CN108201635B - Support for repairing articular subchondral bone - Google Patents
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Abstract
A scaffold for repairing articular subchondral bone comprises a porous salt layer and a porous metal material layer from top to bottom, wherein the porous metal material layer is a gradient porous metal material layer. The bracket with the structure effectively realizes the bionic of the subchondral bone of the artificial joint, enables the subchondral bone to bear complex and large load, has good buffer function, realizes good force transmission, has higher strength than a porous non-metal bracket, overcomes the problem of insufficient rigidity of a high-porosity porous metal material with a single pore, is favorable for being fused with a cartilage layer, has good seepage characteristic, and is favorable for the migration of cells and nutrient solution and the maintenance of proper pressure of liquid in the joint due to the pore size design; the pore size and material design of the scaffold are also beneficial to migration, inhabitation, differentiation and proliferation of cells, and the scaffold is a real scaffold for repairing and regenerating articular subchondral bones.
Description
Technical Field
The invention relates to a prosthesis, in particular to a scaffold for repairing articular subchondral bone.
Background
The human joint has a complex structure, subchondral bones are important components of the joint, the joint bears large complex load during the motion of the human body, and the load born by the joint even reaches more than 7-9 times of the weight of the human body during the motion, which puts high requirements on the subchondral bones of the joint. With the improvement of social and economic levels, the incidence rate of serious injuries such as traffic accidents is also rapidly increased. In China, joint injury caused by wound approximately affects the life of hundreds of thousands of people every year, and approximately 10 thousands of people need to perform artificial joint replacement every year. The incidence of diseases and joints caused by aging in society is increasing, and osteoarthritis and the like can cause damage or defect of joints, thereby causing damage or defect of articular subchondral bone. At present, most of artificial total joint replacement materials adopted for treating osteoarthropathy are hard materials such as metal, ceramic, ultra-high molecular weight polyethylene and the like, and the problems of material failure, aging and the like are easily caused along with the increase of service life, so that postoperative complications are caused by abrasion and looseness, the service life is short, and the cost is high. For this reason, many studies have been conducted on a scaffold for repair of articular subchondral bone.
CN103127553A A preparation method of a nanometer micrometer structure coexisting chitosan double-layer scaffold, the bottom layer of the bone/cartilage repair scaffold is a three-dimensional micrometer chitosan scaffold, is used for providing high porosity and mechanical strength, is suitable for growth of osteoblasts and is used for repairing subchondral bone.
CN101219069A discloses a double-layer composite scaffold for repairing osteochondral, which is characterized in that a simulated subchondral bone layer is made of one or a mixture of more of hydroxyapatite, tricalcium phosphate, polyether-ether-ketone, polylactic acid-polyglycolic acid copolymer, polyglycolic acid, polylactic acid and fibroin; the thickness of the simulated subchondral bone layer is 2 mm-20 mm, the porosity of the layer is 50% -75%, and the pore diameter is 200 μm-500 μm.
CN102526809A A scaffold for repairing osteochondral defects and a preparation method thereof, the scaffold is composed of a cartilage layer with pores and a subchondral bone layer with pores, the cartilage layer and the subchondral bone layer are tightly combined into a whole, wherein the material of the subchondral bone layer is porous titanium or porous titanium oxide or porous titanium alloy.
A repair test for sheep cartilage-subchondral Bone defects using Porous tantalum in combination with autologous periosteum was described in the section of Bone tissue for osteophondric defect repair (E.H.Mrosek et al. Bone Joint Res. 2016; 5: 403-. The results indicate that this structure is not effective in promoting cartilage formation.
Although many studies have been conducted, the structure of the scaffold for repairing the subchondral bone of the joint is still unreasonable, and the scaffold cannot effectively simulate the joint of a human body.
The invention content is as follows:
the invention aims to provide a scaffold for repairing articular subchondral bone, which has a reasonable structure and a good regeneration effect.
