result of the transverse movement of the additional transverse rod relative to the base rod, the lever tilts, axonometry;
[0102] Fig. 44 / 53 shows the spine after an operation with the installation of permanent fixing rods (or, in other words, final rods (the claimed device is not shown);
[0103] Fig. 45 / 53 shows a variant of the claimed device, in which both additional transverse rods are connected to the base rod by means of a means for connecting the base rod to the additional transverse rod, made in the form of a clamp-containing means, with the provision of the possibility, during installation, of fixed rotation of the additional transverse rod around the longitudinal axis of the base rod and its longitudinal movement along the axis of the additional transverse rod (axonometry)
[0104] Fig. 46 / 53 shows an additional crossbar, characterized by the fact that it is mounted on the base bar from its bottom side (axonometry); Fig. 47 / 53 shows another variant, in which the additional crossbar is characterized by the fact that it is mounted on the base bar from its bottom side (axonometry);
[0105] Fig. 48 / 53 shows a variant of the design of a lever with a visor (longitudinal section);
[0106] Fig. 49 / 53 shows photo 1, which depicts the intraoperative installation of the claimed device;
[0107] Fig. 50 / 53 shows X-ray photo 2, which depicts patient A with a diagnosis of grade IV dysplastic scoliosis. Surgery: dorsal correction and stabilization of Th2-L3, performed using the claimed device, X-ray image before surgery;
[0108] In photo 3 of this figure - the same, an x-ray after surgery;
[0109] In photo 4 of this figure - the same, a photograph from the back before the operation;
[0110] In photo 5 of this figure - the same thing, a photo from the back after the operation;
[0111] Fig. 51 / 53 shows X-ray photo 6: patient B with the diagnosis: Dysplastic scoliosis grade IV. Cardiopathology. Surgery: dorsal correction and stabilization of Th2-L3, performed using the claimed device, X-ray image before surgery;
[0112] In photo 7 of this figure - the same, an x-ray after surgery;
[0113] In photo 8 of this figure - the same thing, a photograph from the back before the operation;
[0114] In photo 9 of this figure - the same thing, a photo from the back after the operation;
[0115] Fig. 52 / 53 shows X-ray photo 10: patient B is depicted with a diagnosis of grade IV dysplastic scoliosis. Cardiopathology. Surgery: dorsal correction and stabilization of Th2-L3, performed using the claimed device, X-ray image before surgery;
[0116] In the photo of this figure - the same, an x-ray after surgery;
[0117] In photo 12 of this figure - the same thing, a photograph from the back before the operation;
[0118] Photo 13 of this figure is the same, a photograph from the back after surgery; Fig. 53 / 53 shows X-ray photo 14: patient G is depicted with a diagnosis of: Neuromuscular scoliosis grade IV. Surgery: dorsal correction and stabilization of Th2-L5, performed using the claimed device, X-ray before surgery;
[0119] In photo 15 of this figure - the same, an x-ray after surgery;
[0120] In photo 16 of this figure - the same thing, a photograph from the back before the operation;
[0121] Photo 17 of this figure is the same, a photo from the back after the operation.
[0122] The best embodiment of the invention
[0123] A device 1 for surgically correcting spinal deformities 2 includes a base rod 3 intended for placement along the spine 2 with a gap, and at least a pair of levers 4 mounted thereon, one end 5 of each of which is intended for connection with temporary shortened rods 6 intended for connection with vertebrae 7 of the spine 2, and the other is provided with a handle 8 for acting on the spine 2, wherein each lever 4 is mounted on the base rod 3 by means of an additional transverse rod 9, one end portion 10 of which is connected to the base rod 3 by means of a means 11 for connecting the base rod to the additional transverse rod with the provision of the possibility of fixed rotation of the additional transverse rod around the longitudinal axis of the base rod and its longitudinal movement along the axis of the additional transverse rod,and the other end part 12 of which is transversely connected to the lever 4 by means of a means 13 for connecting an additional transverse rod to the lever, ensuring the possibility of their transverse movement relative to each other and rotation relative to each other (Fig. 1 - Fig. 15). As noted above, the means 13 for connecting the additional transverse rod 9 to the lever 4 contains a volumetric body 14, on one lateral flat face 15 of which, near the adjacent face 16, an opening 17 is made, in which the rod 18 of the screw 19 with the screw thread 20 is fixed. On the opposite side of this lateral flat face 15, near the other adjacent face 21, a projection 22 is made with a transverse through hole 23 with an axis 24 placed in it, and between them a transverse tapering recess 25 is made for the full width of this lateral flat face 15 of the volumetric body 14, and on the axis 24 a plate 26 for fixing the additional transverse rod 9 with a through hole 27 is pivotally fixed,in which the end portion 28 of the rod 18 of the screw 19 with the screw thread 20 is placed with a gap, onto which the nut 29 is screwed with the rotation means 30, which is represented by plates 31 on the nut 29 (wing nut). In this case, on the plate 26 for fixing the additional transverse rod 9, opposite the transverse tapering recess 25, a projection 32 facing into it is made for pressing (fixing) the additional transverse rod 9 (Fig. 16 - Fig. 19).,
