CN102512267A - Bone restoration body with composite porous structure and preparation method thereof - Google Patents
Bone restoration body with composite porous structure and preparation method thereof Download PDFInfo
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Abstract
A bone restoration body with a composite porous structure and a preparation method of the bone restoration body. The bone restoration body comprises a porous metal bracket and an infill body with a porous structure, wherein the porous metal bracket is of a three-dimensional net structure, a plurality of pores are arranged in the inner part of the porous metal bracket, and the infill body with the porous structure is fully filled in all the pores. The preparation method combines the direct metal rapid prototyping technology and the freeze drying technology and comprises the steps of preparing the porous metal bracket by a structural design and the direct metal rapid prototyping technology, pouring uniformly-mixed polymer solution or polymer/biological ceramics mixing solution into the porous metal bracket, carrying out freezing treatment, and then forming the infill body with the porous structure through freeze drying so as to obtain the bone restoration body with the composite porous structure, wherein the infill body with the porous structure has micropore characteristics. The bone restoration body has good mechanics compatibility, can obtain good bone conduction performance and bone induction performance, improves bone integration efficiency and can be used for clinical treatment of segmental bone defect of a bearing part.
Description
Technical field
The present invention relates to a kind of surgical implant and preparation method thereof, be specifically related to a kind of compound porous structure bone repair and preparation method thereof, belong to the biomedical engineering technology field.
Background technology
Because the bone that disease and wound cause is damaged is commonly encountered diseases clinically, also is one of global problem of orthopaedics therapy, is having a strong impact on patient's quality of life.At present, the damaged method of treatment bone has from body bone and allogenic bone transplantation, degradable biomaterial and medical metal material transplants, and tissue engineering technique etc.Though good from the body bone, it is limited to originate, and can bring unnecessary secondary wound to the patient; Allograph bone exists immunogenicity and shortcoming such as pathogenic again; Degradable biomaterial has had application more widely clinically because of having excellent biological compatibility, but owing to lack enough mechanical strengths, the treatment of can only be applied among a small circle, the non-weight bearing area bone is damaged; On a large scale, weight bearing area bone, the damaged treatment in joint can only be adopted the transplanting of metal material clinically; Though medical metal material has excellent biological compatibility; But the shortage biological activity, and therefore the elastic modelling quantity of metal material is far above body bone tissue; Various complication have appearred in postoperative, and therapeutic effect is not ideal enough.Though tissue engineering technique is more advanced, and beginning application gradually clinically, the bone repair of tissue engineering technique structure still lacks enough mechanical strengths, the reparation of be not suitable on a large scale, the weight bearing area bone is damaged at present.Therefore; Research and develop a kind of novel bone repair; The elastic modelling quantity that makes it both have ideal mechanical strength and be complementary with body bone tissue; The excellent biology performance that possesses degradable biomaterial again, for improve on a large scale, the late result of weight bearing area bone defect healing has important scientific meaning and practical value.
Through the retrieval of prior art document is found, application number is 200910265056.9, and (publication number: CN 101716368A) name is called the Chinese invention patent of " being used for porous titanium artificial bone of bone tissue restoration and preparation method thereof " and discloses a kind of porous titanium artificial bone that is used for bone tissue restoration and preparation method thereof.This method is raw material with the titanium valve, makes porous titanium artificial bone through batching, slurrying, foaming, sintering and cleaning successively.Promptly use dispersant, binding agent and hydrogen peroxide are processed mixed solution; In mixed solution, add titanium valve and process slurry, foaming and drying gets porous titanium blank again; Sintering gets the POROUS TITANIUM block in vacuum sintering furnace; After being processed into required form, clean, dry, make the porous titanium artificial bone that is used for bone tissue restoration.Though porous titanium artificial bone of this disclosure of the Invention and preparation method thereof can obtain the three-dimensional porous structure artificial bone; Reduce the adverse effect that stress shielding brings to a certain extent; But the poor controllability of its pore structure, profile also need machining to obtain, and are difficult to be complementary with the profile of defect osseous tissue; And the good biological activity of porous titanium artificial bone shortage, with osseointegration's difficulty.
Summary of the invention
The objective of the invention is to deficiency to prior art; A kind of compound porous structure bone repair is provided; It can overcome, and existing metal species bone repair elastic modelling quantity does not match and the defective of biology performance difference, and the insufficient problem of degradable biomaterial mechanical property; Realize the good mechanical compatibility of bone repair and body bone tissue, promote growing into of new bone, improve the integration of itself and host bone.The present invention also aims to provide corresponding preparation method.
