WO2017156601A1

WO2017156601A1 - High-precision bone realignment system

Info

Publication number: WO2017156601A1
Application number: PCT/BR2016/050054
Authority: WO
Inventors: Cristiano Hossri Ribeiro; Mauricio Sante Bettio MOD; Daniel Ernst
Original assignee: Cristiano Hossri Ribeiro; Mod Mauricio Sante Bettio
Priority date: 2016-03-14
Filing date: 2016-03-14
Publication date: 2017-09-21

Abstract

A new high-precision bone realignment system is composed by a plate and a plate opening device, for use in human or animal bone angle correction surgery, also known as osteotomy. This system comprises a millimetric mechanical device for angle corrections that require opening wedges and can be used in various bones. The system makes continuous corrections of bone deformities possible on a millimetric scale, dispenses with steps of the conventional procedure and increases the safety and accuracy of the surgical procedure. Besides being less invasive than the conventional method, it allows other procedures to be performed during the same surgical intervention, such as ligament reconstruction and treatment of cartilage and meniscus injuries in the case of the knee joint.

Description

FIELD OF THE HIGH CONTROL BONE REALIGNMENT SYSTEM

[001] This report describes the detailed description, accompanied by illustrative figures, of a new high-control bone realignment system, which is comprised of a plate and plate opening device for use in bone correction surgery, human or animal, also called osteotomies. Such system has mechanical millimeter mechanism for angular corrections that require opening wedges and can be used in several bones. The system allows continuous and millimeter correction of bone deformity, suppressing steps of the conventional procedure and adding safety and accuracy to the surgical procedure. In addition to being less invasive than traditional, it also allows other procedures to be performed at the same time as surgery, such as ligament reconstruction, cartilage treatments and meniscal injuries in the case of the knee joint.

[002] This system consists of a single plate with proximal shims and a continuous linear sliding mechanism device that engages the plate. The system works together at the osteotomy site allowing its opening and closing according to the desired angular correction in the opening wedge osteotomy surgeries. This system allows a millimeter correction of bone deformity, facilitating the surgical procedure, reducing the time of corrective surgery and reducing the risks of inaccurate correction.

State of the art

There are some patent documents that describe techniques and devices and mechanisms for correcting malformations of body bone misalignment, but none of these devices or mechanisms have the configuration and function as described in this patent. These documents include the following:

[004] Document PI 0710079-5, BONE BOARD, METHOD FOR PERFORMING A TIBIAL PLATON LEVEL OSTEOTOMY PROCEDURE, AND, TIBIAL PLATON LEVEL OSTEOTOMY KIT, which describes an improved Tibial plateau leveling osteotomy is exposed. The plate is contoured in its proximal head portion to more closely resemble the structure of the tibial bone segment that is cut and rotated during the procedure. The plate also preferably has screw holes in the proximal head portion, which are machined through the pre-contoured proximal head portion, and are configured to form an angle of the screw in a target screw path with respect to osteotomy;

[005] Document MU 8900220-2, FIBERAL AND FEMORAL FIXING SYSTEM WITH ADDITION OSTEOTOMY, which describes a device used especially for the fixation of corrective addition osteotomy of the valgus and knee varus angular deviations, which comprises a structure T-shaped bone plate (1) has rounded profiles and an anatomical shape for both the Tibia (2) and the Femur (3), with a defined thickness where a series of holes, and in the horizontal projection there are holes (4), which promote the fixation of the cancellous screw (5); In the central vertical region there is an oblong hole (6) where it is fixed by screw (6A) of the adjustable shim (7), followed by other distal holes (8) with thread that promote the fixation of the cortical locking screw (9). ; In the Tibial Fixation System (2) its configuration and its design follow the plastic shape of the tibia, and in the Femoral Fixation System (3) its configuration and its design follow the plastic shape of the femur, its holes for fixation of the tibia. screws may vary according to the need for fixing;