[0124] On the lateral flat face 33 of the volumetric body 14, located opposite to the lateral flat face 15, on which the plate 26 for fixing the additional transverse rod is fixed, a rectilinear groove 34 is made along the entire height of the volumetric body 14, and on one face 35 of the volumetric body 14 adjacent to it, a projection 36 is made flush with it with a through hole 37 oriented across the rectilinear groove 34, in which the rod 38 of the screw 39 with the screw thread 40 is fixed, and on the face 41 of the volumetric body 14, opposite to the face 35 of the volumetric body 14 with the projection 36 made with a through hole oriented across the rectilinear groove 34, a projection 42 is formed with a transverse through hole 43 parallel to the rectilinear groove 34, in which the axis is located 44, parallel to this adjacent edge 41, and on the axis 44 the plate 45 for fixing the lever with a recess 46 on the side is pivotally fixed,in which the end portion 47 of the rod 38 of the screw 39 with the screw thread 40 is placed, onto which the nut 48 is screwed with the means 49 for turning by hand, which is represented by plates 50 on the nut 48 (wing nut). On the plate 45 for fixing the lever opposite the rectilinear groove 34, a projection 51 facing into it is made for pressing (fixing, covering) the lever 4 (Fig. 20 - Fig. 29).,
[0125] A distinctive feature of the claimed device is that lever 4 is provided with transverse annular grooves 52 along its length for ease of height adjustment (Fig. 28, Fig. 29). The number of annular grooves may vary (see below for more details).
[0126] On the base rod 3, between the additional transverse rods 9, a transverse rod 53 is mounted, one end 54 of which is provided with a grip 55 for grasping a temporary shortened rod 6, intended for fastening on the vertebrae 7 of the spine 2, and the end part 56 on the other side of the transverse rod 53 is provided with a means for connecting 57 the transverse rod 53 with the base rod 3 with the possibility of transverse movement relative to the base rod 3 (Fig. 30, Fig. 31).
[0127] The means for connecting 57 the transverse rod 53 to the base rod 3 with the possibility of transverse movement relative to the base rod 3 contains a tube 58 placed on the transverse rod 53 with the possibility of free movement along it, that is, along the transverse rod 53, with a hook 59 intended for gripping the base rod 3 on the outer side, with the end facing towards a grip 55 made at the end of the transverse rod 53 in the form of a hook 60 for gripping a temporary shortened rod 6, intended for fastening on the vertebrae 7 of the spine 2, wherein the transverse rod 53 is provided with a screw thread 61, onto which, from the side of the tube 58, on the opposite side of the location relative to this tube of the hook 60 of the grip 55 for gripping the temporary shortened rod 6, a nut 62 with a means 63 for rotation is screwed hand, which is a plate 64 on a nut 62. In addition,the claimed device 1 for surgical correction of spinal deformities 2 is provided with a device 65 for dosed controlled movement along the base rod 3 of an additional transverse rod, which contains an additional transverse rod 67 made with a thickening 66 on one side, in which a through transverse hole 68 is formed with an end projection 69 on one side, in the wall 70 of which an additional through hole 71 is made on one side, the axis 72 of which is located transversely to the longitudinal axis 73 of the movable additional transverse rod 67 and transversely to the longitudinal axis 74 of the through transverse hole 68 in the thickening 66 with a partial intersection of the through transverse hole 68 with the end projection 69 on one side, while in the through transverse hole 68 with the end projection 69 on one side, a rigidly fixed intermediate tube 75 with cavity 76 and with a through hole 77 in wall 78,in which, on one side, a tube 79 with an internal screw thread 80 and with an annular recess 81 on the outer surface is pivotally mounted, and which on the other side has a pair of transverse projections 82 on the outside, wherein a screw 83 is screwed into the thickening 66 of the movable additional transverse rod 67, passing through an additional through hole 71 in the wall 70 of the thickening 66 and through the through hole 77 of the intermediate tube 75 and the rod 84 of which is also located in the annular recess 81 on the outer surface of the tube 79 with an internal screw thread 80, And wherein the base rod 3 is made with a screw thread 85 and is placed inside the tube 79 with an internal screw thread 80 with an annular recess 81 on the outer surface of the thickening 66 of the additional transverse rod 67 (Fig. 32 - Fig. 42).,
[0128] This is the static design of the declared device, as well as some of its components.
[0129] Further, the applicant considers it necessary, for the convenience of the description, to dwell on the disclosure of individual units of the claimed device, and only after that to characterize the assembly and operation of the claimed device as a whole.
[0130] Volumetric body 14.
[0131] To complete the description of volumetric body 14 in statics, the applicant considers it necessary to discuss its assembly. First, the applicant notes that the volumetric body contains two clamping elements: one clamps the additional transverse rod 9, and the other clamps the lever 4.
