RU2666922C2 - Compression-distraction apparatus for bilateral distraction - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine. Compression-distraction apparatus for bilateral distraction includes three plates, an axis and two leadscrews. One of the plates is configured to be connected to the fixed part of the skull, and the plates located on both sides thereof are configured to be connected to the movable parts of the skull. Plate configured to be connected to the fixed part of the skull has a transverse projection with a through hole for the axis oriented along the plane of the plate and with the possibility of rotation of the axis about the longitudinal axis. Plates configured to be connected to the fixed part of the skull each have transverse projection with threaded holes for the leadscrew, wherein threads have a different direction. Said transverse projections are located on the side opposite to the side intended to contact the parts of the skull. Each plate is equipped with a means of connecting the plate to the part of the skull. Leadscrews are connected to the ends of the axis by means of articulated couplings with intersecting axes at an angle of no more than 45° and are mounted with the possibility of turning their axes on the corresponding plate in two planes – horizontal and vertical, passing through the longitudinal axis of the transverse projection of the corresponding plate.EFFECT: invention provides prevention of an undesirable complication caused by displacement of the axes of the leadscrews relative to each other (preventing jamming of leadscrews in the thread) and caused by the displacement of the axes of the leadscrews relative to the central fixed part – vertical displacement (preventing jamming of the axis in the thread, displacement of the apparatus relative to the bone, bending of the axis of the apparatus).8 cl, 27 dwg

Description

A compression-distraction apparatus for bilateral distraction, that is, for bone growth between the bones of the skull that are gradually moving apart from each other in the transverse direction relative to the midline and is intended to eliminate cranial deformation, mainly resulting from premature fusion of cranial sutures, most often sagittal suture, is claimed , more rarely, of several cranial sutures, manifested by scaphocephaly / dolichocephaly, that is, the shape of the head, characterized by elongated longitudinally The pressure-from the frontal bone in the direction of the occipital bone and skull narrowed in the transverse direction.

Thus, the claimed invention relates to the field of neurosurgery, in particular, to children's neurosurgery and is intended for the treatment of mainly children with severe craniocerebral imbalance (mismatch of intracranial volume to the volume of brain tissue) for a gradual phased increase in intracranial volume due to expansion of the cranial cavity in the transverse direction , for example, by spreading the parietal, partially temporal, partially frontal / occipital bones relative to the midline.

There are a number of pathologies associated with premature fusion of sutures between the bones of the cranial vault in young children.

The most common is the sagging of the swept / sagittal suture (that is, the suture between the parietal bones along the midline of the head, starting from the frontal bone and ending at the occipital bone). Premature infiltration of the swept suture limits the ability of the baby’s skull to grow in the transverse direction after birth, growth occurs only in the longitudinal direction. A characteristic deformation of the head occurs - elongated in the longitudinal direction with the forehead protruding forward, an elongated occiput and a decrease in transverse dimensions. This condition is associated with disability of children due to the fact that the growing brain is "not enough space" in the cranial cavity. Since the cranial vault is not formed correctly, has insufficient volume, and the brain grows rapidly in early childhood, due to external mechanical restriction for brain growth, increased intracranial pressure arises. Clinically, this is manifested, in severe cases, by a decrease in vision up to blindness, periodic headaches, and vomiting. Or, during the course of the disease in a milder form, mental retardation, memory impairment, difficulty in assimilating new information. All of the above are signs of craniocerebral imbalance (hereinafter - CD).

To eliminate CD, a number of operations have been proposed aimed at the surgical increase in intracranial volume due to reconstruction of the bones of the cranial vault. In this case, the skull is “disassembled,” and then reassembled with a known “large volume”. At the same time, parts of the skull are “cut out” that simultaneously move away to a certain distance from the remaining part of the skull (see NEUROSURGERY 2000; Craniosynostosis John A. Jane, Jr, Aaron S. Dumont, Kant YK Lin and John A. Jane Sr; Persing JA MOC-PS (SM) CME article: Management considerations in the treatment of craniosynostosis. Plast Reconstr Surg. 2008; 121 (Suppl): 1-11.). Accordingly, after the operation, the volume of the skull increases.

These operations have several disadvantages:

- An increase in intracranial volume after surgery does not always correspond to the planned;

- A simultaneous surgical enlargement of the cranial cavity often leads to the fact that due to the significant gap between the edges of the wound, it is not possible to reduce its edges and adequately suture due to the tension of the scalp (scalp here means everything that covers the skull: skin, subcutaneous tissue, aponeurosis (tendon helmet);

- Often, due to the separation of the bone from the dura mater, “dead spaces” are formed inside the skull between the dura and the bones of the skull, which, in some cases, are filled with blood, cerebrospinal fluid (fluid washing the brain), which leads to the development of inflammation and is a factor risk for developing infectious complications (meningitis, encephalitis);

- Increased invasiveness of the operation, which is due to the fact that the operations are associated with high blood loss requiring blood transfusion. For a child in the first year of life, weighing 10-15 kg, even slight blood loss is extremely dangerous due to the small volume of circulating blood.

To eliminate the above disadvantages, a method of bilateral distraction of the cranial vault was proposed - bone growth between gradually expanding bones of the skull, for example, relative to the midline (overgrown swept suture) using distraction devices.

The method is as follows:

- First, the results of computer and magnetic resonance imaging of the skull are studied (hereinafter referred to as CT and MRI of the skull);

- According to the results of the study, computer simulation of the necessary increase in the volume of the skull for each specific case is performed;

- In the position of the child lying on his back, either drank or bites (with special nippers) the bones of the cranial vault along the lines conditionally bordering the coronal, lambdo-shaped and overgrown swept suture, so that 3 conditional bone fragments are obtained: a fixed central fragment (containing overgrown sagittal suture), and, on the right and left side of it, two movable flaps containing parietal, temporal and, depending on the situation, partially frontal and occipital bones, separated from the rest of the skull throughout Exceptions portion near the base (bone bridge) which performs the role of "door hinge" about which there is motion of the bone segment.

