WO2007128192A1

WO2007128192A1 - A medical strengthened-type porous bioceramics, its preparation method and application

Info

Publication number: WO2007128192A1
Application number: PCT/CN2007/001124
Authority: WO
Inventors: Jianxi Lu; Jiang Chang; Zhen Wang; Kaili Lin; Faming Zhang; Jian Tang
Original assignee: Jianxi Lu; Jiang Chang; Zhen Wang; Kaili Lin; Faming Zhang; Jian Tang
Priority date: 2006-04-26
Filing date: 2007-04-06
Publication date: 2007-11-15
Also published as: CN1850293A; CN100540071C

Abstract

A medical strengthened-type porous bioceramics, its preparation method and application are disclosed. The bioceramics contains two portions of porous structure and dense structure. The dense structure portion is mainly used to increase mechanical strength, and the porous structure portion mainly has the action of allowing cell and tissue ingrowth and making newly-grown tissue have correspondent function. A pore shape, porosity, pore size and size of interior connection can be adjusted according to types of the cell and tissue and requirements of growth; the dense portion can increase the strength up to 2-20 times higher than that of pure porous bioceramics depending on its addition amount. Its preparation method includes slip-casting process, stamping process and slip-casting & stamping process, and a center-, edge- and dispersion-type porous bioceramics can be achieved. Also, the bioceramics having a shape, size, mechanical strength and function which is matched with a human bone to be restored can be obtained.

Description

Medical enhanced porous bioceramic, preparation method and application thereof

Technical field

The invention relates to a medical enhanced porous bioceramic, a preparation method and an application thereof, and the product prepared by the process can be applied to the field of biomedicine, especially orthopedics, plastic surgery, maxillofacial surgery, ENT, brain surgery In other fields, the bone defect and anatomical repair and reconstruction, the product can also be applied to liquid filtration, gas purification, solid separation, industrial catalysis and other fields. Background technique

Bioceramics are medically intended for defect repair and reconstruction of human tissue. In recent years, with the development of ceramic production technology, the bone supply and bone supply are extremely limited in autologous bone transplantation, and the risk of potential disease transmission from bio-products (allogene and xenogenic bone) Other factors have greatly promoted the research and application of bioceramics. Among the most widely used are calcium phosphate bioceramics (hydroxyapatite and tricalcium phosphate), which are mainly used in the repair and reconstruction of defects in hard tissues such as bone tissue.

Bioceramics are classified according to porosity, including porous and dense bioceramics, which have been widely used in the medical field. However, both have their own advantages and disadvantages. For example, dense bioceramics have good mechanical properties, can support and support, but because it does not have microstructures suitable for tissue and cell growth, its organisms Learning properties: such as biodegradability, osteoconductivity, etc.; porous ceramics, although it has a good microporous structure, has good biological properties, but its mechanical properties are poor, can not be stressed parts And the organ plays a good supporting role, so the porous bioceramic can only be used as a tissue growth conductive material for the filling material and the non-load bearing portion. Due to the above factors, the further clinical application of these two ceramics in the medical field is limited. In order to solve the contradiction between the two, it is necessary to have better mechanical properties and better biological properties. The present invention intends to focus on the breakthrough at this point, the purpose of which is to combine the two forms of materials together to make a corresponding anatomical structure for bone defect repair and reconstruction of the anatomical structure, so that the dense part supports Role and tissue guiding of the porous part. Although the two materials are the same chemical composition, due to the difference in structure and specific surface area, there is a significant difference in the degree of degradation. The porous part can be replaced and degraded by tissue during half a year to one year, while the dense part It can last for more than two years and plays a good supporting role. This enhanced bioceramic is expected to be widely used for tissue repair and reconstruction and bone fusion in stressed sites. However, there are many problems in the combination of the two. Especially in the preparation process, there are still many problems that are difficult to solve. For example: The difference in shrinkage rate between the dense and porous materials during the sintering process will cause the interface to detach. And the thermal stress existing on the interface may cause the ceramic to crack or the like. Purpose of the invention

It is an object of the present invention to provide a bioceramic that is dense and porous, i.e., a reinforced porous bioceramic. The bioceramic contains two parts, porous and dense, the dense part acts to enhance the mechanical strength, and the porous part promotes the growth of cells and tissues into the ceramic.