The present invention realizes through following technical scheme:
A kind of compound porous structure bone repair, it comprises porous metals support and loose structure obturator, and said porous metals support is the 3 D stereo RF, and inside has a plurality of holes, and said loose structure obturator riddles in these all holes.
Compound porous structure bone repair of the present invention; Its porous metals support is processed by titanium, titanium alloy, vitallium or rustless steel; Profile is a regular geometric shapes or definite according to patient's patient part, and its hole is of a size of 300-1500 μ m, and porosity is 60%-85%; Said loose structure obturator is microporous polymer or microporous polymer/bioceramic complex, and this microporous polymer is a chitosan, and this bioceramic is hydroxyapatite, tricalcium phosphate or calcium silicates.
Another technical scheme of the present invention is:
A kind of method for preparing of compound porous structure bone repair, it comprises the steps:
The first step; Utilize the direct metal rapid shaping technique, under computer control, adopt metal material to carry out the manufacturing of direct metal rapid shaping, form the porous metals support by rapid forming equipment; This porous metals support is the 3 D stereo RF; Inside has a plurality of holes, and hole is of a size of 300-1500 μ m, and porosity is 60%-85%;
In second step, be prepared into the polymer solution that concentration is 1wt%-5wt% with the acetic acid solution of polymer and 0.2Mol/L is mixed, and carry out evacuation at normal temperatures, residual bubble in the removal solution;
The 3rd step, prepared porous metals support is put in the container suitable with its profile, again polymer solution is poured in this porous metals support, make solution be full of all holes in the said porous metals support, carry out freezing then;
The 4th step, take out the bone repair that freezes, put into vacuum freezing drying oven at once and carry out lyophilization.
The method for preparing of compound porous structure bone repair of the present invention; In its second step; Polymer solution is with the mixed preparation of the acetic acid solution of polymer, bioceramic and 0.2Mol/L; This bioceramic is hydroxyapatite, tricalcium phosphate or calcium silicates, and the mass ratio of said polymer and bioceramic is 1: 1,2: 1,3: 1 or 4: 1, and other technological parameters in this second step are constant;
In second step, described polymer is a chitosan;
In the 3rd step, said cryogenic temperature is-10 ℃ to-70 ℃, and cooling time is 12-24 hour;
In the 4th step, the vacuum of said vacuum lyophilization is 0.1-0.2mbar, and the temperature of vacuum lyophilization is-40 ℃ to-90 ℃, and the time of vacuum lyophilization is 12-24 hour.
The present invention combines the direct metal rapid shaping technique with Freeze Drying Technique; Earlier produce porous metals support with good mechanical compatibility through structural design and direct metal rapid shaping technique; Again polymer solution or polymer/bioceramic mixed solution are poured in the porous metals support; And carry out freezing processing; Pass through lyophilization then, make polymer or polymer/bioceramic complex form loose structure obturator, thereby obtain the compound porous structure bone repair with pore characteristics.The present invention both had ideal mechanical strength and elastic modelling quantity because of the porous metals support, because of the loose structure obturator possesses suitable cell, organizes the pore structure of growing into, can obtain good bone conduction and osteoinductive again, improved the bone integration rate.The present invention can be applied to the treatment of weight bearing area large segmental bone defect clinically.
Description of drawings
Fig. 1 is a structural representation of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing embodiments of the invention are elaborated, this embodiment is that prerequisite has provided detailed embodiment and concrete operating process with technical scheme of the present invention, but protection scope of the present invention is not limited only to following embodiment.
As shown in Figure 1, shown in the compound porous structure bone repair comprise: porous metals support 1 and loose structure obturator 2.
Said porous metals support 1 is to be processed by titanium, titanium alloy, vitallium or rustless steel; It perhaps forms through metal dust microsphere sintering; Perhaps form according to certain space structure form braiding sintering, perhaps utilize the manufacturing of direct metal rapid shaping technique to form by metal fiber wire.The profile of said porous metals support 1 can be designed and manufactured into regular geometric shapes, also can carry out three-dimensionalreconstruction according to the medical image data of patient's patient part, forms anatomy and confirms.Said porous metals support 1 is the 3 D stereo RF, and inside has many holes, and this hole is of a size of 300-1500 μ m, and porosity is 60%-85%.The pore structure of said porous metals support 1 can design arbitrarily, adjusts, optimize, and to satisfy various special requirements, obtains ideal pore structure characteristic, the elastic modelling quantity that makes it possess excellent mechanical intensity and be complementary with body bone tissue.The main effect of this porous metals support 1 is to bear human body own wt and external load, and the elastic modelling quantity that is complementary of formation and body bone tissue, reduces the adverse effect of stress shielding effect.
