WO2018084598A1

WO2018084598A1 - Method for producing protection plate for spinal surgery

Info

Publication number: WO2018084598A1
Application number: PCT/KR2017/012328
Authority: WO
Inventors: 염진섭; 김남국; 최승현
Original assignee: 서울대학교병원; 재단법인 아산사회복지재단; 울산대학교 산학협력단
Priority date: 2016-11-04
Filing date: 2017-11-02
Publication date: 2018-05-11
Also published as: KR101882097B1; KR20180050458A

Abstract

The present invention relates to a method for producing a protection plate for spinal cord surgery, which is used to protect nerves exposed from a damaged vertebra or the missing part of a vertebra removed during surgery. The method for producing a protection plate for spinal surgery, according to the present invention, comprises the steps of: (a) preparing a flat protection plate; (b) heating the protection plate to have increased ductility; (c) placing the heated protection plate on a template having a curved surface, and transforming same into the shape of the template; and (d) cooling the protection plate to maintain the convexly bent transformed shape.

Description

How to make protective plate for spinal surgery

The present invention relates to a method of manufacturing a protective plate for spinal surgery, more specifically, a sufficient amount of protection while protecting the nerves exposed in the damaged or removed bone defects when the vertebrae are damaged or partly removed during spinal surgery A method of making a spinal surgical protective plate used for implanting bone or similar bone union materials.

When the vertebrae are damaged by trauma or tumors, or some of the vertebrae are removed during spinal surgery, the nerves in the vertebrae are exposed to the outside. In this case, the bone or similar materials for bone fusion are implanted for the reconstruction and fusion of the bone, which should be done while protecting the nerves exposed to the outside.

Conventionally, vertebral bone graft surgery protects nerves by fixing a wide plate-shaped autogenous bone obtained from the hip bone of a patient to a structure such as a spinal rod, using a binding means such as thread or wire, and protecting the nerve. The implantation process was performed by additional implantation of bone grafts (BG) from the patient's hip bone.

However, the process of collecting and processing the autologous bone is complicated, and if the defect is large, there may be a problem in that the autologous bone of a sufficient size (a wide-bone autologous bone) cannot be secured. In this case, a vertebral bone graft was performed using a plate replacing the autologous bone in the form of a wide plate.

When a spinal graft is performed using a plate, a plate in the form of a plate is conventionally used. In the case of using a plate, the plate of the upper graft is pressed by the force of the plate to press the plate to compress the nerves, thereby causing pain or paralysis. Since it could be caused, it was necessary to fix it by a strong fixing means made of hard metal so as to resist the pressing force.

In the case of conventional flat plates, tension must be used to resist the pressing force in the orthogonal direction, which is a very inefficient method and does not work well. That is, because the plate-type plate to be fixed by a strong fixing means during the operation, the operation takes a lot of time and the problem that the operation process is complicated. In addition, when the plate is made of a metal material, artificial shade occurs during computed tomography (CT) or magnetic resonance imaging (MRI) after spinal surgery, which makes it impossible to accurately observe tissues around the metal including nerves. Problems also occurred.

In order to solve this problem, if a protective plate for spinal surgery is made of polymer material and has a convex curved shape with an arcuate shape, it can be easily fixed in a non-fastening manner by being supported on a fixture so that both ends of the curved sheet do not spread. I can strongly support the force that the bone presses. In addition, it is also formed of a polymer material can solve the problem caused by artificial shading during CT or MRI imaging.

Hereinafter, the present invention is to propose a method that can be easily produced during the operation of the protective plate for spinal surgery as described above.

Therefore, an object of the present invention is to solve such a conventional problem, it is convex shape and can be fixed by being supported on the fixture so that both convex ends do not open, it is easy to install in a non-fastening manner and the plate is in contact with the nerves It is to provide a method of manufacturing a protective plate for spinal surgery that can be produced in a simple manner by a template having a convex or concave shape during the operation of the spinal surgical protective plate so as not to.