Another object of the present invention is to provide a plurality of methods for preparing a reinforced porous bioceramic which can be adjusted by determining the size of the dense portion according to the requirements of the mechanical strength of the human bone repair portion to prepare a corresponding ceramic.

Another object of the present invention is to provide the above-mentioned application of the enhanced porous bioceramic in the field of biomedicine, especially for the repair and reconstruction of bone defects and organ reconstruction, in orthopedics, orthopedics, maxillofacial surgery, ENT, brain Applications in surgery, etc., can also be applied in industrial fields such as liquid filtration, gas purification, separation of solids, and industrial catalysis. Summary of invention

The medically enhanced porous bioceramic of the present invention is characterized by:

1. The medically enhanced porous bioceramic according to the present invention contains two parts, a dense and a porous one. The dense part mainly plays a role in increasing the mechanical strength, and the porous part mainly serves as a guiding function for the growth of cells and tissues, and can be vascularized to obtain sufficient blood supply nutrition, so that the new tissue forms a corresponding function.

2. The medically-enhanced porous ceramics according to the present invention can determine the size of the dense portion by formula calculation according to the requirements of the mechanical strength of the human bone repairing portion to prepare a corresponding enhanced bioceramic.

3. The anatomical shape and size of the medically enhanced porous bioceramic according to the present invention are completely matched with the defect repairing portion. It can be used to inverse the X-ray and CT scan data of the contralateral anatomy, to create an anatomical model and the corresponding mold, so that the fabricated product matches the anatomical shape and size of the repair site (Fig. 1).

4. The porous microstructure of the medically-enhanced porous bioceramic according to the present invention can be made according to the characteristics of cells and tissue types and growth requirements, and the corresponding pore shape, porosity, pore size and inner diameter, and porous pore size. The ratio is 50 to 1000 μm, the porosity is 50% to 85%, the inner diameter of the pores is 20 to 500 μm, and the pore communication rate is 10% to 100%.

5. The dense portion of the medically-enhanced porous bioceramic according to the present invention is a ceramic reinforcement, which can be changed by changing the shape and volume of the reinforcement, or by controlling the production sintering temperature to change the amount (<10 μιη). The mechanical strength of the reinforced bioceramic is 2 to 200 times higher than that of the single porous bioceramic (Fig. 2), and the microporosity is 0.1% to 20%.

6. The reinforcement of the medically-reinforced porous bioceramic according to the present invention must be distributed at the force receiving portion to support the force and protect the porous portion. 7. The medically enhanced porous bioceramic reinforcement according to the present invention may be in the form of a cylinder, an elliptical cylinder, a square cylinder, a triangular cylinder, and an irregular cylinder (Fig. 3-6). The reinforcement distribution is edge-type at the edge (Fig. 5-6), centered at the center (Fig. 3-4), and two or more reinforcements are dispersed (Fig. 7-12). The arrangement of the reinforcements can be: longitudinal (Fig. 3-10), lateral (Fig. 12), oblique (Fig. 11), cross (Fig. 11) and mixed

(Figure 11-12) Arrange. The number of reinforcements can be from 1 to 20 (Fig. 7-12), and the amount of reinforcement in the entire ceramic volume is from 10% to 90%.

8. The ceramic powder raw material used for preparing the reinforced porous bioceramic according to the present invention has a grain size of 1.0 nm to 100 μm, and may be pure micron (0.1-μμm) or pure nano-powder (<100 nm). It can be a mixture of nano and micro powders. The chemical composition of the powder is selected from biologically active, such as from pure hydroxyapatite or doped hydroxyapatite, pure tricalcium phosphate or doped tricalcium phosphate, hydroxyapatite/tricalcium phosphate two-phase composite ceramic powder, Pure calcium carbonate or doped calcium carbonate, pure or doped alumina, pure zirconia or doped zirconia, titania, aluminum-magnesium spinel, and mixed powders in different ratios between the above various components.

9. The bioceramic can be applied in the field of biomedicine, especially in the fields of orthopedics, orthopedics, maxillofacial surgery, ENT, brain surgery, etc., for the repair and reconstruction of bone defects and anatomical structures, and also for liquid filtration and gas. Purification, solid separation, industrial catalysis and other fields.