[0132] The volumetric body 14 is a single-piece milled part. For assembly, a screw 19 is pressed into the bore 17 of the volumetric body 14 in a permanent manner (it can also be welded) (Fig. 17). After pressing, a plate 26 is installed to secure the additional crossbar using a pressed-in axle 24, which is accomplished as follows:
[0133] • Take axis 24,
[0134] • The projection 22 of the volumetric body 14 is covered on both sides by projections 86 and 87 of the plate 26 for fixing the additional transverse rod with the alignment of through holes 88 and 89 in them with the through hole 23 in the projection 22 and the axis 24 is pressed into the aligned holes, and the plate 26 for fixing the additional transverse rod is turned so that the rod 18 of the screw 19 enters the through hole 27 of the plate 26 for fixing the additional transverse rod, which for this purpose can be made of an elongated shape. A nut 29 is screwed onto the protruding rod 18 of the screw 19.
[0135] The assembly is carried out in a similar manner on the other side of the volumetric body 14.
[0136] For assembly, screw 39 is pressed into through hole 37 of volumetric body 14 in a permanent manner (it can also be welded) (Fig. 21). After pressing in, plate 45 is installed to secure the lever using pressed-in axle 44, which is carried out as follows:
[0137] • Take axle 44, PCI7RU2024 / 000297
[0138] 23
[0139] • The projection 42 of the volumetric body 14 is covered on both sides by projections 90 and 91 of the plate 45 for fixing the lever with the through holes 92 and 93 in them aligned with the through hole 43 in the projection 42 and the axis 44 is pressed into the aligned holes, and the plate 45 for fixing the lever is turned so that the rod 38 of the screw 39 enters the recess 46 on the side of the plate 45 for fixing the lever. A nut 48 is screwed onto the protruding rod 38 of the screw 39.
[0140] Connecting an additional crossbar to the base bar.
[0141] The additional crossbar 9 can be connected to the base bar 3 using a C-shaped clamp 94, which, for example, can be welded to the end of the additional crossbar 9. The C-shaped clamp 94 encloses the base bar 3 in a section that can be smooth (or rough) on the outside or with a screw thread, and is made with holes 95 and 96 with screw threads, into which a screw 97 with an external thread 98 is screwed in (Fig. 6, Fig. 7). This unit is detachable with the possibility of loosening the clamp, moving and / or rotating the additional crossbar 9, followed by compression of the clamp by screwing in the screw 97 and bringing together the sides of the C-shaped clamp 94.
[0142] To ensure dosed controlled movement along the base rod 3 of the additional transverse rod, the claimed device can be equipped with a device 65 for dosed controlled movement along the base rod of the additional transverse rod (Fig. 32 - Fig. 42).
[0143] In this case, the base rod 3 is made with a screw thread 85 on the outside, and the additional transverse rod, which for convenience of distinction from the usual additional transverse rod 9 is called the additional transverse rod, which is designated by the position 67 (Fig. 1, Fig. 32 - Fig. 42), is made, as noted above, with a thickening 66, in which a through transverse hole 68 is formed with an end projection 69 on one side, in the wall 70 of which on one side an additional through hole 71 is made, the axis 72 of which is located transversely to the longitudinal axis 73 of the additional transverse rod 67 and transversely to the longitudinal axis 74 of the through transverse hole 68 in the thickening 66 with a partial intersection of the through transverse hole 68 with the end projection 69 on one side. In this case, the base rod 3 must be made with a screw thread 85 on the outside on that part of the length along which the additional transverse rod 67 must move.On that part of the length of the base rod 67, to which the additional cross rod 9 is attached, its surface should preferably be smooth or rough, but can also have a screw thread.
[0144] To assemble the device 65 for the dosed, controlled movement of the additional transverse rod 67 along the base rod 3, the intermediate tube 75 is taken and pressed into the through transverse bore 68 in the thickening 66 of the additional transverse rod 67. This ensures that these two parts are rigidly connected to each other. It is important that the through bore 77 in the wall 78 of the intermediate tube 75 intersect with the additional through bore 71 in the wall 70 of the widening 66.
[0145] Next, take a tube 79 with an internal screw thread 80 on one side and an annular recess 81 located above it on the outside. Attach a pair of transverse projections 82 to the tube 79 on the opposite side, secured, for example, to a common tubular base that encircles the tube 79 from the outside and is riveted to it. The result is a wing nut.
[0146] Then the resulting assembly (wing nut) is inserted into tube 75.
[0147] Next, the assembly is fixed to each other by screwing the screw thread 99 of the screw 83 into the screw thread 100 at the end section of the additional through hole 71 in the wall 70 of the thickening 66. In this case, the screw 83 passes through the additional through hole 71 in the wall 70 of the thickening 66 and through the through hole 77 of the intermediate tube 75, and the rod 84 of which is also located in the annular recess 81 on the outer surface of the tube 79 with the internal screw thread 80. As a result, if you start to rotate the tube 79, applying force to the transverse projections 82, then the tube 79 will rotate around its longitudinal axis in the tube 75, but will not fall out of it due to the screw 83.
[0148] If we now screw the base rod 3 with the screw thread 85 into the tube 79 onto its internal screw thread 80, then by rotating the tube 79 and applying force to the pair of transverse projections 82, the additional transverse rod 67 will move along the base rod 3.
