Engineering construction composite artificial bone

Abstract

The utility model discloses an engineering construction composite artificial bone based on architectural engineering and a manufacturing method thereof, the engineering construction composite artificial bone comprises a bioactive material and a mechanical support bracket, the bioactive material is used as a main body, the mechanical support bracket is contained in the bioactive material, and the bioactive material and the mechanical support bracket are tightly combined to form an artificial bone tissue complex. The mechanical support bracket can provide mechanical support for the artificial bone tissue complex so as to meet the load requirement in the bone repair process. The artificial bone tissue complex can further achieve one or more functions through surface modification and / or a carrying structure used for carrying a bone growth promoting material release system and / or a drug release system arranged in the artificial bone tissue complex so as to meet the clinical requirements of anti-inflammation, anti-infection, anti-tumor, anti-osteoporosis, bone integration promotion and the like. According to the utility model, the osseointegration performance and the mechanical property of the material are considered, and a new scheme is provided for large-area bone defect repair, bone structure filling and supporting and parts needing long-term load bearing.

Description

TECHNICAL FIELD

[0001] The utility model belongs to biomedical engineering field, especially relate to a kind of engineering construction composite artificial bone. BACKGROUND

[0002] With the population aging and the increase of orthopedic diseases, the treatment method of bone defect is increasingly concerned, especially in the spine and limbs load-bearing parts. Some bone repair materials or support structures are usually used to integrate repair, but both have some shortcomings, as follows:

[0003] For bone repair materials, the bone repair materials with strong bone integration ability at present are mainly calcium matrix, silicon matrix material and polymer, magnesium metal, which have certain bone integration ability, but the mechanical properties are not satisfactory, and cannot meet the mechanical requirements of load-bearing area. For example: calcium matrix material has low tensile strength and bending strength, and is prone to brittle fracture, and is difficult to withstand complex load. Calcium material is prone to fatigue failure, especially for high-strength load-bearing area. Silicon matrix material has weak mechanical properties, and usually has low compressive strength and toughness, and is difficult to withstand long-term mechanical load in high load-bearing area, and has high brittleness, and is prone to crack propagation and fracture under impact or fatigue load. The mechanical strength of polymer material is low, and it is difficult to meet the requirements of high compression strength and bending resistance of bone replacement in load-bearing area. Polymer may appear creep phenomenon under continuous load, resulting in change of implant shape, functional failure, degradation, fracture and even loss of mechanical properties of polymer material in the body, especially in load-bearing environment. Magnesium metal has certain bone induction performance, but the degradation is uncontrollable and the degradation toxicity is high, and cannot be used alone. At present, it can only be used for surface modification of material and released through slow-release system.

[0004] And the polymer+calcium matrix / silicon matrix composite material has the following problems: 1. The contradiction between mechanical properties and biological properties: composite materials need to meet high mechanical strength and excellent biological activity at the same time, but it is difficult to achieve ideal balance between the two. 2. Insufficient interface bonding strength: the interface bonding between polymer and calcium matrix or silicon matrix is often poor, which may lead to delamination, peeling or failure of composite material. Other bone integration composite materials mainly improve bone integration ability and anti-inflammatory, anti-infection, anti-tumor and other functions, but still difficult to meet the bone replacement repair of load-bearing area.

[0005] For the support structure, the microporous titanium alloy material with good mechanical properties and good biocompatibility is the most widely used material, but it has the following shortcomings: 1. The bonding force between titanium alloy and bone is poor, the bone integration ability is not enough, and the prosthesis loosening is easy to occur; 2. The elastic modulus of pure titanium alloy is large, and the interface bone collapse and titanium alloy sinking are easy to occur; 3. Although the microporous structure can occur a certain bone integration, the bone integration ability is weak, and can only be limited to the interface 1-3mm range, and cannot be integrated deeply, and the interface mechanical properties are poor. The above materials also do not have anti-infection and anti-inflammatory ability. The composite material combined with titanium alloy is currently limited to surface modification.