10. The medically-reinforced porous bioceramic described above may be formed by co-molding, compression molding or molding.

(1) The principle of grouting is to reserve a gap when making a ceramic organic porous support, and then the slurry is dried and formed. After the shaped body is sintered, the stent portion is removed to form a porous portion, and the reserved gap is formed by the infusion filling portion to form a dense reinforcement.

(2) Molding is carried out by first forming a dense or porous portion by molding, and then making another matching portion around the portion.

(3) The principle of co-formation is to make a dense or porous portion by die pressing, followed by grouting to form another matching portion. The process flow of the medical enhanced porous bioceramic of the invention:

1) According to the shape and size of the product, make the corresponding split mold (main body, plug body and chassis). The mold must be added with a magnification factor of 1% to 50% depending on the shrinkage of the ceramic powder during sintering.

2) According to the use of the product and the method of use, the volume of the reinforcement can be arbitrarily designed; or the volume of the reinforcement can be determined by formula calculation. The calculation formula of the volume volume of the reinforcing body in the invention:

Where: Sd—the cross-sectional area of the dense reinforcement in the ceramic;

St~ "The total cross-sectional area of the final ceramic product;

Σ—the compressive strength of the final ceramic product;

σ ₀ — compressive strength of the porous ceramic;

Η—constant 1 to 4, which is related to the desired mechanical property improvement factor and the original powder grain size of the reinforced portion. In general, if the desired mechanical property improvement ratio is more than 20 times, the η value generally takes 1 and is less than 20 Take 3 to 4 times; the original powder of the reinforced part is nanometer (<100nm), η has a larger value, and the micron powder η has a smaller value.

3) The reinforced ceramic can be formed by co-molding, compression molding or molding by injection molding. Α, grouting

a. Fill the selected organic plastic particles into the selected mold cavity, add organic solvent or warm, cover the mold plug or / and insert the corresponding metal rod for 15 minutes, then rinse and fix with distilled water. Mold drying forms a porous organic framework.

b. Prepare the ceramic powder and water in a certain ratio and stir for 1 to 10 hours to form a fluid slurry.

c. The dried organic framework was placed in a correspondingly sized mold, and then the prepared slurry was poured, and after 1 to 5 hours, the green body was demolded to form a green body, which was dried in a dry box for 12 hours.

B, compression molding

a. The selected organic pore-forming agent and the ceramic powder are uniformly mixed in a certain ratio, and then filled into the selected mold cavity, and the mold plug body is pressed for several minutes, and then the porous body is taken out by demoulding.

b. Place the porous body in the center of the selected larger mold, leave the required gap around it, fill in the ceramic powder, cover the plug for a few minutes, and then release the porous compact composite. Blank body.

C. Molding-grouting synergistic forming

a. The ceramic powder is filled into the selected mold cavity, and after the mold plug is pressed for a few minutes, the compact body is taken out.

b. Put the dense body into the mold, fill the organic pore-forming agent around the body or/and the central cavity, add organic solvent or warm for a few minutes, then rinse and fix with steamed water. Put in a dry box for a few hours.

c. Prepare the ceramic powder and water in a certain ratio, and stir for 1 to 10 hours to form a fluid slurry. d. The slurry is directly poured into the organic framework and dried in a dry box for several hours to form a porous dense composite body.

4) Put the above-mentioned step 3) the dried organic framework into a sintering furnace, gradually heat up to 200 ° C to 400 ° C to gasify and eliminate organic matter, and then continue to heat up to 1000 ° C - 1400 Ό sintering into the desired Enhanced porous bioceramics. In the present invention, regular and irregular plastic particles which can be dissolved by an organic solvent and heat are selected as materials for making a porous scaffold. Preferred plastic particle raw materials are olefin polystyrene, polyethylene, polypropylene, polyvinyl chloride, polyamide. , polyurethane, polymethyl methacrylate, paraffin and naphthalene, etc., which burn at high temperatures without leaving any harmful substances. The hot melt point of the plastic particles should be between 100 ° C and 400 ° C. The plastic particles are between 100 and 1000 microns in diameter. The organic solvent may be selected from acetone, diacetone, bromochloromethane, methyl isobutyl ketone, chloroform or the like according to the plastic particle component. The binder should be selected from particles which adhere to the above raw materials.