- Distraction devices are installed in the obtained gaps between the movable (lateral) and fixed (central) segments of the skull and are fixed (attached) to the bones using microscrews;

- Then, by means of apparatuses, the head is gradually expanded in the transverse direction, due to the symmetrical extension of the movable segments containing the parietal, temporal and, depending on the situation, partially frontal and occipital bones relative to the midline.

A known compression and distraction apparatus that implements this method for eliminating skull deformation, mainly resulting from (premature) premature fusion of cranial sutures, including a group of plates (otherwise called working sites), one group is designed to connect to the fixed part of the skull, and the other to connect with a movable part of the skull, each of which (optionally) has a transverse protrusion from the side opposite to the side intended for contact with parts of the skull, while dy is oriented transverse projection along the plate through-hole with a screw thread. Threaded lead screw, interacts through a through hole with a screw thread with a transverse protrusion of the plate. Accordingly, when torque appears on the lead screw, the transverse protrusion of the plate rigidly attached to the skull bone, along with this bone, is displaced relative to the lead screw (see Distraction Osteogenesis Technique for the Treatment of Nonsyndromic Sagittal Synostosis. Johns D, Blagg R , Kestle JR, Riva-Cambrin JK, Siddiqi F, Gociman B. Plast Reconstr Surg Glob Open. 2015 Aug 10; 3 (7): e474).

The main disadvantage of using this apparatus with the method of bilateral distraction described above is the need to use a large number of devices (3-4 pcs) and the resulting complications:

- The presence of several devices increases the risk of crossing the distraction vectors of each device, respectively, it becomes possible to jam the axis of the device in the thread, the displacement of the device relative to the bone;

- With an increase in the number of devices, the risk of asymmetry during the extension of the parietal bones increases;

- With an increase in the number of devices, the invasiveness of the operation increases, the risk of damage to the dura mater increases during the installation and fixation of devices with microscrews, which can lead to the expiration of cerebrospinal fluid, potential infection, the development of meningitis and encephalitis in the postoperative period;

- Increased likelihood of infectious complications due to an increase in the number of wounds on the skin through which the driveshafts of the devices come to the surface;

- With the increase in the number of devices, the cost of treatment increases.

Another significant drawback is certain design flaws of the apparatus:

- the device of the devices does not provide a hinge transmission that allows the device to change shape while maintaining the axis of distraction, when one part of each device is rotated at an angle to the adjacent part of the device in accordance with the movement of the plane of the moving bone fragment not in a horizontal plane, but in an arc (according to the type " opening door ") (an example of a change in the angle between adjacent parts of the apparatus is illustrated in Fig. 26 and Fig. 27);

- the transverse protrusions are fixed to the plates of the apparatus rigidly, which entails the possibility of jamming the spindle of the apparatus in the thread of the transverse protrusion, or the displacement of the apparatus relative to the bone with increasing clearance between the bones, due to the displacement of the working plates of the apparatus in the horizontal plane relative to each other (example of a change in the angle between the axis of the screw and the axis of the plate is illustrated in Fig. 24 and Fig. 25).

These disadvantages are due to the following reasons.

As indicated above, the essence of the method is that by means of successive cuts in the parietal, partially temporal, partially frontal / occipital bones, parts of the cranial vault are separated, forming three segments: fixed, containing, for example, an overgrown swept stitch and two movable on either side of it containing, for example, the parietal and / or partially temporal and / or partially frontal and / or occipital bones, "extended" to the sides in the process of distraction. Several Martin devices are installed in the gap between the bones (see the prospectus), containing several groups of plates, each device is connected to the skull so that one group of plates of each device is rigidly attached to the fixed part of the skull, and the other is rigidly attached to the movable parts of the skull. Then, with the help of threaded spindles, they begin by rotating the spindles to gradually move one group of plates from another together with the parts of the skull attached to them.

In FIG. 24 and 26 show the devices at the initial stage after installation on the skull.

When the spindles of each device rotate, the moving part of the skull is gradually removed from the fixed part.

The applicant considers it necessary to pay particular attention to the examination of the following disadvantage of the known device, which is detected by the gradual removal of parts of the skull.

If we consider each device separately, it is clear that when the plates are gradually removed from each other, the longitudinal axis of the lead screw connected to the moving part of the skull tends to rotate clockwise or counterclockwise relative to the longitudinal axis on the fixed part of the skull (see Fig. 24 and Fig. 25).

Consider this process in more detail:

In FIG. 1, FIG. 24, FIG. 25, FIG. 26, FIG. 27 shows the apparatus 1 at the initial and final stages of extension (distraction).

1. The non-parallel position of the longitudinal axes of the leadscrews can occur when the osteotomy line on the skull is formed not in a straight line (seen from above), but in an arc (see Fig. 24, Fig. 25), or, for example, if the plates are not properly fixed with protrusions on the skull. As can be seen, after moving, when the gap 69 between the parts of the skull 2 is filled with regenerate 72, the longitudinal axis of the rotary screw 30 of the claimed apparatus rotated relative to the longitudinal axis 21 by an angle a clockwise (FIG. 25). In this case, the longitudinal axis of the second rotary screw 29 of the apparatus rotated relative to the longitudinal axis 21 by an angle a counterclockwise (Fig. 25).

If the distraction length is small and the angle a is small, then the displacement of the axes will be compensated by sampling the gaps between the moving parts of the apparatus (due to the sampling of backlash).

However, with a considerable length of distraction, such a significant distortion of the lead screw mounted on the movable part of the skull inside its threaded through transverse hole will occur that it will either jam the threaded joint or tear off the plate connected to it from the movable part of the skull.

In FIG. 25 shows that although the longitudinal axis of one screw was rotated relative to the other, however, due to the claimed invention, jamming did not occur, since the lead screw is placed in the transverse protrusion of the plate with the possibility of rotation around the vertical axis of the protrusion.

At the same time, looking at each device installed on gradually expanding parts of the skull, a side view shows that the plates are removed from each other not in a straight line, but in an arc (movement of the bone fragment according to the principle of the “opening door”), accompanied by movement of the plane a plate fixed on the moving part of the skull relative to the plane of the plate fixed on the fixed part of the skull upward in the vertical direction (due to the anatomical features of the cranial vault) (see Fig. 26 and Fig. 27).