[0006] In summary, at present, there is still a lack of artificial bone which can have good bone integration and meet the mechanical load of weight-bearing area and has diversified biological activity functions, and it still cannot meet the diversified needs of the clinic, therefore, a new type of engineering construction composite artificial bone combined with construction engineering is urgently needed. Practical new type content

[0007] The purpose of the present application is to provide an engineering construction composite artificial bone which can take into account the bone integration performance and mechanical properties of the material.

[0008] The present application is implemented in the following manner: an engineering construction composite artificial bone comprises a biological active material and a mechanical support bracket; the biological active material serves as the main body, and contains the mechanical support bracket inside and is tightly combined with each other to form an engineering construction integrated artificial bone tissue complex; the mechanical support bracket is used to provide mechanical support for the integrated artificial bone tissue complex to meet the load requirements in the bone repair process.

[0009] Further, the mechanical support bracket is in a honeycomb shape, a bifurcation shape, a grid shape, a fence shape or a tree branch shape; the mechanical support bracket is a biodegradable composite support or a non-degradable support.

[0010] Further, the surface and / or the inside of the artificial bone tissue complex is loaded with a bone growth promoting material release system and / or a drug release system.

[0011] Further, the surface and / or the inside of the integrated artificial bone tissue complex is provided with a loading structure, and the loading structure is used to accommodate the bone growth promoting material release system and / or the drug release system; or the bone growth promoting material release system and / or the drug release system is coated on the surface of the loading structure.

[0012] Further, the loading structure is a cavity structure; the cavity structure is located on the surface of the integrated artificial bone tissue complex; or the cavity structure is communicated from the surface of the integrated artificial bone tissue complex to the inside of the artificial bone tissue complex.

[0013] Further, the release speed of the release system adopts a gradient design, wherein the release speed of the bone growth promoting material and / or the drug near the bone contact end is greater than the release speed of the bone growth promoting material and / or the drug away from the bone contact end.

[0014] Further, the bone growth promoting material release system and / or the drug release system comprises at least one of a coating on the outer surface of the integrated artificial bone tissue complex, a microsphere and a microcapsule release system located in the mounting structure.

[0015] Further, the bioactive material has micropores for bone tissue ingrowth, and the opening rate of the micropores on the bioactive material is 50% to 80%, and the pore size is 100 μm to 500 μm.

[0016] Further, the integrated artificial bone tissue complex is internally provided with a channel for blood vessels to grow into and provide growth space for bone tissue, and the channel is communicated to the outer surface of the integrated artificial bone tissue complex.

[0017] Compared with the prior art, the utility model has the beneficial effects that:

[0018] 1. The engineering construction composite artificial bone provided by the utility model is internally provided with a mechanical support support, can provide sufficient mechanical support and toughness, meets the load requirements in the bone repair process, provides a new treatment scheme for large-area bone defect repair, bone structure filling support and parts needing long-term weight bearing.

[0019] 2. The mechanical support support is tightly wrapped in the bioactive material, the bioactive material can enhance the integration with the bone tissue, and the bone integration effect reaches an optimal state through natural biological reaction with the bone tissue. DETAILED DESCRIPTION

[0020] Figure 1 is a three-dimensional structure schematic view of the engineering construction composite artificial bone provided by the utility model embodiment;

[0021] Figure 2 is a top view schematic view of the engineering construction composite artificial bone provided by the utility model embodiment;

[0022] Figure 3 is a side view schematic view of the engineering construction composite artificial bone provided by the utility model embodiment;

[0023] Figure 4 is a cross-sectional view schematic view of the engineering construction composite artificial bone provided by the utility model embodiment.

[0024] Figures 5A-5H is a schematic view of several shapes of the mechanical support support provided by the utility model embodiment;

[0025] Figure 6 is a cross-sectional view of a grid-shaped mechanical support bracket provided by the embodiment of the present application;

[0026] Figure 7A is an application schematic diagram of the engineering structured composite artificial bone between two spinal bones provided by the embodiment of the present application;

[0027] Figure 7B is an application schematic diagram of the engineering structured composite artificial bone in lower limb bone defect provided by the embodiment of the present application.