Said loose structure obturator 2 distributes and riddles in all holes of porous metals support 1, thereby forms the compound porous structure bone repair with it jointly.Said loose structure obturator is the structure with pore characteristics that is formed by polymer or polymer/bioceramic complex, and the size of its micropore is generally 10-200 μ m.This polymer is a chitosan, and this bioceramic is for being bioactive materials such as hydroxyapatite, tricalcium phosphate or calcium silicates.The main effect of this loose structure obturator 2 is to improve the biology performance of bone repair, promotes growing into and the formation of bone newly of cell, tissue, and the bone of realizing ideal is integrated.
The above-mentioned general process that utilizes the direct metal rapid shaping technique to make porous metals support 1 is: carry out the three-D space structure design and optimization through computer-aided design (CAD) software earlier; Then the cad data that is designed being carried out hierarchy slicing handles; And convert the data format of rapid forming equipment acquiescence to; Last by rapid forming equipment according to the data of handling well, under computer control, carry out the manufacturing of direct metal rapid shaping, form porous metals support 1.
The method for preparing of compound porous structure bone repair according to the invention comprises the steps:
The first step; Utilize the direct metal rapid shaping technique, under computer control, adopt metal material to carry out the manufacturing of direct metal rapid shaping, form porous metals support 1 by rapid forming equipment; This porous metals support 1 is the 3 D stereo RF; Inside has a plurality of holes, and hole is of a size of 300-1500 μ m, and porosity is 60%-85%.
In second step, be prepared into the polymer solution that concentration is 1wt%-5wt% with the acetic acid solution of polymer and 0.2Mol/L is mixed, and carry out evacuation at normal temperatures, residual bubble in the removal solution;
In second step; Polymer solution also can be used the mixed preparation of the acetic acid solution of polymer, bioceramic and 0.2Mol/L; This bioceramic is hydroxyapatite, tricalcium phosphate or calcium silicates; The mass ratio of said polymer and bioceramic is 1: 1,2: 1,3: 1 or 4: 1, and other technological parameters in second step are constant.
The 3rd step; Prepared porous metals support 1 is put in the container suitable with its profile; Again polymer solution is poured in this porous metals support 1, makes polymer solution be full of all holes in the said porous metals support 1, carry out freezing then; Cryogenic temperature is-10 ℃ to-70 ℃, and cooling time is 12-24 hour.
The 4th step, take out the bone repair that freezes, to put into vacuum freezing drying oven at once and carry out lyophilization, the vacuum of vacuum lyophilization is 0.1-0.2mbar, and temperature is-40 ℃ to-90 ℃, and the time is 12-24 hour.
Through some embodiment compound porous structure bone repair method for preparing according to the invention is done further to specify below.
Embodiment 1
At first utilize computer-aided design (CAD) software Unigraphics to carry out the design of porous metals support 1 three-D space structure; The three-dimensional porous structure that is designed is an alveolate texture, and hole is of a size of 300 μ m, and porosity is 60%; Then the cad data that is designed being carried out hierarchy slicing handles; And convert rapid forming equipment default data form to, again by rapid forming equipment according to handling data well, under computer control, adopt Titanium as material; Carry out the manufacturing of direct metal rapid shaping, form POROUS TITANIUM metal rack 1.The acetic acid solution of certain amount of chitosan and 0.2Mol/L is mixed, be prepared into the polymer solution that concentration is 1wt%, and carry out evacuation at normal temperatures, remove residual bubble in the solution.Prepared POROUS TITANIUM metal rack 1 is put in the container suitable with its profile; Again polymer solution is poured in the POROUS TITANIUM metal rack 1; Make polymer solution be full of all holes in the said POROUS TITANIUM metal rack 1, place-10 ℃ of environment to carry out then freezing 12 hours.The bone repair that taking-up freezes is put into vacuum freezing drying oven at once, carries out lyophilizing, forms the micro porouse chitoglycan obturator, and pore size wherein is generally 10-200 μ m.Vacuum is set at 0.2mbar, and cryogenic temperature is-40 ℃, and freeze-drying time is 12 hours, can obtain said compound porous structure bone repair after the lyophilizing.
