CN100486543C - Compound artificial joint with artificial cartilage structure - Google Patents

Compound artificial joint with artificial cartilage structure Download PDF

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Publication number
CN100486543C
CN100486543C CNB200510022493XA CN200510022493A CN100486543C CN 100486543 C CN100486543 C CN 100486543C CN B200510022493X A CNB200510022493X A CN B200510022493XA CN 200510022493 A CN200510022493 A CN 200510022493A CN 100486543 C CN100486543 C CN 100486543C
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artificial
support unit
compound
joint body
artificial cartilage
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CN1792350A (en
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李玉宝
张利
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Sichuan University
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Sichuan University
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Abstract

A composite artificial joint with artificial cartilage structure features that an artificial cartilage structure layer made of polyvinyl alcohol hydrogel is arranged on the end face of a mechanical supporting unit, which may use a composite material structure body made of nano-hydroxy apatite and/or medical high-molecular material and/or porous mechanical supporting structure and contains the chtosan sponge carrying growth factor. The connection end of mechanical supporting unit and base bone has at least one convex fixing structure.

Description

The compound artificial joint body of band artificial cartilage structure
Technical field
What the present invention relates to is a kind of compound artificial joint body with artificial cartilage structure, can be used as articular cartilage damage or pathological changes and repairs artificial implant.
Background technology
Articular cartilage damage and pathological changes are the common diseases of clinical orthopaedics, because articular cartilage is depletion of blood fortune and single connective tissue, himself repair ability is extremely limited, in case take place to damage or pathological changes, be difficult to spontaneous recovery even cause the joint to be damaged, substitute so must carry out cartilage.
Articular prosthesis is mainly passed through in articular cartilage treatment clinically---as the articular prosthesis displacement of metal/ultra-high molecular weight polyethylene composite component form commonly used.The major defect of present joint replacement, one is that artificial joint is short service life.Metal and ultra-high molecular weight polyethylene compatibility are difficult to form liquid-film lubrication, cause producing too much abrasive dust, thereby cause living tissue foreign body reaction on every side and induce articular prosthesis loosening; Its two, be that operation the time must be excised a large amount of healthy bone, and these healthy bone play an important role aspect shock-absorbing.Thereby to light, moderate osteoarthritis patient, can adopt artificial cartilage displacement damaged cartilage, thereby reservation healthy bone: to severe osteoarthritis patient, can design and have novel artificial joint that cushion (being artificial cartilage) supports, reduce post-operative complication and also prolong its service life to realize effectively lubricating.
According to the characteristics of cartilage self, the requirement that should satisfy as the artificial cartilage substitution material comprises: good biomechanical property, excellent lubrication and wearability, with substrate bone firm connectivity and biocompatibility etc.The present cartilage substitution material multiselect highly elastic material close with the cartilage biomechanical property is as silicone rubber, polyurethane and polyvinyl alcohol (PVA) hydrogel etc.Wherein: silastic material is easy to wearing and tearing, and the oily matter in the easy absorb body fluids causes short ageing to lose efficacy; As the embedded material of need life-time service, the degradation property of polyurethane haves much room for improvement.
Studies show that normal articular cartilage is a kind of liquid-solid phase material, has two-phase, permeability is non linear correlation with load variations, shows as viscoelasticity.Early stage in load-bearing, it is the principal mode that bears a heavy burden that liquid film is pressed, and makes stress drop on the cartilage solid matrix to minimum, is the protection to substrate.Because the solid matrix of articular cartilage is to have infiltrative parenchima, hydrone can be in the barometric gradient current downflow, and moisture can be extruded lubricate gradually when continuing to bear a heavy burden.The molecule of PVA hydrogel material is cross-linked network and distributes, be combined with the negative electric charge group that the PVA molecular ionization produces on the network structure, hydrone is dispersed in the ground filling in network structure, has the liquid-solid phase basic structure similar with articular cartilage, can be counted as the mixture of incompressible medium on a kind of biphase not miscible, microcosmic, one is cancellated constituent mutually, and one is to be distributed in wherein and can mobile hydrone mutually.Under the load effect, liquid also can infiltrate and extrude, and the liquid of extruding from material is entrainmented as lubricant.Therefore, the PVA hydrogel is expected to simulate the mechanical behavior of articular cartilage, is moisture many micropores and the permeable material tissue with similar natural cartilage, shows similar behavior characteristics when bearing load.In addition, the PVA hydrogel also has excellent biological compatibility and bio-tribology characteristic and the mechanical property similar to articular cartilage, and does not degrade in vivo.Thereby the PVA hydrogel is at present as one of preferred material of artificial cartilage.
