KR102148814B1 - Bone graft of biodegradable metal and method for preparing therefor - Google Patents

Abstract

The present invention relates to a bone graft material of a biodegradable metal applied to a bone defect site. The bone graft material includes a graft block which is a porous structure having a plurality of cavities formed on a surface or inside the surface, wherein the graft block is made of a biodegradable metal.

Description

Bone graft material of biodegradable metal and its manufacturing method {BONE GRAFT OF BIODEGRADABLE METAL AND METHOD FOR PREPARING THEREFOR}

The present invention relates to a graft material and a manufacturing method, and more particularly, to a bone graft material of a biodegradable metal applied to a bone defect and a manufacturing method thereof.

The importance of biomaterials for artificial bones is increasing due to the development of medical technology such as various disasters, accidents, and implant procedures. Various types of bone graft materials have been developed to regenerate damaged or insufficient bone tissue used in orthopedic surgery, dentistry, plastic surgery, and neurosurgery.

In general, the classic and common method of bone graft is an autograft, in which a part of bone tissue is collected and transplanted. The advantage of autologous bone grafts is that they use their own bones, so there is no transmission of infectious diseases or immune rejection, so the probability of failure is low and bone fusion occurs quickly and reliably. However, autogenous bone transplantation involves collecting bones from other parts of the body, making it difficult to obtain a sufficient amount of transplanted bones, causing damage to other parts of the body, increasing patient pain, and having problems of secondary infection. There is a high possibility of complications at the site, and there is a disadvantage that the bone tissue contracts more than 50% after actual healing.

Allograft or xenograft, which is used as a bone graft material by demineralizing other people's bone tissue, is a concern for various infections such as immune disease and AIDS, and delays bone fusion with immune rejection. The results are not satisfactory due to problems such as a decrease in the strength of bone tissue after healing, and the remaining xenograft material that remains unabsorbed after a long time. Synthetic bones, mixed bones, etc., which are chemically produced similar to bones, have problems such as toxicity, contamination, and immune rejection of chemical substances used in manufacturing processes such as demineralization and sterilization.

In addition, in such an artificial bone for transplantation, the bone graft material remains without being completely absorbed into the tissue, reducing the tissue strength of the new bone or limiting the physiological function, there is a high possibility of infection in the future, the healing rate is slow, and the mechanical properties are weak. So it can be easily broken.

In addition, in order to reduce the possibility of failure due to surgical errors due to differences in the size, location, and shape of the graft material during artificial bone graft surgery, patient-customized production of artificial bone tissue according to the size and shape of the bone defect is precise and good. It is becoming necessary for the prognosis of surgery.

US 2008-0249638 A1 JP 2010-504785 A JP 2015-536724 A JP 2002-0082231 A

Embodiments of the present invention are to provide a bone graft material that has excellent bone regeneration ability and biocompatibility, and does not decompose and remain in tissue after bone regeneration, and a method of manufacturing the same.

The bone graft material of biodegradable metal according to an embodiment of the present invention includes a graft block, which is a porous structure having a surface or a plurality of cavities formed therein, and the graft block may be a biodegradable metal.

In addition, the cavity may have a through hole penetrating the implantation block.

In addition, the diameter of the through hole may be 7 μm or more.

In addition, the porous structure is a retis structure, a trabecular bone structure, a spongy bone structure, a spongy bone structure, a compact bone structure, a pyramid truss structure, an octed truss structure, a kagome truss structure, and At least one of the fractal structures may be provided.

In addition, the shape of the implantation block may be any one of a polyhedron, a rotating body, and a plate shape.

In addition, the implantation block, the central portion; And a protrusion protruding from the center.

In addition, a plurality of implantation blocks may be provided, and a diameter of a void between the plurality of implantation blocks may be 7 μm or more.

In addition, it may further include a binder that binds the implantation blocks.

In addition, the protrusion may have a round cross section.

In addition, the protrusion may have a tapered or curved shape in a line direction radiating from the center.

In addition, the implanted block may be manufactured by any one of metal 3D printing, blazing, welding, sintering, wire weaving, and elution.

In addition, at least one of a membrane, a shielding membrane, collagen, autogenous bone, allogeneic bone graft material, mixed bone graft material, xenograft bone graft material, synthetic bone graft material, and physiological basis may be further included.

In addition, the implantation block may have a plurality of protrusions partially raised in the outer shape.

In addition, the implantation block may include a wire.

In addition, the wire may have a closed curve in cross section.

In addition, the wire may have an empty space.

In addition, the wire may have a hollow disposed therein.

In addition, the first wire may have a communication part through which the hollow and the outside communicate.