Problems to be solved by the present invention are not limited to the above-mentioned problems, and other problems not mentioned will be clearly understood by those skilled in the art from the following description.

The object of the present invention is a method of making a protective plate for spinal cord surgery used for implanting bone and similar bone union materials while protecting nerves exposed to damaged vertebrae or defects of vertebrae removed during surgery. As regards the present invention, comprising the steps of: (a) preparing a template; (b) heating the planar protective plate to increase ductility; (c) seating the heated flat protective plate on the template and deforming according to the shape of the template; And (d) cooling the protective plate to maintain the deformed shape.

Here, the shape of the template may be a shape of a curved surface convex or concave in one direction.

Here, the shape of the template may be a shape in which a plurality of surfaces convex or concave bent in one direction are formed.

Here, before step (a), the method may further include obtaining a spine image of the patient, and in step (a), the template may be prepared according to the characteristics of the affected part including the spine shape obtained by analyzing the image. have.

Here, the step (a) is the step of designing the template according to the characteristics of the affected area including the spine shape obtained by analyzing the image; And manufacturing the designed template with a 3D printer.

Here, the protective plate may be formed of a polymer.

Here, the protective plate may be formed of a bioabsorbable material.

Here, the planar protective plate may be formed in a mesh structure.

Here, the flat protective plate may be manufactured by a 3D printer.

Here, the template may have a convex or concave curved shape even in a direction perpendicular to the one direction.

Here, the protective plate for spinal surgery is supported and fixed so that both convex ends are not extended to the structure formed around the vertebrae, it may further comprise the step of cutting the protective plate for spinal surgery according to the shape of the structure. .

Here, the flat protection plate may be heated using hot water in the step (b).

Here, in step (d), the protection plate may be cooled using cold water.

According to the manufacturing method of the protective plate for spinal surgery of the present invention as described above has the advantage that can be produced a protective plate for spinal surgery having a convex cross-section in a simple manner according to the spine shape and affected part of the patient during surgery.

In addition, since it can be manufactured using a polymer material, an artificial shade does not occur during CT (computed tomography) or MRI (magnetic resonance imaging) imaging after surgery.

1 is a perspective view of a protective plate for spinal surgery manufactured according to the present invention.

Figure 2 is a perspective view for explaining the concept that the protection plate for spinal surgery produced according to the present invention is fixed to the affected part.

3 is a perspective view showing a state in which the protective plate for spinal surgery of Figure 1 is fixed to the vertebrae.

Figure 4 is a perspective view of the spinal cord surgical plate is separated in FIG.

5 is a flow chart of the manufacturing method of the protective plate for spinal surgery according to an embodiment of the present invention.

FIG. 6 is a view sequentially showing a process according to FIG. 5.

Figure 7 is a perspective view showing another form of the protective plate for spinal surgery produced in accordance with the present invention.

FIG. 8 is a perspective view illustrating a state in which the protection plate for spinal surgery of FIG. 7 is fixed to the vertebrae.

9 is a perspective view showing another form of the protective plate for spinal surgery produced in accordance with the present invention.

Details of the embodiments are included in the detailed description and drawings.

Advantages and features of the present invention and methods for achieving them will be apparent with reference to the embodiments described below in detail with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but can be implemented in various different forms, and only the embodiments make the disclosure of the present invention complete, and the general knowledge in the art to which the present invention belongs. It is provided to fully inform the person having the scope of the invention, which is defined only by the scope of the claims. Like reference numerals refer to like elements throughout.

Prior to the description of the manufacturing method of the protective plate for spinal surgery according to an embodiment of the present invention, the protective plate for spinal surgery manufactured according to the present invention will be described first with reference to FIGS.