At first utilize computer-aided design (CAD) software Unigraphics to carry out the design of porous metals support 1 three-D space structure; The three-dimensional porous structure that is designed is the diamond point minor structure; Hole is of a size of 700 μ m, and porosity is 70%, then the cad data that is designed is carried out hierarchy slicing and handles; And convert rapid forming equipment default data form to; Again by rapid forming equipment according to handling data well, under computer control, adopt titanium alloy to carry out the manufacturing of direct metal rapid shaping, form porous titanium alloy support 1.The acetic acid solution of certain amount of chitosan, hydroxyapatite and 0.2Mol/L is mixed, and the mass ratio of chitosan and hydroxyapatite is 4: 1, is prepared into the polymer solution that concentration is 5wt%, and carries out evacuation at normal temperatures, removes residual bubble in the solution.Prepared porous titanium alloy support 1 is put in the container suitable with its profile; Again polymer solution is poured in the porous titanium alloy support 1; Make polymer solution be full of all holes in the said porous titanium alloy support 1, place-70 ℃ of environment to carry out then freezing 24 hours.The bone repair that taking-up freezes is put into vacuum freezing drying oven at once, carries out lyophilizing, forms micro porouse chitoglycan/hydroxyapatite complex, and pore size wherein is generally 10-200 μ m.Vacuum is set at 0.1mbar, and cryogenic temperature is-90 ℃, and freeze-drying time is 24 hours.Can obtain the compound porous structure bone repair after the lyophilizing.
Embodiment 3
At first utilize computer-aided design (CAD) software Unigraphics to carry out the design of porous metals support 1 three-D space structure; The three-dimensional porous structure that is designed is the diamond point minor structure; Hole is of a size of 1500 μ m, and porosity is 85%, then the cad data that is designed is carried out hierarchy slicing and handles; And convert rapid forming equipment default data form to; Again by rapid forming equipment according to handling data well, under computer control, adopt rustless steel to carry out the manufacturing of direct metal rapid shaping, form porous stainless steel bracket 1.The acetic acid solution of certain amount of chitosan, hydroxyapatite and 0.2Mol/L is mixed, and the mass ratio of chitosan and hydroxyapatite is 2: 1, is prepared into the polymer solution that concentration is 3wt%, and carries out evacuation at normal temperatures, removes residual bubble in the solution.Prepared porous stainless steel bracket 1 is put in the container suitable with its profile; Again polymer is poured in the porous stainless steel bracket 1; Make polymer solution be full of all holes in the said porous stainless steel bracket 1, place-55 ℃ of environment to carry out then freezing 18 hours.The bone repair that taking-up freezes is put into vacuum freezing drying oven at once, carries out lyophilizing, forms micro porouse chitoglycan/hydroxyapatite complex, and pore size wherein is generally 10-200 μ m.Vacuum is set at 0.15mbar, and cryogenic temperature is-70 ℃, and freeze-drying time is 18 hours, can obtain the compound porous structure bone repair after the lyophilizing.
Embodiment 4
At first utilize computer-aided design (CAD) software Unigraphics to carry out the design of porous metals support 1 three-D space structure; The three-dimensional porous structure that is designed is the diamond point minor structure; Hole is of a size of 700 μ m, and porosity is 70%, then the cad data that is designed is carried out hierarchy slicing and handles; And convert rapid forming equipment default data form to; Again by rapid forming equipment according to handling data well, under computer control, adopt titanium alloy to carry out the manufacturing of direct metal rapid shaping, form porous titanium alloy support 1.The acetic acid solution of certain amount of chitosan, tricalcium phosphate and 0.2Mol/L is mixed, and the mass ratio of chitosan and tricalcium phosphate is 1: 1, is prepared into the solution that concentration is 5wt%, and carries out evacuation at normal temperatures, removes residual bubble in the solution.Prepared porous titanium alloy support 1 is put in the container suitable with its profile; Again polymer solution is poured in the porous titanium alloy support 1; Make polymer solution be full of all holes in the said porous titanium alloy support 1, place-20 ℃ of environment to carry out then freezing 24 hours.The bone repair that taking-up freezes is put into vacuum freezing drying oven at once, carries out lyophilizing, forms micro porouse chitoglycan/tricalcium phosphate complex, and pore size wherein is generally 10-200 μ m.Vacuum is 0.1mbar, and cryogenic temperature is-90 ℃, and freeze-drying time is 24 hours, can obtain the compound porous structure bone repair after the lyophilizing.