A method of manufacturing a bone graft material of a biodegradable metal according to an embodiment of the present invention comprises: preparing basic molded particles of a biodegradable metal having pores on the surface or inside; And sintering, melting, welding, and weaving the basic molded particles to form the implanted block of the porous structure.

The bone graft material of biodegradable metal according to another embodiment of the present invention includes a graft block, which is a porous structure having a surface or a plurality of cavities formed therein, the graft block is a biodegradable metal material, and the graft block is , center; A protrusion protruding from the outer surface of the central portion; And an extended portion protruding from the protruding portion, wherein the extended portion and the protruding portion may be arranged in different directions.

In addition, at least one of the central portion, the protrusion, and the expansion portion may have a protrusion protruding from an outer surface.

In addition, the protrusion may have a smaller width in a direction away from an outer surface of at least one of the central portion, the protrusion portion, and the expansion portion.

The bone graft material of biodegradable metal according to another embodiment of the present invention includes a graft block, which is a porous structure having a surface or a plurality of cavities formed therein, and the graft block is a biodegradable metal material, and the graft block Silver, a first wire forming a plurality of polygons of the closed circuit; A second wire forming a plurality of closed-circuit polygons and disposed to be spaced apart from the first wire; And a third wire connecting the first wire and the second wire to each other.

In addition, at least one of the first wire, the second wire, and the third wire may have a hollow formed therein in a length direction, and a through hole connected to the hollow.

In addition, a polygon formed by the first wire and a polygon formed by the second wire may not overlap each other when viewed in a plan view.

The bone graft material of biodegradable metal according to another embodiment of the present invention includes a graft block, which is a porous structure having a surface or a plurality of cavities formed therein, and the graft block is a biodegradable metal material, and the graft block Silver, central; A first protrusion protruding from an outer surface of the central portion; And a second protrusion protruding from an outer surface of the central portion, and a shape of the first protrusion and a shape of the second protrusion may be different from each other.

In addition, the biodegradable metal may be one of pure magnesium, magnesium alloy, and magnesium compound.

In addition, the magnesium alloy is one of strontium, HA (Hydroxy Apatite), silver (Ag), niobium, yttrium, zirconium, lithium, zinc and calcium in magnesium. It may be an alloy in which the above is mixed.

Examples of the present invention show that the bone graft material of biodegradable metal itself has excellent bone regeneration ability, and is completely dissolved over time after the procedure to generate new bones with high strength and excellent physiological function.

1 is a surface diagram of a magnesium alloy having a porous structure,
2 is a view showing a structure according to an embodiment of a porous structure,
3 to 6 are views showing various external shapes of the implantation block,
7 and 8 are a plan view and a front view showing a part of the implantation block,
9 to 13 are a front view, a cross-sectional view, and a perspective view of a part of the wire or basic molded particles,
14 is a flowchart of a method of manufacturing a biodegradable metal bone graft material according to an embodiment of the present invention

Hereinafter, the present invention will be described in more detail with reference to the drawings.

Terms such as first and second may be used to describe various elements, but the elements should not be limited by the terms. These terms are used only for the purpose of distinguishing one component from another component. For example, without departing from the scope of the present invention, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element. The term and/or includes a combination of a plurality of related listed items or any of a plurality of related listed items. 'Or' can be interpreted as a logical sum in the context, but in general, it has the same meaning as'and/or' unless there is a direct description of'otherwise' or'logical exclusive sum', that is, interpreted as a logical sum. do.

When a component is referred to as being "connected" or "connected" to another component, it is understood that it may be directly connected or connected to the other component, but other components may exist in the middle. Should be. On the other hand, when a component is referred to as being "directly connected" or "directly connected" to another component, it should be understood that there is no other component in the middle. In addition, the fact that the first component and the second component are connected or connected on the network means that data can be exchanged between the first component and the second component by wire or wirelessly.

In addition, the suffixes "module" and "unit" for the constituent elements used in the following description are given in consideration of only ease of writing in the present specification, and do not impart a particularly important meaning or role by themselves. Therefore, the "module" and "unit" may be used interchangeably with each other.

When such components are implemented in an actual application, two or more components may be combined into one component, or one component may be subdivided into two or more components as necessary. The same reference numerals are assigned to the same or similar elements throughout the drawings, and detailed descriptions of elements having the same reference numerals may be replaced by descriptions of the above-described elements and may be omitted.

Furthermore, the present invention covers all possible combinations of the embodiments indicated herein. The various embodiments of the present invention are different from each other but are not mutually exclusive. One embodiment of a specific shape, structure, function, and characteristic described herein may be implemented in another embodiment. For example, the components mentioned in the first and second embodiments can perform all functions of the first and second embodiments.