In the present invention, the mold material is not particularly limited and may be made of a material which is chemically inert to the solvent to be used, such as stainless steel, ceramics, glass, gypsum or the like. The mold must have one or more feed ports. The mold body must be in the form of a longitudinal pair or a multi-part body, and the joints between the parts should be very close. This facilitates the release of the porous frame. DRAWINGS

Figure 1 is a photograph of a femoral head of a reinforced porous bioceramic made according to an anatomical model mold;

Figure 2 is a comparison of mechanical properties of reinforced porous bioceramics and non-reinforced porous bioceramics;

Figure 3 is a schematic view of a centrally-reinforced porous bioceramic, the cylindrical ceramic center is a cylindrical dense portion, and the edge is a porous portion;

Figure 4 is a schematic view of a central type of enhanced porous bioceramic, the central portion of the cylindrical ceramic is a rectangular parallelepiped portion, and the edge is a porous portion;

Figure 5 is a schematic view of an edge-type enhanced porous bioceramic, the central portion of the cylindrical ceramic is a porous portion of a polygonal columnar body, and the edge is a dense portion;

Figure 6 is a schematic view of an edge type reinforced porous bioceramic, the central portion of the cylindrical ceramic is a porous portion of a triangular columnar body, and the edge is a dense portion;

Figure 7 is a schematic view of a dispersion-type enhanced porous bioceramic, the cylindrical ceramic has a dense portion at the center and the periphery, and the annular body between the two is a porous portion;

Figure 8 is a schematic view of a dispersion-type enhanced porous bioceramic, the cylindrical ceramic porous portion is equidistantly distributed with six cylindrical compacts of uniform size, and a dense body of a peripherally annularly wrapped porous portion; Figure 9 is a schematic view of a dispersion-type enhanced porous bioceramic, the cylindrical ceramic porous portion is equidistantly distributed with eight cylindrical compacts of uniform size;

Figure 10 is a schematic view of a dispersion-type enhanced porous bioceramic, wherein the cylindrical ceramic dense portion is equidistantly distributed with six cylindrical porous bodies of uniform size;

Figure 11 is a schematic view of a dispersion-enhanced porous bioceramic, wherein the cubic ceramic multi-part L is equidistantly distributed with five diagonally oblique cylindrical compacts of uniform size;

Figure 12 is a schematic view of a dispersion-type enhanced porous bioceramic, wherein the cubic ceramic multi-part L is equidistantly distributed with five longitudinal and five transversely aligned cylindrical compacts;

Figure 13 is a scanning electron micrograph of the interface between the dense and porous portions of the reinforced porous bioceramic;

Figure 14 is a photograph of the edge-type enhanced porous bioceramic;

Figure 15 is a photograph of a central enhanced porous bioceramic. DETAILED DESCRIPTION OF THE INVENTION Example 1:

The edge-type reinforced porous bioceramic produced by the grouting process uses tricalcium phosphate as the raw material (the powder shrinkage rate is 15%), and the cylinder with a diameter of 18 mm and a height of 20 mm is required to achieve the resistance of 70 MPa. The compressive strength, and the porosity of the porous portion was 70%, the pore diameter was 500 - 600 μm, and the pore diameter was 120 μm. The compressive strength of the porous portion was 2.0 MPa.

Specific steps are as follows:

1. Calculated according to the above formula, the enhancement range is 35 times, tricalcium phosphate is a micron powder, n is taken 1, and thus

S _t = (l 8/2) ² X 3.1416 - 254.46 let ²

Porous part diameter = >/(254-201)/3.1416 X2 = 8.22 mm Reinforced part thickness = (18 - 8.22)/2 = 4.89 mm

Since the area is larger and the edge annular dense reinforcement method is more suitable, since the shrinkage rate of the ceramic sintering process is 15%, the actual porous portion has a diameter of 9.45 mm and the reinforcement has a thickness of 5.62 mm.