The non-parallel position of the longitudinal axes of the lead screws 29 and 30 relative to the longitudinal axis 21 occurs as the moving parts of the skull 11 (distraction) move apart relative to the stationary part 9, due to the movement of the edge of the bone 69 not in a straight plane, but in an arc (on the principle of “opening door” "), (See Fig. 26, Fig. 27) As you can see, after moving, when the gap 69 between the parts of the skull 2 is filled with regenerate 72, the longitudinal axis of the rotary screw 30 of the claimed apparatus rotated relative to the longitudinal axis 21 of the axis 22 clockwise β arrow (Fig. 27). In this case, the longitudinal axis of the second rotary screw 29 of the apparatus rotated relative to the longitudinal axis 21 of the axis 22 by an angle β counterclockwise (Fig. 27).

If the distraction length is small and the angle β is small, then the displacement of the axes will be compensated by sampling the gaps between the moving parts of the apparatus (due to the sampling of backlash).

However, with a significant length of distraction, there will be such a significant skew of the lead screw mounted on the movable part of the skull inside its threaded through cross hole that it will either jam the threaded joint, or tear off the plate connected to it from the movable part of the skull, or bend the screw .

In FIG. 27 it is shown that although the longitudinal axes of the screws 30 and 29 were rotated relative to the longitudinal axis 21, due to the claimed invention, jamming did not occur, since the lead screws are connected to the axis 22 by means of articulated couplings with the possibility of rotation in the vertical plane and placed in sphere-shaped bodies (nuts) 35 with the possibility of rotation in two planes - horizontal and vertical. The objective of the claimed technical solution is:

1. reducing the number of distraction apparatus used;

2. prevention of the above undesirable complication caused by the displacement of the axes of the lead screws relative to each other (prevention of jamming of the lead screws in the thread);

3. prevention of the above undesirable complication caused by the displacement of the axes of the propellers relative to the central fixed part - vertical displacement (prevention of jamming of the axis in the thread, displacement of the apparatus relative to the bone, bending of the running axis of the apparatus).

The technical result is achieved by the fact that in the compression-distraction apparatus for bilateral distraction,

- comprising several groups of plates, one of which is designed to connect to the fixed part of the skull, and the other is intended to connect to the moving parts of the skull adjacent to the fixed part, the movable edge of each moving part of the skull being adjacent to the fixed part of the skull,

- In this case, each of the plates has a transverse protrusion from the side opposite to the side intended for contact with parts of the skull,

- these transverse protrusions are equipped with directional screws oriented along the planes of the plates with the possibility of rapprochement and distance of the plates from each other,

- and each plate is equipped with a means of connecting the plate with a part of the skull,

according to the invention

- Each group of plates contains three plates, one of which is designed to connect to the fixed part of the skull, and plates located on both sides of it, designed to connect to the moving parts of the skull,

- Moreover, the transverse protrusion of the plate intended for connection with the fixed part of the skull is made with a through hole oriented along its plane, in which the axis is rotatable around the longitudinal axis,

- And the lead screws are located in the screw holes of the protrusions of the plates intended for connection with the moving parts of the skull, have different thread directions, are connected to the ends of the axis by means of articulated couplings with intersecting axes at an angle of not more than 45 °,

- and mounted with the possibility of rotation of their axes on the corresponding plate in two planes - horizontal and vertical, passing through the longitudinal axis of the transverse protrusion of the corresponding plate.

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

This technical solution has the following advantages compared to the prototype described in the above source Distraction Osteogenesis Technique for the Treatment of Nonsyndromic Sagittal Synostosis. Johns D, Blagg R, Kestle JR, Riva-Cambrin JK, Siddiqi F, Gociman B. Plast Reconstr Surg Glob Open. 2015 Aug 10; 3 (7): e474):

- reducing the number of devices, which significantly reduces the risk of complications:

- reducing the number of devices reduces the risk of crossing the distraction vectors of each device, respectively, reduces the risk of jamming of the axis of the device in the thread, the displacement of the device relative to the bone;

- With a decrease in the number of devices, the risk of asymmetry during the extension of the parietal bones decreases;

- With a decrease in the number of devices, the invasiveness of the operation decreases, the risk of damage to the dura mater during installation and fixation of the devices with microscrews decreases, which accordingly reduces the risks of cerebrospinal fluid leakage, potential infection, the development of meningitis and encephalitis in the postoperative period;

- Reduces the likelihood of infectious complications due to a decrease in the number of wounds on the skin through which the driveshafts of the devices come to the surface;

- With a decrease in the number of devices, the cost of treatment decreases.

- the absence of undesirable complications caused by the displacement of the axes of the lead screws relative to each other (prevention of jamming of the axis in the thread and prevention of the displacement of the compression-distraction apparatus relative to the bone, prevention of bending of the lead screws).

In addition, another significant advantage is the prevention of the following disadvantages of the well-known apparatus, taken in detail above, adopted as the closest analogue (prototype):

- in the device of each claimed device, a hinge transmission is provided, allowing the device to change shape while maintaining the distraction axis, when one part of each device is rotated at an angle to the adjacent part of the device in accordance with the movement of the plane of the moving bone fragment not in a horizontal plane, but in an arc (by type “Opening door”) (an example of a change in the angle between adjacent parts of the apparatus is illustrated in Fig. 26 and Fig. 27);

- the transverse protrusions are fixed to the plates of the device with the possibility of rotation, which prevents the jamming of the spindle of the device in the thread of the transverse protrusion, or the displacement of the device relative to the bone with an increasing gap between the bones, due to the displacement of the working plates of the device in a horizontal plane relative to each other (example of a change in the angle between the axis of the screw and the longitudinal axis is illustrated in Fig. 24 and Fig. 25).

In addition, in relation to the claimed device, the applicant considers it necessary to highlight the following clarifications of the set of its essential features relating to particular cases of implementation or use.