[0149] The base rod 3 can be either solid or composite, as shown in Fig. 1 and Fig. 32.
[0150] After familiarizing himself with the assembly of the main units, the applicant then reports on the installation of the entire device as a whole and its use in operations.
[0151] There may be several options for installing and using the declared device during the operation.
[0152] The applicant below provides the following installation option for the claimed device.
[0153] Preoperative planning begins with a thorough radiographic examination, CT and MRI scanning, and, if necessary, myelography of the spine segment where surgery is planned. During preoperative preparation, the type and degree of spinal deformity are determined using radiographic data. Radiographic parameters are calculated, which are used to assess spinal balance and determine the required degree of correction, the number and location of supporting elements, spinal mobility, and the need and extent of spinal osteotomies for spinal mobilization. The type, length, and thickness of the necessary supporting elements (pedicle screws), the type and length of rods, etc. are determined.With the patient in a prone position on the operating table, after anesthesia has been administered, the patient has been prepared for intraoperative neuromonitoring (if necessary), and the surgical field has been prepared, a surgical approach is established based on the planned surgical scope. Using various instruments, the posterior elements of the vertebrae at the surgical level—the spinous processes, vertebral arches, and intervertebral joints—are skeletonized (exposed).
[0154] Following this, three temporary shortened rods (6) are secured to the vertebrae at the poles and at the apex of the deformity on the concave side of the primary deformity curve using transpedicular screws (101) (transpedicular fixation). The number of screws per temporary shortened rod in the lumbar spine may be two or more, and two or more in the thoracic spine.
[0155] The technique for installing transpedicular screws is well known and is not the subject of the present invention, and therefore is not discussed in detail. As an example, reference may be made to the transpedicular screws described, for example, in the description of Russian Federation Patent for Invention No. 2810365, priority date 04 / 28 / 2023, IPC A61B 17 / 70, A61B 17 / 88, or Russian Utility Model Patent No. 154118, priority date 11 / 13 / 2014, IPC A61B 17 / 70, or US Patent for Invention No. 6869433, priority date 03 / 22 / 2005, IPC A61B 17 / 70).
[0156] It's worth noting that the term "transpedicular" derives from the Latin "pedicula arcus vertebrae" (meaning "pedicle of the vertebral arch") and the Latin prefix "trans-" (meaning "through"). Thus, the term refers to the dorsal-ventral placement of the screw through the pedicle of the vertebral arch.
[0157] Transpedicular screws are classified as having monoaxial (non-rotating) heads, which are integral with the screw's threaded portion, or polyaxial (rotating) heads, which can be positioned at an angle to the screw's main working portion. Polyaxial transpedicular screws offer advantages during installation, as they facilitate fixation even in the most complex anatomical areas of the spine, where the rotational component is not linear but curved. Furthermore, the greater the screw head's angle of inclination, the easier it is to install the fixation device. This translates into reduced intraoperative time, anesthesia duration, blood loss, and postoperative patient outcome.
[0158] With the claimed invention, it is more practical to use polyaxial transpedicular screws (although monoaxial screws can also be used if necessary). Polyaxial transpedicular screws 101 are inserted one at a time into the vertebral bodies in a posterior-anterior direction through the pedicles.
[0159] Each polyaxial transpedicular screw 101 consists of a head 102 and a rod 103 with a screw thread 104 on one side and a spherical thickening 105 on the other side, wherein the head 102 has a through hole 106, in which on one side there is a spherical thickening 105 of the rod with the possibility of its rotation and without the possibility of falling out, and on the other side there is a screw thread 107 for screwing in a locking screw (nut) 108 and there is a groove 109 for installing a temporary shortened rod 6 or a permanent rod along the entire length of the metal structure. The spherical thickening 105 has a slot (recess) 110 for transmitting torque from the tool (screwdriver) when installing the polyaxial transpedicular screw 101 into the vertebra, and the locking screw (nut) 108 has a slot 111 for transmitting torque from the tool (screwdriver) when screwing in the locking screw (nut) 108 (Fig. 10).
[0160] During the operation, three groups of polyaxial transpedicular screws are installed on the 7 vertebrae of the 2 vertebrae: the outer group 112, the opposite outer group 113, and the central group between them 114 (Fig. 8). Installation occurs under X-ray control of anatomical landmarks; screws are inserted through the roots of the arches into the vertebral bodies in accordance with the dimensions calculated before the operation. The lumbar group contains two or more polyaxial transpedicular screws 101, and the upper thoracic group and the group on the concave side of the apex of the deformity contain two (preferably three, for greater load distribution) or more polyaxial transpedicular screws 101, depending on the specific situation.
[0161] Note: Each group may contain two and / or three or more pedicle screws depending on the specific situation.
[0162] After installing the polyaxial transpedicular screws, one temporary shortened rod 6 is installed in the heads of the screws of each group, which, in order to prevent their displacement, are rigidly fixed with locking screws (nuts) 108 by screwing them into the screw thread 107 in the heads 102.