In reality is implanted replacement process, how PVA cartilage prosthese stably is fixed in the articular cartilage defect position, still still fail a satisfied problem that solves so far both at home and abroad.At present the fixing means that uses has: 1. mechanical fixation: combine with metal web during material, reach fixing PVA cartilage prosthese by the fixing metal net.Because wire netting lacks biological activity, can not induce or promote the growth or the reconstruction of substrate bone, thus biological fixation can't be formed, and the fatigue rupture of wire netting and corrosion and damage all can influence it and fix and result of use in the frequent use.2. chemical fixation: PVA cartilage prosthese is bonded on the substrate bone with special binding agent.But also can't keep for a long time and fixedly secure because of binding agent lacks biological activity and osteoinductive and aging regression in vivo thereof.
Although above-mentionedly can overcome easy to wear loosening, boundary lubrication difference that metal-ultra-high molecular weight polyethylene exists articular prosthesis, silicone rubber, polyurethane joint cushion material and deficiency such as easily aging than PVA hydrogel artificial cartilage implant material, but its PVA smooth surface, the inanimate object activity, the binding ability differences of cartilage prosthese and bone substrate etc. are still the problem that it fixed and brought into play repair function that influences.
Summary of the invention
Given this, the present invention will provide a kind of compound artificial joint body with artificial cartilage structure, can solve the held stationary problem of above-mentioned implanting prosthetic at the articular cartilage defect position satisfactorily.
The compound artificial joint body of band artificial cartilage structure of the present invention, be on a mechanics support unit with relative articular surface to the mill abutting end be provided with polyvinyl alcohol hydrogel artificial cartilage structure layer, the link of mechanics support unit on the other side and substrate bone is provided with at least one fixedly male structure.
Result of the test shows, the moisture content of this polyvinyl alcohol (PVA) hydrogel artificial cartilage layers material in the compound artificial joint body structure of above-mentioned band artificial cartilage structure generally can be 80wt%~90wt%, the thickness of material layer can be a kind of optimal design according to the performance indications of natural joint cartilage in 0.5mm~7mm scope generally.Said fixedly male structure generally can be 3~6 column form structures in the body structure of joint, and its diameter can be 2mm~5mm, and length is 2mm~10mm.
Said this mechanics support unit in the compound artificial joint body of above-mentioned band artificial cartilage structure, except that the various materials with respective strengths modulus that can adopt at present existing report and/or use, wherein special recommendation is used, and is at present composite material structures that the nanometer hydroxy apatitel medical polymer material of research and report is arranged more.Wherein, the calcium/phosphorus ratio of calcium/phosphorus ratio in nano-apatite or the osteoid apatite and nature bone apatite is close, has ideal biological activity.Said medical macromolecular materials can have the bigger range of choice; as comprise polyamide 6; polyamide 66; polyamide 6 12; polyamide 11; polyamide 12; polyamide 1212; polyamide 46; polyamide 2; polyglutamic acid; polyglutamic acid/polyglutamic acid ethyl ester copolymer; polyglutamic acid/poly-leucine copolymer; poly--the methyl glutamate/poly-β-benzyl-L-aspartic acid ester copolymer; poly-hydroxyalkyl-L-glutaminate; poly-N-acyl group-4-hydroxyproline ester; poly-N-acyl group-L-tryptophan ester; collagen; polyamide-based composition such as gelatin, and/or comprise TPO; the aromatic polyester class; polyoxyethylene; polylactic acid; Merlon; aliphatic polyester; cellulose; in the non-polyamide high polymer material such as polyvinyl alcohol one or more.
As the main body mechanics support unit in the compound artificial joint body of band artificial cartilage structure of the present invention, preferred what recommend to adopt is nanometer hydroxyapatite/polyamide 6, nanometer hydroxyapatite/polyamide 66, nanometer hydroxyapatite/polyethylene kind become the to grade composite of form.Wherein, the nanometer hydroxyapatite microgranule is distributed in as inorganic phase disperse on the one hand and plays potentiation in the polymeric matrix, on the other hand, its higher surface activity and biological activity and enable with the similarity of nature bone apatite on The Nomenclature Composition and Structure of Complexes and the surrounding bone tissue forms direct synostosis.Polyamide 6, polyamide 66 and polyethylene etc. then are engineering plastics, have good mechanical performance, and biocompatibility are good, and the foreign body reaction that causes in vivo is little.Research confirms that above-mentioned three class composites all have the mechanical strength suitable with the human body cortical bone, can be used for the damaged reparation of human loaded bone clinically.
