JP2008029745A - Bone joint material and bone joint material set for enhancement of bone adhesion - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a bone joint material and a bone joint material set, capable of enhancing the substitution and regeneration of a living bone, reducing the period for bone adhesion at the joint position, and restoring the living bone without leaving a cavity. <P>SOLUTION: The bone joint material is composed of a dense complex made of biodegradable/bioabsorbable polymers including bioabsorbable and bioactive bioceramic powder. Holes 1b and 5b bored on the center line of bone joint material bodies (a screw 1 and a pin 5) are filled with a filling material 2 impregnated with a biological bone growth factor composed of a porous complex made of the polymers, or the holes of the bone joint material bodies are filled with a filling material without impregnation of the biological bone growth factor. The bone joint material set is the combination of the bone joint material body with the filling material and the bone growth factor, or the combination of the bone joint material body, the filling material and the bone growth factor, or the combination of the bone joint material body and the bone growth factor-impregnated filling material, or the combination of the bone joint material body and the filling material without impregnation of the bone growth factor. The bone growth factor reduces the period for bone adhesion, and the bioceramic power facilitates substitution for the living bone. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

The present invention relates to a biodegradable and bioresorbable bone cement that is preferably used for bone fixation and fixation as described below and has excellent bioactivity and accelerates bone fusion.
1. Fracture joints in osteosynthesis a) Intra-articular fractures such as ankle joint, knee joint, hip joint, elbow joint and shoulder joint, and open reduction fixation for periarticular fracture b) Metacarpal bone, metatarsal bone, etc. 1. Open reduction and fixation for small bone fractures in limbs 2. Fixation of bone graft in bone grafting a) Fixation of bone graft in hip replacement surgery b) Fixation of bone grafting in knee replacement surgery c) Fixation of bone grafting in tumor curettage Bone fragment fixation in osteotomy a) Bone fragment fixation in acetabular rotational osteotomy b) Bone fragment fixation in hallux valgus correction osteotomy c) Bone fragment fixation in wrist arthroplasty (Kapanji method) 4 . Others a) Temporary fixation of joints (temporal fixation of the shin joint)
b) Above 1. Appropriate fracture joints other than a), fixation

  Conventionally, bone bonding materials such as screws and pins made of metal or ceramics are used for bone fixation. However, since these bone bonding materials have a remarkably high elastic modulus compared with living bones, there is a problem that depending on the strength, the strength of the bone around the bonding material is reduced. In particular, metal screws may be harmful to the body due to gradually released metal ions for more than 10 years after implantation. Therefore, when a fracture is healed, it should be removed from the body at an early stage. There is also a concern that surgery will have to be done.

  Under such circumstances, research has been conducted on screws made of biodegradable absorbable polymers that do not require re-operation. Further, the present applicant has provided bioactive and biodegradable absorbability containing bioactive and bioabsorbable bioceramics powder in biodegradable absorbent polymer in order to satisfy the high demands of doctors and patients. In addition, various bone joint materials such as screws and pins have been developed (Patent Documents 1 and 2).

Also, with the composite material, a through-hole through which a Kirschner wire for inserting and screwing the screw in a predetermined position with high precision is drilled (a so-called hollow screw called a cannulated screw) Also developed.
JP-A-11-70126 JP-A-10-85231

In addition to the non-hollow screw, the screw of Patent Document 1 and the pin of Patent Document 2 are formed by conductive formation of bone tissue by the bioactivity of the exposed bioceramic powder as the polymer advances hydrolysis in vivo. Any of these will be replaced with living bone and disappear. However, it takes a long time for bone fusion to occur, as with other materials such as metals and bioceramics, and it takes a long time for the screw to completely replace bone and disappear after bone fusion is obtained. There is a problem that it takes. On the other hand, it is well known that biological bone growth factors such as BMP (Bone Morphogenic Protein) are effective in promoting the replacement and regeneration of living bones. It is used in the field. However, such biological bone growth factors cannot be directly contained in biodegradable and absorbable polymer screws or pins. It is a process of strengthening and molding these osteosynthesis materials, and it involves a thermal history of at least 100 degrees Celsius, so at the time, these biological bone growth factors are heat denatured and lose their efficacy. It is.

  Also, in the case of a cannulated screw, since bone tissue does not penetrate into the through-hole and is difficult to grow (bone ingrowth), the screw is almost absorbed and decomposed until bone replacement. There was also a problem that it remained hollow. For this purpose, it is conceivable to pack autogenous bone particles collected from other sites, but since the sampled sites remain as defective sites, it is necessary to further measure the filling of artificial bone fragments, and complete repair by the own bones. Must not.

The present invention has been made to solve the above-described problems, and aims to provide an excellent solution by the functions expressed by the following basic components.
1. (Structure)
Although it is a hollow body, it has high mechanical strength and its maintenance period worthy of a biodegradable and resorbable bone joint material, and itself has osteoconductivity and osteoinductivity in its through hole. It is filled with a porous material that functions as a scaffold that promotes bone invasion and regeneration, or a substitute bone having a porous form and mechanical strength similar to bone, and this porous body is biological It is a complex consisting of three components, including bone growth factor.
2. (Function)
A) Mechanical strength as an overall osteosynthesis material although it is a composite composed of three components (torque strength at the time of insertion, and strength necessary for joining bones separated for some reason, such as fractures) And has the ability to maintain it for a period of at least 3 months, which is necessary for normal bone healing.
B) The cancellous bone-like porous body filled in the through-hole is more than a hollow dense body having strength higher than the outermost cortical bone ensuring high strength while exhibiting osteoconductivity and osteoinductivity. Are also broken down and absorbed more quickly. Prior to or in parallel with the behavior, the biological bone growth factor that is carried is gradually released, so that it plays a role as a scaffold for efficiently promoting the induction formation of autologous bone.
C) This period is much earlier than the three months required for normal bone fusion and has the potential to complete bone fusion early in the weeks. Therefore, the bed leaving time of the patient is shortened all at once, and the patient, the doctor, and the hospital all receive great benefits.
D) Thereafter, the hollow biodegradable and resorbable osteosynthesis material and the porous scaffolding constituting the osteosynthesis material are gradually decomposed and absorbed in the living body, and finally completely replaced with the living bone. Is restored to the correct state.
E) Biological bone growth factor, which is susceptible to heat and chemical denaturation, can be added to a porous body containing open cells solubilized or suspended as an injection solution or drip solution, so it does not denature .