1. Each lead screw can be mounted with the possibility of rotation of its axis in two planes, horizontal and vertical, passing through the longitudinal axis of the transverse protrusion of the corresponding plate using various structural solutions of these nodes. The applicant has developed several options for them. According to the applicant, it is most expedient that the transverse protrusion is made integral and contains a sphere-shaped body with a through threaded hole inside for screwing in a lead screw (or in other words, with a through cross hole with a screw thread inside for screwing in a lead screw), and rigidly fixed to the plate is a transverse fence, and the sphere-shaped body is placed in the transverse fence with the possibility of rotation in two planes - horizontal and vertical.

In this case, it is desirable that the transverse guard be a hollow cylinder, one end of which is closed by a transverse plate and the other by a lid, through holes in the side wall of the cylinder opposite to each other would be provided for the lead screw and its rotation, in the transverse plate and cover recesses of a spherical shape (spherical recesses) to accommodate a spherical body, and the recess of the spherical shape of the lid would have a groove on the spherical surface, and the spherical body had a protrusion, for example, cylindrical Otori placed in the groove.

The cap can be connected in various ways to the end of the cylinder, for example, welded.

Preferably, said means for connecting the plate to the skull bone would comprise a screw and through holes in the plate to fix it to the skull. Such a tool is simple in design, convenient to install during the operation, and reliable in operation.

To increase the reliability of moving the movable part of the skull, it is advisable that the means for connecting the plate with the bone of the skull would additionally contain additional transverse protrusions in contact with the ends of the parts of the skull at the cut points.

2. The claimed device can be used for surgery on various parts of the skull. However, according to the applicant, it is most optimal to use the claimed technical solution for the case when each group of plates contains a plate designed to connect with the fixed part of the skull, for example, with an overgrown sagittal - swept suture of the skull in the central part, and a pair of plates intended for connection with moving parts of the skull, which are, for example, sawn parietal and / or partially temporal and / or partially frontal and / or occipital bone of the skull.

3. To ensure the rotation of the movable part of the apparatus relatively stationary (side view) (see Fig. 26 and Fig. 27), it is desirable that each lead screw be mounted rotatably relative to the transverse protrusion of the plate intended for connection with the fixed part skull, for example, due to the fact that the lead screw is attached to the axis in the transverse protrusion of the plate connected to the fixed part of the skull using an articulated coupling.

This design of the unit is characterized by ease of manufacture and use, as well as reliability in operation.

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 in the drawing.

In FIG. 1 shows the claimed compression-distraction apparatus for bilateral distraction

In FIG. 2 shows a general view of a compression-distraction apparatus for bilateral distraction with one group of plates, a top view;

In FIG. 3 is the same, partial longitudinal section along AA in FIG. 2 with one group of plates;

In FIG. 4 separately shows the transverse protrusion of the plate, intended for connection with the fixed part of the skull, front view;

In FIG. 5 is the same, section BB in FIG. four;

In FIG. 6 shows a plate for connecting to the fixed part of the skull, side view with partial tears;

In FIG. 7 is the same, plan view, with additional transverse protrusions not bent, can be bent, for example, previously or during the operation;

In FIG. 8 shows a unit with a transverse protrusion 31, a plate 16 and a lead screw 29 (see. Fig. 3), and the details of the node are spaced in space, axonometric;

In FIG. 9 shows separately the transverse guard of the transverse protrusion 31 in FIG. 8 is a side view;

In FIG. 10 is the same, section BB in FIG. 9;

In FIG. 11 is the same, section GG in FIG. 10;

In FIG. 12 depicts separately the sphere-shaped body 35 of the transverse protrusion 31 in FIG. 8 is a side view;

In FIG. 13 is the same, section DD in FIG. 12;

In FIG. 14 shows separately the cover 43 of the transverse protrusion 31 in FIG. 8 is a partial cutaway side view;

In FIG. 15 is the same, view along arrow E in FIG. fourteen;

In FIG. 16 shows a fork of a swivel coupling, side view;

In FIG. 17 is the same, view along arrow G in FIG. 16;

In FIG. 18 is the same, section along II in FIG. 16 (note: in this figure, the cross section is given after assembly, as a result of which the cylindrical tapered end 67 of the lead screw 29 was inserted into the through hole 66 in the base 65 of the yoke 62 and rigidly attached to the yoke 62, for example, by laser welding to form a weld 68);

In FIG. 19 shows a crosspiece of an articulated coupling, side view;

In FIG. 20 is the same, section along KK in FIG. 19;

In FIG. 21 shows a pin of a swivel coupling, a perspective view;

In FIG. 22 shows a shaft of a swivel coupling, a perspective view;

In FIG. 23 shows a fork of a swivel coupling, a perspective view;

In FIG. 24 shows an embodiment of the use of a distraction apparatus for bilateral distraction mounted on a schematically shown cranial vault. View from above;

In FIG. 25 shows the same apparatus in FIG. 24 after the plates are intended to be connected to the moving parts of the skull;

In FIG. 26 shows an embodiment of the use of a distraction apparatus for bilateral distraction mounted on a schematically shown cranial vault. Front view (frontal plane);

In FIG. 27 shows the same apparatus in FIG. 26 after the plates are intended to be connected to the moving parts of the skull.

Compression-distraction apparatus 1 for bilateral distraction to eliminate cranial deformity 2, mainly resulting from premature fusion of cranial sutures 3, most often sagittal suture 10 or, more rarely, several cranial sutures, manifested by scaphocephaly-dolichocephaly (i.e., the shape of the head 4, characterized by elongated in the longitudinal direction (i.e., from the frontal bone 5 towards the occipital bone 6) and the skull 2 narrowed in the transverse direction, includes

- several groups of 7 plates 8 (in Fig. 1, the invention is illustrated by two groups 7 of three plates 8 in each group 7) intended for connection with the fixed part 9 of the skull 2, for example, with the fixed part of the skull containing the overgrown sagittal-swept stitch 10 skull 2 in the central part, and plates 8 for connecting to the movable parts 11 of the skull 2 located on both sides of the fixed part 9 of the skull 2, which are, for example, sawn parietal 14, and / or partially temporal, and / or partially frontal 5 and / or occipital 6 bones (depending on the clinical situation) of the skull 2 with an intact part 12 at the base 13 of the skull 2. Moreover, the movable edge 56 of each movable part 11 of the skull 2 is adjacent to the edge 57 of the fixed part 9 of the skull 2.