Behind the artificial articular cartilage implant into body, its initial secure is most important for the success or not of implanting.Stable implant-bone interface can make the substrate osseous tissue grow into gradually in the implant hole, vascularization takes place gradually, and form ripe bone; And if the interface of implant one bone takes place loosening or displacement, be easy to damage freshman bone tissue, and hinder its vascularization, osseous tissue can't normally be grown in the prosthese hole, just forming a fibrous connective tissue layer at the interface, the calcification hardening gradually of this layer further influences implant and combines with interface between the substrate bone, thereby cause graft failure.The main body mechanics support unit of the compound artificial joint body of the band artificial cartilage structure that the present invention is above-mentioned is used for being provided with one or more fixedly male structure with the link of substrate bone, fixedly male structure as forms such as above-mentioned post, rods, by the respective aperture that on the substrate bone, gets out, fixedly male structure is inserted wherein, plays the effect of initial secure.Afterwards, along with the prolongation of time, the concurrent angiogenicization of growing into gradually of osseous tissue can form ripe bone, and biotype firm between the prosthese of realize implanting and the substrate bone combines, and combination also will be firm more more for a long time the implantation time.
The essential condition of osteanagenesis comprises osteoblast, partial blood fortune and the osteogenic induction factor etc.Wherein but osteoblast can be transformed by the noble cells in the local mesenchymal tissue, and if can have the fully three-dimensional hole that connects in the main body mechanics support unit, then will help growing into and the foundation of blood fortune of blood vessel.In the main body mechanics support unit of different materials and/or composition form, though multipotency has corresponding hole or slit, but on the said structure basis, the support rack type mechanics supporting construction that said mechanics support unit is adopted as the hole that has more greatly, particularly can be interconnected then is more and ideal especially.For example, make said this have that porosity in the mechanics support unit of more macroporous support rack type mechanics supporting construction form reaches 80%~95%, average pore size is 1mm~during 4mm, promptly can obtain well-content effect.
Even more ideal further also to be filled with the chitosan sponge body that carries somatomedin in above-mentioned mechanics support unit hole, particularly adopting the chitosan sponge body that makes this year of somatomedin is that to have the loose structure that porosity is 85%~95%, pore-size is 50~500 μ m be good.Studies show that, improve the porosity of chitosan sponge body, will help freshman bone tissue and vascular tissue to wherein growth, thereby be easy to more realize that biotype fixedly secures; The size of pore-size is for osteoblastic differentiation, propagation and growth, so that it is all influential to form freshman bone tissue and blood vessel at last in hole: the hole greater than 150~500 μ m can be beneficial to osteoblastic growth, can be beneficial to the conveying of growing into of blood vessel and nutrient substance and the drainage of metabolic waste less than the hole of 100 μ m.
In the compound artificial joint body structure of above-mentioned band artificial cartilage structure, a large amount of oh groups is arranged on the strand of PVA hydrogel, can and main body mechanics support unit in the polyamide strand on amide group and amino on the chitosan molecule chain and oh group between hydrogen bond action takes place, and microcosmic machinery packing interaction also can take place in the PVA hydrogel in the brace aperture of mechanics support unit, and the two synergistic result can make and can combine securely between the mechanics support unit of PVA hydrogel layer and its basilar part in the above-mentioned compound artificial joint body structure of the present invention.
The somatomedin of appendix on above-mentioned chitosan sponge body bone-inducing factor, be the another essential condition, particularly carrier material of osteanagenesis in forming process as no exothermic phenomenon then can protect the induced osteogenesis activity of somatomedin unaffected.Said somatomedin can be in the osteogenic induction factors such as bone morphogenetic protein, transforming growth factor, skeletal growth factor, basic fibroblast growth factor, insulin like growth factor at least a, the weight ratio of somatomedin/chitosan generally all allows in 0.5~1/100 scope.