[006] Document BR 1 12012000387-9 (WO201 1005327) OSTEOTOMY BOARD, CONDUCTING BOARD AND METHOD FOR USE, which describes an orthopedic plate configured specifically for use in osteotomies, where part of the plate extends to a portion of A first bone segment and part is external to the cortical surface of an adjacent bone segment to secure the segments to allow them to fuse together. The plate has a first end and a second end where the end that is inserted into the bone has a bevel and a through hole having a hole axis, optionally at an angle to the longitudinal axis of the plate, and which may receive a screw. , handle or pin. THE The second end of the plate includes a locking screw hole and optionally including a compression slot extending in one direction to a screw hole at the opposite end. A plate controller having a recess holding the plate is used to insert the plate into the bone; and

[007] Document BR 1 1 2012 010733 0 (WO201 1055353), MULTI-ADJUSTABLE OSTEOTOMY PLATE, where the invention relates to a mechanical device for correcting a malformation of the bones of the body. The device is continuously adjustable, making the surgeon's job easier and reducing surgery time, thereby reducing the risk of infection and, above all, ensuring the desired precision for surgery. The device comprises a top plate (1) suitable for sliding over a bottom plate (2) by means of a guide (7). The plates of said device may be screwed to either side of an angular notch made in the bone. The plates respectively comprise: top (5) and bottom (6) bone notch bearings. Said bearings form an acute angle chamfer which substantially corresponds to the notch surfaces. One of the plates is provided with a set screw (4) for continuous adjustment of relative positions of the plates. The device also comprises a lock screw (3) suitable for maintaining the open position of the device and, consequently, the final angle of the bone notch in the desired position. The upper bearing of the angled bone adjustment notch is suitable for correcting the angle of the beveled surface of the bearing, in particular the inclination of the tibia, by means of a tapered screw (8) adjusting an angular space of the bearing.

State of the art problem to solve

[008] In BR 1 1 2012 010733 0 for application to the femur and tibia, a device comprising an upper plate that slides vertically on a lower plate is described, the two plates having orthogonal wedges that take up the notch made in the tibia. The lower plate has side guides that allow the upper plate to slide, which is effected by an adjusting screw that derives from the lower plate. A second locking bolt holds the plates in the chosen opening. for that procedure. In this patent the surgical procedure consists of making the tibial notch, positioning and fixing the upper plate and the lower plate on both sides of the bone and then retract with the adjustment screw. The coupling system of the two parts of the first plate is more unstable and more difficult to fix. This increases the risk of loss of the desired correction for the operated limb; since two components must be well fixed to each other and also to the bone.

[009] This patent uses two plates that have some drawbacks in their adjustment and placement, which may have subsequent consequences for the patient. The multi-adjustable plate, object of the present invention has only one plate, solving all the above mentioned drawbacks. In the plate of the present invention, only one component is fixed and remains in the bone. Opening is performed by an opening and closing instrument that engages with the fixed plate. But, after setting the desired (opening) wedge, this equipment is removed; and only one material (plaque) remains attached to the bone; eliminating the point of instability that existed in the coupling for both parts of the plate.

Description of the figures

[010] The following are references to the figures accompanying this descriptive report, for a better understanding and illustration of it, in an illustrative and non-limiting way:

Figure 1 shows the schematic view of the high control bone realignment system, showing its use in two different situations;

Figure 2 shows the perspective view of the high control bone realignment system in the assembled situation, highlighting all its configuration details;

Figure 3 shows the front view of the high control bone realignment system showing its use with minimal adjustment, highlighting a tibial osteotomy as an example of utilization;

Figure 4 shows the frontal view of the high control bone realignment system, showing its use with intermediate adjustment, highlighting a tibial osteotomy as an example of use.

Brief Description of the Invention [01 1] The following is a non-restrictive preferred embodiment of the present high control osteotomy bone realignment system, object of this patent, where the configuration and dimensions may vary in the appropriate form for each desired model and application; describing one of the constructive possibilities that lead to the concretization of the object described and the way it works.