The invention is illustrated by the example when the movable part 11 of the skull 2 is a sawn parietal bone 14 of the skull 2.

Each group of 7 plates 8 contains three plates 8. Consider them in more detail.

One of these plates 8 is designed to connect with the fixed part 9 of the skull 2 with the overgrown sagittal suture 10 of the skull in the fixed part 9 located in the central part of the skull.

For convenience, this plate, designed to connect with the fixed part 9 of the skull 2, is indicated by 15.

Two other plates 8 are intended for connection with the movable part 11 of the skull 2.

For convenience, plates intended for connection with the movable part 11 of the skull 2 are indicated by the numbers 16 and 17.

Moreover, each of the plates 15, 16, 17 has a transverse protrusion 18 from the side opposite to the side intended for contact with parts of the skull 2.

Moreover, these transverse protrusions 18 are equipped with lead screws 29, 30 oriented along the planes of the plates with the possibility of rapprochement and distance of the plates from each other.

Each plate is equipped with a means of connection with the corresponding part of the skull.

Consider their designs in detail.

As indicated above, each group of 7 plates 8 contains three plates 15, 16, 17: one plate 15 of them is designed to connect with the fixed part of the skull 9, for example, with an overgrown sagittal suture 10 of the skull 2 in the central part, and two other plates 16 and 17 are located on both sides of the plate 15 and are designed to connect with the movable parts 11 of the skull 2, which are, for example, sawn parietal bones 14 of the skull with an intact part 12 (a bone bridge that acts as a hinge - like a “door hinge”) base of the skull 13.

The transverse protrusions of 18 plates 15, 16, 17 have their own design features and for this reason the applicant assigned them separate positions.

Let's consider them separately.

The transverse protrusion of the plate 15, intended for connection with the fixed part of the skull 9, for example, containing the overgrown sagittal suture 10 of the skull in the central part, is indicated by 19 and has the name: transverse protrusion 19 of the plate 15, intended for connection with the fixed part 9 of the skull 2. It made with a through hole 20 oriented along the plane of the plate 15, in which an axis 22 of a cylindrical shape is placed with the possibility of rotation around its longitudinal axis 21. The transverse protrusion 19 of the plate 15, intended for connection with the fixed part 9 of the skull 2, has an additional protrusion 23, which is fixedly placed in the window 24 of the plate 15 and is rigidly connected to it, for example, by laser welding. The plate 15 is made with additional transverse protrusions 25, which are introduced into the gap (cut) 69 between the bones along the line of the osteotomy and are designed to improve the fixation of the plate 15 on the bone. In addition, the plate has through holes 26. Bone screws (not shown in the figures) are installed in these through holes 26 to secure and fix the plate to the bone.

At the ends of the axis 22, articulated couplings 27 and 28 are fixed, the other ends of which are rigidly connected to the lead screws 29 and 30.

The lead screws 29 and 30, in turn, are located in the threaded holes of the protrusions 18 of the plates 16, 17 (or, in other words, in the screw holes of the protrusions 18 of the plates 16, 17), designed to connect with the movable parts 11 of the skull 2, representing themselves, for example, sawn parietal bones 14 of the skull 2 with an intact part 12 at the base of the skull 13.

Let us dwell in more detail on these designs of lead screws in the protrusions of the plates.

As noted above, the transverse protrusions 18 of the plates 16, 17 have their own design features and for this reason the applicant assigned them separate positions.

Consider in detail the transverse protrusion of the plate 16 or the transverse protrusion of the plate 17, the structures of which are the same. Each of them is designed to connect with the movable part 11 of the skull 2 and has the name: transverse protrusion 31 of the plate 16, designed to connect with the movable part 11 of the skull 2, or the transverse protrusion 32 of the plate 17, designed to connect with the movable part 11 of the skull 2.

Since the designs of these transverse protrusions are the same, then we will consider the design of one of them, namely, the transverse protrusion 31 of the plate 16, designed to connect with the movable part 11 of the skull 2.

The plate 16, intended for connection with the movable part 11 of the skull 2, and its lead screw 29, intended for connection with the plate 16, are interconnected by the aforementioned transverse protrusion 31, fixed with the possibility of rotation of the screw on this plate 16 around the vertical axis 33 ( Fig. 3, Fig. 8) and the horizontal axis 34 (Fig. 8) of this transverse protrusion 31 (Fig. 3, Fig. 8), into the through threaded hole 36 of which (Fig. 8) (or, in other words, into the through threaded hole) screw 29 screwed in.

The applicant has developed several design options for the previously indicated transverse protrusion 31, which allows rotation of the spindle 29 on the plate 16 around the vertical axis 33 and the horizontal axis 34 of the transverse protrusion 31.

Below, the applicant offers one of the most optimal, in his opinion, design options for this site.

According to this embodiment, the plate 16, designed to connect with the movable part 11 of the skull 2, and the lead screw 29, designed to connect with it, are interconnected by means of a transverse protrusion 31, fixed with the possibility of rotation of the screw on this plate around the vertical axis 33 and horizontal axis 34 of this transverse protrusion (FIG. 2, FIG. 3, FIG. 8).

The transverse protrusion 31, is made integral and contains

- a sphere-shaped body 35 with a through threaded hole 36 inside (or, in other words, with a through transverse hole 36 with a screw thread inside) for screwing the lead screw 29, and the sphere-shaped body 35 has a protrusion 37 on the vertical axis 33 of the transverse protrusion 31, for example, a cylindrical forms. A sphere-shaped body 35 is rotatably arranged about a vertical axis 33 and a horizontal axis 34 in a cavity 38 of the hollow cylinder 40, which for this is made one size larger than the size of the sphere-shaped body 35, and has a gap from it equal to, for example, 0.1 mm .