The purpose of the invention is realized by the following technical scheme:
a scaffold for repairing articular subchondral bone is sequentially composed of a porous salt layer and a porous metal material layer from top to bottom, wherein the porous metal material layer is a gradient porous metal material layer. The material of the structure effectively realizes the bionic of the subchondral bone of the artificial joint, avoids the problem of insufficient strength of a single non-metallic material, enables the subchondral bone to bear complex and large loads, enables nutrient solution and cells to be transferred by the porous structure, and facilitates the fusion with the cartilage layer by the porous salt layer, thereby promoting the repair of the artificial joint.
Further, the scaffold for repairing articular subchondral bone comprises a porous salt layer and a porous inorganic salt layer.
Further, in the scaffold for repairing articular subchondral bone, the porous inorganic salt layer is prepared by hydroxyapatite, tricalcium phosphate, ammonium hyaluronate or tetrabutylammonium hyaluronate, and is particularly favorable for fusion with a cartilage layer.
Further, in the scaffold for repairing articular subchondral bone, the porous organic salt layer is made of chondroitin sulfate, glycerophosphate, fructose phosphate, glucose phosphate, L-serine phosphate, adenosine phosphate, glucosamine or galactosamine, and is particularly favorable for fusion with the cartilage layer.
Further, the porous metal material layer is a porous tantalum layer, or a porous titanium and alloy layer thereof, or a porous niobium layer, or a porous cobalt-based alloy layer, or a porous stainless steel layer, or a porous nickel-titanium alloy layer, or a porous composite metal material layer.
Furthermore, the pore diameter of the porous salt layer is 3-10 μm, and further, the porous salt layer of the artificial joint repair material has a pore diameter of 3-10 μm, and the porous salt layer of the structure is compounded with other porous material layers, so that the scaffold for repairing the articular subchondral bone has good seepage characteristics, on one hand, cells, nutrient solution and the like in bone marrow can pass through, and meanwhile, cartilage and subchondral bone are isolated to a certain degree, and the liquid pressure in an articular cavity is properly released and buffered when the scaffold is stressed, and is not lowered too much.
Further, the scaffold for repairing the articular subchondral bone comprises an upper layer and a lower layer; wherein, the aperture of the upper layer of the porous metal material connected with the porous salt layer is 50-100 μm, the aperture of the lower layer of the porous metal material is 100-1000 μm, and the pores inside and between the layers of the porous metal material are communicated. When the material with the structure is used for repairing the artificial joint, the force transmission and absorption effects are good, the strength is high, the bone tissue can grow in more conveniently, and the bone cells can be output from the upper layer of the porous metal material; or the pore diameter of the porous metal material layer is gradually increased from 50-100 μm to the pore diameter of the far end surface of the porous metal material layer away from the porous salt layer, which is increased from 50-100 μm, and the pore diameter of the far end surface of the porous metal material layer is increased to 100-1000 μm, and the pores inside the porous metal material layer are communicated with each other, so that the two porous metal material layers have the equivalent effect.
Furthermore, in the scaffold for repairing articular subchondral bone, the gradient porous metal material of the gradient porous metal material layer is a porous metal material formed by preparing pores with larger pore diameters by using the porous metal material with the smallest gradient as a raw material, the pores of the porous metal materials with the different gradients forming the gradient porous metal material are communicated with each other, and the porous metal material with the structure is not only close to the subchondral bone structure, but also remarkably reduces the influence of the connection interface between the gradients. Furthermore, the gradient porous metal material layer takes a perforated porous metal material with 3-10 μm holes as a raw material, two layers of materials with larger hole diameters are manufactured, and a gradient porous metal material layer with an upper layer, a middle layer and a lower layer is formed, wherein the hole diameter of the upper layer porous metal material layer adjacent to the porous polymer material layer is 3-10 μm, the hole diameter of the middle layer porous metal material layer is 50-100 μm, the hole diameter of the lower layer porous metal material layer is 100-1000 μm, holes in the porous metal materials and between the layers are mutually perforated, the artificial joint repairing material with the structure not only has better force transmission and absorption effects, but also has the effects of a first layer and a second layer which play a role of cortical bone and bear large load, and a third layer which plays a role of cancellous bone, has a buffering effect and has better seepage characteristics, promoting the repair of subchondral bone and cartilage.