Bone morphogenetic protein (BMP) has two kinds of osteogenic abilities: (1) increases the skeletonization characteristic of analogy osteoblast; (2) phenotypic expression by osteoprogenitor cell induced osteogenesis cell.The mode of BMP induced osteogenesis mainly is by endochondral ossification, but also can intramembranous ossification mode skeletonization.
Transforming growth factor (TGF-β) can stimulate intermembranous mesenchymal cell proliferation, differentiation, promotes skeletonization and chondroblast propagation, stimulates type i collagen synthetic, induces in the film and the endochondral ossification process, thereby promotes the damaged healing of bone.
Insulin like growth factor (IGF) is an important skeletonization regulatory factor, and it can directly act on growth hormone receptor, the mediation osteoblastic proliferation.
Basic fibroblast growth factor (bFGF) can stimulate bone and its cells propagation, promotes osteoblastic differentiation, increases bone formation; BFGF also can be used as a kind of stimulant of capillary proliferation, when stimulating capillary endothelial cell migration and propagation, promote the secretion of activator of plasminogen, the parts of fine extracellular matrix of degraded damage location, promote blood capillary in the broken ends of fractured bone and graft, to grow into, nutrition is provided, transport calcareous, thereby to need to promote the cartilage skeletonization of blood confession, quicken the ossified of defective region.
Skeletal growth factor (SGF) but stimulating osteoblast propagation and active, thereby increase bone formation.Chitosan is a kind of biodegradable polycation polysaccharide, and biocompatibility is good, and hydrophilic is strong, is beneficial to sticking, break up and breeding of cell; Its catabolite is alkalescence, can improve cell activity; Hydroxyl and amino on its strand have high reaction activity and high, can combine with protein and other, also can with trace element (as Zn, Fe, Mn, Ca etc.) complexation, thereby the chitosan sponge body is commonly used for the carrier material of some somatomedin.
To carry the even filling of chitosan sponge body of somatomedin in the macropore of aforementioned body mechanics support unit, on the one hand, this main body mechanics support unit can give compound artificial joint cartilage prosthese higher mechanical strength, can bear the physiological loads effect at this position behind the assurance prosthese implant into body; Filling carrying a somatomedin chitosan sponge body and then can induce or promote osteoblastic differentiation, growth and propagation in macropore, and the loose structure of chitosan sponge body and degradability thereof all are beneficial to the creeping substitution of new bone tissue and the foundation of blood fortune.
The damaged place of chitosan sponge body implantable bone of above-mentioned somatomedin will be loaded with, cell is to the effect of osteoblast differentiation and the support effect of chitosan sponge body by growth factor-induced or before promoting skeletonization, new bone tissue can be grown in this porous support gradually, and the degraded of chitosan can realize the creeping substitution and the vascularization of new bone tissue again.In addition, but with the trace element of the chitosan complex also activity of stimulating osteoblast, promote the generation of new bone.Above-mentioned synergistic result induces and promote new bone tissue to be full of the macropore hole of main body mechanics supporting bracket within a short period of time, and vascularization gradually, fix thereby form biotype between the mechanics support unit of realizing compound artificial joint cartilage assembly and the substrate bone, the while also prolongs prosthese service life in vivo greatly.
Be appreciated that thus, the compound artificial joint body of the band artificial cartilage structure of said structure form of the present invention, initial period behind implant into body can be given implant stability at once by firm mechanical chimeric of the fixedly male structure in its mechanics support unit and substrate osteogenesis.Prolongation with the time of implantation, then can induce and/or promote the substrate osseous tissue in the mechanics support unit of compound artificial joint body, to grow into, thereby realize that gradually mechanical interlocked the and biotype between implant and self substrate bone fixedly secures, and with the prolongation of implanting the time, fixing will be firm further also.
Mechanics support unit in the compound artificial joint body of the band artificial cartilage structure of the above-mentioned form of the present invention, particularly has the polyvinyl alcohol hydrogel artificial cartilage structure layer on the mechanics support unit of support rack type mechanics supporting construction form of hole, and/or the chitosan sponge body that is loaded with somatomedin of filling in its hole, except that can preparing by the generation type of existing similar structures, comparatively simple a kind of mode is to finish by multiple dipping-deposition-dry run.