In order to achieve the above object, an osteosynthesis material according to claim 1 of the present invention is an osteosynthesis material comprising a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive. A hole having at least one end opened in the main body is filled with a filler composed of a porous composite of a biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive. Further, this is characterized by containing a biological bone growth factor.
An osteosynthesis material according to an eleventh aspect of the present invention includes at least one end of an osteosynthesis material body comprising a dense composite of biodegradable and absorbable polymer containing bioresorbable and bioactive bioceramic powder. Is characterized in that a hole is opened and filled with a filler composed of a porous composite of a biodegradable and absorbable polymer containing a bioceramic powder that is bioabsorbable and bioactive. Is.

In addition, the osteosynthesis material set according to claim 2 of the present invention that achieves the above object comprises (1) a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive. A bone-bonding material body is filled with a porous composite of biodegradable and absorbable polymer containing bio-ceramic powder that is bio-absorbable and bio-active. A bone-incorporating material body containing a filler filled with a material, and (2) a biological bone growth factor contained in the filler,
The osteosynthesis material set according to claim 3 of the present invention comprises (1) a dense composite of biodegradable and absorbable polymer containing bioabsorbable and bioactive bioceramic powder, and at least one end is open. A bone-bonding material main body having holes formed therein, and (2) a bio-degradable absorbable material containing a bio-ceramic powder that is bio-absorbable and bio-active, and is a filler filled in the hole of the bone-bonding material main body. A combination of a polymer porous composite and (3) a biological bone growth factor contained in the filler,
The osteosynthesis material set according to claim 4 of the present invention comprises (1) a dense composite of biodegradable absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive, and at least one end is open. A bone-bonding material main body having holes formed therein, and (2) a bio-degradable absorbable material containing a bio-ceramic powder that is bio-absorbable and bio-active, and is a filler filled in the hole of the bone-bonding material main body. It is characterized by combining a porous structure of a polymer and containing a biological bone growth factor,
The osteosynthesis material set according to claim 5 of the present invention comprises (1) a dense composite of biodegradable absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive, and at least one end is open. A bone-bonding material main body having holes formed therein, and (2) a bio-degradable absorbable material containing a bio-ceramic powder that is bio-absorbable and bio-active, and is a filler filled in the hole of the bone-bonding material main body. It is characterized by combining with a polymer porous composite.

  In the above-mentioned osteosynthesis material and osteosynthesis material set, the content of the bioceramic powder of the dense composite constituting the osteosynthesis main body is 30 to 60% by mass, and the porous composite constituting the filler The bioceramic powder content is preferably 60 to 80% by mass. Further, the porosity of the porous composite constituting the filler is preferably 60 to 90%, the continuous pores account for 50% or more of the total pores, and the pore diameter of the continuous pores is preferably 50 to 600 μm. The biological bone growth factor impregnated in the filler is BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-b), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast Growth Factor), Any one of PRP (platelet-rich plasma) or a mixture of two or more of them is preferable.

  Representative examples of the osteosynthesis material main body in the osteosynthesis material and the osteosynthesis material set of the present invention, a screw having a hole drilled on the center line from the upper end surface of the screw head toward the screw tip side, It is a pin having a hole filled with a filler from one end surface to the other end surface on the center line.

  When the osteosynthesis main body is, for example, a screw, the osteosynthesis material according to claim 1 of the present invention is screwed into the bone of the fracture portion, and when the osteosynthesis main body is, for example, a pin, This is driven into the bone of the fractured part and fixed. When the fracture portion is joined and fixed with the bone joining material according to claim 1, the bone joining material body made of a dense composite of biodegradable absorbable polymer containing bioceramics powder has pores filled with the filling material. Although it is a hollow body with a perforated hole, it has sufficient mechanical strength and is not rapidly hydrolyzed by body fluids, so it maintains its strength for a period of at least 3 months, which is necessary for normal bone healing, and ensures that the bone joint is located. Can be fixed. On the other hand, the filler made of a porous composite of biodegradable absorbable polymer containing bioceramic powder filled in the pores of the osteosynthesis main body is a cancellous bone-like porous body, Osteoblasts permeate the inside of the porous composite through continuous pores and decompose faster than the bone composite material body of the dense composite while exhibiting osteoconductivity and osteoinductivity due to the bioactivity of the bioceramic powder. Is absorbed. Prior to or in parallel with this decomposition and absorption, biological bone growth factors such as BMP are gradually released, so that the induction formation of living bone (autologous bone) is efficiently promoted, Bone fusion will be completed in a few weeks, much earlier than the three months required for bone fusion. After that, the osteosynthesis body and filler are further decomposed and resorbed, and finally completely replaced with living bone formed by osteoconduction or osteoinduction, and the above-mentioned hole of the osteosynthesis body becomes a cavity. Restored to the original state that does not remain. In addition, the biological bone growth factor contained in the filler composed of a porous composite has no thermal history during the production of the osteosynthesis main body, so there is no fear of heat denaturation, and the above bone growth promoting action To demonstrate. In addition, since the bioceramic powder contained in the filler and the bone cement main body is absorbable in the living body, it does not remain or accumulate in the replaced living bone, and leaches and remains in soft tissue or blood vessels. Nor.

  In the osteosynthesis material according to an eleventh aspect of the present invention, after the bone at the fracture portion is joined and fixed by the osteosynthesis material body, a biological bone growth factor such as BMP prepared separately is injected and impregnated into the filler. Thus, the same function and effect as those of the osteosynthesis material of claim 1 can be obtained.

  In the osteosynthesis material set according to claim 2 of the present invention, when the osteosynthesis material body with filler is, for example, a screw with filler, this is screwed into the bone of the fracture portion, and the osteosynthesis material with filler is When the body is a pin with a filler, for example, it is driven into the bone of the fractured part, and the bone is joined and fixed. Then, a biological bone growth factor such as BMP is injected and impregnated into the filler. In this way, the same effect as that of the osteosynthesis material of claim 1 can be obtained.

  In the osteosynthesis material set according to claim 3 of the present invention, after the bone of the fracture portion is joined and fixed by the osteosynthesis main body, the filler is filled in the hole opened at least one end of the osteosynthesis main body. BMP or other biological bone growth factor is injected into and impregnated into the bone, or the bone at the fracture portion is joined and fixed by the osteosynthesis main body, and then the filler is impregnated with biological bone growth factor. Is used by filling the hole of the osteosynthesis material body, and the use of this makes it possible to obtain the same effects as the osteosynthesis material of claim 1.

  In the osteosynthesis material set according to claim 4 of the present invention, after the bone of the fracture portion is joined and fixed by the osteosynthesis body, the filler impregnated with a biological bone growth factor such as BMP is added to the osteosynthesis body. At least one end is filled in a hole that is open and used. By using such a hole, the same effect as that of the osteosynthesis material of claim 1 can be obtained.