[0028] In the figure, 1 is a bioactive material; 2 is a mechanical support bracket; 21 is an inner hole; 3 is an artificial bone tissue complex; 31 is a carrying structure; 32 is a channel; 33 is a micropore; 4 is a drug sustained-release ball. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical scheme and advantages of the present application more clear, the present application will be further described in detail below with reference to the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and do not limit the present application.

[0030] The embodiment provides an engineering structured composite artificial bone, which refers to Figures 1-4 The structure of the engineering structured composite artificial bone is shown. The engineering structured composite artificial bone comprises a bioactive material 1 and a mechanical support bracket 2, the bioactive material 1 serves as a main body, the inside of the bioactive material 1 contains the mechanical support bracket 2 and is combined with the mechanical support bracket 2 to form an engineering structured integrated artificial bone tissue complex 3. Specifically, the bioactive material 1 can be filled in the mechanical support bracket 2, or the bioactive material 1 can be filled in the inside of the mechanical support bracket 2 and covered on the surface of the mechanical support bracket 2. The bioactive material 1 can provide good osteointegration ability, and the osteointegration effect reaches the optimal state through natural biological reaction with bone tissue, and the mechanical support bracket 2 can provide mechanical support and toughness for the integrated artificial bone tissue complex 3 to meet the load requirements in the bone repair process, provide a new treatment scheme for large-area bone defect repair, bone structure filling support and parts needing long-term weight bearing.

[0031] The close combination between the bioactive material 1 and the mechanical support bracket 2 is similar to the structure of “reinforcing steel + cement” in building engineering, and can be realized through high-temperature sintering, 3D printing, plasma spraying or filling and the like.

[0032] Specifically, the bioactive material 1 can be a bioceramic composite microparticle or a porous bioglass; wherein the material of the bioceramic composite microparticle is one or a combination of two or more of calcium hydroxide, calcium phosphate or nanosilica. The mechanical support scaffold 2 is made of one or several of, but not limited to, tantalum alloy, magnesium alloy, polylactic acid (PLA) and its copolymer, ceramic and its composite, polymer, carbon fiber and its composite.

[0033] The specific shape of the mechanical support scaffold 2 is not limited, and is designed by mechanical calculation to be any shape or style that can provide sufficient mechanical support for the entire composite artificial bone, for example, it can be Figure 5A a bar grating as shown, Figure 5B a honeycomb as shown, Figure 5C , Figure 5D a bifurcation as shown, Figure 5E , Figure 5F , Figure 5G a mesh as shown, Figure 5H a tree branch as shown, and the like.

[0034] Further, the surface and / or interior of the integrated artificial bone tissue complex 3 can carry a bone growth promoting material release system and / or a drug release system. As one implementation, a carrying structure 31 can be designed on the surface and / or interior of the integrated artificial bone tissue complex 3 to accommodate the bone growth promoting material release system and / or the drug release system, and as another implementation, the bone growth promoting material release system and / or the drug release system can also be coated on the surface of the carrying structure 31. The bone growth promoting material and / or the drug in the sustained release system are continuously and slowly released, and the drug can be selected according to the specific condition of the patient, and has different functions in different application scenarios.

[0035] Preferably, the bone growth promoting material is a porous calcium phosphate-based material, a silicon-based biomaterial, a polymer, a collagen and protein-based material, chitosan, a carbon-based material, a nanocomposite polymer composite material; wherein the silicon-based biomaterial can include a bioglass.

[0036] Structurally, the above-mentioned bone growth promoting material release system and / or drug release system includes at least one of a coating on the outer surface of the integrated artificial bone tissue complex 3, a microsphere and a microcapsule release system located in the carrying structure 31.