Mechanics support unit with support rack type mechanics supporting construction form with hole is an example, and itself and the compound of polyvinyl alcohol hydrogel can be adopted following mode:
With an end have the fixing suitable length of the mechanics support unit structure other end of male structure (as length 1/4) immerse in the poly-vinyl alcohol solution, and can impel poly-vinyl alcohol solution to be full of hole by measures such as pressurization or vacuum, with mechanics support unit structure and container in the lump fully low temperature (as≤-20 ℃) freezing after, room temperature thaw again.Like this freeze-thaw several times repeatedly can make that to form mode that chemical bonding and microcosmic machinery interlocking combine between polyvinyl alcohol hydrogel and mechanics support unit compound mutually be overall structure.
When employing had the mechanics support unit of support rack type mechanics supporting construction form of hole, the compound of the chitosan sponge body of filling in its hole and the mechanics supporting bracket of mechanics support unit also can be realized by above-mentioned dipping-deposition-dry run.One of its concrete mode can be described below:
The chitosan powder is dissolved in the chitosan solution that is mixed with dilute acetic acid solution, and with an amount of selected growth factor solution mix homogeneously.The mechanics support unit is immersed in this mixed liquor, take out fully freezing final vacuum lyophilization after under pressurization or condition such as vacuum, making mixed solution be full of hole in the mechanics support unit fully.Immerse weakly alkaline solution (as 10wt% ammonia etc.) neutralization then and remove acetic acid wherein, be washed to lyophilization again after the neutrality.
Below, foregoing of the present invention is described in further detail again by the specific embodiment by the accompanying drawing illustrated embodiment.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
Description of drawings
Fig. 1 is a kind of structural representation of the compound artificial joint body of band artificial cartilage structure of the present invention.
The specific embodiment
In the structure of the compound artificial joint body of this band artificial cartilage structure as shown in the figure, a mechanics support unit 4 is arranged, it is used for relative with relative articular surface 7 end closed in grinding-in to be compounded with by moisture content being the artificial cartilage structure layer 1 that the polyvinyl alcohol hydrogel of 80wt%~90wt% forms, and thickness is 0.5~7mm; Mechanics support unit 4 other end places being used for relatively with it being connected with the substrate bone are provided with 3~6 bar-shaped fixedly male structure 2, and bar-shaped protruding diameter is 2mm~5mm, and length is 2mm~10mm.
Mechanics support unit 4 is the formed support rack type mechanics supporting structure with hole 3 of medical composite material of one of forms such as nanometer hydroxyapatite/polyamide 6, nanometer hydroxyapatite/polyamide 66, nanometer hydroxyapatite/polyethylene, its porosity is 80%~95%, and average pore size is 1mm~4mm.Also be filled with the chitosan sponge body 5 of the loose structure form of carrying somatomedin in its hole 3, the porosity of chitosan sponge body 5 is 85%~95%, and pore-size is 50~500 μ m.What the somatomedin of appendix can be in above-mentioned bone morphogenetic protein, transforming growth factor, skeletal growth factor, basic fibroblast growth factor, the insulin like growth factor on the chitosan sponge body is at least a, and wherein the weight ratio of somatomedin/chitosan is 0.5~1/100.
Preparation example 1
It is the 3wt% chitosan solution that is mixed with in the dilute acetic acid solution of 2wt% that 2g chitosan powder is dissolved in 65ml concentration, adds guanidine hydrochloride solution (wherein BMP weight is 0.04g) and the mix homogeneously of BMP therein.With band hold-down bars and aperture is that the macropore mechanics support unit structure of nanometer hydroxyapatite/polyamide 6 of 1~4mm immerses in this mixed liquor, in 10 -2~10 -1Make mixed solution be full of the macropore brace aperture fully under the individual atmospheric pressure, it is taken out after under-10 ℃~-20 ℃ freezing 24 hours, again in 10 -4~10 -3Lyophilization is 24~36 hours under the individual atmospheric pressure.Take out then it immersed in the 10wt% ammonia after 2~6 hours, reuse deionized water cyclic washing to pH be about 7, and in-5 ℃ freezing 24 hours, once more in 10 -4~10 -3Vacuum lyophilization is 16~24 hours under the individual atmospheric pressure, promptly gets compound porous support unit.
1/4 length that is used for composite polyvinyl alcohol hydrogel (PVA) direction end on the above-mentioned compound porous support unit is partly immersed the PVA solution of 15~20wt%, pressurization makes PVA solution be full of hole, and with its in the lump in-20 ℃ freezing 12~18 hours down, at room temperature natural thaw after the taking-up.After 3~5 times, unnecessary PVA hydrogel is removed in cutting to an above-mentioned freezing melting process, promptly gets the compound artificial joint body of the said band artificial cartilage structure of the present invention repeatedly.