  In the osteosynthesis material set according to claim 5 of the present invention, after the bone of the fracture portion is joined and fixed by the osteosynthesis main body, the filler is filled in the hole opened at least one end of the osteosynthesis main body. BMP or other biological bone growth factor prepared separately is injected and impregnated, or the bone of the fractured part is joined and fixed by the osteosynthesis material body, and then the biological bone growth factor separately prepared is added to the filler. It is impregnated and used by filling the hole of the osteosynthesis main body with the filler. By using the filler in this manner, the same effect as the osteosynthesis of claim 1 can be obtained. .

  In the above-mentioned osteosynthesis material or osteosynthesis material set, the content of the bioceramic powder of the dense composite constituting the osteosynthesis main body is set to 30 to 60% by mass, and the biosynthesis of the porous composite constituting the filler When the ceramic powder content is 60 to 80% by mass, the osteosynthesis material body can be replaced with living bones without losing the required strength, and can be replaced with living bone. Good bone inductivity is exhibited and can be replaced with living bone at an early stage. Moreover, the porosity of the porous composite constituting the filler is 60 to 90%, the continuous pores occupy 50% or more of the whole pores, and the pore size of the continuous pores is 50 to 600 μm. Biological bone growth factor can be easily injected and impregnated into the filler, and body fluids and osteoblasts can easily invade, so that hydrolysis of the filler progresses early and bone tissue is induced and formed. In a short period of time, the filler is completely replaced with living bone and disappears.

  Hereinafter, specific embodiments of the present invention will be described in detail with reference to the drawings.

  1A and 1B show an osteosynthesis material according to an embodiment of the present invention, in which FIG. 1A is a front view of the osteosynthesis material, FIG. 1B is a longitudinal sectional view of the osteosynthesis material, and FIG. It is a top view of material.

  This osteosynthesis material drills a circular deep hole 1b reaching from the upper end surface of the screw head 1a to the vicinity of the screw tip on the center line of the osteosynthesis body formed on the screw 1, and the diameter and depth of the hole 1b. The above-mentioned hole 1b is filled with a cylindrical filler 2 having a diameter and a length matching the thickness and impregnated with a biological bone growth factor.

  Although the hole diameter of the said hole 1b of the screw 1 is not specifically limited, It is preferable to set to about 1/3 to 2/3 of the diameter of the axial part of the screw 1 (diameter of the trough part between the screw threads 1c). If the hole diameter of the hole 1b is larger than 2/3 of the diameter of the screw shaft portion, the strength of the screw 1 is reduced, and there is a risk of breaking when screwing into the fractured portion. Since the filler 2 to be formed becomes too thin and the ratio occupied by the filler 2 becomes small, and the effect of promoting the formation of living bone and bone fusion becomes insufficient, both are not preferable.

  The head portion 1a of the screw 1 has a square planar shape with rounded corners provided at the four corners, and the screw head portion 1a is externally fitted with a rectangular tube-shaped tip portion and rotated. It is designed to be screwed into the fracture part. Therefore, the screw head 1a is harder to break when screwed than a screwdriver with a cross groove formed in the screw head, so the screw 1 is firmly tightened until the lower surface of the screw head 1a is pressed against the bone. It can be screwed and tightened.

  The shape of the screw head 1a is not limited to the head having the above-mentioned square planar shape, and for example, a head having a hexagonal or octagonal planar shape, or a cross groove for inserting a Phillips screwdriver is formed. Various shapes, such as a head with a single-slot groove for inserting a flat-blade screwdriver, a head with a square hole, hexagon wrench or octagon wrench, or a head with a hexagon or octagon hole. it can. Then, this wrench insertion hole may be filled with the filler 2 impregnated with a biological bone growth factor as a hole 1b filled with the filler 2.

  A plurality of small holes (not shown) communicating with the hole 1b filled with the filler 2 are formed in the screw shaft portion of the screw 1 within a range in which the strength required for the osteosynthesis main body can be maintained. May be. When such a small hole is drilled, body fluid and osteoblasts can easily enter the filler 2 through the small hole, and biological bone growth factor can easily exude as the filler 2 is decomposed and absorbed. Therefore, there is an advantage that the growth and bone fusion of living bones can be further promoted.

  The screw 1 forms the screw thread 1c over the entire length of the screw shaft portion, but the screw thread 1c may be partially formed from the middle to the tip of the screw shaft portion. In addition, the screw 1 forms a hole 1c for filling the filler 2 from the upper end surface of the screw head 1a to the vicinity of the screw tip, but forms a hole penetrating from the upper end surface of the screw head 1a to the screw tip. And you may fill the filler 2 over the full length of this penetrated hole.

  The osteosynthesis material body formed on the screw 1 is composed of a dense composite of biodegradable and absorbable polymer containing bioresorbable and bioactive bioceramics powder, As a raw material biodegradable and absorbable polymer, crystalline poly-L-lactic acid or polyglycolic acid is suitable, and in particular, viscosity average Poly-L-lactic acid having a molecular weight of 150,000 or more, desirably about 200,000 to 600,000 is very preferably used.

  The bioceramic powder to be contained in the dense composite constituting the screw 1 (bone bonding material main body) is bioactive, has a bioresorbability and is totally absorbed by the living body, and is completely replaced with bone tissue. Uncalcined and uncalcined hydroxyapatite, uncalcined and uncalcined calcium phosphate, dicalcium phosphate, tricalcium phosphate, tetracalcium phosphate, octacalcium with good bone conduction (induction) ability and good biocompatibility Powders such as phosphate, calcite, serabital, diopsite and smallpox are preferably used. Among them, uncalcined and uncalcined hydroxyapatite, tricalcium phosphate, and octacalcium phosphate are optimal because they have extremely high bioactivity, excellent osteoconductivity, low toxicity and are absorbed into the body in a short period of time. It is. These bioceramic powders have a particle size of about 30 μm or less, preferably about 10 μm or less, more preferably about 0.1 to 5 μm in consideration of dispersibility in the biodegradable absorbable polymer and absorbability to the living body. Things are used.