1 is a perspective view of a protective plate for spinal surgery manufactured according to the present invention, Figure 2 is a perspective view for explaining the concept that the protective plate for spinal surgery manufactured according to the present invention is fixed to the affected part, Figure 3 is Figure 1 Figure 4 is a perspective view showing the spinal surgery protection plate is fixed to the vertebrae, Figure 4 is a perspective view of the spinal cord surgical protection plate is separated from FIG.

Protective plate 100 for spinal surgery produced according to the present invention is to protect the nerves exposed to the defects of the vertebrae 200 during spinal surgery, the defects of the vertebrae 200 so that the nerves are not exposed to the outside The site is fixed to cover using the protective plate 100, and the bone fragments or similar bone fusion materials taken from the bone of the patient is implanted on the upper portion of the protective plate 100. That is, the protection plate 100 serves to protect the nerve tissue exposed by the bone graft or similar materials for bone union when performing the implantation process to obtain bone union while complementing the missing bone.

Protective plate 100 for spinal surgery produced according to the invention is characterized in that it has a convexly curved shape in one direction as shown in FIG. At this time, the cross-sectional area convexly curved in the direction perpendicular to the longitudinal direction of the vertebrae 200 to surround the vertebrae 200 has an arcuate shape.

In addition, the protective plate 100 may be formed in a mesh structure, as shown in Figure 1, by the mesh structure can prevent the graft bone to slide and move when the graft bone is implanted thereon, the grating The load-bearing performance can be improved by adjusting the spacing between them and the thickness of the grid.

At this time, the protection plate 100 for spinal surgery produced according to the present invention can be fixed to surround the vertebrae 200 in a non-fastening manner without a separate fastening means. Since the shape of the protective plate 100 is convex upwardly convex, if the protective plate 100 can be supported so as not to be unfolded by a load pressed from above by the graft bone, the protective plate 100 is a defective portion of the vertebrae 200. Can be fixed at

FIG. 2 is a diagram illustrating this concept, by which both ends of the protection plate 100 are supported by the fixtures 170 formed on the left and right sides of the convexly curved protection plate 100 so that the protection plate 100 is additionally fastened. It can be fixed stably without. As a fixture 170 supporting the protective plate 100, a spinal screw 115, which is used for fixing the spine, may be used, which will be described later with reference to FIG. 3.

When the protective plate 100 is formed in a flat shape, it must be strongly fixed with a hard material to support the load by the upper graft bone. However, if the cross section, such as the protective plate 100 of the present invention has a curved shape convex upward convex, the curved plate 100 will not be able to be unfolded if it only resists the force pushing to the side in the direction to be unfolded. That is, if it can only resist the force to be extended to the side can be structurally strong resistance to the force pressing the plate 100 by the graft. As described above, the flat plate has to be fixed with a strong tension to resist the force pushed by the graft bone from the top, but as shown in FIG. 1, the convex plate 100 may resist the pushing force to the side. With enough support, you can resist the pressure from the top. This simplifies the surgical process and dramatically shortens the operation time.

As shown in FIG. 3, during spinal surgery, spinal fixation screws 115 are often used on both sides, and the spinal fixation screws 115 may support the protective plate 100 on both sides. In more detail, both ends of the protective plate 100 which is bent upwardly convex in the neck of the spinal fixing screw 115 may be positioned so that the protective plate 100 may not be extended from side to side. Since both ends of the protective plate 110, which are convex and curved upward, are supported by contact with a neck of the spinal fixing screw 115, the protective plate 100 can be easily fixed to the affected part.

In addition, as the protection plate 100 is bent upwardly convex, when the protection plate 100 is fixed as shown in FIG. 3, spaces between the nerves covered by the protection plate 100 and the protection plate 100 may be formed. There is a number. Therefore, the protective plate 100 does not touch the nerve during spinal surgery, so the protective effect of the nerve is excellent.

3 illustrates an example in which the protection plate 110 is supported by a neck just below the head of the spinal screw 115, but in some cases, the spinal screw 115 is located below the spinal screw 115. Of course, the protection plate 110 may be supported on the body portion of the body, or may be supported by the spinal rod 110.