In the present invention, the bone graft material may be transplanted to a bone defect site to generate, induce, or conduct new bone. The bone graft material according to the present invention is mainly composed of a biodegradable metal, but may be substantially involved in bone conduction, bone induction, or bone formation. Autogenous bone, allogeneic bone, heterogeneous bone, mixed bone, synthetic bone, and the like may be mixed with the present graft material to further influence bone conduction, bone induction, or bone formation. In the present specification, bone generation, induction, and/or conduction may be used interchangeably with terms such as bone regeneration, bone generation, and bone fusion.

The biodegradable metal bone graft material according to the present invention can be used for orthopedics, dentistry, plastic surgery, neurosurgery, and the like. In addition, the biodegradable metal bone graft material may be used as a scaffold, and may be used as an implant, a bone plate, a bone pin, or a bone screw. .

1 is a surface view of a magnesium alloy having a porous structure, FIG. 2 is a view showing a structure according to an embodiment of a porous structure, FIGS. 3 to 6 are views showing various external shapes of an implanted block, and FIG. 7 And FIG. 8 is a plan view and a front view showing a part of the implantation block, and FIGS. 9 to 13 are a front view, a cross-sectional view, and a perspective view of a part of a wire or basic molded particle.

1 to 11, the biodegradable metal bone graft material according to an embodiment of the present invention may include a graft block (10 (representative symbol); 10-n (n is a natural number)) (the same hereinafter). have.

It is preferable that the material of the implantation block 10 is a biodegradable metal.

In contrast to general metal materials that do not melt in the living body or artificial bone tissues such as existing heterogeneous bone and synthetic bone, the biodegradable metal according to the present invention refers to a metal having a property that melts and disappears in the living body after a certain period of time. Biodegradable metal is magnesium, calcium, Mg2Ag, manganese, iron, zinc, silicon, yttrium, strontium, silver (Ag), zirconium, lithium (lithium), niobium (niobium), at least one metal of gadolinium or It may contain a metal alloy.

In the present invention, the biodegradable metal is preferably (pure) magnesium, a magnesium alloy, and/or a magnesium compound, and a magnesium alloy or a magnesium compound such as Mg2Ag may be more preferable. Magnesium alloy is a mixture of one or more of strontium, HA (Hydroxy Apatite), silver (Ag), niobium, yttrium, zirconium, lithium, zinc, and calcium with magnesium. It can be one metal material. The present invention is not limited thereto, and magnesium alloys having various composition ratios may be used.

The implantation block 10 may be a structure of basic skeletal function having a plurality of cavities 20 (20-n). The cavity 20 may be formed on or inside the implantation block 10. The inner surface of the cavity 20 may be provided with a fine protrusion protruding into the cavity 20 having a shape similar to the protrusion 140 shown in FIG. 6. In this case, when the body tissue is inserted into the cavity 20, a portion of the body tissue is caught in the microscopic projections, thereby preventing the position of the implantation block 10 from being changed.

The plurality of cavities 20 may form a porous region. The porous region may be formed by at least one layer in which cavities having the same cross-sectional shape and the same cross-sectional area form a pattern, or by a skeleton forming a plurality of cavities. A detailed description of this will be described later.

The cavity 20 may have a through hole 30 penetrating through the implantation block 10.

It is advantageous for blood or various human tissues to pass through the implantation block 10. Accordingly, it is preferable that a through hole 30 or the like is formed so that smooth blood flow movement is possible and the largest white blood cells among blood components can be freely moved. Accordingly, based on the average or maximum size of white blood cells, the through hole 30 or the cavity 20, in particular, the through hole 30 preferably has a diameter of 12 μm or more. And, considering the size of the neutrophils and basophils, the diameter of the through-hole 30 may be 7 μm or more. Here, the diameter means the diameter of the inscribed circle inscribed with the cavity 20 or the through hole 30.

A space filled with blood clots such as blood between the bone graft material of biodegradable metal made of magnesium or magnesium alloy and the damaged bone tissue can grow bone tissue and regenerate new bone. Biodegradable metals are biodegraded during the process of new bone formation, which can promote the formation of new bone. Over time, the space where biodegradable metals such as magnesium alloy existed is replaced with new bones, and new bones in a complete form without residual bone grafts (foreign substances) that were found in existing artificial bones such as synthetic bones and heterogeneous bones can be regenerated.

Magnesium alloy or the like promotes the generation of new bone and gradually biodegrades over time and disappears completely, as well as having a strength similar to that of an actual bone tissue, and thus can provide a support function. In addition, it is easy to deform, such as bending and cutting, during transplantation, and there are many convenient points for performing an artificial bone graft. The implantation block 10 of a porous structure of a biodegradable alloy may well induce various ions required for regeneration of bone cells, in particular, calcium and phosphorus ions, and allow the derived material to adhere well.