[0163] After this, the spatial structure of the claimed device, consisting of a base rod 3, additional transverse rods and levers 4, is installed on the temporary shortened rods 6 and secured with locking screws.
[0164] Let's take a look at its assembly.
[0165] First, take the base rod 3, install one additional cross rod 9 on it, which is fixed in the C-shaped clamp 94 by means of a screw 97 (Fig. 2, Fig. 6). This was described in detail above.
[0166] Then, the second additional transverse rod 67 is installed and fixed on the base rod 3 using a pre-assembled device 65 for the dosed, controlled movement of the additional transverse rod 67 along the base rod 3 (Fig. 2 - Fig. 4, Fig. Fig. 32 - Fig. 42). The design of this unit and its assembly were described in detail above. If force is applied to the pair of transverse projections 82 and turned (manually or with a special key), then the additional transverse rod 67 moves along the base rod 3. Then, pre-assembled volumetric bodies 14 are mounted on the additional transverse rods 9 and 67 (Fig. 3 - Fig. 5). The design and assembly of the volumetric body 14 were described in detail above.As noted above, each volumetric body 14 has two functions: clamping additional crossbars 9 and 67 and fixing the volumetric body 14 on levers 4, which thereby provides the ability to change the position of the base rod 3 in height.
[0167] To ensure this, an additional transverse rod 9 is first inserted into the transverse tapering recess 25 of one volumetric body 14 and fixed in it by a plate 26 for fixing the additional transverse rod by tightening the nut 29 (Fig. 3, Fig. 19, Fig. 28, Fig. 29).
[0168] Then, an additional transverse rod 67 is inserted into the transverse tapering recess 25 of the other volumetric body 14 and fixed in it by the plate 26 for fixing the additional transverse rod by tightening the nut 29 (Fig. 3, Fig. 19, Fig. 28, Fig. 29).
[0169] After this, a lever 4 is inserted into the rectilinear groove 34 of each volumetric body 14, which is clamped (fixed) using a lever fixing plate 45 by tightening a nut 48 (Fig. 4, Fig. 22, Fig. 28, Fig. 29).
[0170] Each lever has transverse annular grooves 52 along its length. This allows the height of the volumetric body 14 on each lever 4 to be adjusted. Furthermore, each lever 4 has a transverse projection 115 on one side, the ends of which have longitudinal projections 116 with hooks 117 at the end, as well as inclined projections 118 opposite the corresponding hooks 117 with holes 119 with screw threads 120 for screwing in screws 121.
[0171] During assembly, after inserting the levers 4 into the volumetric body 14, the longitudinal projections 116 with hooks 117 at the end, as well as the inclined projections 118 of one lever, cover the corresponding temporary shortened rod 6, fixed to the spine 2 with the help of the extreme group 112 of polyaxial transpedicular screws, and are then rigidly fixed to it by screwing in the screws 121.
[0172] Similarly, the other lever 4 embraces the temporary shortened rod 6, fixed to the spine 2 with the help of the other extreme group 113 of polyaxial transpedicular screws, and is then rigidly fixed to it by screwing in screws 121 (Fig. 13).
[0173] A handle 8 is placed on the opposite end of each lever 4 for acting on the spine 2. For this purpose, the end of the lever 4 is made in the form of an octagon 122 with an annular groove 123 and a projection 124 under it, and the handle 8 has a transverse octagonal through hole 125, which covers the end of the lever in the form of an octagon, and the handle 8 is fixed on the end of the lever 4 by means of a screw 126, screwed into a through hole 127 in the handle 8 opposite the annular groove 123. During assembly, the handle 8 is placed on the end of the lever and fixed with a screw 126. The direction of the handle can be changed depending on the required vector of action of the lever.
[0174] In the later stages of correction, after the required volume of osteotomy has been performed throughout the deformity and all supporting elements (pedicle screws) have been installed under conditions of ongoing and constantly increasing controlled distraction on the concave side of the deformity due to periodic rotations of the wing nut of device 65 and the movement of the latter along the base rod 3, transverse traction 53 is assembled, mounting it between additional transverse rods 9 and 67 in the most advantageous position relative to the temporary shortened rod installed in the central group of transpedicular screws on the concave side of the deformity apex. This additional unit is intended for translational correction of the primary arch of the deformity by pulling its apex in the direction of base rod 3. In this case, correction is performed in both the frontal and sagittal planes, depending on the location of base rod 3.To do this, first a tube 58 is put on it with the possibility of free movement along the transverse traction 53 with a hook 59 on the outer side intended for gripping the base rod 3, with the end facing towards the hook 60 grip made at the end of the transverse traction 53 for gripping the temporary shortened rod 6, fixed to the spine 2 with the help of the central group 114 of polyaxial transpedicular screws.
[0175] Then screw nut 62 onto screw thread 61 of transverse rod 53, pulling hook 60 toward hook 59, thereby performing a translation maneuver and adjusting the curvature of the main arc of the spine.
[0176] Levers, as in the closest analogue, are used to correct deformation in three planes.