  The content of the bioceramic powder of the dense composite constituting the screw 1 (bone bonding material main body) is preferably in the range of 30 to 60% by mass, and if it exceeds 60% by mass, the dense composite May cause weakening of the strength of the screw 1, and if it is less than 30% by mass, formation of bone conduction by the bioceramic powder becomes insufficient, and it takes a long time for the screw 1 to completely replace the living bone. Inconvenience occurs. The content of the bioceramic powder may be constant throughout the dense complex constituting the screw 1 within the range of 30 to 60% by mass, or the center line of the dense complex. It may be continuously changed so that the content rate increases sequentially from the outer periphery to the outer periphery. The screw 1 made of a dense composite in which the content of bioceramics powder is inclined as in the latter has an outer peripheral portion (the outer peripheral portion of the screw head 1a and the outer peripheral portion of the screw shaft portion) with a high content of bioceramic powder. ) Has a merit that the loosening of the screw 1 and the like can be prevented because the bone tissue is conductively formed at an early stage and combined with the living bone in a short period of time.

  The screw 1 (bone bonding material main body) is formed from a biodegradable absorbable polymer containing bioceramics powder to form a cylindrical dense composite compact, and this compact is shown in FIG. It is manufactured by cutting into such a screw shape. In that case, when a compact body of a dense composite is formed by means of compression molding or forging and cutting is performed, the dense composite is compressed to further increase the degree of compactness, and polymer molecules and crystals are Since it is oriented obliquely from the periphery toward the center line, it is possible to obtain a screw 1 having much higher strength and hardness. Note that the screw 1 may be manufactured by cutting a formed lump in which polymer molecules are uniaxially oriented by stretching.

  On the other hand, the filler 2 filled in the hole 1b opened at least at one end of the screw 1 (bone bonding material main body) is a pore of a biodegradable and absorbable polymer containing a bioceramic powder that is bioabsorbable and bioactive. The porous ceramics has continuous pores inside, and a part of the bioceramic powder is exposed on the inner surface of the continuous pores and on the surface of the porous composite. The filler 2 is impregnated with an appropriate amount of biological bone growth factor.

  The porous composite composing the filler 2 does not need to be as strong as the screw 1 (bone cement main body) made of a dense composite, and does not break when filling the hole 1b of the screw 1. It is sufficient if it has the strength of cancellous bone, and it is necessary to quickly disintegrate and replace it with living bone at an early stage. Decomposable / absorptive polymers include safe, fast degrading, not very brittle, amorphous or crystalline / amorphous poly-D, L-lactic acid, L-lactic acid and D, L-lactic acid copolymer Suitable are lactic acid and glycolic acid copolymer, lactic acid and caprolactone copolymer, lactic acid and ethylene glycol copolymer, and lactic acid and para-dioxanone copolymer. Used mixed . These biodegradable and absorbable polymers have a viscosity average molecular weight of about 50,000 to 600,000 considering the strength suitable for the filler 2 made of a porous composite and the period of in vivo degradation and absorption. Are preferably used.

  In consideration of the strength suitable for the filler 2, the invasion and stabilization of osteoblasts, the impregnation of biological bone growth factor, etc., the porosity composite constituting the filler 2 has a porosity of 60 to 90. %, Preferably 65-85%, continuous pores account for 50% or more of the total pores, preferably 70-90%, and the pore size of the continuous pores is 50-600 μm, preferably 100-400 μm . When the porosity exceeds 90% and the pore diameter is larger than 600 μm, the physical strength of the porous composite is too low, and the filler 2 becomes brittle. On the other hand, when the porosity is less than 60%, the continuous pores are less than 50% of the total pores, and the pore size of the continuous pores is smaller than 50 μm, an appropriate amount of biological bone growth factor can be quickly injected and impregnated. It becomes difficult, and invasion of bodily fluids and osteoblasts becomes difficult, and the hydrolysis of the pore structure and the induction formation of the bone tissue are slowed down. The time required until the hole 1b of the screw 1 is filled becomes longer. However, it has been found that the presence of continuous pores as fine as about 1 to 0.1 μm in combination with the above-mentioned preferred pore diameters can induce osteoinductivity.

  The porosity of the porous composite constituting the filler 2 may be constant over the entire range of the composite within a range of 60 to 90%, and the porosity becomes closer to the outer peripheral surface and the upper and lower end faces. The rate may increase continuously. In addition, the pore diameter of the continuous pores may be constant over the entire composite within a range of 50 to 600 μm, or may gradually increase toward the outer peripheral surface and the upper and lower end surfaces. The filler 2 made of a porous composite whose porosity and pore diameter are inclined as described above can be quickly impregnated with an appropriate amount of biological bone growth factor from the upper and lower end faces and the outer peripheral surface having a large porosity and pore diameter. In addition, since the hydrolysis from the upper and lower end surfaces and the outer peripheral surface is fast, and the invasion of osteoblasts and the induction formation of bone tissue are active, the replacement with living bone is further promoted.

  The bioceramic powder to be contained in the porous composite constituting the filler 2 is the same as the bioceramic powder contained in the dense composite constituting the screw 1 described above. Bioceramics powder having a particle size of about 1 to 5 μm has no fear of cutting fibers formed by means such as spraying shortly when producing a porous composite by the method described later. Since the absorbability is also good, it is preferably used.

  The content of the bioceramic powder of the porous composite constituting the filler 2 is preferably 60 to 80% by mass, and the content is constant throughout the porous composite within this range. Or the content rate may become high continuously, so that it approaches the outer peripheral surface or both upper and lower end surfaces. When the content exceeds 80% by mass, coupled with the high porosity of the porous composite, the physical strength of the filler 2 made of the porous composite decreases, and when the content is below 60% by mass, Since the bioactivity of the porous composite is lowered, the induction formation of the bone tissue is delayed, and the time until the hole 1b of the screw 1 is filled by the total replacement with the living bone becomes longer. The more preferable content rate of bioceramics powder is 60-70 mass%. In addition, the filler 2 made of a porous composite whose content rate is inclined as described above has a large bioactivity of the surface layer portion with a high content rate, and induced formation of osteoblasts and bone tissue is particularly active, Replacement with living bone is further promoted.

  Further, the surface of the filler 2 made of the porous composite may be subjected to an oxidation treatment such as corona discharge, plasma treatment, hydrogen peroxide treatment, and the like. The surface wettability is improved, and osteoblasts grow more effectively through continuous pores in the filler 2 through the minute gap between the filler 2 and the hole 1b of the screw 1, Thus, the entire replacement of the hole 1b is further promoted, and the hole 1b filled with the filler of the screw 1 is quickly filled with the living bone. Of course, this oxidation treatment may be performed on the surface of the screw 1 made of a dense composite.