Bone structures created with existing bone graft materials (external bone, synthetic bone, mixed bone, etc.) do not have a normal reticular bone structure, and are not absorbed even after a long time after bone graft surgery, so that bacteria penetrate due to the remaining graft material. It is vulnerable to immunity and lacks normal immune function, and bone tissues transplanted with conventional artificial bone graft materials are often broken and destroyed.

Steel or titanium implants used for bone fracture or orthopedic treatment require removal surgery after the fracture is cured, but when the biodegradable metal bone graft material according to the present invention is applied to the implant, secondary surgery I don't need this.

The porous structure of the graft block 10 is a trabecular bone structure, a spongy bone structure, a spongy bone structure, a compact bone structure, a lattice structure, a pyramid truss structure, an octed truss structure. , Kagome truss structure, and may have at least one of the fractal (fractal) structure.

The bone graft material made of biodegradable metal can function as a scaffold, and bone regeneration can be performed well as the bone tissue is similar to the bone tissue at the defect site. Accordingly, in order to adopt a structure similar to the bone tissue of the defective site, the graft block 10 is preferably adopted in any one of trabecula, spongy, sponge, compact bone structure, or a combination of two or more. The operator may use the implantation block 10 having a required structure.

Since manufacturing similar to the human bone structure may take a lot of cost or time, the implantation block 10 may be manufactured in a grid, various truss structures, or a fractal structure. At this time, by adjusting the size or distribution of the cavity, it is possible to manufacture the implantation block 10 similar to various human bone structures.

The graft block 10, which is a skeleton of a bone graft material made of biodegradable metal, may preferably have a shape corresponding to a bone defect site of a patient. Therefore, after obtaining a defect shape (3D model) corresponding to the defect area using radiographic data such as CT and a scanner, the defect shape is metal 3D printed, and a biodegradable metal having the same shape as the bone defect area. The bone graft material of can be produced.

The implantation block 10 is generally and preferably has an atypical shape so that it can be used immediately, or the implantation block 10 is customized to a patient in response to an image such as 3D CT. However, in the production of an atypical shape or customized production of patients, it takes a lot of time and cost, and it is not easy to produce a 3D model corresponding to the defect shape, and an unclear radiograph due to the influence of metal pins or implants near the defect area There are difficulties in custom-made according to. Accordingly, a plurality of implant blocks 10 of a bone graft material made of biodegradable metal according to an exemplary embodiment of the present invention are provided, and a plurality of different grains, lumps, sizes, and shapes are provided, and can be customized for patients by using them separately or in combination. have.

The minimum unit of the biodegradable metal bone graft material may be one graft block 10 or a graft block 10 in which a few pieces are combined. Such a minimum unit may be provided in the form of a powder, and may be variously molded into granules, pellets, chips, and various blocks (stereoscopic) based on the minimum unit, or may be manufactured into a gel, paste, strip, or the like.

The outer shape of the implantation block 10, the outer shape of the approximate and overall shape may be any one of a polyhedron, a rotating body, and a plate shape. The plate shape may have a through hole and/or a protruding protrusion. For example, the external shape of the implantation block 10 may be a sphere as illustrated in FIG. 3 or a hexahedron as illustrated in FIG. 4.

A polyhedron may include a triangular pyramid, a square pyramid, a hexahedron, a polygonal column, and a regular polyhedron, and the rotating body may include a sphere, an elliptical sphere, a cylinder, an elliptical cylinder, a cone, and the like. The plate shape means a flat three-dimensional shape, and may be manufactured in a shape such as a membrane, a mesh, or a sheet.

5 and 6, the implantation block 10 may include a central portion 110 (110-n) and a protrusion 120 (120-n).

The central part 110 may be the basic shape of the implantation block 10 as shown in FIGS. 3 and 4.

One or more protrusions 120 may be provided as part of the implantation block 10 protruding from the central portion 110. It is preferable that the protrusion 120 has a round cross section, that is, a closed curve such as a circle or an ellipse.

The graft block 10, which is the basic particle of the bone graft material of biodegradable metal, is engaged with each other or with adjacent bones to provide resistance to shearing force, and a constant porosity is preferably maintained when the graft blocks 10 are engaged. Shear force resistance allows the bone graft material of biodegradable metal to serve as a support due to mechanical rigidity, and a certain porosity allows blood or bone-generating material to pass through the inside of the bone graft material of biodegradable metal. The porosity may vary depending on the volume of the central portion 110, and it is preferable that the minimum pore size is 12 μm or more based on the white blood cell size. Considering the size of the basophil and basophil, the minimum pore size may be 7 μm or more.

The protrusion 120 may have a shape that is tapered or curved in a radial direction, which may improve manufacturability, adjust a space between the implantation blocks 10 or improve a bonding force.