[0177] Compared to the closest analogue, the following movements are possible:
[0178] • movement of the additional transverse rod 67 along the base rod 3, approaching or moving away from the additional transverse rod 9 with the possibility of rotation around the axis of the base rod 3 clockwise or counterclockwise (allows for gradual intraoperative distraction of the main arc of deformation from the concave side, providing a high constant force of action, leading to simultaneous correction of deformation in three planes, regardless of additional corrective three-plane actions due to levers 4);
[0179] • movement along additional transverse rods 9 and 67 (allows adjustment of the position of base rod 3 relative to the surgical wound, thereby providing free access to the elements of the spine, and also allows changing the global frontal balance of the spinal column and changing the angle of action of transverse traction 53 on the apex of the main arc of deformation); • vertical movement along the lever (allows adjustment of the vertical position of base rod 3 relative to the spinal column with a pronounced sagittal component of deformation, also allows changing the global sagittal balance of the spinal column and changing the angle of action of transverse traction 53 on the apex of the main arc of deformation);
[0180] • rotation around the axes of the levers (allows changing the local frontal tilt of the vertebral segments in the area of the caudal and cranial poles of the metal structure, thereby providing additional correction of the global frontal balance of the spine and a powerful tool for correcting the tilt of the shoulder girdle and the frontal tilt of the pelvis, respectively);
[0181] • rotation of the entire spatial declared device around the additional transverse rods 9 and 67, bending of the spine due to the effect of translational movement of any section of the spine located between the additional transverse rods 9 and 67 by means of transverse traction 53 due to the controlled convergence of the hook 60 of the gripper for grasping the temporary shortened rod 6 and the hook intended for grasping the base rod 3 (allows for one-time correction of the sagittal balance depending on the location of the base rod 3).
[0182] The device also allows for the free implementation of additional corrective maneuvers along the spinal column, such as derotation maneuvers, local distraction / contraction, and direct local derotation of vertebrae while maintaining distraction throughout the deformity. Unlike its closest analogue, it can simultaneously target two or more curves in cases of combined scoliotic deformities.
[0183] The above-mentioned movements provide more precise manipulation of all areas of the spinal deformity under conditions of constant distraction within the deformity itself, which creates conditions for more effective localized three-plane correction at the apex of the deformity by moving the vertebral elements away from each other on the concave side. This gradual, measured distraction significantly reduces the risk of complications associated with traction of peripheral nerves, cervical nerve structures, and cranial nerves, which may accompany intraoperative halo- and halo-femoral traction or the single-stage correction typical of the closest analog, while providing significantly greater localized corrective effects.By gradually increasing the distraction effect throughout the surgical intervention, conditions are created for the gradual adaptation of soft tissues (muscles, ligaments, tendons, blood vessels and neural structures) to traction effects.
[0184] Upon achieving the desired degree of correction of the deformity, the structure (i.e., the assembly of the claimed device and the spine) is rigidly fixed in space and on the contralateral (opposite) side of the spine, a permanent fixing rod 128, previously modeled in accordance with the required correction, is placed into the heads of the transpedicular screws previously installed in other free vertebrae. At this stage, the claimed device allows for additional corrective maneuvers to be performed on the contralateral side (de-rotation maneuver, segmental contraction / distraction, direct segmental derotation) by maintaining the mobility of the spinal column throughout the deformity against the background of only selective fixation with temporary shortened rods of three short segments in the region of the poles and the apex of the deformity on the ipsilateral (same) side.
[0185] After installation and rigid fixation of the permanent fixation rod 128 on the contralateral side, the claimed device is dismantled and, after removal of all temporary shortened rods, a second permanent fixation rod 128 is installed on the side of the spine where it was installed (Fig. 44). At the final stage, final corrective actions are performed on the elements of the metal structure, including local segmental distraction actions on the concave side, contraction actions on the convex side of the apex of the arch or arches of deformity, contraction and distraction actions in the area of the poles of the metal structure, and local derotation actions. After final rigid fixation of the locking screws (nuts) in the heads of the transpedicular screws, posterior spondylodesis is performed with a local bone autograft, the wound is washed with antiseptic solutions, and sutured layer by layer.
[0186] The applicant further cites the following feature of the use of the assembled claimed device for the correction of spinal deformities:
[0187] • After the claimed device is installed on the shortened rods 6, it is used to perform moderate primary dosed distraction of the spine on the concave side of the deformity and moderate primary three-plane manipulations with the levers 4.
[0188] • After this, the distraction effects are suspended, since the muscles, tendons and ligaments resisting the correction require time to adapt to the distraction effect and stretching. With a certain periodicity, and in accordance with the neuromonitoring data, the distraction effects are repeated. • The periods of suspension of distraction effects are used for bilateral installation of the remaining polyaxial (or, if necessary, monoaxial) transpedicular screws into the free vertebrae, including the subsequent installation of permanent fixation rods 128 in them. Also, the time intervals between subsequent distraction effects are used to sequentially perform osteotomies throughout the deformity, which weakens the resistance to the distraction effect. It should be noted that the radicality of osteotomies required to achieve satisfactory correction of deformities is significantly reduced when using the claimed device.At the same time, the gradual, time-consuming nature of the correction performed using the claimed device (which distinguishes it favorably from the standard correction method and correction using the closest analogue, where the main correction is carried out almost simultaneously) allows for a significant reduction in the potential risks of complications with abrupt, one-stage correction, especially in patients with severe concomitant diseases (cardiac pathology, kidney pathology, risk of developing superior mesenteric artery syndrome, etc.).