Embodiment 5
At first utilize computer-aided design (CAD) software Unigraphics to carry out the design of porous metals support 1 three-D space structure; The three-dimensional porous structure that is designed is the diamond point minor structure; Hole is of a size of 700 μ m, and porosity is 70%, then the cad data that is designed is carried out hierarchy slicing and handles; And convert rapid forming equipment default data form to; Again by rapid forming equipment according to handling data well, under computer control, adopt rustless steel to carry out the manufacturing of direct metal rapid shaping, form porous stainless steel bracket 1.The acetic acid solution of certain amount of chitosan, calcium silicates and 0.2Mol/L is mixed, and the mass ratio of chitosan and calcium silicates is 3: 1, is prepared into the solution that concentration is 5wt%, and carries out evacuation at normal temperatures, removes residual bubble in the solution.Prepared porous stainless steel bracket 1 is put in the container suitable with its profile; Polymer solution is poured in the porous stainless steel bracket 1; Make polymer solution be full of all holes in the said porous stainless steel bracket 1, place-30 ℃ of environment to carry out then freezing 24 hours.The bone repair that taking-up freezes is put into vacuum freezing drying oven at once, carries out lyophilizing, forms micro porouse chitoglycan/calcium silicates complex, and pore size wherein is generally 10-200 μ m.Vacuum is 0.1mbar, and cryogenic temperature is-90 ℃, and freeze-drying time is 24 hours, can obtain the compound porous structure bone repair after the lyophilizing.
Claims (13)
1. compound porous structure bone repair; It is characterized in that: said bone repair comprises porous metals support and loose structure obturator; Said porous metals support is the 3 D stereo RF, and inside has a plurality of holes, and said loose structure obturator riddles in these all holes.
2. compound porous structure bone repair according to claim 1 is characterized in that: said porous metals support is processed by titanium, titanium alloy, vitallium or rustless steel.
3. compound porous structure bone repair according to claim 1 and 2 is characterized in that: the hole of said porous metals support is of a size of 300-1500 μ m, and porosity is 60%-85%.
4. compound porous structure bone repair according to claim 1 is characterized in that: the profile of said porous metals support is a regular geometric shapes or definite according to patient's patient part.
5. compound porous structure bone repair according to claim 1 is characterized in that: said loose structure obturator is a polymer.
6. compound porous structure bone repair according to claim 1 is characterized in that: said loose structure obturator is polymer/bioceramic complex.
7. compound porous structure bone repair according to claim 6 is characterized in that: said bioceramic is hydroxyapatite, tricalcium phosphate or calcium silicates.
8. according to claim 5 or 6 described compound porous structure bone repairs, it is characterized in that: said polymer is a chitosan.
9. the method for preparing of a compound porous structure bone repair, it is characterized in that: said method for preparing comprises the steps:
The first step; Utilize the direct metal rapid shaping technique, under computer control, adopt metal material to carry out the manufacturing of direct metal rapid shaping, form the porous metals support by rapid forming equipment; This porous metals support is the 3 D stereo RF; Inside has a plurality of holes, and hole is of a size of 300-1500 μ m, and porosity is 60%-85%;
In second step, be prepared into the polymer solution that concentration is 1wt%-5wt% with the acetic acid solution of polymer and 0.2Mol/L is mixed, and carry out evacuation at normal temperatures, residual bubble in the removal solution;
The 3rd step, prepared porous metals support is put in the container suitable with its profile, again polymer solution is poured in this porous metals support, make polymer solution be full of all holes in the said porous metals support, carry out freezing then;
The 4th step, take out the bone repair that freezes, put into vacuum freezing drying oven at once and carry out lyophilization.
10. the method for preparing of compound porous structure bone repair according to claim 9; It is characterized in that: in said second step; Polymer solution is with the mixed preparation of the acetic acid solution of polymer, bioceramic and 0.2Mol/L; This bioceramic is hydroxyapatite, tricalcium phosphate or calcium silicates, and the mass ratio of said polymer and bioceramic is 1: 1,2: 1,3: 1 or 4: 1, and other technological parameters in this second step are constant.
11. the method for preparing according to claim 9 or 10 described compound porous structure bone repairs is characterized in that: in said the 3rd step, said cryogenic temperature is-10 ℃ to-70 ℃, and cooling time is 12-24 hour.
12. method for preparing according to claim 9 or 10 described compound porous structure bone repairs; It is characterized in that: in said the 4th step; The vacuum of said vacuum lyophilization is 0.1-0.2mbar; The temperature of vacuum lyophilization is-40 ℃ to-90 ℃, and the time of vacuum lyophilization is 12-24 hour.
13. the method for preparing according to claim 9 or 10 described compound porous structure bone repairs is characterized in that: in said second step, described polymer is a chitosan.
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