When fixing the protective plate 100 using the spinal fixing screw 115, the neck of the spinal fixing screw 115 is attached to the protective plate 100 as shown in FIG. 4 so as to further strengthen the fixing force. The groove 105 may be formed at a predetermined position corresponding to the spinal screw 115 at both ends of the protective plate 100 so as to surround the protective plate 100. Therefore, since the groove 105 of the protective plate 100 is inserted into and inserted into the neck of the spinal screw 115, the fixing force of the protective plate 100 can be further strengthened.

In the description with reference to FIG. 3, the fixing plate 100 is fixed by supporting both ends of the protection plate 100 using the spinal fixing screw 115, but a separate screw, nail, and spike are described. Fixing device 170, such as back to the vertebrae to support both ends of the protective plate 100 by using it to secure the protective plate 100, the protruding portion of the bone formed around the protective plate ( The protection plate 100 may be fixed by supporting both ends of the 100.

Hereinafter, a method of manufacturing a protective plate for spinal surgery according to an embodiment of the present invention will be described with reference to the drawings.

5 is a flow chart of a method of manufacturing a protective plate for spinal surgery according to an embodiment of the present invention, Figure 6 is a view showing the process according to Figure 5 in sequence, Figure 7 is a spinal surgery produced according to the present invention Figure 8 is a perspective view showing another form of the protective plate, Figure 8 is a perspective view showing a state in which the protective plate of the spinal surgery of Figure 7 fixed to the vertebrae, Figure 9 is a protective plate for spinal surgery produced according to the present invention It is a perspective view which shows another form of.

Method of manufacturing a protective plate for spinal surgery according to an embodiment of the present invention comprises the step of preparing a template 500 (S310), heating the flat plate (100a) (S320), heated protective plate (100a) ) May be included in the template 500 to be deformed (S330), and to cool the deformed protective plate 100 (S340). In addition, cutting the protection plate 100 may further include a step (S350).

In order to manufacture the convex spine surgical protection plate 100 as shown in Figure 1, to prepare a template with a curved surface (S310).

Template 500 may be prepared in various forms in advance according to the size of the protective plate 100, the shape of the curved surface to be made in advance to select the appropriate template 500 according to the characteristics of the affected part, but in the present invention It can be produced considering the characteristics of the affected area directly during surgery. Here, the characteristic of the affected part may mean the shape of the spine 200 of the patient, the location of the affected part, the size of the affected part, and the like.

During surgery, the patient's spine 200 can be acquired by using a medical imaging device and analyzed to determine characteristics of the patient's own spine 200, and information about the location of the affected part and the size of the affected part can also be identified. .

Next, when the information on the characteristics of the affected part including the shape of the spine 200, the location of the affected part and the size of the affected part is grasped, based on this, the protective plate 100 for spinal surgery in which the size, curvature, etc. of the protective plate is reflected. Can be designed in 3D. Thus, by designing a template having a curved surface corresponding to the shape of the designed protective plate in 3D, it is possible to produce a custom template directly during surgery using a 3D printer according to the 3D design.

Next, the flat plate protection plate (100a) is heated to increase the ductility to facilitate the deformation of the shape (S320).

Protective plate 100 for spinal surgery according to an embodiment of the present invention may be made of a non-metallic material containing a polymer. When using metal materials, artificial tones may occur during computed tomography (MRI) or magnetic resonance imaging (MRI) after spinal surgery, resulting in inability to accurately control nerves and surrounding tissues. There is an advantage that such artificial shading does not occur when using a non-metallic material. More preferably, the protective plate 100 according to the present invention may be formed of a bioabsorbable material such as PCA, PVA, PDS, PLA, PDA, PLDLA.