2. Select a cylindrical mold with an inner diameter of 9.45mm, fill the mold cavity with yam organic particles with a diameter of 575~690μπι, add acetone to cover the mold plug for 15 minutes, rinse with distilled water, and release the mold to form a porous Organic framework. 3. The tricalcium phosphate ceramic powder and water were prepared in a weight ratio of 3:2, and stirred for 3 hours to form a fluid slurry.

4. Use a gypsum cylinder mold with an inner diameter of 20.7 mm and a height of 50 mm. Place the organic frame at the center of the mold, and the distance between the sides is required to be equal (5.62 mm). Subsequently, the above prepared slurry was poured, and after 1 hour, it was released into a 45 ° C dry box and dried for 12 hours.

5. Place the perfused and dried frame into a sintering furnace, gradually heat up to 400 °C to gasify and eliminate organic matter, and then continue to heat up to 1200 to form edge-reinforced ceramics (Fig. 13-14). Example 2:

The central reinforced porous bioceramic produced by the compression molding process uses tricalcium phosphate as a raw material (15% powder shrinkage) to produce a cylinder with a diameter of 20 mm and a twist of 20 mm. The product is required to have an anti-40 MPa resistance. The compressive strength, and the porosity of the porous portion was 70%, the pore diameter was 500 - 600 μm, and the pore diameter was 120 μm. The compressive strength of the porous portion was 2.0 MPa.

Specific steps are as follows:

1. Calculated according to the above formula, the enhancement range is 20 times, the tricalcium phosphate is a micron powder, n is taken 1, and thus

S _t = (20/2) ² X3.1416 = 314 mm ²

S _d

314 Enhancement

11.56 mm porous part thickness = (20 - 11.56) / 2 = 4.22mm

Since the shrinkage rate during the sintering of the ceramic is 15%, the actual reinforcing portion has a diameter of 13.29 mm and the porous portion has a thickness of 4.85 mm.

2. Select a cylindrical stainless steel mold with an inner diameter of 13.29 mm, mix paraffin particles with a diameter of 575 to 690 mm and tricalcium phosphate powder in a volume ratio of 7:3, fill the mold cavity (XXg), and cover the mold plug. After releasing the pressure of 1000 kg for 3 minutes, the mold was released, and the porous body was taken out.

3. Select a cylindrical stainless steel mold with an inner diameter of 23 mm and a height of 50 mm, and place the porous blank in the center of the mold. The distance between the sides is required to be equal (4.85 mm). Then, the tricalcium phosphate powder is placed in the peripheral gap and the plug is placed. After the body was pressurized to 1000 kg for 3 minutes, the porous dense composite body was taken out.

4. Place the composite body in a sintering furnace, gradually heat up to 200-400 Torr gasification to eliminate organic matter, and then continue to heat up to 105 (TC sintered into reinforced ceramics (Figure 15). Example 3:

The edge-type reinforced porous bioceramic produced by the molding-slurry co-forming process uses tricalcium phosphate as a raw material (15% powder shrinkage) to produce a cylinder with a diameter of 30 mm and a height of 30 mm. The compressive strength of 20 MPa, and the porosity of the porous portion is 70%, the pore diameter is 500 - 600 μm, and the pore diameter is 120 μm. The compressive strength of the porous portion was 2.0 MPa.

Specific steps are as follows:

1. Calculated according to the above formula, the enhancement is more than 10 times, the tricalcium phosphate is a micron powder, n is taken 1, and thus

S _t - (30/2) ² X 3.1416 = 707 ram ²

Porous part diameter =

20.96 mm reinforced part thickness = (30 - 20.96) / 2 = 4.52 mm

Since the shrinkage rate of the ceramic sintering process is 15%, the actual porous portion has a diameter of 24.10 mm and the reinforcement has a thickness of 5.20 mm.

2. Select a circular stainless steel mold with a cavity inner diameter of 34.5 mm and a central cylindrical diameter of 24.10 mm (the thickness of the ring wall is 5.20 mm), fill XXg of tricalcium phosphate powder into the cavity of the mold, cover the mold plug, and add 1000kg of pressure. After 3 minutes, the mold was released and the dense body was taken out.