[0189] It should also be noted that the design of the claimed device maintains maximum accessibility to the spinal elements after its installation. Therefore, the standard surgical procedure is not disrupted and there is no delay in inserting the remaining supporting elements (pedicle screws) or mobilizing the spinal column during osteotomies. Additional time is spent solely on the initial installation of the claimed device, the installation of the transverse traction rod, and periodic repeated increases in the degree of distraction by turning the nut of the device 65 for dosed, controlled movement along the base rod 3. Conversely, the use of the claimed device reduces the overall duration of the surgical intervention by reducing the need for more radical and extended osteotomies, simplifying corrective manipulations, and reducing the time spent on hemostasis due to the reduced radicality of the intervention.
[0190] A clinically significant feature of the claimed device is its indispensability for the correction of spinal deformities in patients with a significant decrease in bone density or significant anatomical abnormalities that preclude the placement of a sufficient number of support elements at the apex of the deformity. In such cases, the use of the claimed device allows for safe, satisfactory deformity correction through distraction of the entire spinal column, which is automatically and inevitably accompanied by simultaneous three-plane correction at the apex of the deformity. The ability to distribute the load across multiple vertebrae during the placement of temporary shortened rods, to which the four arms of the claimed device are attached, prevents screw pullout during corrective interventions in conditions of significant bone density loss.
[0191] The applicant notes that numerous modifications of the claimed device are possible; for example, it may contain a pair of additional transverse rods 9 (Fig. 45). Various arrangements of the additional transverse rods 9, 67 are also possible, including, in some cases, on opposite sides of the deformity, which may be more appropriate in the presence of two or more arches in combined deformities with a pronounced frontal balance disorder and a deviation of the vertical axis of the spine. Furthermore, if necessary, it is possible to use various sizes of the elements of the claimed device, for example, base rods 3 or levers 4 of varying lengths depending on the anthropometric data of a particular patient.
[0192] The applicant considers it necessary to pay special attention to the fact that the transverse tapering recess 25 of the volumetric body 14 and the rectilinear groove 34 along the entire height of the volumetric body 14 are connected to each other by means of an opening 129 (Fig. 16, Fig. 20, Fig. 29) with the possibility of partially placing an additional transverse rod 9 in the transverse annular groove 52 of the lever 4. This enables their independent rotation around their own axes, which increases the number of degrees of freedom of the device, and, consequently, the range of possible manipulations with the spine. In other words, with such a connection, when the entire structure is rotated relative to the lever 4, unwanted displacement (sliding) of the additional transverse rod 9 relative to the lever 4 is prevented, which increases the ease of use during surgery.
[0193] The invention is used in operations.
[0194] The results of using the claimed invention are shown in the photographs: photograph 2 - photograph 17.
[0195] Industrial applicability
[0196] The claimed invention allows:
[0197] • To increase the efficiency and simplicity of correction of severe spinal deformities by increasing the possibilities of local and global intraoperative distraction of the spinal column and three-plane spatial change in the position of its individual parts;
[0198] • Reduce the need for an additional surgical stage (ventral release) and / or radical surgical mobilization of the spinal column, which are necessary to achieve effective three-plane correction of severe spinal deformities in the absence of pronounced distraction effects from the concave side of the deformity;
[0199] • Reduce the duration of surgery and the volume of intraoperative blood loss, as well as the risks of intraoperative and postoperative complications associated with the need for more radical mobilization of the spine in the absence of pronounced distraction effects from the concave side of the deformity;
[0200] • Conduct additional corrective maneuvers (derotation maneuver, segmental contraction / distraction, direct segmental derotation) under conditions of continued distraction effect by maintaining the mobility of the spinal column throughout the deformation;
[0201] • Provide effective and safe correction of spinal deformities with a significant decrease in bone density or significant anatomical abnormalities that preclude the possibility of installing a sufficient number of supporting elements at the level of the apex of the deformity, as well as with severe concomitant pathology of the internal organs.
[0202] • expand the arsenal of tools when carrying out this type of operation.
[0203] PC17RU2024 / 000297
[0204] 39
[0205] Sources of information taken into account: Sucato, DJ and Zhang, N. (March 2017) A Novel Posterior-Rod-Link Reducer System Provides Safer Easier and Better Correction of Severe Scoliosis. Paper #097 Presented at AAOS Annual Meeting, San Diego, CA. http: / / 0:\ФВП\ТПФ\Деротационные турки\Rod Link Reducer.mht (prototype).
