CN101905032B - Method for forming composite rhBMP-2 elasticity modulus graded porous titanium alloy support rod for femoral head and neck - Google Patents
Method for forming composite rhBMP-2 elasticity modulus graded porous titanium alloy support rod for femoral head and neck Download PDFInfo
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- CN101905032B CN101905032B CN 201010226525 CN201010226525A CN101905032B CN 101905032 B CN101905032 B CN 101905032B CN 201010226525 CN201010226525 CN 201010226525 CN 201010226525 A CN201010226525 A CN 201010226525A CN 101905032 B CN101905032 B CN 101905032B
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Abstract
The invention relates to a method for forming a composite rhBMP-2 elasticity modulus graded porous titanium alloy support rod for the femoral head and the neck. Titanium alloy powder is prepared with an electrode induction melting gas atomization method, and the integrated elasticity modulus graded porous titanium alloy support rod consisting of a head part, a body part and a tail part is prepared according to actually measured biomechanical parameters of the femoral head, the neck and a rotor, wherein the head part and the body part are prepared by sintering the titanium alloy powder and pore-forming agents through the adoption of a cold rolling method, the tail part is prepared by directly sintering the titanium alloy powder, and the porous titanium alloy support rod is immersed in a rhBMP-2/gelatin controlled release microsphere solution. The product prepared by the method can simulate the biomechanical properties of the femoral head and the neck of a human body to the utmost extent, thereby being beneficial to the stress transfer between materials and bone tissue interfaces, avoiding poor bone restoration caused by the stress shielding effect; and simultaneously, sustained-release microspheres on which bone induced growth factors (rhBMP-2) are loaded endue the materials per se with good bone conductivity.
Description
Technical field
The present invention relates to a kind of preparation method for the treatment of the support stick of early ischemic necrosis of femoral head, be specifically related to the construction method of the elastic modelling quantity alternation femoral head and neck porous titanium alloy support rod for femoral head of a kind of compound rhBMP-2.
Background technology
Ischemic necrosis of femoral head is young and middle-aged common orthopaedic disease.Along with disease progression, the patient that 60-80% arranged due to collapse of the femoral head, be out of shape and cause that traumatic arthritis has to carry out replacement of total hip, cause great loss for thus patient, family and society.Femur head necrosis early treatment is improper or to treat untimely are all the main causes that cause this consequence.At present the method for control femoral head osteonecrosis and prevention collapse of the femoral head has multiplely, comprises that mainly decompression in restricted heavy burden, marrow, free fibula transplantation and femur head necrosis are rebuild the support of rod fixing etc.
The metal porous tantalum of bone trabecula, elastic modelling quantity are 3.00GPa, and porosity is 70-80%, have been applied to Orthopedic Clinical with its good biocompatibility and enough mechanical strengths, rebuild rod etc. comprising porous tantalum surface artificial articular prosthesis and femur head necrosis.Femur head necrosis is rebuild rod with the porous tantalum preparation, and is little with wound, go out the characteristics such as insufficiency of blood, hospital stays be short and be applied to more and more the early stage downright bad treatment of femoral head, effectively alleviates or stoped the further deterioration of femur head necrosis and subsiding of cartilage surface.Yet, this single porous tantalum rod exists certain deficiency: the one, although the porous tantalum rod can play certain support structure effect, but at design aspect and reckon without the variation characteristic of the biomechanics of femoral head and neck, and the biomechanical property of the Proximal femur of human body (especially elastic modelling quantity aspect) exists notable difference, not so unavoidable can coupling by region stress, produce stress-shielding effect, thereby affect the bone reconstruction around support stick; The 2nd, the porous tantalum rod is single porous metal material, does not possess the induced osteogenesis activity, repairs the femoral head tissue of pathological changes with it, is difficult to the satisfied repair of performance; The 3rd, porous tantalum rod complicated process of preparation, domestic this technology of preparing that there is no, the complete dependence on import of product.Therefore, the support system of seeking a kind of bionical human femur under loading incidence biomechanics characteristic and having simultaneously a good bone repair ability just becomes new problem.
Titanium is as the inert metal element, stable chemical performance, and titanium and alloy material preparation technology thereof are simple, more are fit to suitability for industrialized production.Studies confirm that; porous titanium alloy (Ti2448) material has good histocompatibility, avirulence; good bone conductibility and enough comprcssive strength; especially its elastic modelling quantity can transfer to lower than a lot (0.70GPa＜3.00GPa) of porous tantalum; porosity can reach 50～70%; the aperture is 100～500 μ m; and has very large modulability; when guaranteeing mechanical strength; can satisfy to a greater degree Proximal Femur tissue biological mechanics to the requirement of elastic modelling quantity, thereby satisfy the needs of bone growth, reparation.