3. Fill the central cavity of the dense body (diameter 24.10 mm) with PMMA organic spherical particles with a diameter of 575~690 mm until it is level with the plane of the ring. After adding acetone for 15 minutes, rinse it with distilled water and place it in 45 Ό dry. Inside the box, dry for 12 hours.

4. Prepare XXg tricalcium phosphate ceramic powder and water in a ratio of 3:2, and stir for 3 hours to form a fluid slurry.

5. Inject the paddle directly into the organic frame, place it in a 45 °C oven and dry for 12 hours.

6. Place the porous dense composite body into a sintering furnace, gradually heat up to 200-400 ° C to gasify and eliminate organic matter, and then continue to heat up to 1350 Ό to form a reinforced ceramic. Example 4:

The dispersion-enhanced porous bioceramic produced by the grouting process uses tricalcium phosphate as a raw material (the powder shrinkage rate is 15%) to produce a cylinder having a diameter of 60 mm and a height of 40 mm, and contains eight cylindrical reinforcements. The product is required to achieve a compressive strength of 30 MPa, and the porous portion has a porosity of 70%, a pore diameter of 500 to 600 μm, and a pore diameter of 120 μm. The compressive strength of the porous portion was 2.0 MPa. Specific steps are as follows:

1. Calculated according to the above formula, the enhancement range is more than 15 times, the tricalcium phosphate is a micron powder, n is taken 1, and thus,

S _t == C60/2) ² X3.1416 = 2827 mm

Reinforced part diameter

Mm

Since the shrinkage rate of the ceramic sintering process is 15%, the actual diameter of each reinforcement is 16.45 mm.

2. Select a cylinder mold with an inner diameter of 69 mm, fill the mold cavity with a diameter of 575~690μιη into the mold cavity, add acetone, and insert 8 metal rods with a diameter of 16.45 iran at equal intervals for 15 minutes. Thereafter, it was rinsed with distilled water, and demolded to form a porous organic framework.

3. Prepare XXg tricalcium phosphate ceramic powder and water in a ratio of 3:2, and stir for 3 hours to form a fluid slurry.

4. Use a gypsum cylinder mold with an inner diameter of 69 mm and a height of 50 mm to place the organic frame into the mold. Subsequently, the above prepared slurry was poured, and after 1 hour, it was released into a 45 ° C dry box and dried for 12 hours.

5. Place the perfused and dried frame into a sintering furnace, gradually heat up to 400 ° C to gasify and eliminate organic matter, and then continue to heat up to 1200 Ό to form a reinforced ceramic (Figure 9). Example 5

- A 42-year-old female patient with a right middle tibia and a bone tumor. The middle and lower segment of the humerus was resected 30 mm during surgery. The bone defect was replaced with the enhanced bioceramic prepared in Example 3 and added. Steel plate screws are fixed. Two weeks after the operation, the patient can move to the ground. After four weeks, the X-ray film shows new bone formation.

Claims

Claim

What is claimed is: 1. A medically-reinforced porous bioceramic, characterized in that the bioceramic comprises two parts, porous and dense; the porous portion has a pore diameter of 50 to 1000 μm, a porosity of 50 to 85% _{; and the} dense portion is a ceramic reinforcement. Distributed in the force-receiving part, supporting the force and protecting the porous part, the reinforcement occupies 10~90% in the porous bioceramic body.

The medically-reinforced porous bioceramic according to claim 1, wherein the porous portion has an inner diameter of 孑 L of 20 to 500 μm and a pore communication ratio of 10 to 100%.

The medically-reinforced porous bioceramic according to claim 1, wherein the reinforcement has a shape of a cylinder, an elliptical cylinder, a square cylinder, a triangular cylinder or a irregular cylinder.

4. The medically-reinforced porous bioceramic according to claim 1, wherein said reinforcement is distributed in an edge type, a center type or a dispersion type; and said reinforcement is arranged in a longitudinal direction, a transverse direction, an oblique direction, One of a cross or a mixed arrangement.

A medically-reinforced porous bioceramic according to claim 1, 3 or 4, wherein said reinforcement has a distribution of from 1 to 20.

The medically-reinforced porous bioceramic according to claim 1, 3 or 4, wherein the reinforcing body has a pore size of less than ΙΟμιη and a microporosity of 0.1 to 20%.