For example, referring to FIG. 5, the protrusion 120 may include a conical protrusion 120-1 in which the width of one end (base) at the center 110 side is wider than the width of the other end (tip) in the radial direction. . Contrary to the conical protrusion 120-1, the protrusion 120 may include a truncated protrusion 120-2 whose one end is narrower than the other end.

The conical protrusion 120-1 is tapered outward, and the other end may be formed to be pointed or round. The conical protrusion 120-1 has a circular cross section, but is not limited thereto.

The truncated cone 120-2 is tapered inward, and the other end may be formed to be round or flat.

The implantation block 10 includes a plurality of conical protrusions 120-1 and truncated protrusions 120-2, and may be combined with them so that they are alternately arranged or arranged in a predetermined pattern.

At least one of the conical protrusion 120-1 and the truncated cone 120-2 may include the protrusion 140 of FIG. 6 that protrudes from the outer surface.

Referring to FIG. 6, the implantation block 10 may further include an extension part 130 (130-n) that is coupled to the protrusions 120-3 and 120-4 and extends to the outside.

The protrusions 120-3 and 120-4 may protrude in various directions from the central portion 110-2 of the implantation block 10-6. In this case, the plurality of protrusions 120-3 and 120-4 may be radially arranged from the center 110-2. In particular, the plurality of protrusions 120-3 and 120-4 may be arranged in different directions.

The expansion part 130 may include a first expansion part 130-1 extended to both sides or a second expansion part 130-2 extended to one side. Among the plurality of implantation blocks 10, the first extension part 130-1 of the first implantation block and the second extension part 130-2 of the second implantation block are interposed like Velcro to improve mechanical strength. I can.

The expansion part 130 as described above may be formed in the form of at least one of the conical protrusion 120-1 and the truncated cone 120-2 shown in FIG. 5. In particular, when a plurality of extension parts 130 are provided, at least one of the plurality of extension parts 130 may be in the shape of the conical protrusion 120-1 of FIG. 5, and the rest of the plurality of extension parts 130 are shown in FIG. 5 It may be in the form of a truncated conical protrusion 120-2. For example, based on FIG. 6, one of the first expansion part 130-1 or the second expansion part 130-2 may be a conical protrusion 120-1, and the first expansion part 130-1 ) Or the other of the second extension part 130-2 may be a truncated cone protrusion 120-2.

In another embodiment, when the extension part 130 extends from the end of the protrusion 120-4 to both sides like the first extension part 130-1, one end of the first extension part 130-1 is shown in FIG. The conical protrusion 120-1 may have the same or similar shape, and the other end of the first extension 130-1 may have the same or similar shape as the truncated conical protrusion 120-2 of FIG. 5.

The first and second extensions 130-1 and 130-2 as described above may be formed in different directions. For example, when the first extension part 130-1 and the second extension part 130-2 are disposed nearby, the first extension part 130-1 and the second extension part 130-2 When disposed on the same plane, the first and second extensions 130-1 and 130-2 may not be parallel to each other. In this case, the first extension part 130-1 and the second extension part 130-2 not only support forces applied in different directions, but also increase the contact area between the implantation block 10 and blood. I can make it.

Referring to FIG. 6, the implantation block 10 may include a plurality of protrusions 140 partially raised in an external shape. The protrusion 140 functions like unevenness and can increase a surface area in contact with blood.

The protrusion 140 may protrude from an outer surface of at least one of the central portion 110, the protrusion 120, and the expansion portion 130. In particular, the protrusion 140 may prevent the position of the implantation block 10 from shifting after the implantation block 10 is implanted. In particular, the protrusion 140 may be disposed on a surface of the implantation block 10 that contacts the body when the implantation block 10 is implanted.

The central part 110, the protrusion 120, the extension part 130, and the protrusion 140 are made of the same material as the implantation block 10, and may be manufactured in the same manner as the implantation block 10, and may be manufactured integrally. I can.

The porous structure of the implanted block 10 may be fabricated by any one of 3D printing, blazing, welding, sintering, wire weaving, and elution.

Porous magnesium alloys are made by metal 3D printers, or foamed magnesium alloys, blazing, welding, sintering, magnesium alloy wire weaving, and powdery forms with different melting temperatures so that human blood can be filled and passed through the porous internal voids. It can be prepared using various methods such as a vapor phase method, a liquid phase method, a wet method, such as a method of making a porous magnesium alloy by eluting the salt after mixing a salt or a silica atom of a magnesium alloy or a magnesium compound.