[0037] As shown in Figures 1-3As shown, the microspheres described above can be drug release spheres 4, which have a coating layer and a core, and the coating layer covers the core. The coating layer is a material that can be absorbed by the human body, which can be one or more of ceramic and glass materials, biodegradable polymers, natural polymer materials, chitosan, nanomaterials, hydrogel materials, and ceramic-polymer composite materials. The core is one or more of bone growth promoting materials, drugs, magnesium alloys, zinc alloys, and hydrogels. Through the structural design, the drug release spheres 4 can slowly release the bone growth promoting materials and / or drugs, accelerating the effect of bone healing and repair.

[0038] Further, the release rate of the bone growth promoting materials and / or drugs in the release system adopts a gradient design, wherein the release rate of the bone growth promoting materials and / or drugs near the bone contact end is greater than that of the bone growth promoting materials and / or drugs away from the bone contact end. The gradient design of the release rate can maintain the local drug concentration, improve the drug utilization efficiency, and provide personalized treatment.

[0039] As described above, the mounting structure 31 is located on the surface, inside, or both the surface and inside of the integrated artificial bone tissue complex 3. As an example, as shown, the mounting structure 31 can be a cavity structure, which has at least one port communicating to the outer surface of the integrated artificial bone tissue complex 3, so as to facilitate the placement of the release system outside the integrated artificial bone tissue complex 3, and facilitate the exudation of the bone growth promoting materials and / or drugs in the release system to contact with the bone tissue. Figures 1-3

[0040] Further, micro-pores 33 can also be designed on the bioactive material 1. The structure of such micro-pores 33 can be for bone tissue to grow into, and the pore size and porosity of the micro-pores 33 meet the biomechanical and bone tissue regeneration requirements. Preferably, the opening rate of the micro-pores 33 on the bioactive material 1 is 50% to 80%, and the pore size is 100 μm to 500 μm. It should be noted that the specific shape of the micro-pores 33 is not limited, which can be a square hole as shown in Figure 1 , or other shaped holes, such as circular holes, or the entire bioactive material 1 can be designed in a shape similar to a sponge, and the holes on the sponge are micro-pores 33, as shown by the black dots in the bioactive material 1 in Figure 1 and Figure 4 .

[0041] Figure 6 ​A cross-sectional structure of a grid-shaped mechanical support bracket is shown, the mechanical support bracket 2 is hollow in the middle, forming an inner hole 21, the inner hole 21 penetrates the top and bottom of the mechanical support bracket 1, by designing the inner hole 21, the speed of drug delivery in the length direction of the artificial bone can be accelerated, and the bone and blood vessels can also grow in. The support structure inside the mechanical support bracket 2 is composed of plate blocks connected to each other, or plate blocks and rod members connected to each other. It should be noted that a carrying structure 31 can be provided on the plate blocks of the mechanical support bracket 2, and the bioactive material 1 can be covered on the surface of the plate blocks of the mechanical support bracket 2.

[0042] Please refer to Figure 1 、 Figure 4 , a cross-sectional structure of an artificial bone tissue complex filled with a bioactive material in a mechanical support bracket is shown, the integrated artificial bone tissue complex 3 has at least two layers of structure. Further, a plurality of channels 32 for blood vessels to grow into are provided inside the integrated artificial bone tissue complex 3, the channels 32 are in the same direction as the inner hole 21, and both penetrate the top and bottom of the mechanical support bracket 1, the channels 32 are relatively thin compared to the inner hole 21, the channels 32 and the inner hole 21 are connected to each other through micropores 33, and are connected to the outer surface of the artificial bone tissue complex 3.

[0043] The embodiment also provides a method for manufacturing an engineered composite artificial bone, comprising the following steps:

[0044] The mechanical support bracket 2 is prepared by a specific mold forming technology or a 3D printing technology;

[0045] The surface of the mechanical support bracket 2 is treated to form a rough topography on the surface of the mechanical support bracket 2, so as to combine with the bioactive material 1 to form a tight bonding effect, for example, a spraying, laser etching, chemical etching, coating treatment or the like can be used to achieve.