7. The method for preparing a medically-reinforced porous bioceramic according to claim 1, which is characterized by using any one of grouting, compression molding or injection molding and co-molding, firstly according to the mechanical strength of the human bone repairing portion. The requirement to determine the size of the dense part by the formula (1), the selected mold,

Where: Sd—the cross-sectional area of the dense reinforcement in the ceramic;

St—the total cross-sectional area of the final ceramic product;

Σ—the compressive strength of the final ceramic product;

σ ₀ — compressive strength of the porous ceramic;

Η—constant 1 to 4 _;

Then according to three forming processes, the specific steps are:

Α, grouting

(a) filling the organic plastic particles into the mold cavity, adding organic solvent or heating, covering the mold plug or / and inserting the metal rod, rinsing and fixing with distilled water, releasing the mold to form a porous organic framework; (b) preparing the ceramic powder and water in a weight ratio, stirring for 1 to 10 hours to form a fluid slurry;

(c) placing the dried organic framework into a correspondingly sized mold, and then injecting the slurry prepared in the step (b), after 15 hours, demolding to form a green body and drying in a dry box for 12 hours;

(d) placing the dried framework prepared in step (c) into a sintering furnace, gradually heating to 200-400 Torr to remove organic matter, and then continuing to raise the temperature to 1000-140 (TC _;

B, compression molding

(a) uniformly mixing the selected organic pore-forming agent and the ceramic powder, and then filling the selected mold cavity, pressing the mold plug body for a few minutes, and then releasing the porous body;

(b) Put the porous body into the center of the selected larger mold, leave the required gap around it, fill in the ceramic powder, cover the plug and pressurize, and then release the porous compact composite Blank body; '

(c) placing the composite body obtained in the step (b) into a sintering furnace, first raising the temperature to 200-40 (TC removes the organic matter, and then heats it to 1000-1400 ° C to be sintered;

C, compression molding and grouting synergistic forming

(a) filling the ceramic powder into the selected mold cavity, pressing the mold plug body to pressurize, and then releasing the compact body;

(b) Put the dense body into the mold, fill the organic pore-forming agent around the body or / and the central cavity, add organic solvent or warm, rinse with distilled water, dry and make An organic framework;

(c) mixing the ceramic powder with water and stirring for 1 to 10 hours to form a fluid slurry;

(d) directly injecting the slurry into the organic framework prepared in the step (b), and drying in a dry box to form a porous dense composite body;

(e) The composite body obtained in the step (d) is placed in a sintering furnace, first heated to 200-400 Torr to remove the organic matter, and then heated to 1000-1400 ° C for sintering.

8. The method of preparing a medically enhanced porous bioceramic according to claim 7, wherein:

(1) The plastic particles are one of polystyrene, polyethylene, polypropylene, polyvinyl chloride, polyamide, polyurethane, polymethyl methacrylate, paraffin and naphthalene; the particle size of the plastic particles is 100. ~1000μηι _;

(2) The organic solvent is selected from the group consisting of acetone, diacetone, bromochloromethane, methyl isobutyl ketone or chloroform depending on the plastic particle component.

The method for preparing a medically-reinforced porous bioceramic according to claim 7, wherein the ceramic powder used is biologically active pure hydroxyapatite, miscellaneous hydroxyapatite, pure tricalcium phosphate, Doped with tricalcium phosphate, hydroxyapatite and tricalcium phosphate composite ceramic, pure calcium carbonate, doped calcium carbonate, pure alumina, doped alumina, pure zirconia, doped zirconia, titania, aluminum-magnesium spinel Stone or a mixture between them; the grain size of the ceramic powder Between 1.0 nm and 100 microns, it is a pure micron, pure nano or a mixture of micro and nano.

10. Use of a medically enhanced porous bioceramic according to claim 1 for use in orthopedics, orthopedics, maxillofacial surgery, ENT or brain surgery for the repair and reconstruction of bone defects and anatomical structures.

11. The use of a medically enhanced porous bioceramic according to claim 10, wherein said repairing and reconstructing is performed by inversely modeling the X-ray and CT scan data of the contralateral anatomy to produce an anatomical model and Corresponding molds match the anatomical shape and size of the finished product to the repair site.