The hollow cylinder 40 in the lower part has a transverse plate 41 having a depression of a spherical shape 42, in which the lower part of the spherical body 35 is placed. In the side wall of the hollow cylinder 40, opposite each other, through openings 45 are provided for the lead screw 29 to ensure its rotation in a plane parallel to the surface of the plate 16, facing in the opposite direction from the surface of the bone of the skull, around axis 33 (i.e., in the horizontal plane), and in a vertical plane around axis 34 (Fig. 8). The transverse plate 41 may be molded integrally with the hollow cylinder 40.

The cover 43 from the side of the cavity 38 of the hollow cylinder 40 has a spherical recess similar to a spherical recess 42 in the transverse plate 41, as well as a groove 44 on a spherical surface, a little more than, for example, 0.1 mm wide, of the diameter of the cylindrical protrusion 37 on a spherical body 35, and a depth slightly greater than the height of the cylindrical protrusion 37, for example, 0.1 mm. In the spherical recess of the lid 43, the upper part of the spherical body 35 is placed, and a cylindrical protrusion 37 of the spherical body 35 is placed in the groove 44 of the lid 43.

The cover 43 may be welded to the end face of the hollow cylinder 40, for example by laser welding.

In the absence of a cylindrical protrusion 37 in the groove 44 during rotation of the lead screw 29, a sphere-shaped body 35 with a through threaded hole 36 (in other words, a “nut”) will rotate together with the lead screw 29 due to the presence of friction in the threaded connection, i.e. there will be no movement of the lead screw 29 relative to the spherical body 35 in the axial direction, and, therefore, there will be no distraction, that is, there will be no movement of the movable part of the bone of the skull relatively motionless. Due to the presence of a cylindrical protrusion 37 in the groove 44, the sphere-shaped body 35 is not able to rotate with the lead screw when the lead screw rotates and when there is a friction moment in the threaded connection.

In addition, with this design, it is simultaneously possible to swing the lead screw relative to the center of the sphere-shaped body in horizontal and vertical planes.

Thanks to the swinging of the longitudinal axis of the screw in the horizontal plane, the non-parallelism of the axes of the lead screws in the horizontal plane during installation and during distraction is compensated. And thanks to the swing of the screw axis in the vertical plane, the rise of the movable part of the bone during distraction is compensated, which is clearly seen in FIG. 27.

In the manufacture of the transverse protrusion 31, first the rectangular transverse protrusion 49 at the lower end of the hollow cylinder 40 is inserted into the rectangular hole 47 in the plate 16 and rigidly connected to each other, for example, by laser welding. Then, a sphere-shaped body 35 is placed in the cavity 38 of the hollow cylinder 40 and fixed on top by the cover 43 so that the protrusion 37 is in the groove 44 of the cover 43 and so that the sphere-shaped body 35 can rotate inside the cavity 38 of the hollow cylinder 40. Then, through the threaded transverse hole 36 ( with a screw thread inside) screw the lead screw 29 (Fig. 8).

In the assembled position, the lead screw 29 is capable of horizontal and vertical rotation relative to the plate 16.

For fastening on the bones of the skull, each plate 16 or 17 has through holes 26 for, for example, screwing in bone screws to fix and fix the plates on the bones.

To facilitate the movement of parts of the skull at the ends of each plate 16 or 17, transverse protrusions 46 are made, which are inserted into the gap (cut) 69 between the bones along the line of the osteotomy and are designed to improve fixation on the bone.

The end of the lead screw 29 is secured, for example, by laser welding in the adapter 70, in which the head 73 of the cardan shaft 51 is mounted, fixed in the adapter by a screw 71. By means of an articulated coupling 50, the head 73 is connected to the cardan shaft 51, consisting of axes 52 and 53, connected by a swivel clutch 54. The axis 53 has at the end a thickening 55 of a turnkey hexagonal shape for driving into rotation.

Lead screws 29 and 30 are placed in the corresponding screw-threaded holes of the protrusions of the plates, intended for connection with the movable parts of the skull, and have different thread directions. Due to this, when rotating any lead screw in one direction, the plates 16 and 17 come closer to each other, and when rotating in the other direction, they move away from each other.

As can be seen, the claimed device contains four articulated couplings, each with intersecting axes at an angle of at least 45 °, namely:

- swivel coupling 28 for connecting the end of the lead screw 30 and the axis 22,

- an articulated sleeve 27 for connecting the end of the lead screw 29 and the axis 22 on the other hand,

an articulated coupling 50 for connecting the end of the spindle 29 to the end of the axis 52 of the driveshaft 51, and

- an articulated coupling 54 for connecting the ends of the axles 52 and 53 of the cardan shaft 51. By design, these articulated couplings are the same.

Since the designs of the four articulated couplings are the same, the applicant gives an explanation of the design of one of them, especially since they are not the subject of the invention.

In order not to clutter the figures, the applicant explains the design using the example of the articulated coupling 27.

In FIG. 3 shows a cross section of this articulated coupling in FIG. 2.

The articulated sleeve 27 comprises a spider 48 (FIG. 3, FIG. 19 - FIG. 20), which is a cube-shaped body with axial through holes 58 and 59 intersecting within the cube-shaped body. In addition, the hinge clutch includes a rod 60 (Fig. 22), a pair of fingers 61 (Fig. 21) and a pair of forks 62 (Fig. 16 - Fig. 18, Fig. 23). Each fork 62 consists of a pair of legs 63 with through holes 64 in each foot, made integrally with the base 65 with a through hole 66 at the base of the fork (Fig. 28 - Fig. 30).

During assembly, the cylindrical tapered end 67 of the lead screw 29 is first inserted into the through hole 66 in the base 65 of the yoke 62 (FIG. 18). The lead screw 29 is rigidly attached to the plug 62, for example, by laser welding with the formation of a weld 68.

Similar actions are done with another fork, to which the longitudinal axis 21 is attached.

After that, the paws 63 of both forks 62 cover the crosspiece 48 and fix the connection using the rod 60 and a pair of fingers 61.

As you know, articulated couplings are well-known mechanisms that provide rotation of a pair of shafts, if possible the occurrence of misalignment of their longitudinal axes (see, for example, the Handbook of a mechanical engineering designer, authors V.I. Anuryev and others, 2nd edition, revised and supplemented, Mashgiz Moscow, 1963, p. 321-323). For this reason, the applicant considers the description of this node sufficient, especially since it is well-known, is not the subject of the invention and any other design could be used instead, providing the function of transferring rotation from one axis to another, if it is possible to cross their longitudinal axes.