[0046] The mechanical support bracket 2 is combined with the bioactive material 1 to form an artificial bone tissue complex 3 by high-temperature sintering, 3D printing, plasma spraying or filling and curing;

[0047] During the manufacturing of the artificial bone tissue complex 3, or after the manufacturing of the bone tissue bracket complex 3, a pore structure 31 is manufactured on the surface and / or inside of the bone tissue bracket complex 3;

[0048] Different functional materials containing bone growth promoting materials and / or drug release systems are embedded in the pore structure 31.

[0049] In summary, the composite artificial bone of the embodiment has at least the following advantages compared with traditional bone repair materials:

[0050] 1. The mechanical support scaffold 2 can provide sufficient mechanical support to meet the load requirements during the bone repair process.

[0051] 2. When the mechanical support scaffold 2 is combined with the bioactive material 1, it can enhance the integration with bone tissue. At the same time, these bioactive materials can gradually degrade during use, and the degradation rate matches the bone healing rate, avoiding the long-term impact of artificial materials on bone tissue. The bone integration effect reaches the optimal state through the natural biological reaction with bone tissue.

[0052] 3. The structure can carry a sustained-release system containing bone growth promoting materials and / or drugs. The bone growth promoting materials and / or drugs in the sustained-release system are continuously and slowly released, which can accelerate bone healing and repair.

[0053] 4. Referring to Figures 7a and 7b, it has different functions in different application scenarios, providing new solutions for the repair of large-area bone defects, bone structure filling and support, and parts that need to bear weight for a long time.

[0054] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. An engineered construct composite artificial bone, characterized by, The application relates to an integrated artificial bone tissue composite, which comprises a bioactive material and a mechanical support bracket; the bioactive material is used as a main body, the mechanical support bracket is contained in the bioactive material, and the bioactive material and the mechanical support bracket are closely combined to form the integrated artificial bone tissue composite; the mechanical support bracket is used for providing mechanical support for the integrated artificial bone tissue composite to meet the load requirement in the bone repair process.

2. The engineered constructured composite artificial bone according to claim 1, wherein, The mechanical support bracket is in a honeycomb structure, a bifurcation structure, a grid structure, a fence structure or a tree branch structure. The mechanical support bracket is a biodegradable composite support or a non-degradable support.

3. The engineered constructured composite artificial bone according to claim 1, wherein, The surface and / or the interior of the artificial bone tissue composite are provided with a bone growth promoting material release system and / or a drug release system.

4. The engineered constructured composite artificial bone according to claim 3, wherein, The surface and / or the interior of the integrated artificial bone tissue composite are provided with a carrying structure for accommodating the bone growth promoting material release system and / or the drug release system. Alternatively, the bone growth promoting material release system and / or the drug release system are coated on the surface of the carrying structure.

5. The engineered constructured composite artificial bone according to claim 4, wherein, The carrying structure is a cavity structure. The cavity structure is located on the surface of the integrated artificial bone tissue composite. Alternatively, the cavity structure is communicated from the surface of the integrated artificial bone tissue composite to the interior of the artificial bone tissue composite.

6. The engineered construct composite artificial bone according to any one of claims 3-5, wherein, The release speed of the release system is designed in a gradient mode, wherein the release speed of the bone growth promoting material and / or the drug close to the bone contact end is greater than the release speed of the bone growth promoting material and / or the drug far from the bone contact end.

7. The engineered construct composite artificial bone according to any one of claims 3-5, wherein, The bone growth promoting material release system and / or the drug release system comprises at least one of a coating on the outer surface of the integrated artificial bone tissue composite, a microsphere and a microcapsule release system in the carrying structure.

8. The engineered constructured composite artificial bone according to claim 1, wherein, The bioactive material is provided with micropores for bone tissue growth, the opening rate of the micropores on the bioactive material is 50%-80%, and the pore size is 100-500 mu m.

9. The engineered constructured composite artificial bone according to claim 1, wherein, The integrated artificial bone tissue composite is provided with a pore channel for blood vessels to grow and provide growth space for bone tissue, and the pore channel is communicated to the outer surface of the integrated artificial bone tissue composite.

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