3D printing is a method of creating a three-dimensional object, and is also referred to as a rapid prototyping technique. In order to form the implantation block 10 according to the present invention, a layered printing technique using an additive processing principle may be used. The method of using powdery materials is to form a thin film by shooting a laser or an electron beam into the bucket containing the powder to dissolve the powder, then spraying the powder again and repeating the steps of dissolving the powder in a specific area to shape the object. I can. After the object is formed, post-treatment steps such as surface processing may be required. The method of dissolving the powder may be a method such as direct metal laser sintering (DMLS), electron beam melting (EBM), or selective laser melting (SLM). , Is not limited thereto.

The formation of the implantation block 10 by the lamination method may form porous regions in various regions and desired sizes, locations, and depths. Such a porous region can provide a large surface area, thereby increasing bone regeneration.

Methods of manufacturing a porous structure made of metal can be very diverse.

In the sintering method, a biodegradable metal is made into powder or wire, then put in a container or pressed with an appropriate pressure to have weak strength, and then the powder or wire is bonded to each other by maintaining a temperature lower than the melting point of the biodegradable metal. It can be made to form a cavity while having strength.

In a modified sintering method, instead of directly applying heat in the sintering method, biodegradable metal powder or wire is placed between conductive electrodes, and then high current is applied to the electrode to generate heat at the contact portion between the powder or wire to form a porous sintered body. Can be generated.

In addition, the temperature may be increased after mixing the polymer with the biodegradable metal powder or wire. The polymer decomposes and disappears at a low temperature, and metal powder or wire is sintered at a higher temperature, so that an implanted block having an appropriate mechanical strength can be manufactured. At this time, the porosity and strength of the sintered body are determined according to the sintering temperature, pressing force, and the mixing ratio of polymer and metal, and appropriate conditions can be selected if necessary.

On the other hand, a metal porous structure may be manufactured by mixing a water-soluble salt and a biodegradable metal powder, molding at high temperature, and dissolving the water-soluble salt. When the mixture of the water-soluble salt and the biodegradable metal powder is pressurized at an appropriate temperature (lower than the melting point of the metal), the metal powders are bonded to each other to form a structure, forming a composite material having the water-soluble salt therein. When the composite material is immersed in water, the water-soluble salt is dissolved, so that the implantation block 10 of a porous structure can be manufactured. The water-soluble salt may be provided with NaNO2, KNO2, NaNO3, NaCl, CuCl, KNO3, KCl, LiCl, KNO3, PbCl2, MgCl2, CaCl2, BaCl3, and the like.

In addition, a metal porous structure may be manufactured by completely melting the biodegradable metal material and injecting a foaming agent that generates gas.

In addition, after plating or coating a biodegradable metal on the surface of the porous polymer, a metal porous structure may be manufactured by raising the temperature to remove the polymer.

The biodegradable metal bone graft material according to the present invention may further include any one or a combination of a membrane, a shielding membrane, collagen, autogenous bone, allogeneic bone graft material, mixed bone graft material, xenograft material, synthetic bone graft material, and a physiological basis.

After bone graft surgery, the biodegradable metal is completely decomposed and absorbed, resulting in slight shrinkage in volume, volume, and shape. When used in combination with an existing artificial bone graft material, the existing artificial bone graft material can compensate for this contracted part.

When mixed with the existing bone graft material, the residual graft material of the existing bone graft material remains to some extent, but the new bone is created even in the space occupied by the biodegradable metal, so that the total amount of new bone generated is significantly higher than that of using only the existing bone graft material. have.

The physiological base may include at least one of a bone growth factor, a bone inducing substance, a functional drug, and a functional ingredient, and may include a drug for therapeutic purposes.

The biodegradable metal bone graft material includes a plurality of graft blocks 10 and may further include a binder for bonding the graft blocks 10. The binding agent is preferably biocompatible, and rather than a strong binding force for binding metals, it is sufficient if the plurality of implanted blocks 10 provide a binding force sufficient to maintain a certain shape.

The porous structure may be a lattice structure. To this end, referring to FIGS. 7 to 10, the implantation block 10 may include a wire 210 (210-n). The implantation block 10 may be composed of a wire 210. The wire 210 may be plural or one.

The wires 210 may be stacked in a lattice structure. The outer surface of the wire 210 may be provided with a protrusion 140 shown in FIG. 6. A plurality of such protrusions 140 may be provided, and the plurality of protrusions 140 may be disposed to be spaced apart from each other on the surface of the wire 210.

7 and 8, the biodegradable metal wires 210 are arranged side by side at a predetermined interval to form a first layer, and a plurality of first wires 210-1 adjacent to the first layer. A plurality of second wires 210-2 may be disposed to form a second layer to form a plurality of cavities 20-7.

The plurality of second wires 210-2 are disposed to intersect with the first wires 210-1, and may be disposed side by side with a predetermined distance from each other. In this drawing, although it is arranged to be orthogonal to the first wire 210-1, the present invention is not limited thereto and may be crossed in a diagonal direction. In addition, the second wire 210-2 is coupled to the first wire 210-1 in the radial direction, but may be coupled to the first wire 210-1 in the longitudinal direction.