Preparation example 2
It is the 3wt% chitosan solution that the dilute acetic acid solution of 2wt% is mixed with that 2g chitosan powder is dissolved in 65ml concentration, adds 10mg TGF-β powder therein and stirs.The macropore mechanics support unit structure that will have hold-down bars and aperture and be nanometer hydroxyapatite/polyamide 66 of 1~4mm immerses in this mixed liquor, in 10 -2~10 -1Make mixed solution be full of the macropore brace aperture fully under the individual atmospheric pressure, take out after under-10 ℃~-20 ℃ freezing 24 hours, again in 10 -4~10 -3Lyophilization is 24~36 hours under the individual atmospheric pressure.Take out the back and immerse 10wt% ammonia after 2~6 hours, reuse deionized water cyclic washing to pH be about 7, and in-5 ℃ freezing 24 hours, once more in 10 -4~10 -3Vacuum lyophilization is 16~24 hours under the individual atmospheric pressure, promptly gets compound porous support unit.
1/4 length of the above-mentioned compound porous support unit other end is partly immersed in the container of the PVA solution that fills 15~20wt%, and pressurization makes PVA solution be full of hole, and puts-20 ℃ in the lump and descended freezing 12~18 hours, takes out under the room temperature and melts naturally.After 3~5 times, unnecessary PVA hydrogel is removed in cutting to this freeze-thaw process, promptly gets the compound artificial joint body with artificial cartilage structure repeatedly.
Preparation example 3
It is the 3wt% chitosan solution that the dilute acetic acid solution of 2wt% is mixed with that 2g chitosan powder is dissolved in 65ml concentration, adds 10mg IGF powder therein and stirs.The macropore mechanics support unit structure that will have hold-down bars and aperture and be nanometer hydroxyapatite/polyamide 66 of 1~4mm immerses in this mixed liquor, in 10 -2~10 -1Make mixed solution be full of its hole fully under the individual atmospheric pressure, it is taken out after under-10 ℃~-20 ℃ freezing 24 hours, again in 10 -4~10 -3Lyophilization is 24~36 hours under the individual atmospheric pressure.Take out the back and immerse in the 10wt% ammonia after 2~6 hours, reuse deionized water cyclic washing to pH be about 7, and in-5 ℃ freezing 24 hours, again in 10 -4~10 -3Vacuum lyophilization is 16~24 hours under the individual atmospheric pressure, promptly gets compound porous support unit.
1/4 length of the above-mentioned compound porous support unit other end is partly immersed in the container of the PVA solution that fills 15~20wt%, pressurization makes PVA solution be full of hole, with complex stephanoporate bracket with the container of containing PVA solution place-20 ℃ freezing 12~18 hours down, take out at room temperature to place and melt.After 3~5 times, unnecessary PVA hydrogel is removed in cutting to this freeze-thaw process, promptly gets the compound artificial joint body with artificial cartilage structure repeatedly.
Preparation example 4
It is the 3wt% chitosan solution that the dilute acetic acid solution of 2wt% is mixed with that 2g chitosan powder is dissolved in 65ml concentration, adds 3mg bFGF and 3mg SGF powder therein and stirs.To have the nanometer hydroxyapatite that hold-down bars and aperture are 1~4mm/poly macropore mechanics support unit structure immerses in this mixed liquor, in 10 -2~10 -1Make mixed solution be full of the macropore brace aperture fully under the individual atmospheric pressure, take out the back in-10 ℃~-20 ℃ freezing 24 hours, again in 10 -4~10 -3Lyophilization is 24~36 hours under the individual atmospheric pressure.Then it is immersed in the 10wt% ammonia after 2~6 hours, reuse deionized water cyclic washing to pH be about 7, again at-5 ℃ after freezing 24 hours, in 10 -4~10 -3Vacuum lyophilization is 16~24 hours under the individual atmospheric pressure, promptly gets compound porous support unit.
1/4 length of the above-mentioned compound porous support unit other end is partly immersed in the container of the PVA solution that fills 15~20wt%, pressurization makes PVA solution be full of hole, and with its in the lump in-20 ℃ freezing 12~18 hours down, take out under the room temperature of back and place thawing in 2~4 hours.After 3~5 times, unnecessary PVA hydrogel is removed in cutting to this freeze-thaw process, promptly gets the compound artificial joint body with artificial cartilage structure repeatedly.