Claims
Invention formula 1. A device for the surgical correction of spinal deformities, comprising a base rod designed for placement along the spine with a gap, and at least a pair of levers mounted thereon, one end of each of which is intended for connection with temporary shortened rods intended for connection with the vertebrae of the spine, and the other is provided with a handle for mechanical action on the spine in three planes, characterized in that each lever is mounted on the base rod by means of an additional transverse rod, one end portion of which is connected to the base rod by means of a means for connecting the base rod to the additional transverse rod, ensuring the possibility of fixed rotation of the additional transverse rod around the longitudinal axis of the base rod and its longitudinal movement along the axis of the additional transverse rod,and the other end part of which is transversely connected to the lever by means of a means for connecting an additional transverse rod to the lever, ensuring the possibility of their transverse movement relative to each other and rotation relative to each other., 2. The device according to paragraph 1, characterized in that the means for connecting the additional transverse rod to the lever contains a volumetric body, on one lateral flat face of which, near the adjacent face, an opening is made in which the rod of a screw with a screw thread is fixed, on the opposite side of this lateral flat face, near the other adjacent face, a projection with a transverse through opening with an axis placed in it is made, and between them a transverse tapering recess is made for the full width of this face of the volumetric body, and a pivotally fixed axis is made on the axis a plate for fixing an additional transverse rod with a through hole, in which the end portion of the rod of a screw with a screw thread is placed with a gap, onto which a nut with a means for rotating by hand is screwed, and on the plate for fixing the additional transverse rod opposite the transverse tapering recess a projection facing into it is made, wherein on the lateral flat face of the volumetric body, located opposite with respect to the lateral flat face, on which the plate for fixing the additional transverse rod is fixed, a rectilinear groove is made along the entire height of the volumetric body, and on one face of the volumetric body adjacent to it a projection with a through hole is made flush with it, oriented transversely to the rectilinear groove, in which the rod of a screw with a screw thread is fixed, and on the face of the volumetric body opposite with respect to the face of the volumetric body with the formed projection with a through hole oriented transversely to the rectilinear groove,a projection with a transverse through hole parallel to a rectilinear groove in which an axis is placed is formed, parallel to this adjacent face, wherein a plate for fixing the lever with a recess in which the end part of the rod of the screw with a screw thread is placed, onto which a nut with a means for rotating by hand is screwed, is pivotally fixed on the axis, and on the plate for fixing the lever opposite the rectilinear groove a projection facing into it is made, wherein the transverse tapering recess of the volumetric body and the rectilinear groove along the entire height of the volumetric body are connected to each other by an opening with the possibility of partially placing an additional transverse rod in the transverse annular groove of the lever through the opening.
3. The device according to paragraph 2, characterized in that the lever is made with transverse annular grooves along its length.
4. The device according to paragraph 3, characterized in that the transverse annular grooves are made to the full height of each lever.
5. The device according to item 1, characterized in that each additional transverse rod is mounted on the base rod from its lower side.
6. The device according to item 1, characterized in that the base rod has different lengths.
7. The device according to item 1, characterized in that each lever is equipped with a visor on the side of the handle.
8. The device according to claim 1, characterized in that at least one transverse rod is mounted on the base rod between the additional transverse rods, one end of which is provided with a grip for grasping a temporary shortened rod intended for fastening to the vertebrae of the spine, and the end part on the other side of the transverse rod is provided with a means for connecting the transverse rod to the base rod with the possibility of transverse movement relative to the base rod, and the means for connecting the transverse rod to the base rod with the possibility of transverse movement relative to the base rod contains a tube placed on the transverse rod with the possibility of free movement along it, with a hook intended for grasping the base rod on the outer side, with the end facing the side of the grip made at the end of the transverse rod in the form of a hook for grasping a temporary shortened rod intended for fastening to the vertebrae of the spine,wherein the transverse rod is provided with a screw thread, onto which, from the side of the tube opposite to the side where the hook of the grip for gripping the temporary shortened rod is located relative to this tube, a nut with a means for rotating by hand is screwed.
9. The device according to claim 1, characterized in that at least one additional transverse rod is provided with a device for dosed controlled movement along the base rod of the additional transverse rod, which contains a device made on an additional transverse rod with a thickening on one side, in which a through transverse hole is formed with an end projection on one side, wherein in the wall of the thickening an additional through hole is made, the axis of which is located transversely to the longitudinal axis of the additional transverse rod and transversely to the longitudinal axis of the through transverse hole in the thickening with a partial intersection of the through transverse hole with an end projection on one side, wherein in the through transverse hole with an end projection on one side an intermediate tube with a cavity and with a through hole in the wall is rigidly fixed, in which on one side a tube with an internal screw thread and with an annular recess on the outer surface is pivotally mounted, and which on the other side has a pair of transverse projections on the outside, wherein a screw is screwed into the thickening of the movable additional transverse rod,passing through an additional through hole in the wall of the thickening and through the through hole of the intermediate tube and the rod of which is also located in an annular recess on the outer surface of the tube with an internal screw thread, and wherein the base rod is made with a screw thread and is placed inside the tube with an internal screw thread with an annular recess on the outer surface of the thickening of the additional transverse rod.
10. The device according to claim 1, characterized in that the number of temporary shortened rods is at least a pair.
Citation Information
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