9 and 10, the wire 210 may form a pattern.

Referring to FIG. 9, the wire 210 includes a third wire 210-3 forming a third layer of a predesigned pattern, and a fourth wire 210 forming a second layer of a predesigned pattern over the third layer. -4), and a fifth wire 210-5 of a pre-designed pattern may be provided on the fourth layer. In this embodiment, the first to third layers may form a pattern by repeating the cavities 10-8 of hexagonal cross-sections. The cross-sections of the cavities 10-8 forming the pattern may be any one of polygons including hexagons, circles, ellipses, and the like.

In this case, the first wire 210-1 and the third wire 210-3 may be arranged similarly to the sixth wire 210-6 and the eighth wire 210-8 to be described above.

Referring to FIG. 10, the wire 210 may include sixth to eighth wires 210-6 to 8 forming a plurality of cavities 10-9. The sixth wire 210-6 and the eighth wire 210-8 form a layer of a pre-designed pattern, and the seventh wire 210-7 may function as a pillar.

The sixth wire 210-6 and the eighth wire 210-8 as described above may form a polygon in a closed circuit shape. In this case, the sixth wire 210-6 and the eighth wire 210-8 may be disposed so as to cross each other on a plane. In this case, the closed circuit formed by the sixth wire 210-6 may not overlap each other when viewed in a plan view from the closed circuit in which the eighth wire 210-8 is formed.

In this case, the seventh wire 210-7 may connect the sixth wire 210-6 and the eighth wire 210-8. At this time, the seventh wire 210-7 is the sixth wire 210-6 or the eighth wire at a polygonal vertex formed by one of the sixth wire 210-6 or the eighth wire 210-8. 210-8) may be connected to one side of the polygon formed by the other.

If the seventh wire 210-7 is connected to the polygonal edge formed by the sixth wire 210-6 and the polygonal edge formed by the eighth wire 210-8, the sixth wire 210-6 ) Or the other one of the sixth wire 210-6 or the eighth wire 210-8 by the seventh wire 210-7 according to the deformation of one of the eighth wires 210-8 The stability of the block 10 may be impaired. Each of the third to eighth wires 210-3 to 8 may be formed of a plurality of piece wires.

The implantation block 10 of a porous structure formed of the first to eighth wires 210-1 to 8 may be manufactured by 3D printing or a wire weaving method.

The first to eighth wires 210-1 to 8 may have a polygonal cross section, but are preferably a closed curve such as a circle or an ellipse.

The first to eighth wires 210-1 to 8 as described above are not limited to the above, and the protrusions shown in FIG. 6 on at least one surface of the first to eighth wires 210-1 to 8 ( 140) is also possible. When the first to eighth wires 210-1 to 8 are disposed, these protrusions may be fixed to the human body to prevent at least one of the first to eighth wires 210-1 to 8 from moving.

A protrusion 140 shown in FIG. 5 may be provided on the outer surface of the wire 210 as described above. In this case, the protrusion may protrude into the closed circuit formed by the wire 210. In this case, the protrusion may be disposed to face the center of the closed circuit formed by the wire 210. In this case, the protrusion may prevent the wire 210 from being separated or moving in the body tissue disposed inside the closed circuit.

11 to 13, the wire 210 may include empty spaces 260, 270, and 280. More specifically, the wire 210 may include at least one of a pore 260 formed on its surface, a hollow 270 formed therein, and a communication portion 280 communicating with the hollow 270. In this case, as described above, at least one of the pores 260, the hollow 270, and the communication part 280 may have microprotrusions disposed therein. In this case, the contact area with blood, etc. inserted into at least one of the pores 260, the hollow 270, and the communication part 280 may be increased due to the microprotrusions. In addition, when microprotrusions are formed in the pores 260 and the communication part 280, when the biodegradable metal bone graft material formed of the wire 210 is placed on the body, the biodegradable metal bone graft material is prevented from moving at the initial stage of placement. Can be prevented.

The biodegradable metal bone graft material should maintain a constant volume and size at the defect site, that is, the graft site at the beginning of the procedure. The empty space, in particular, the hollow 270 may increase a contact surface area with blood or the like without affecting mechanical strength, and further improve the decomposition speed of the wire 210.