On the other hand, bone morphogenetic protein (BMPs) is one group of one group of skeletal growth factor that is present in substrate, especially the BMP-2 effect is the strongest, can induce undifferentiated mescenchymal stem cell and bone precursor to osteoblastic directed differentiation and propagation, promote osteoblast differentiation ripe, participate in growth promoter and the process of reconstruction thereof of bone, and then the damaged reparation of accelerated bone.Gelatine microsphere is as good slow-released system, and it has good histocompatibility and reliable degradation property, can be used as the carrier of a lot of medicines and somatomedin, forms controlled release system, avoids one of medicine, the factor to cross the property effect.Gelatin-compounded rhBMP-2 microsphere in vivo, can discharge slowly rhBMP-2 along with the degraded of gelatine microsphere, thereby reach lasting, stable bone inductive effect.
Summary of the invention
the object of the invention is to overcome the deficiency of existing treatment early ischemic necrosis of femoral head method, seek a kind of biomechanics characteristic that can bionical as far as possible human femur under loading incidence, the Stress Transfer that is conducive to material-osseous tissue interface, avoid the bone faulty restoration that causes due to stress-shielding effect, load simultaneously the sustained-release micro-spheres of bone inductive factor (rhBMP-2), make material itself have good osteoconductive nature, possesses simultaneously the construction method of the elastic modelling quantity alternation femoral head and neck porous titanium alloy support rod for femoral head of the compound rhBMP-2 of bone-inducting active preferably.
For achieving the above object, the technical solution used in the present invention is:
1) preparation of elastic modelling quantity alternation porous titanium alloy support rod for femoral head
At first by " electrode induction melting gas atomization " preparation titanium alloy powder, the integrated elastic modulus alternation porous titanium alloy support rod for femoral head that then preparation is comprised of head, body and afterbody according to the biomechanical parameter between the femoral head of surveying, cervical region, rotor;
The preparation of described head is to adopt " cold-rolling practice " that titanium alloy powder and pore creating material polymethyl methacrylate are got the powder block by the volume ratio mixed-forming of 1: 1, again the powder block is made at 1000～1400 ℃ of sintering, the particle diameter of pore creating material is the 32-60 order, the length of head is 2.50cm, diameter is 1.00cm, and elastic modelling quantity is 3.00Gpa;
The preparation of described body be adopt " cold-rolling practice " with titanium alloy powder and pore creating material polymethyl methacrylate by 1: the volume ratio mixed-forming of 1-4 gets the powder block, again the powder block is made at 1000～1400 ℃ of sintering, the particle diameter of pore creating material is the 60-100 order, the length of body is 6.50-9.00cm, diameter is 1.00cm, and elastic modelling quantity is 0.70-3.00Gpa;
The preparation of described afterbody is that titanium alloy powder is made at 1000～1400 ℃ of sintering, and the length of afterbody is 1.00cm, and diameter is 1.40cm, and elastic modelling quantity is 15.00GPa, and the surface of afterbody is screw-like, and afterbody bottom surface central authorities are interior hexagonal lock hole;
2) preparation of rhBMP-2/ gelatin control-release microsphere
Add the gelatin dry powder of rhBMP-2, the 1g of 8 μ g at room temperature to stir by every 100ml plasma water, obtain rhBMP-2/ gelatin control-release microsphere after vacuum drying, in-80 ℃ of preservations, with standby;
3) rhBMP-2/ gelatin control-release microsphere and porous titanium alloy support rod for femoral head is compound
Will be through step 2) the rhBMP-2/ gelatin control-release microsphere of preparation redissolves uniformly according to 1g: 100ml and obtain rhBMP-2/ gelatin control-release microsphere solution in plasma water, again will be through step 1) the elastic modelling quantity alternation porous titanium alloy support rod for femoral head of preparation first is soaked in 24h in rhBMP-2/ gelatin control-release microsphere solution after ultrasonic cleaning, then under-93.3kPa, the negative pressure pump evacuation is placed 30min, can obtain being rich in hole the porous titanium alloy support rod for femoral head of the elastic modelling quantity alternation of rhBMP-2/ gelatine microsphere.