The scaffold for repairing the articular subchondral bone provided by the invention is used for simulating the articular subchondral bone structure by reasonably designing the structures of the porous salt layer and the porous metal material layer by means of simulation; the porous metal part of the gradient structure can bear complex and large load and has good buffer function, the bracket for repairing the articular subchondral bone realizes good force transmission, has excellent mechanical property, the strength of the porous non-metallic material is higher than that of the porous non-metallic material, but the strength or toughness of the porous non-metallic material is often insufficient, and moreover, the scaffold for repairing the articular subchondral bone is superior to the high-porosity porous metal with single pore, the high-porosity porous metal material with single pore has insufficient rigidity, the scaffold for repairing articular subchondral bone has good seepage characteristic, the pore size is designed to be beneficial to the migration of cells and nutrient solution and to the maintenance of proper pressure of liquid in joints; the pore size and material design of the scaffold for repairing the articular subchondral bone are also beneficial to the inhabitation, differentiation and proliferation of cartilage and osteocyte, so that the scaffold is a real articular subchondral bone repairing and regenerating material.
Drawings
The invention will be further elucidated with reference to the embodiments and drawings.
Fig. 1 is a schematic structural view of a scaffold for repairing articular subchondral bone according to the present invention.
Fig. 2 is a schematic view showing the structure of a scaffold for the repair of articular subchondral bone in example 6.
Detailed Description
The following description will be made in conjunction with the accompanying drawings, which are provided to explain the embodiments of the present invention in detail and to explain the detailed embodiments and the specific operation procedures based on the technical solutions of the present invention, but the scope of the present invention is not limited to the following embodiments.
Example 1
Referring to fig. 1, the scaffold for repairing articular subchondral bone of the present embodiment is composed of a porous salt layer 1 and a porous metal material layer 2 in this order from top to bottom. The porous salt layer 1 is a porous inorganic salt layer and is prepared by porous hydroxyapatite, the aperture of the porous inorganic salt layer is 3-6 mu m, the porosity is 43 percent, and the thickness is 0.5 mm; the porous metal material layer 1 is porous titanium alloy, the material is TC4, wherein the porous titanium alloy has two layers, as shown in figure 1, the aperture of the upper layer 2-1 connected with the porous salt layer is 3-10 μm, the porosity is 38%, the thickness is 2mm, the aperture of the lower layer 2-2 is 100-450 μm, the porosity is 82%, the thickness is 4mm, and the pores inside and between the layers of the porous titanium alloy are communicated. The preparation method of the material for repairing the artificial joint comprises the following steps:
(1) and mixing, compacting and sintering titanium alloy TC4 powder and a pore-forming agent to prepare the porous titanium alloy upper layer.
(2) And preparing the porous titanium alloy lower layer by using a foam slurry dipping method.
(3) And connecting the upper porous titanium alloy layer and the lower porous titanium alloy layer into an integral porous titanium alloy by vacuum diffusion welding.
(4) And preparing a porous hydroxyapatite layer on the upper surface of the porous titanium alloy of the integral porous titanium alloy by using a vacuum freeze drying technology, and preparing the scaffold for repairing the articular subchondral bone of the embodiment.
Example 2
The scaffold for repairing articular subchondral bone in this example is similar to example 1, except that the porous metal material layer is porous niobium, the pore diameter of the upper layer is 75 μm to 100 μm, the porosity is 43%, the pore diameter of the lower layer is 400 μm to 700 μm, the porosity is 78%, the pores inside and between the porous niobium layers are interconnected, the pore diameter of the porous hydroxyapatite is 5 μm to 10 μm, the porosity is 36%, and the preparation method is similar to example 1.
Example 3
The scaffold for repairing the articular subchondral bone in the embodiment is similar to that in embodiment 1, except that the porous metal material layer is made of nickel-titanium alloy, the pore diameter of the upper layer is 50-80 μm, the porosity is 39%, the pore diameter of the lower layer is 700-1000 μm, the porosity is 72%, the pores in and among the porous nickel-titanium alloy layers are communicated with each other, the porous salt layer is made of ammonium hyaluronate, the pore diameter of the porous salt layer is 4-8 μm, the porosity is 38%, and the preparation method is similar to that in embodiment 1.