  The filler 2 made of the above porous composite can be produced, for example, by the following method. First, a biodegradable polymer is dissolved in a volatile solvent, and a bioceramic powder is mixed to prepare a suspension. The suspension is made into a fiber by means of spraying or the like, and the fibers are intertwined. Form an aggregate. Then, this fiber assembly is immersed in a volatile solvent such as methanol, ethanol, isopropanol, dichloroethane (methane), chloroform, etc. to make it swell or semi-molten, and this is pressed to correspond to the hole 1b of the screw 1. It is a cylindrical porous fiber fusion assembly, and the fibers of this fiber fusion assembly are made into a matrix by substantially disappearing the fibrous form while shrinking and fusing, and the interfiber gap is rounded continuously. The filler 2 is produced by changing the form into a porous composite that has become pores.

  On the other hand, biological bone growth factors impregnated in the porous composite constituting the filler 2 include BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-b), EP4 (Prostanoid Receptor), b- There are FGF (basic fibroblast growth factor), PRP (platelet-rich plasma), etc., and these biological bone growth factors are enclosed in the container 3 alone or in combination of two or more. It is also preferable to add osteoblasts derived from living organisms to these biological bone growth factors. These biological bone growth factors and organism-derived osteoblasts added thereto are impregnated in the filler 2 in a state of being solubilized or suspended as an injection solution or an infusion solution.

  When the filler 2 is impregnated with these biological bone growth factors and osteoblasts, the biological bone growth factor exudes prior to or in parallel with the hydrolysis of the filler 2 to proliferate osteoblasts, Since the growth is greatly promoted, it depends on the region and the growth factor, but bone union is completed within a few weeks, and bone tissue is formed in the surface layer portion of the porous composite constituting the filler 2 Then, the entire porous composite is immediately replaced with the living bone, and the hole 1b of the screw 1 is filled with the living bone. Of the above biological bone growth factors, BMP and EP4 are particularly effective for bone growth. PRP is plasma rich in platelets, and the addition of this promotes the formation of new bone. In some cases, other growth factors such as IL-1, TNF-α, TNF-β, and IFN-γ may be mixed.

  The bone bonding material having the above-described structure is one in which the screw 1 (bone bonding material main body) is screwed into the bone of the fractured portion to be bonded and fixed. The screw 1 made of a dense complex of the biodegradable absorbable polymer contained therein has a sufficient mechanical strength and is not rapidly hydrolyzed by body fluids although it is a hollow body having a hole 1b opened at one end. The strength can be maintained for a period of at least 3 months necessary for normal bone fusion, and the bone joint can be fixed securely. On the other hand, the filler 2 made of a porous composite of biodegradable absorbable polymer containing bioceramic powder inserted into the hole 1b of the screw 1 passes through the continuous pores into body fluid or the inside of the porous composite. Osteoblasts penetrate and are decomposed and absorbed faster than the screw 1 of the dense complex while exhibiting osteoconductivity or osteoinductivity due to the bioactivity of the bioceramic powder. Prior to or in parallel with this decomposition and absorption, biological bone growth factors such as BMP carried on the filler 2 are gradually released, so that the induction formation of living bone is efficiently promoted. Bone fusion is completed in a matter of weeks, depending on the site and biological bone growth factors, much earlier than the three-month period required for bone fusion. Thereafter, the screw 1 and the filler 2 are further decomposed and resorbed, and finally completely replaced with living bone formed by bone conduction or bone induction, so that the hole 1b of the screw 1 does not remain as a cavity. Restored to the state. Moreover, since the biological bone growth factor impregnated in the filler 2 made of a porous composite does not have a thermal history during the manufacture of the screw 1, it exerts a bone growth promoting action without heat denaturation. Moreover, since the bioceramic powder contained in the filler 2 and the screw 1 is absorbable in the living body, it does not remain and accumulate in the replaced living bone, and does not leach and remain in the soft tissue or blood vessel. .

  2A and 2B show an osteosynthesis material according to another embodiment of the present invention. FIG. 2A is a front view of the osteosynthesis material, FIG. 2B is a longitudinal sectional view of the osteosynthesis material, and FIG. It is a top view of a joining material.

  This bone bonding material is formed by forming the bone bonding material main body on the pin 5, and a circular hole 5 a having both ends opened on the center line of the pin 5 from one end surface (upper end surface) of the pin 5 to the other. Perforated to the end face (lower end face). A cylindrical filler 2 having a diameter and a length corresponding to the hole diameter and length of the hole 5a and impregnated with a biological bone growth factor is filled in the hole 5a.

  This pin 5 (bone bonding material body) is made of a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive similar to the screw 1 described above. The tapered surface 5b and the flange-shaped stepped portion 5c are alternately formed on the outer peripheral surface, and the pin 5 is inserted into the hole formed in the bone of the fracture portion. When driven, the outer peripheral edge portion of the bowl-shaped step portion 5c bites into the living bone so that it does not come off. The hole diameter of the hole 5a through which the pin 5 passes is preferably about 1/3 to 2/3 of the diameter of the pin 5 (the diameter of the narrowest portion of the lower end of the tapered surface 5b), and the hole diameter is larger than this. Then, the strength of the pin 5 is lowered and there is a possibility that the pin 5 is broken when it is driven into the fractured portion. When the hole diameter is smaller than this, the filler 2 becomes too thin and the ratio of the filler 2 becomes small. The effect of promoting the induction of bone formation becomes insufficient.

  The shape of the pin 5 is not limited to this embodiment. For example, a pin having a simple cylindrical shape or a rectangular tube shape in which a hole 5a penetrating on the center line is formed, or four of the rectangular tube shape pins are used. It is possible to obtain a desired shape such as one in which slopes and stepped portions are alternately formed on the side surface so as not to be removed. Further, the hole 5a is not limited to a through hole having both ends opened, and may naturally be a deep bottomed hole that extends from one end surface (upper end surface) of the pin 5 to the other end surface (lower end surface). When such a bottomed hole is used, the strength of the lower end (tip) of the pin 5 is high, and therefore the possibility that the lower end (tip) of the pin 5 is broken during driving is reduced.

  On the other hand, the filler 2 is composed of a porous composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive. In this embodiment, the filler 2 has a hole 5a through which the pin 5 penetrates. It is formed in a cylindrical shape having a diameter and length that matches the pore diameter and length, and is impregnated with the bone growth factor described above. If the hole 5a is thin and long, it is not easy to insert and fill the thin and long filler 2 corresponding to the hole 5a. Therefore, a short cylindrical filling having a diameter that matches the hole diameter of the hole 5a. It is preferable to fill the filler 2 over the entire length of the hole 5a by preparing a plurality of the materials 2 and inserting the plurality of fillers 2 into the holes 5a of the pins 5 in order.