Advantage of the present invention is: 1. compare with the traditional method such as reduce pressure in traditional marrow, this prosthetic material has been inherited femoral head and has been rebuild rod advantage in the treatment femoral head osteonecrosis: go out that insufficiency of blood, operation are simple, few intercurrent disease, good effect; 2. this prosthetic material has the characteristic of high strength, low elastic modulus, in use, can guarantee that skeleton is to the demand of prosthetic material intensity, and its elastic modelling quantity is more near osseous tissue, can obviously improve the mechanics transmission of material surface-osseous tissue, thereby avoid stress-shielding effect, promote knitting; 3. the characteristics that this prosthetic material is larger are to have the elastic modelling quantity transmutability, biomechanics characteristic that can bionical as much as possible femoral head and neck, thus avoid to a greater extent local stress-shielding effect, promote knitting; 4. this prosthetic material combines with biotic factor (rhBMP-2)/gelatine microsphere, make when originally just having had good bone conductibility, also had controlled, lasting, stable osteoinductive energy, really accomplish to promote to greatest extent the bone reparation of early ischemic necrosis of femoral head, prevent the generation of the complication such as collapse of the femoral head.
Description of drawings
Fig. 1 is the electromicroscopic photograph of the porous titanium alloy material for preparing of the present invention;
Fig. 2 is the structural representation of the elastic modelling quantity alternation femoral head and neck porous titanium alloy support rod for femoral head of the compound rhBMP-2 for preparing of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing, the present invention is described in further detail.
Preparation method of the present invention is as follows:
1) preparation of elastic modelling quantity alternation porous titanium alloy support rod for femoral head
At first by " electrode induction melting gas atomization " preparation titanium alloy powder, then adopt " cold-rolling practice " that titanium alloy powder and the molding of pore creating material polymethyl methacrylate hybrid process of preparation are got the powder block, the powder block is obtained the porous titanium alloy block materials at 1000～1400 ℃ of sintering.In manufacturing process, according to the biomechanical parameter between the femoral head of surveying, cervical region, rotor, by adjusting the volume ratio of titanium alloy powder and pore creating material polymethyl methacrylate, and the granular size of pore creating material, thereby change porosity and the aperture of material, in order to prepare stage by stage the integrated porous titanium alloy support rod for femoral head that matches with human femur under loading incidence biomechanics, making the aperture that makes final material is 100～500 μ m, porosity can reach 50～70% (seeing Fig. 1), and the elastic modelling quantity scope is 0.70～15.00Gpa;
Described integrated porous titanium alloy support rod for femoral head namely in a jacket (sheath material adopt pure titanium) according to the distribution situation uniform distribution of elastic modelling quantity, wait to be prepared into and carry out machine according to accessory size after block materials and add, last molding.The porous titanium alloy support rod for femoral head length that finally makes is about 10.00 ± 2.50cm, considers that skeleton varies in size, and body length is comprised of head, body and afterbody take 0.50cm as alternation unit:
Referring to Fig. 2, head 3: long 2.50cm, diameter 1.00cm, elastic modelling quantity are the 3.00GPa left and right, and the volume ratio of titanium alloy powder and pore creating material is 1: 1, and the pore creating material granular size is the 32-60 order;
Body 4: long 6.50cm, diameter 1.00cm is the changeover portion of an elastic modelling quantity alternation, and elastic modelling quantity is 0.70～3.00Gpa, the volume ratio of titanium alloy powder and pore creating material polymethyl methacrylate is 1: (1～4), pore creating material granular size are 60～100 orders;
Afterbody 5: long 1.00cm, diameter is 1.40cm, elastic modelling quantity is 15.00GPa, the volume ratio of titanium alloy powder and pore creating material is 1: 0, namely do not add pore creating material, only obtain the porous titanium alloy block materials at 1000～1400 ℃ of sintering, realize the preparation of porous material by the gap between titanium alloy powder.The surface is screw-like, is used for being locked of barred body and cortical bone position.Afterbody bottom surface central authorities are interior hexagonal lock hole 6, and the length of side is about 0.30cm, is 0.80cm deeply, are used for screwing in the draw-in groove of support stick.The screw-like of tail surface and lock hole all after material is made, process by lathe and milling machine.
2) preparation of rhBMP-2/ gelatin control-release microsphere
Add the gelatin dry powder of rhBMP-2, the 1g of 8 μ g at room temperature to stir by every 100ml plasma water, obtain rhBMP-2/ gelatin control-release microsphere after vacuum drying, in-80 ℃ of preservations, with standby;
3) rhBMP-2/ gelatin control-release microsphere and porous titanium alloy support rod for femoral head is compound
Will be through step 2) the rhBMP-2/ gelatin control-release microsphere of preparation redissolves in plasma water to get rhBMP-2/ gelatin control-release microsphere solution uniformly according to 1g: 100ml, again will be through step 1) the elastic modelling quantity alternation porous titanium alloy support rod for femoral head of preparation first is soaked in 24h in rhBMP-2/ gelatin control-release microsphere solution after ultrasonic cleaning, then under-93.3kPa, the negative pressure pump evacuation is placed 30min, can obtain being rich in hole the porous titanium alloy support rod for femoral head of the elastic modelling quantity alternation of rhBMP-2/ gelatine microsphere 2.