Example 4
The porous salt layer of the scaffold for repairing the articular subchondral bone is a porous organic salt layer, is prepared from chondroitin sulfate, and has the pore diameter of 3-10 mu m, the porosity of 40% and the thickness of 0.6 mm; the porous metal material layer adopts porous titanium which is a gradient porous material and has the structure that: the pore diameter is gradually increased from 50-80 μm on the surface connected with the porous salt layer to 100-500 μm on the far end surface of the porous titanium layer away from the porous salt layer, the thickness is 4mm, and the pores inside the porous titanium are mutually communicated. The preparation method comprises the following steps: preparing a porous titanium model by using a computer three-dimensional modeling, preparing porous titanium by using a selective laser sintering technology according to the model, preparing a chondroitin sulfate solution, immersing the surface of the porous titanium with the pore diameter of 50-80 mu m into the chondroitin sulfate solution for 0.3mm, and freeze-drying to obtain a composite body with the porous chondroitin sulfate and the porous titanium, namely the scaffold for repairing the subchondral bone of the joint of the embodiment.
Example 5
The scaffold for the repair of articular subchondral bone of the present example is similar to example 4, except that the porous metal material layer is made of stainless steel 316L, and has a structure of: the pore diameter is gradually increased from 70-100 μm on the surface connected with the porous salt layer to 500-1000 μm on the far end surface of the porous titanium layer away from the porous salt layer, and the thickness is 3.5mm, and the porous salt layer is prepared from glucosamine. The scaffold for articular subchondral bone repair was prepared in a manner similar to that of example 4.
Example 6
Referring to fig. 2, in the scaffold for repair of articular subchondral bone of the present example, the porous salt 1 is prepared using tricalcium phosphate and has a thickness of 0.5 mm. The porous metal material layer is made of a porous CoCrMo alloy, the porous CoCrMo alloy is a gradient porous material with an upper layer, a middle layer and a lower layer, the pore diameter of an upper porous CoCrMo alloy layer 3 adjacent to the porous salt layer 1 is 3-10 mu m, the thickness is 0.8mm, the pore diameter of the middle layer 4 is 50-75 mu m, the cavity wall material of the pore is the porous CoCrMo alloy with the pore diameter of 3-10 mu m, the thickness is 2mm, the pore diameter of the lower layer 5 is 100-650 mu m, the cavity wall material is the porous CoCrMo alloy with the pore diameter of 3-10 mu m, the thickness is 4mm, and the pores in the porous CoCrMo alloy and between the layers are mutually communicated. The preparation method comprises the following steps:
(1) taking CoCrMo alloy powder with the grain diameter of 30nm and ethyl cellulose powder with the grain diameter of 5-15 mu m, and mixing the CoCrMo alloy powder and the ethyl cellulose powder according to the volume ratio: ethyl cellulose powder 7: 3, mixing, repeatedly stirring to uniformly mix, putting the mixed powder into a hard alloy die, applying 10MPa pressure to flatten, and preparing a green body of the upper-layer porous CoCrMo alloy.
(2) Taking CoCrMo alloy powder with the grain diameter of 30nm, ethyl cellulose powder with the grain diameter of 5-15 mu m, urea with the grain diameter of 65-85 mu m, and mixing the CoCrMo alloy powder and the urea according to the volume ratio: ethyl cellulose powder: the urea is 7: 3: 25, mixing, repeatedly stirring to make the mixture uniform, putting the mixture into a die containing an upper-layer porous CoCrMo alloy green body, applying 10MPa pressure to flatten the mixture to form the green body integrating the upper-layer porous CoCrMo alloy and the middle-layer porous CoCrMo alloy.
(3) Taking CoCrMo alloy powder with the grain diameter of 30nm, ethyl cellulose powder with the grain diameter of 5-15 mu m, urea with the grain diameter of 180-750 mu m, and mixing the CoCrMo alloy powder and the urea according to the volume ratio: ethyl cellulose powder: the urea is 7: 3: 25, mixing, repeatedly stirring to make the mixture uniform, putting the mixture into a mold containing a green body which is formed by synthesizing an upper-layer porous CoCrMo alloy and a middle-layer porous CoCrMo alloy into a whole, applying 400MPa pressure to compact the mixture, and maintaining the pressure for 27s to form the green body which is formed by synthesizing the upper-layer porous CoCrMo alloy, the middle-layer porous CoCrMo alloy and the lower-layer porous CoCrMo alloy into a whole.