  Also in this bone bonding material, a plurality of small holes (not shown) communicating with the holes 5a filled with the filler 2 are formed in the pin 5 within a range in which the required strength can be maintained, whereby the body fluid In addition to facilitating the contact and infiltration of the osteoblasts with the filler 2, it is also possible to facilitate the exudation of biological bone growth factors to further promote the growth and bone healing of living bones.

  The dense composite of biodegradable absorbent polymer constituting the pin 5, the bioceramic powder contained therein, the content thereof, and the like are the same as those of the screw 1 of FIG. Is omitted. Moreover, the porous composite of the biodegradable absorbent polymer constituting the filler 2, the porosity, the proportion of continuous pores, the pore diameter of the continuous pores, the bioceramic powder contained therein, the content thereof, etc. Since these are the same as those of the filler 2 in FIG.

  When such a bone bonding material pin 5 (bone bonding material main body) is driven into a hole drilled in the bone of the fracture portion and bone is bonded and fixed, as in the case of the bone bonding material formed on the screw 1 described above, The pin 5 retains sufficient strength for a period of at least 3 months required for bone fusion, ensuring that the bone joint is securely fixed, while the filler 2 is rapidly hydrolyzed and releases biological bone growth factor Therefore, although it depends on the region and bone growth factor, the bone fusion at the joint and fixing portion is completed in about several weeks, and the filler 2 replaces the living bone relatively early due to the bioactivity of the bioceramic powder. Therefore, the hole 5a of the pin 5 is filled with the living bone. Finally, the pin 5 is also completely replaced with the living bone and disappears, and the hole 5a is restored without remaining as a cavity.

  In still another embodiment of the osteosynthesis material according to the present invention, the osteosynthesis material body made of a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive is described above. The biodegradable absorption containing the above-mentioned bioabsorbable and bioactive bioceramic powder in a hole 1b or 5a formed in the screw 1 or the above-described pin 5 and having at least one end of the bone-bonding material body opened. A filler 2 (a filler not impregnated with biological bone growth factor) made of a porous polymer porous composite is inserted.

  Such an osteosynthesis material is prepared by screwing the osteosynthesis material body into the bone of the fractured portion, or after the bone is joined and fixed by driving, or before the fixation of the bone, the biology prepared separately. By injecting and impregnating the target bone growth factor into the filler 2, the same effects as those of the osteosynthesis material can be obtained. In that case, when the small holes communicating with the holes 1b and 5a are formed in the osteosynthesis main body formed on the screw 1 or the pin 5, the biological bone growth factor can be easily impregnated. There are advantages.

  FIG. 3 shows one embodiment of an osteosynthesis material set according to the present invention, in which (a) is a longitudinal sectional view of the osteosynthesis material body containing the same set, and (b) is a biological bone of the same set. It is a front view of the container which put the growth factor.

  This osteosynthesis material set is formed in a screw 1 and a bone-injection material body with a filler filled with a filler 2 in a hole 1b formed on the center line and having an opening at least one end thereof, and a container 3 such as an ampoule. It is combined with an encapsulated biological bone growth factor and packed in a bag or a case, for example. Since the screw 1 (bone bonding material main body) is the same as the screw 1 in the bone bonding material of FIG. 1 described above, and the filler 2 is also the same as the filler 2 in the bone bonding material of FIG. 1 described above, Description is omitted. Further, the biological bone growth factor is the same as the biological bone growth factor impregnated in the filler 2 in the above-mentioned osteosynthesis material shown in FIG. 1, and is solubilized or suspended as an injection solution or an infusion solution. Since it is enclosed in the container 3 in the state where it was made, description is abbreviate | omitted.

  Such an osteosynthesis material set includes the container 3 after the screw 1 containing the filler 2 (the osteosynthesis material body containing the filler) is screwed into the bone of the fractured portion and the bone is joined or fixed. And the biological bone growth factor is injected into the filler 2 and impregnated for use. When used in this manner, the screw 1 retains sufficient strength for a period of 3 months required for bone fusion to securely fix the osteosynthesis, while the filler 2 is biologically hydrolyzed rapidly. Bone growth factor exudes, depending on the site and bone growth factor, but the bone fusion at the joint is completed within a few weeks, and the biomaterial of the bioceramics powder is relatively early due to the bioactivity of the filler. In order to replace bone, the hole 1b of the screw is filled with living bone. Finally, the screw 1 is also completely replaced with the living bone and disappears, and the hole 1b is restored without remaining as a cavity.

  FIG. 4 shows another embodiment of the osteosynthesis set according to the present invention, (a) is a front view of the osteosynthesis material body of the set, (b) is a front view of the filler of the set, ( c) is a front view of a container containing a bone growth factor, and FIG. 5 is a cross-sectional view of the main body of the bone cement.

  The osteosynthesis material set includes an osteosynthesis body formed on the screw 1, a filler 2 filled in a hole 1b formed on the center line of the screw 1, and a living organism enclosed in a container 3 such as an ampoule. For example, it is packed in a bag or a case in combination with a bone growth factor. The screw 1 (bone bonding material main body) is made of a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive, as shown in FIG. A hole 1d through which the Kirschner wire 4 is inserted is formed on the center line of the screw 1 so as to penetrate from the upper end surface of the screw head 1a to the screw tip, and the Kirschner wire insertion hole 1d is filled with the filler 2. This is also used as the hole 1b. The screw 1 is formed so that the screw head 1a has a square planar shape with rounded corners at the four corners, similarly to the screw 1 of FIG. Thus, it is not formed over the entire length of the screw shaft part, but is formed partially from the middle of the screw shaft part to the tip.

  On the other hand, the filler 2 is composed of a porous composite of a biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive, and is formed on the center line of the screw 1. It is formed in a cylindrical shape having a diameter and a length corresponding to the hole 1b (Kirschner wire insertion hole 1d). However, when the hole 1b for filling the filler is thin and long, it has a diameter that matches the hole 1b and is about 1/2, 1/3, or 1/4 of the length of the hole 1b. It is preferable to divide and form a short cylindrical filler having a length of 2 mm, align two, three or four short fillers together with the screw 1. Since such a short filler can be inserted into the hole 1b of the rain screw 1 in order, there is an advantage that the insertion work is easy even if the hole 1b is long.

  The dense composite of biodegradable absorbable polymer constituting the screw 1 (bone bonding material main body), the bioceramics powder to be contained therein, the content thereof, and the like are the same as those of the screw 1 of FIG. Since there is, description is abbreviate | omitted. Further, the porous composite of biodegradable absorbent polymer constituting the filler 2, the porosity, the proportion of continuous pores, the pore diameter of the continuous pores, the bioceramic powder to be contained, the content thereof, etc. Since it is the same as that of the filler 2 in the bone bonding material of FIG. 1, description is abbreviate | omitted. Furthermore, since the biological bone growth factor enclosed in the container 3 is the same as the biological bone growth factor enclosed in the container 3 in the osteosynthesis set of FIG.