Claims (1)
1. the construction method of the elastic modelling quantity alternation femoral head and neck porous titanium alloy support rod for femoral head of compound rhBMP-2 is characterized in that:
1) preparation of elastic modelling quantity alternation porous titanium alloy support rod for femoral head
At first by " electrode induction melting gas atomization " preparation titanium alloy powder, the integrated elastic modulus alternation porous titanium alloy support rod for femoral head that then preparation is comprised of head, body and afterbody according to the biomechanical parameter between the femoral head of surveying, cervical region, rotor;
The preparation of described head is to adopt " cold-rolling practice " that titanium alloy powder and pore creating material polymethyl methacrylate are got the powder block by the volume ratio mixed-forming of 1: 1, again the powder block is made at 1000～1400 ℃ of sintering, the particle diameter of pore creating material is the 32-60 order, the length of head is 2.50cm, diameter is 1.00cm, and elastic modelling quantity is 3.00GPa;
The preparation of described body be adopt " cold-rolling practice " with titanium alloy powder and pore creating material polymethyl methacrylate by 1: the volume ratio mixed-forming of 1-4 gets the powder block, again the powder block is made at 1000～1400 ℃ of sintering, the particle diameter of pore creating material is the 60-100 order, the length of body is 6.50-9.00cm, diameter is 1.00cm, and elastic modelling quantity is 0.70-3.00GPa;
The preparation of described afterbody is that titanium alloy powder is made at 1000～1400 ℃ of sintering, and the length of afterbody is 1.00cm, and diameter is 1.40cm, and elastic modelling quantity is 15.00GPa, and the surface of afterbody is screw-like, and afterbody bottom surface central authorities are interior hexagonal lock hole;
2) preparation of rhBMP-2/ gelatin control-release microsphere
Add the gelatin dry powder of rhBMP-2, the 1g of 8 μ g at room temperature to stir by every 100mL plasma water, obtain rhBMP-2/ gelatin control-release microsphere after vacuum drying, in-80 ℃ of preservations, with standby;
3) rhBMP-2/ gelatin control-release microsphere and porous titanium alloy support rod for femoral head is compound
Will be through step 2) the rhBMP-2/ gelatin control-release microsphere of preparation redissolves in plasma water to get rhBMP-2/ gelatin control-release microsphere solution uniformly according to 1g: 100mL, again will be through step 1) the elastic modelling quantity alternation porous titanium alloy support rod for femoral head of preparation first is soaked in 24h in rhBMP-2/ gelatin control-release microsphere solution after ultrasonic cleaning, then under-93.3kPa, the negative pressure pump evacuation is placed 30min, can obtain being rich in hole the porous titanium alloy support rod for femoral head of the elastic modelling quantity alternation of rhBMP-2/ gelatine microsphere.
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| CN102178556A (en) * | 2011-04-07 | 2011-09-14 | 北京畅想天行医疗技术有限公司 | Femoral head support frame and manufacturing method thereof |
| CN102293693B (en) * | 2011-06-01 | 2013-06-26 | 中国人民解放军第四军医大学 | Porous titanium alloy human cervical interbody fusion cage with bioactivity and preparation method thereof |
| CN104645419B (en) * | 2014-12-02 | 2017-04-12 | 中国人民解放军第四军医大学 | Preparation method of porous titanium-alloy femoral head support rod in bionic bone trabecula structure |
| CN105796214B (en) * | 2016-03-08 | 2017-11-07 | 吴志宏 | A kind of porous metals neck Invasive lumbar fusion device of directional sustained-release rhBMP 2 |
| CN112168431A (en) * | 2020-10-23 | 2021-01-05 | 中国人民解放军空军军医大学 | Functional bionic porous titanium alloy femoral head support rod and preparation method thereof |
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| CN101317790A (en) * | 2008-05-16 | 2008-12-10 | 北京天新福医疗器材有限公司 | Metal bone support device for femoral head putrescence |
| CN101418392A (en) * | 2008-12-08 | 2009-04-29 | 大连交通大学 | Bio-medical porous titanium products and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101317790A (en) * | 2008-05-16 | 2008-12-10 | 北京天新福医疗器材有限公司 | Metal bone support device for femoral head putrescence |
| CN101418392A (en) * | 2008-12-08 | 2009-04-29 | 大连交通大学 | Bio-medical porous titanium products and preparation method thereof |
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