(4) And putting the green body into a vacuum furnace, and performing vacuum sintering and heat treatment to obtain the porous CoCrMo alloy with the three-layer gradient structure.
(5) And spraying tricalcium phosphate on the upper surface of the porous CoCrMo alloy by plasma spraying to form a porous tricalcium phosphate layer, thus obtaining the articular subchondral bone repairing scaffold of the embodiment.
Example 7
This example is similar to example 6, except that the porous salt layer is made of tetrabutylammonium hyaluronate, the porous metal layer is made of tantalum, the pore size of the intermediate layer 4 is 70 μm to 100 μm, and the pore size of the lower layer 5 is 600 μm to 1000 μm, which is similar to example 6.
The implant made of the subchondral bone repairing material in example 7 is compounded with an autologous sheep periosteum and then implanted into a cartilage-subchondral bone defect of a sheep tibial joint for 14 weeks, and histological observation shows that bone tissues grow into 94% of a porous tantalum pore and cartilage defects are basically repaired.
Claims (7)
1. The utility model provides a support for articular subchondral bone restoration which characterized in that: the bracket is sequentially composed of a porous salt layer and a porous metal material layer from top to bottom, the porous metal material layer is a gradient porous metal material layer, and the aperture of the porous salt layer is 3-10 μm; the porous metal material layer comprises an upper layer and a lower layer, wherein the pore diameter of the upper layer of the porous metal material connected with the porous salt layer is 50-100 mu m, the pore diameter of the lower layer of the porous metal material is 100-1000 mu m, and the pores inside and between the layers of the porous metal material are communicated.
2. A scaffold for the repair of articular subchondral bone according to claim 1, characterized in that: the porous salt layer is a porous inorganic salt layer or/and a porous organic salt layer.
3. A scaffold for the repair of articular subchondral bone according to claim 2, characterized in that: the porous inorganic salt layer is prepared from hydroxyapatite or tricalcium phosphate.
4. A scaffold for the repair of articular subchondral bone according to claim 1, 2 or 3, characterized in that: the porous metal material layer is a porous tantalum layer or a porous titanium layer or a porous niobium layer or a porous cobalt-based alloy layer or a porous stainless steel layer or a porous nickel-titanium alloy layer or a porous composite metal material layer.
5. A scaffold for the repair of articular subchondral bone according to claim 1, 2 or 3, characterized in that: the pore diameter of the porous metal material layer is gradually increased from the pore diameter of the surface connected with the porous salt layer to 50-100 mu m and is transited to the pore diameter of the far end surface of the porous metal material layer deviated from the porous salt layer to 100-1000 mu m, and the pores in the porous metal material layer are mutually communicated.
6. The scaffold for the repair of articular subchondral bone according to any one of claims 1, 2 or 3, characterized in that: the gradient porous metal material of the gradient porous metal material layer is a porous metal material formed by manufacturing holes with larger pore diameters by using the porous metal material with the smallest gradient level as a raw material, and the holes of the porous metal materials with the gradient levels forming the gradient porous metal material are communicated with each other.
7. The utility model provides a support for articular subchondral bone restoration which characterized in that: the bracket is sequentially composed of a porous salt layer and a porous metal material layer from top to bottom, the porous metal material layer is a gradient porous metal material layer, and the aperture of the porous salt layer is 3-10 μm; the method is characterized in that: the gradient porous metal material layer takes a perforated porous metal material with 3-10 mu m pores as a raw material, two layers of materials with larger pore diameters are manufactured, and the gradient porous metal material layer with an upper layer, a middle layer and a lower layer is formed, wherein the pore diameter of the upper layer porous metal material layer adjacent to the porous salt layer is 3-10 mu m, the pore diameter of the middle layer porous metal material layer is 50-100 mu m, the pore diameter of the lower layer porous metal material layer is 100-1000 mu m, and the pores inside and between the layers of the porous metal material are mutually perforated.
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