Preparation example 5
It is the 3wt% chitosan solution that the dilute acetic acid solution of 2wt% is mixed with that 2g chitosan powder is dissolved in 65ml concentration, adds 8mg BMP and 1mg bFGF powder therein and stirs.The macropore mechanics support unit structure that will have hold-down bars and aperture and be nanometer hydroxyapatite/polyamide 6 of 1~4mm immerses in this mixed liquor, in 10 -2~10 -1Make mixed solution be full of the macropore brace aperture fully under the individual atmospheric pressure, take out the back in-10 ℃~-20 ℃ freezing 24 hours, again in 10 -4~10 -3Lyophilization is 24~36 hours under the individual atmospheric pressure.Then it is immersed in the 10wt% ammonia after 2~6 hours, with the deionized water cyclic washing to pH be about 7, and in-5 ℃ freezing 24 hours, again in 10 -4~10 -3Vacuum lyophilization is 16~24 hours under the individual atmospheric pressure, promptly gets compound porous support unit.
1/4 length of the above-mentioned compound porous support unit other end is partly immersed in the container of the PVA solution that fills 15~20wt%, pressurization makes PVA solution be full of hole, and it is placed in the lump-20 ℃ freezing 12~18 hours down, take out the back room temperature and place and melted in 2~4 hours.After 3~5 times, unnecessary PVA hydrogel is removed in cutting, promptly gets the compound artificial joint body with artificial cartilage structure repeatedly in above-mentioned freeze-thaw operating process.

Claims (10)

1. be with the compound artificial joint body of artificial cartilage structure, it is characterized in that a mechanics support unit (4) go up with relative articular surface (7) be provided with polyvinyl alcohol hydrogel artificial cartilage structure layer (1) to grinding abutting end, this mechanics support unit (4) is gone up relative with described artificial cartilage structure layer (1) the link place that is used for substrate bone (6), is provided with at least one fixedly male structure (2).
2. the compound artificial joint body of band artificial cartilage structure as claimed in claim 1, the moisture content that it is characterized in that said polyvinyl alcohol hydrogel artificial cartilage layer (1) is 80wt%~90wt%, thickness 0.5~7mm; Said fixedly male structure (2) is the column structure of 3~6 diameter 2mm~5mm, length 2mm~10mm.
3. the compound artificial joint body of band artificial cartilage structure as claimed in claim 1 is characterized in that the composite material structure of said mechanics support unit (4) for nanometer hydroxyapatite and medical macromolecular materials.
4. the compound artificial joint body of band artificial cartilage structure as claimed in claim 3 is characterized in that said medical macromolecular materials are a kind of in polyamide 6, polyamide 66, the polyethylene.
5. as the compound artificial joint body of the described band artificial cartilage structure of one of claim 1 to 4, it is characterized in that said mechanics support unit (4) is for having the support rack type mechanics supporting construction of hole (3).
6. the compound artificial joint body of band artificial cartilage structure as claimed in claim 5 is characterized in that the porosity in the said mechanics support unit (4) is 80%~95%.
7. the compound artificial joint body of band artificial cartilage structure as claimed in claim 5 is characterized in that the average pore size of the hole (3) in the said mechanics support unit (4) is 1mm~4mm.
8. the compound artificial joint body of band artificial cartilage structure as claimed in claim 5 is characterized in that being filled with in the hole (3) of said mechanics support unit (4) the chitosan sponge body (5) that carries somatomedin.
9. the compound artificial joint body of band artificial cartilage structure as claimed in claim 8, the chitosan sponge body (5) that it is characterized in that said year somatomedin are that porosity is 85%~95%, pore-size is the loose structure of 50~500 μ m.
10. the compound artificial joint body of band artificial cartilage structure as claimed in claim 8, it is characterized in that the somatomedin of said appendix on the chitosan sponge body is at least a in bone morphogenetic protein, transforming growth factor, skeletal growth factor, basic fibroblast growth factor, the insulin like growth factor, the weight ratio of somatomedin/chitosan is 0.5/100~1/100.
CNB200510022493XA 2005-12-31 2005-12-31 Compound artificial joint with artificial cartilage structure Expired - Fee Related CN100486543C (en)

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