When formed of a polymer material can be easily cut with a surgical scissors, it is possible to cut the protective plate 100 according to the size of the surgical site during surgery. Therefore, as described above with reference to Figure 4, when fixing the protective plate 100 to the surgical site, the groove 105 for inserting the neck of the spinal fixing screw 115 is to determine the position during surgery for surgery It may be formed by cutting with scissors. This will be described later.

In addition, a mesh structure may be formed on the flat protective plate 100a as shown in FIG. 6. The spacing, size and shape of the mesh can be adjusted as described above.

In the present invention, the flat protective plate 100a including the mesh structure can also be manufactured using a 3D printer (not shown) during surgery. When preparing the flat protective plate 100a using a 3D printer (not shown), the size of the flat protective plate 100a and the shape of the mesh structure according to the size of the vertebrae 200 of the patient, the position of the affected part, etc. The back can be designed and manufactured directly at the surgery site. In the present invention, the flat plate type protection plate 100a is not limited to being manufactured and prepared directly during surgery using a 3D printer (not shown), and may be prepared in advance by various known methods.

As described above, since the protective plate 100 is formed of a polymer material in the present invention, when the prepared flat protective plate 100a is heated, it may be deformed to increase ductility. At this time, the hot water 410 may be used as a method of heating the flat plate-shaped protection plate 100a, but is not limited thereto. When the hot water 410 is used, the flat plate type protection plate 100a may be dipped in a warm water 410 heated at an appropriate temperature for a predetermined time, as shown in FIG. 6.

At this time, it is important to control the temperature of the hot water 410, if the temperature of heating the plate-type protection plate 100a is too high, the ductility of the plate-type protection plate 100a becomes too large to handle, and if too low deformation is It may not happen easily. In addition, the temperature can be changed according to the material of the polymer, etc., when the production using the PCL (Poly-Caprolactone), the experimental results showed that the optimum results in the range of 55 ℃ ~ 60 ℃.

Next, the protection plate 100a, which is heated and ductile, is seated on the template 500 having the prepared curved surface, thereby deforming the shape of the protection plate 100a according to the shape of the template 500 (S330). The shape of the template 500 may be a shape convexly curved in one direction as shown in FIG. 6, but is not limited thereto. In the above-described step, when the flat protective plate 100a is heated and seated on the convex curved template 500 in a state of ductility, the shape of the protective plate 100 can be easily deformed according to the shape of the template 500. have.

As in the above-described step, the heated protective plate 100a is seated on the template 500 to cool and deform the protective plate 100 in a state where the shape of the protective plate 100 is deformed according to the shape of the template 500. The shape can be maintained (S340). In this case, the protection plate 100 may be exposed to the atmosphere to use natural cooling. Preferably, the cold water 420 or cold water 420 is supplied to the template 500 while the protection plate 100 is seated. ), The protection plate 100 can be cooled.

Cooling the deformed protective plate 100 in the state seated on the template 500 as described above to maintain the deformed shape, by using the protective plate 100 in the neck of the spinal fixing screw 115 as shown in FIG. ) Can be easily fixed in a non-fastening way. In this case, as described with reference to FIG. 4, a hole 105 into which the neck is inserted may be formed in the protection plate 100 so as to further strengthen the fixing force (S350). Therefore, in consideration of the position to be mounted on the surgical site, the hole 105 can be formed by cutting using surgical scissors during surgery.

5 and 6 is a method of manufacturing a protective plate for spinal surgery according to an embodiment of the present invention described above with reference to FIGS. 5 and 6 can be simply made during the operation, can be actively produced during the operation according to the characteristics of the affected part of the patient .

As shown in FIG. 7, the protection plate 100 for spinal surgery manufactured according to the present invention is convexly curved in a direction perpendicular to the longitudinal direction of the vertebrae 200 and at the same time in the longitudinal direction of the vertebrae 200. It may also be formed to be convexly curved. That is, the rectangular flat plate-shaped protection plate 100a may be convexly curved in the horizontal and vertical directions, respectively. In this case, as shown in FIG. 8, a space formed between the vertebrae 200 and the convex bent protection plate 100 in the longitudinal direction of the spine may prevent foreign substances from entering during surgery. As convexly curved, the features that can strongly support the load on the top and the features that can be easily fixed in a non-fastening manner are the same as the above.