The use of compression-distraction apparatus 1 for bilateral distraction of the skull 2 is as follows.

The proposed technical solution to the problem is illustrated by the example of using the claimed device for the operation: "Osteotomy of the bones of the cranial vault, the installation of distraction devices."

1. In preparation for surgery, the patient performs computed tomography (hereinafter - CT) of the bones of the skull;

2. According to the data obtained during CT, a three-dimensional model of the patient’s skull is performed;

3. Based on this model, osteotomy lines, distraction vectors (directions along which the moving parts of the skull move apart), the locations of the compression-distraction apparatuses, their number are modeled (designed);

4. During the operation, the patient under anesthesia is given the position of "lying on his back";

5. After processing the skin, a bicoronary skin incision is made (ie, an incision through the arch of the skull from ear to ear).

6. Separate (layers of tissue are separated) and skin flaps of the frontal and occipital region recline.

7. According to the preliminary plan, the lines of osteotomy are determined and marked out. Thus, to form three parts on the cranial vault: a fixed part 9, for example, containing an overgrown sagittal suture 10; two movable parts 11, containing, for example, parietal 14 and / or partially temporal and / or partially frontal 5 and / or occipital 6 bones (depending on the clinical situation),

8. The periosteum (the tissue covering the bones of the skull) is dissected along these lines and the temporal muscles are dissected at the base 13.

9. Four or more milling holes are made along the lines of the osteotomy (the line along which the bone will be cut).

10. By using the made milling holes in the skull, bone is cut or bitten in accordance with previously marked osteotomy lines.

11. Thus, three parts are formed: the stationary part 9, for example, containing an overgrown sagittal suture 10; a pair of moving parts 11, containing, for example, the parietal 14 and / or partially temporal and / or partially frontal 5 and / or occipital 6 bones (depending on the clinical situation) with the intact part 12 (a bone bridge acting as a hinge, type of “door hinge”) at the base 13 of the skull 2. Moreover, the movable edge 56 of each movable part 11 of the skull 2 is adjacent to the edge 57 of the fixed part 9 of the skull 2.

12. In the gap 69 obtained by means of an osteotomy, at least a pair of compression-distraction apparatuses for bilateral distraction 1 are installed and fixed between the movable edge 56 and the adjacent edge 57 of the skull bones.

13. For this, the plate 15 for connecting with the fixed part 9 of the skull 2 is mounted on the fixed part 9 of the skull 2, and the plates 16 and 17 for connecting with the moving parts 11 of the skull 2 are mounted on the moving parts 11 of the skull 2 so that the transverse protrusions 25 and 46 of these plates were in the gap 69 between the movable 11 and the stationary 9 parts of the skull 2 (Fig. 1).

14. The plates 15, 16 and 17 are fixed (attached) to the bone through the holes 26 using, for example, screws (that is, optional) (in the figures, the screws are not shown so as not to overload them).

15. The wounds are sutured in layers so that the propeller shafts 51 remain outside, and the plates 15, 16 and 17 with transverse protrusions 19, 31, 32, respectively, are immersed under the skin. Aseptic dressings are applied to the head.

16. After 5-7 days, an overview radiography of the skull bones is performed in two projections in order to verify the correct position of the compression-distraction apparatus for bilateral distraction 1 according to the calculated positions.

17. After making sure that the compression-distraction apparatus for bilateral distraction 1 are located correctly, distraction begins according to a pre-developed protocol, depending on the specific case.

18. For this, for example, for the case depicted in FIG. 1, one revolution of the driveshaft 51 is carried out using a special key, dressed with an end hexagonal cavity for a 6-sided thickening 55. The rotation is carried out, for example, 360 ° twice a day with an interval of 12 hours, daily for 40-70 days, depending from a specific case. At each turn, rotation from the driveshaft 51, through an articulated coupling 50, is transmitted to the adapter 70, from which it is transmitted to the spindle 29. The adapter 70 is designed to transmit rotation from the key to the spindle 29. In addition, the adapter is designed to disconnect the cardan shaft 51 from lead screw 29 after completion of distraction. To fix the driveshaft 51 in the adapter there is a screw 71. The design of the adapter is not the subject of the present invention and therefore is not disclosed in detail, but is shown schematically.

19. During rotation of the lead screw 29, due to the fact that the thread at the lead screw 30 is opposite to that of the lead screw 29 (at the lead screw 30 the thread is left, and at the lead screw 29 the thread is right, or vice versa), the plates are gradually symmetrically removed 16 and 17 from each other, and accordingly from the plate 15 located between them, fixed to the fixed part 9 of the skull 2.

20. Due to this, there is a gradual separation of the edges 56 and 57, the moving parts 11 and the fixed part of the skull 9. At the same time, a gradual expansion of the cranial vault in the transverse direction is achieved.

21. As the moving parts 11 move apart from the fixed part 9, a bone regenerate 72 is formed in the gaps 69 between them.

22. At the same time, due to the anatomical features of the cranial vault 2, as the plates 16 and 17 move apart, the misalignment between the longitudinal axes of the spindles 29 and 30 in the horizontal and vertical plane increases. The spindles 29 and 30 are rotated relative to the plate 15 fixed to the fixed part 9, skull 2, and plates 16 and 17 relatively fixed to the moving part 11 of the skull 2, to a certain angle a in the horizontal plane (Fig. 24, Fig. 25), and at a certain angle β in the vertical plane (Fig. 26, Fig. 27). The rotation of the lead screws 29 and 30 in a horizontal plane relative to the plates 16 and 17, mounted on the movable parts 11 of the skull 2, occurs as a result of the rotation of the sphere-shaped body 35 inside the hollow cylinder 40. The rotation of the lead screws 29 and 30 in a horizontal plane, relative to the plate 15 mounted on the fixed part 9 of the skull 2 occurs due to the articulated couplings 27 and 28. If there was no rotation through the angle a (see prototype), the screw 29 would skew inside the through threaded hole 36, that is, the screw would jam the connection or separation of the entire plate 16 from the movable part 11 of the skull 2. If there were no rotation through angle β (see prototype), the lead screw 29 would skew along the longitudinal axis, including inside the through threaded hole 36, that is, the threaded would jam connection, the separation of the entire plate 16 from the movable part 11 of the skull 2, or bending of the lead screw 29.