  The above-mentioned bone bonding material set is used for bonding and fixing bones at the fracture portion in the following manner. First, the Kirschner wire 4 is inserted into a hole 1b (Kirschner wire insertion hole 1d) formed on the center line of the screw 1 (bone bonding material main body), and the screw 1 is used as a guide for the target portion of the fracture portion. The bones are joined and fixed accurately by screwing in a predetermined direction. Then, the Kirschner wire 4 is removed and the hole 1b of the screw 1 is filled with the filler 2, and the container 3 is opened to inject and impregnate the biological bone growth factor into the filler 2, or the filler Before filling 2, the container 3 is opened, and the biological bone growth factor is impregnated into the filler 2, and the filler 2 impregnated with this bone growth factor is filled into the hole 1 b of the screw 1. If it does in this way, the effect similar to the osteosynthesis set of FIG. 3 mentioned above will be acquired.

  Each of the above-mentioned osteosynthesis material sets uses the biological bone growth factor enclosed in the container 3 as a combination material, but the osteosynthesis material set of the present invention does not necessarily combine the biological bone growth factor. It is not necessary to use the constituent material. FIG. 6 shows an osteosynthesis material set in which such a biological bone growth factor is not used as a constituent material of the combination. (A) is a front view showing the osteosynthesis material body of the same set, and (b) is the same diagram. It is a front view which shows the filler of a set, and (a) and (b) of FIG. 7 is sectional drawing and a top view of the same bone joining material main body.

  This osteosynthesis material set is a combination of an osteosynthesis material body formed on a large screw 1 for great trochanteric fracture and a filler 2 filled in a hole 1b formed on the center line of the large screw 1. For example, it is packed in a bag or case. The large screw 1 (main body of bone bonding material) is composed of a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive, as shown in FIG. Further, on the center line of the large screw 1, a large hole 1e having a female screw on the inner surface and a hole 1d through which the Kirschner wire 4 is inserted are formed so as to penetrate from the upper end surface of the screw head 1a to the screw tip. These large holes 1e and Kirschner wire insertion holes 1d are also used as holes 1b into which the filler 2 is inserted. The head 1a of the large screw 1 is formed in a hexagonal column shape as shown in FIGS. 6 (a) and 7 (b), and the portion near the tip of the screw shaft portion has a male screw top portion. Is formed, and a male screw 1c having a valley at a round groove is formed. And as shown to (a) of FIG. 6, the small outer groove | channel 1f is formed in the outer peripheral surface of a screw shaft part in parallel with a centerline.

  On the other hand, the filler 2 is composed of a porous composite of a biodegradable and absorbable polymer containing a bioceramic powder that is bioabsorbable and bioactive, and as shown in FIG. A large diameter cylindrical portion 2a having a diameter and a length corresponding to the large hole 1e of the large screw 1 and a small diameter cylindrical portion 2b having a diameter and a length corresponding to the Kirschner wire insertion hole 1d are integrally formed coaxially and integrally. Is.

  The above-described dense composite of biodegradable and absorbable polymer constituting the large screw 1 (bone bonding material main body) for joining the greater trochanteric fracture, the bioceramics powder to be contained therein, the content thereof, etc. Since it is the same as that of the screw 1 of 1, the description is omitted. Moreover, the porous composite of the biodegradable absorbent polymer constituting the filler 2, the porosity thereof, the proportion of continuous pores, the pore diameter of the continuous pores, the bioceramic powder to be contained, the content thereof, etc. Since it is the same as that of the filler 2 in the osteosynthesis of FIG. 1 mentioned above, description is abbreviate | omitted.

  The above-mentioned osteosynthesis material set is used for joining and fixing fracture portions such as the femoral head in the following manner. First, a Kirschner wire is inserted from the large hole 1e of the large screw 1 (bone bonding material main body) into the Kirschner wire insertion hole 1d, and using the Kirschner wire as a guide, the large screw 1 is accurately placed in the target location of the fracture portion in a predetermined direction. Screw to fix bone. Then, the Kirschner wire is extracted, the filler 2 is filled using the large hole 1e of the large screw 1 and the Kirschner wire insertion hole 1d as the holes 1b filled with the filler, and the biological material separately prepared for the filler 2 is prepared. Before the bone growth factor is injected and impregnated, or the filler 2 is inserted, the biological bone growth factor prepared separately is impregnated into the filler 2 and the biological bone growth factor is impregnated. The filler 2 is inserted into the large hole 1e and the Kirschner wire insertion hole 1d. If it does in this way, the effect similar to the osteosynthesis material set of FIG.3 and FIG.5 mentioned above will be acquired.

  In addition, as an osteosynthesis set according to another embodiment of the present invention in which a biological bone growth factor is not used as a combination material, biodegradation including bioresorbable bioactive ceramic powder is included. A screw (bone joint material body) comprising a dense composite of absorptive polymer and having a hole for inserting a filler on the center line thereof drilled from the upper end surface of the screw head toward the screw tip; A filler inserted into a pore, comprising a porous composite of biodegradable absorbable polymer containing bioabsorbable and bioactive bioceramic powder and impregnated with biological bone growth factor An osteosynthesis material set that is packed in a bag or case in combination with something can be mentioned.

  Such an osteosynthesis material set is used by fixing the bone of the fractured part with the screw (the osteosynthesis body) and then filling the hole of the screw with a filler impregnated with biological bone growth factor. By doing so, the same effect as the osteosynthesis material set of FIG.3, FIG.5, FIG.6 mentioned above is acquired.

  In any of the osteosynthesis sets according to the four embodiments described above, the osteosynthesis main body is a screw, and a hole for filling the filler on the center line is formed from the upper end surface of the screw head to the screw tip side. The osteosynthesis material body of the osteosynthesis material set is a pin for osteosynthesis in which a hole for filling the filler on the center line is drilled from one end surface to the other end surface of the pin. Needless to say, it may be.