In the present invention, simply preparing a template 500 to correspond to the shape of the protective plate 100 of FIG. 7, the protective plate 100 for spinal surgery according to the present invention by the method described with reference to FIGS. 5 and 6. Can be produced. Therefore, in the present invention, the protection plate 100 for spinal surgery of various shapes can be manufactured during surgery without being limited to the above-described shape.

In another shape of the spinal surgical protective plate 100 is produced in accordance with the present invention, as shown in Figure 9, the protective plate 100 is a spine of the quadrangular surface so that the convex cross-section is convex polygonal shape It may be a shape bent in the plural in the longitudinal direction of the bone 200. Accordingly, by preparing a template 500 having a shape in which a plurality of curved surfaces are formed in one concave or convex shape corresponding to the shape of FIG. 9, and for the spinal surgery of FIG. 9 by the method described with reference to FIGS. 5 and 6. The protective plate 100 can be manufactured.

The scope of the present invention is not limited to the above-described embodiment, but may be embodied in various forms of embodiments within the scope of the appended claims. Without departing from the gist of the invention claimed in the claims, it is intended that any person skilled in the art to which the present invention pertains falls within the scope of the claims described in the present invention to various extents which can be modified.

Claims

A method for manufacturing a spinal cord surgical protective plate used for implanting bone and similar bone fusion materials while protecting nerves exposed to damaged vertebrae or defects of vertebrae removed during surgery,

(a) preparing a template;

(b) heating the planar protective plate to increase ductility;

(c) seating the heated flat protective plate on the template and deforming according to the shape of the template; And

(d) cooling the protective plate to maintain a deformed shape manufacturing method of a spinal surgery protection plate comprising.
The method of claim 1,

The shape of the template is a method of manufacturing a protective plate for spinal surgery is a shape of a curved surface convex or concave in one direction.
The method of claim 1,

The shape of the template is a convex or concave method of manufacturing a protective plate for spinal surgery is a shape formed with a plurality of surfaces bent in one direction.
The method of claim 1,

Before step (a),

Obtaining a spinal image of the patient,

In the step (a), the method of manufacturing a protective plate for spinal surgery to prepare the template according to the characteristics of the affected area including the spine shape obtained by analyzing the image.
The method of claim 4, wherein

Step (a) is

Designing the template according to a characteristic of an affected part including a spine shape obtained by analyzing the image; And

Method of producing a protective plate for spinal surgery comprising the step of manufacturing the designed template with a 3D printer.
The method of claim 1,

The protective plate is a method of manufacturing a protective plate for spinal surgery is formed of a polymer.
The method of claim 6,

The protective plate is a method of manufacturing a protective plate for spinal surgery is formed of a bioabsorbable material (bioabsorbable material).
The method of claim 1,

The planar protective plate is a method of manufacturing a protective plate for spinal surgery is formed in a mesh structure.
The method of claim 7, wherein

The flat protective plate is a manufacturing method of the protective plate for spinal surgery produced by a 3D printer.
The method of claim 2,

The template is a method of producing a protective plate for spinal surgery in the shape of a curved surface convex or concave also in a direction perpendicular to the one direction.
The method of claim 2 or 3,

The protective plate for spinal surgery is supported and fixed so that both convex ends are not extended to the structure formed around the vertebrae,

Method of manufacturing a protective plate for spinal surgery further comprising the step of cutting the protective plate for spinal surgery according to the shape of the structure.
The method of claim 1,

Method of manufacturing a protective plate for spinal surgery to heat the plate-shaped protective plate using hot water in the step (b).
The method of claim 1,

Method of producing a protective plate for spinal surgery to cool the protective plate using cold water in the step (d).