[012] The high control bone realignment system, object of the present invention, is a set consisting of a single plate (1) and an opening device (5), with the plate showing proximal shims (2), and a central slot (3) to be traversed by the wedges (4) of the wedging opening device (5) (4), and which functions as a vise, applying an axial force to the bone to open a bone wedge, having the set screw (6) engaged promotes movement between the shims (2 and 4) to the desired angle in the notch made in the bone.

Description of the invention

More precisely the high control bone realignment system, object of the present patent, is a multi-adjustable plate assembly by means of an opening device (5), with the osteotomy plate configured by a single plate. (1) with at least one respective proximal wedge support (2), which works in conjunction with the opening device (5) with continuous linear sliding mechanism, also provided with at least one wedge support (4), which slides in the central slot (3) of said single plate (1) by driving an adjusting screw (6), applying an axial force to the bone, thereby distancing and / or approximating the distance between the shims (2 and 4) so A sliding force is applied by applying a force to the wedges which can be adjusted by means of a millimeter ruler (7) running through a guide (8) located on the body (9) of the opening device (5), which also includes a fastening means. (10) to the single plate (1), the l allows a range of openings according to bonesize and / or medical indication, ranging from at least 0 to 20 mm. The single plate (1) forms a joint splint, and has at least two proximal wedge shims (2) in its upper third, in addition to the central tear (3) and holes for permanent fixation (11) to the bone. the most extreme upper hole also serves for connecting the movable fastening means (10) of the opening device (5).

Where bone screws (10,12) with or without locking mechanism may be applied to the movable side of the plate in the final alignment position according to planning, navigation or control surgery.

The opening device (5) has the same principle of operation of a vise, being formed by a body (9) with a guide (8) traversed by a millimeter ruler (7), at whose end is located by at least one movable wedge bracket (4) which can be moved by actuating the adjusting screw (6) through the body (9), from which the fastening means (10) to the plate (1), consisting of a pin, is derived. (12) with thread compatible with the upper hole of the plate.

[016] The procedure for the placement of the multi-adjustable plate comprises, in the femur / tibial direction, the previous fixation of the upper side of the single plate (1) in the notch made in the tibia by the wedge shims (2) attached to the bone, and connecting the opening device (5) with the shims (4) inserted into the central groove (3) in a dimension that provides alignment with the shims (2), allowing an axial force to be applied to the bone to open a bone wedge. Once this is done, the adjusting screw (6) is turned to move the wedge movable wedges (4) from the wedge fixed wedges (2) to the desired opening limit by moving the wedges so as to apply a force on them. they move them away by the desired distance. When the underside of the single plate (1) is fixed, the opening device (5) is removed and the fixing is completed by placing and tightening the screws in the holes (11) to the bones, where the bone screws can be applied without removing the opening device.

Thus, the high control bone realignment system, object of the present invention, provides for the use of a single plate (1) associated with a sliding opening device (5) in a central slot of said single plate, which presents proximal wedges such as the wedges of the opening device which, as already commented, slide in the central groove thereof, such that, by turning the adjusting screw (6) of said opening device, there is a gap between the wedges (2 , 4) until reaching the desired final angle in the bone notch. The opening device has the principle of a vise, but with only one jaw represented by a millimeter sliding bracket with millimeter or inch markings indicating the distance between the wedges and which is equivalent to the opening of the wedges and can be used to measure alignment , since the distance is equivalent to the bone correction angle. The millimeter ruler slide bracket is positioned in a guide in the body of the opening device, which also includes the adjusting screw, and the means of attachment to the single plate.

[018] In the high control bone realignment system, object of the present patent, the plate (1) and opening device (5) unite via positive / non-positive connection before surgery, and disconnect after performing the procedure. opening and fixing the plate. Both components have one or two shims on each component depending on where they are used. The shims on the plate are fixed while those on the opening device are movable. These shims adhere to the bone and allow axial force to be applied against the bone to promote bone opening, thereby establishing a wedge in the bone whose angular opening will promote bone alignment.