  In addition, both of the bone bonding material and the bone bonding material set described above are composed of a porous composite of a biodegradable and absorbable polymer in which the filler 2 includes a bioceramic powder that is bioabsorbable and bioactive. However, the filler 2 may be formed of a porous composite of biodegradable absorbable polymer that does not contain bioceramic powder, and the filler 2 may be impregnated with biological bone growth factor. Good. When the filler 2 containing no bioceramic powder is impregnated with the biological bone growth factor in this way, the conduction or induction formation of the living bone is somewhat inferior to the filler containing the bioceramic powder. Although it cannot be denied, the bone union at the joint is completed in about a few weeks due to the exudation of the biological bone growth factor carried on the filler 2, so that the patient's bed leaving time is greatly shortened. Patients, doctors, and hospitals can all benefit greatly and one of the main objectives of the present invention can be fully achieved.

1 shows one embodiment of an osteosynthesis material according to the present invention, in which (a) is a front view of the osteosynthesis material, (b) is a longitudinal sectional view of the osteosynthesis material, and (c) is a plane of the osteosynthesis material. FIG. The other embodiment of the osteosynthesis material which concerns on this invention is shown, (a) is the front of the osteosynthesis material, (b) is a longitudinal cross-sectional view of the osteosynthesis material, (c) is the osteosynthesis material It is a top view. 1 shows an embodiment of an osteosynthesis material set according to the present invention, in which (a) is a longitudinal cross-sectional view of the osteosynthesis material body with filler of the set, and (b) is a biological bone growth factor of the set. It is a front view of the container put. The other embodiment of the osteosynthesis material set which concerns on this invention is shown, (a) is a front view of the osteosynthesis material main body of the set, (b) is a front view of the filler of the set, (c) is It is a front view of the container which put the biological bone growth factor of the same set. It is a longitudinal cross-sectional view of the osteosynthesis material main body of the set. The further another embodiment of the osteosynthesis material set which concerns on this invention is shown, (a) is a front view of the osteosynthesis material main body of the set, (b) is a front view of the filler of the set. (A) is a longitudinal cross-sectional view of the osteosynthesis material body of the set, and (b) is a plan view of the osteosynthesis material body of the set.

Explanation of symbols

1 Screw (Bone joint body)
DESCRIPTION OF SYMBOLS 1a Screw head 1b, 5a Hole which at least one end is opened 1c Screw thread 1d Kirschner wire insertion hole 1e Large hole 2 Filler 3 Container containing biological bone growth factor 4 Kirschner wire 5 Pin (bone joint material main body)

Claims (16)

  A bone-bonding material body made of a dense composite of biodegradable and absorbable polymer containing bioresorbable and bioactive bioceramic powder is drilled with a hole having at least one end opened in the body. It is characterized in that it is filled with a filler composed of a porous composite of a biodegradable absorbable polymer containing a resorbable and bioactive bioceramic powder, and further containing a biological bone growth factor. Osteosynthesis. A bone-bonding material body made of a dense composite of biodegradable and absorbable polymer containing bioresorbable and bioactive bioceramic powder is drilled with a hole having at least one end opened in the body. An osteosynthesis material body with a filler filled with a filler composed of a porous composite of a biodegradable absorbable polymer containing an absorbable and bioactive bioceramic powder;
A biological bone growth factor contained in the filler,
An osteosynthesis material set characterized by combining the above. An osteosynthesis material body comprising a dense composite of biodegradable and absorbable polymer containing bioabsorbable and bioactive bioceramic powder, and having a hole with at least one end opened;
A filler filled in the pores of the osteosynthesis material body, comprising a porous composite of biodegradable absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive;
A biological bone growth factor contained in the filler,
An osteosynthesis material set characterized by combining the above. An osteosynthesis material body comprising a dense composite of biodegradable and absorbable polymer containing bioabsorbable and bioactive bioceramic powder, and having a hole with at least one end opened;
A bone filling material for filling the pores of the osteosynthesis material body, which is composed of a porous composite of a biodegradable and absorbable polymer containing a bioceramic powder that is bioabsorbable and bioactive, and is a biological bone Including growth factors,
An osteosynthesis material set characterized by combining the above. An osteosynthesis material body comprising a dense composite of biodegradable and absorbable polymer containing bioabsorbable and bioactive bioceramic powder, and having a hole with at least one end opened;
A filler filled in the pores of the osteosynthesis material body, comprising a porous composite of biodegradable absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive;
An osteosynthesis material set characterized by combining the above.   The content of the bioceramics powder of the dense composite constituting the bone cement main body is 30 to 60% by mass, and the content of the bioceramics powder of the porous composite constituting the filler is 60 to 80% by mass. The osteosynthesis material set according to any one of claims 2 to 5, wherein the osteosynthesis material set is%.   The porosity of the porous composite constituting the filler is 60 to 90%, the continuous pores account for 50% or more of the total pores, and the pore size of the continuous pores is 50 to 600 µm. The osteosynthesis material set according to any one of claims 2 to 5.   Biological bone growth factors include BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-b), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast Growth Factor), and PRP (platelet-rich plasma). The osteosynthesis material set according to any one of claims 2 to 5, which is any one or a mixture of two or more.   The osteosynthesis main body is a screw, and a hole filled with a filler from the upper end surface of the screw head toward the screw tip side is drilled on the center line of the screw. The osteosynthesis material set according to any one of claims 2 to 5.   The bone bonding material main body is a pin, and a hole filled with a filler from one end surface to the other end surface of the pin is formed on the center line of the pin. Item 6. The osteosynthesis set according to any one of Items 5.   A bone-bonding material body made of a dense composite of biodegradable and absorbable polymer containing bioresorbable and bioactive bioceramic powder is drilled with a hole having at least one end opened in the body. An osteosynthesis material filled with a filler made of a porous composite of a biodegradable and absorbable polymer containing an absorbable and bioactive bioceramic powder.   The content of the bioceramics powder of the dense composite constituting the bone cement main body is 30 to 60% by mass, and the content of the bioceramics powder of the porous composite constituting the filler is 60 to 80% by mass. The osteosynthesis material according to claim 1 or 11, wherein the osteosynthesis material is%.   The porosity of the porous composite constituting the filler is 60 to 90%, the continuous pores account for 50% or more of the total pores, and the pore size of the continuous pores is 50 to 600 µm. The osteosynthesis material according to claim 1 or 11.   Biological bone growth factors include BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-b), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast Growth Factor), and PRP (platelet-rich plasma). The bone cement according to claim 1, which is any one or a mixture of two or more.   The osteosynthesis main body is a screw, and a hole filled with a filler from the upper end surface of the screw head toward the screw tip side is drilled on the center line of the screw. The osteosynthesis material according to claim 1 or 11.   The osteosynthesis material body is a pin, and a hole filled with a filler from one end surface to the other end surface of the pin is drilled on the center line of the pin. Item 12. The bone cement set according to item 11.

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