23. After reaching the calculated width of the gap (the estimated magnitude of the distraction), x-ray is performed in two projections, making sure that the required length of the distraction is reached, stop further movement.

24. After 8-24 weeks (retention period - the period of ossification of bone regenerate 72, in the resulting gap 69) CT is performed.

25. After that, compression and distraction apparatus for bilateral distraction 1 are removed under operating conditions under anesthesia from small skin incisions.

The above example illustrates the operation in the case of premature fusion of the sagittal-swept suture, with the development of the disease - scaphocephaly.

However, the claimed device can be used in relation to other areas of the cranial vault, including with an offset relative to the midline (for example, in the presence of complex deformation of the skull when several cranial sutures are healed).

According to the applicant, during the operation, the number of compression-distraction apparatus for bilateral distraction required for its implementation (for example, two or more) is determined in each case depending on the specific circumstances (Fig. 1).

The invention is illustrated by clinical examples.

Example 1

Patient M., 1 year 10 months, was admitted with a diagnosis of Partial craniostenosis. Synostosis of the sagittal suture. Scafocephaly

Complaints of admission to deformity of the skull. Delayed mental and motor development.

An examination revealed that the child’s suffering is caused mainly by intracranial hypertension (increased intracranial pressure), as a result of cranio-cerebral imbalance due to premature closure of the sagittal suture,

A standard operation was performed: osteotomy of the cranial bones, 2 distraction apparatuses for bilateral distraction, according to this invention, were installed.

Performed distraction of the occipital region according to the protocol: the size of the distraction is 38 mm, with a frequency of 1 mm per day. Distraction suffered satisfactorily. Bilateral distraction apparatuses were removed 8 weeks after retention was completed.

With distraction, manifestations of intracranial hypertension (increased intracranial pressure) were completely resolved. The child quickly began to acquire psychomotor skills. The shape of the skull has changed for the better, the transverse dimensions of the skull have increased due to the parietal tubercles.

This operation and method of treatment illustrates an example of the use of the claimed invention.

The use of the claimed device allowed to reduce the number of distraction apparatus used. Due to this, it was possible

- reduce the risk of intersection of the distraction vectors of each apparatus, respectively, reduce the likelihood of jamming of the axis of the apparatus in the thread, the displacement of the apparatus relative to the bone;

- reduce the risk of asymmetry during the extension of the parietal bones;

- reduce the morbidity of the operation and the risk of damage to the dura mater during the installation and fixation of devices with microscrews;

- reduce the likelihood of infectious complications due to a decrease in the number of wounds on the skin through which the driveshafts of the devices come to the surface;

- reduce the cost of treatment.

In addition, the device of the devices is provided with a hinge transmission, which allows the device to change shape while maintaining the axis of distraction, in accordance with the movement of the edge of the movable bone fragment in an arc (like an opening door).

The transverse protrusions are fixed to the plates of the apparatus with the possibility of rotation of the lead screw, which reduces the possibility of jamming of the axis of the apparatus in the thread of the transverse protrusion, or displacement of the apparatus relative to the bone with an increasing gap between the bones.

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

Claims (8)

1. A compression-distraction apparatus for bilateral distraction, including three plates, an axis and two lead screws, one of the plates is designed to connect to the fixed part of the skull, and the plates located on both sides of it are designed to connect to the moving parts of the skull, a plate designed for connection with the fixed part of the skull, has a transverse protrusion with a through hole oriented along the plane of the plate for the axis with the possibility of its rotation around the longitudinal axis, the plate is designed which are connected to the fixed part of the skull, each have a transverse protrusion with threaded holes for the lead screw, while the threads have a different direction, said transverse protrusions are located on the side opposite to the side intended for contact with the parts of the skull, and each plate is equipped with means for connecting the plate with a part of the skull, the lead screws are connected to the ends of the axis by means of articulated couplings with intersecting axes at an angle of not more than 45 ° and are mounted with the possibility of rotation of their axes according the plate in two planes - horizontal and vertical, passing through the longitudinal axis of the transverse protrusion of the corresponding plate. 2. The device according to claim 1, characterized in that each lead screw is mounted with the possibility of rotation of their axes on the corresponding plate in two planes - horizontal and vertical, passing through the longitudinal axis of the transverse protrusion of the corresponding plate by the fact that the transverse protrusion is made integral and contains a sphere-shaped body with a through threaded hole inside for screwing in the lead screw and a transverse guard rigidly fixed to the plate, the sphere-shaped body being placed in the transverse enclosure AI with the ability to rotate in two planes - horizontal and vertical. 3. The device according to p. 2, characterized in that the transverse fence is a hollow cylinder, one end of which is closed by a transverse plate, and the other by a lid, through holes in the side wall of the cylinder opposite each other are made for the lead screw and its rotation in the transverse the plate and the lid have spherical indentations for accommodating a spherical body in the cavity of the hollow cylinder, the indentation of the spherical shape of the lid has a groove on the spherical surface and the spherical body has a protrusion that is placed in the groove. 4. The device according to p. 3, characterized in that the protrusion of a sphere-shaped body has a cylindrical shape. 5. The device according to p. 3, characterized in that the cover is welded to the end of the cylinder. 6. The device according to p. 1. characterized in that the means for connecting the plate to the skull bone contains a screw and a through hole in the plate. 7. The device according to p. 6, characterized in that it has additional means of connecting the plate with the skull bone in the form of a transverse protrusion for insertion into the cut between the bones along the line of the osteotomy. 8. The device according to claim 1, characterized in that the plate for connecting to the fixed part of the skull is designed for the area with the overgrown sagittal - swept suture of the skull in the central part, and a pair of plates for connecting to the moving parts of the skull is designed for the parietal and / or partially temporal , and / or partially frontal and / or occipital bone.

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