As described above, the wire 210 may have a 3D shape. In this case, the wire 210 may include at least one of a conical protrusion 120-1 and a truncated cone 120-2 as shown in FIG. 5. At this time, at least one of the conical protrusion 120-1 and the truncated protrusion 120-2 may be disposed in various directions from the surface of the wire 210. In particular, at least one of the conical protrusion 120-1 and the truncated protrusion 120-2 may protrude into a space formed by the wire 210. In the above case, at least one of the conical protrusion 120-1 and the truncated cone 120-2 may be provided in plural. At this time, at least one of the conical protrusions 120-1 and the truncated protrusions 120-2 may be arranged to be spaced apart from each other in the length direction of the wire 210, and may be disposed in different directions from each other.

In another embodiment, the wire 210 may include at least one of the protrusions 120-3 and 120-4, the extensions 130-1 and 130-2, and the protrusion 140, as shown in FIG. 6. At this time, at least one of the protrusions 120-3 and 120-4, the extensions 130-1 and 130-2, and the protrusion 140 may protrude from the outer surface of the wire 210, and the wire 210 has a three-dimensional shape. When forming a shape, it may be formed to protrude the inner space.

Therefore, the bone graft material made of biodegradable metal can be decomposed as quickly as possible after implantation in the body by increasing the area in contact with blood. In addition, when the biodegradable metal bone graft material is initially disposed in the body, it may be inserted into or caught in the body tissue, thereby maintaining the initial position and not being separated from the body tissue.

14 is a flowchart of a method of manufacturing a biodegradable metal bone graft material according to an embodiment of the present invention. See FIGS. 1 to 13.

The present manufacturing method may include preparing basic molded particles of biodegradable metal having pores on the surface or inside (S310). 11 to 13 is a part of the wire 210, but it can be seen as a basic molded particles in a fragment. The basic molded particles may further include a hollow 270 and a communication part 280 in addition to the pores 260.

When the basic molded particles are prepared, the implanted block of the porous structure may be molded by any one of sintering, melting, welding, and weaving of the basic molded particles (S320). Each technique refers to what was previously described. The forming step may include metal 3D printing, which can be seen as a kind of sintering or melting.

In addition, although the preferred embodiments of the present invention have been illustrated and described above, the present invention is not limited to the specific embodiments described above, and the technical field to which the present invention belongs without departing from the gist of the present invention claimed in the claims. In addition, various modifications are possible by those of ordinary skill in the art, and these modifications should not be individually understood from the technical spirit or prospect of the present invention.

10: implantation block 20: cavity
30: through hole 60: hollow
70: communication unit 110: center
120: protrusion 130: extension
140: protrusion 210: wire
260: pore 270: hollow
280: communication unit

Claims (21)

Including an implanted block, which is a porous structure having a plurality of cavities formed on the surface or inside the surface
The material of the implantation block is a biodegradable metal,
The transplant block,
center;
A protrusion protruding from the outer surface of the central portion; And
Includes; an extension protruding from the protrusion,
The extended portion and the protruding portion are arranged in different directions,
At least one of the central portion, the protrusion, and the extension portion is a biodegradable metal bone graft material having a protrusion protruding from an outer surface. The method of claim 1,
The cavity is a bone graft material of biodegradable metal having a through hole penetrating the graft block. The method of claim 2,
The through hole has a diameter of 7 μm or more, a bone graft material of biodegradable metal. The method of claim 1,
The porous structure is a letis structure, a trabecular bone structure, a spongy bone structure, a spongy bone structure, a compact bone structure, a pyramid truss structure, an octed truss structure, a kagome truss structure, and a frectal structure. Biodegradable metal bone graft material having at least any one of the structures. delete delete The method of claim 1,
The graft block is a metal 3D printing, blazing, welding, sintering, wire weaving, and a bone graft material of biodegradable metal produced by any one of the elution method. The method of claim 1,
Membrane, shielding membrane, collagen, autologous bone graft material, allogeneic bone graft material, xenograft material, synthetic bone graft material, mixed bone graft material, biodegradable metal bone graft material further comprising at least any one of a physiological basis. The method of claim 1,
At least one of the central portion, the protrusion portion, and the extension portion includes a wire, a bone graft material of biodegradable metal. The method of claim 9,
The wire is a bone graft material of biodegradable metal whose cross section is a closed curve. The method of claim 9,
The wire has a hollow disposed therein, biodegradable metal bone graft material. The method of claim 11,
The wire is a bone graft material of biodegradable metal having a communication portion through which the hollow and the outside communicate. delete delete delete The method of claim 1,
The protrusion is a biodegradable metal bone graft material whose width is reduced in a direction away from an outer surface of at least one of the central part, the protrusion part, and the expansion part. delete delete delete delete The method of claim 1,
The biodegradable metal is one of pure magnesium, magnesium alloy, and magnesium compound,
The magnesium alloy contains at least one of strontium, HA (Hydroxy Apatite), silver (Ag), niobium, yttrium, zirconium, lithium, zinc, and calcium. Bone graft material of biodegradable metal, which is a mixed alloy.

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