[019] The system is an active part of bone realignment. The sliding opening mechanism may be on the plate, in one plane, or on a different plane of the plate to meet different technical needs and access routes. The opening device has a safety lock that prevents unintentional closing of the wedge during the opening maneuver. However, the wedge can be closed (decreased) voluntarily by operating the sliding opening mechanism in the opposite direction.

[020] The opening device has graduation in millimeters or inches to indicate the distance of the spacers, which equals ^x opening wedge. Shim opening can be used to measure alignment since the distance equals ^x bone correction. The system allows for a correction interval appropriate to the size of the bone and the need for medical indication, eg 0 to 20 mm for knee osteotomies.

[021] The plate should be fixed above and below the bone cut. The number of holes available for mounting depends on where the card is used. THE Fixation of the plate to the bone can be done with screws with or without locking mechanism, because their holes can be threaded or not. One end of the plate can be clamped before the opening of the wedge is initiated, which provides greater security for this step. For this purpose, it is not necessary to disconnect the instrument from the board.

[022] Once the desired end position of bone correction and alignment is reached, the other end of the plate is fixed. Once the plate has been secured, the opening device can be disconnected without changing the position of the plate and the alignment achieved. In addition, the fixed part of the system may be proximal or distal to the bone according to medical need, and there is no impediment on the part of the system to limit its orientation (Figure 1).

[023] Also with regard to the refinement of bone correction, the system not only allows the use of navigation, but also allows its full operability and efficiency, since the opening of the bone is continuous and millimeter.

Benefits

[024] Thus, the high control bone realignment system, object of the present patent, as described above, presents a new and unique configuration that gives it great advantages over the osteotomy devices, plates and elements currently used and found in the present study. market. These advantages include: greater stability to perform bone correction during the opening of the wedge, and fixation after the completion of the procedure; the fact that it has only one component that is fixed and remains in the bone, which eliminates the point of instability existing at the interface of the pieces when using two plates or other devices; the fact that, after defining the wedge (desired end angle), the opening device is immediately removed with only the plate remaining; provide reduction of surgical procedure time; and provide greater accuracy with the millimeter aperture system. In addition to the advantages of providing greater stability to perform bone correction during the opening of the wedge, with greater accuracy, and with the reduced risk of loss of correction. [025] Thus, from the configuration and operation characteristics described above, it can be clearly noted that the HIGH CONTROL BONE REALIGNMENT SYSTEM is a new state of the art device which is subject to innovation, inventive activity and unprecedented industrialization, which earn it the Privilege of Invention Patent.

Claims

CLAIM

1 - HIGH CONTROL BONE REALIGNMENT SYSTEM, a system for use in bone, human or animal angular correction surgeries, also called osteotomies, characterized by being a multi-adjustable plate assembly through an opening device (5), which connect via a positive / non-positive connection prior to surgery, with the osteotomy plate configured as a single plate (1) with at least one proximal wedge support (2), which works in conjunction with the opening device ( 5) with continuous linear sliding mechanism and a safety lock, also provided with at least one wedge support (4), which slides in the central slot (3) of said single plate (1) by the actuation of an adjusting screw ( 6), applying an axial force on the bone, thereby distancing and approximating the distance between the shims (2 and 4) continuously sliding by applying an axial force on the wedges, which can be adjusted by means of a graduated millimeter ruler (7) running through a guide (8) located on the body (9) of the opening device (5), which also includes a means of attachment (10) to the single plate (1), which allows a range of openings according to bonesize and / or medical indication; where the single plate (1) forms a joint splint, and has at least two proximal wedge shims (2) in its upper third, in addition to the central tear (3) and the permanent fixation holes (11) to the bone, wherein the most extreme upper hole is also for connecting the movable fastening means (10) of the opening device (5); wherein the opening device (5) is formed by a body (9) provided with a guide (8) traversed by a millimeter ruler (7), at whose end is located at least one support (4) capable of movement with the drive from the adjusting screw (6) through the body (9), from which the fixing means (10) is composed of a screw (12) with a thread compatible with the upper hole.