CN103271760A - High-intensity multi-degradation-resistant-protection degradable internal fracture fixation materials and preparation method thereof - Google Patents
High-intensity multi-degradation-resistant-protection degradable internal fracture fixation materials and preparation method thereof Download PDFInfo
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- CN103271760A CN103271760A CN2013101987976A CN201310198797A CN103271760A CN 103271760 A CN103271760 A CN 103271760A CN 2013101987976 A CN2013101987976 A CN 2013101987976A CN 201310198797 A CN201310198797 A CN 201310198797A CN 103271760 A CN103271760 A CN 103271760A
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Abstract
The invention provides high-intensity multi-degradation-resistant-protection degradable internal fracture fixation materials and a preparation method of the materials. The internal fracture fixation materials are formed by a degradable braided rope structure and a surface-layer multi-hole structure. The preparation method of the high-intensity multi-degradation-resistant-protection degradable internal fracture fixation materials includes the steps of preparing the braided rope structure through degradable fibers with degradation-resistant protective layers on the surfaces, and then coating the surface of the braided rope structure by degradation-resistant materials to form a multi-hole surface layer. According to the high-intensity multi-degradation-resistant-protection degradable internal fracture fixation materials, the biocompatible degradable materials are completely used, the special inner supporting braided rope structure and multi-degradation-resistant protections on the surface enable a support to have high mechanical intensity and slow intensity losses and also have good biocompatibility and excellent bone conduction performance, and the problems that the internal fracture fixation materials in a use process are not high in intensity, rapid in intensity loss, poor in bone conduction performance and the like are solved.
Description
Technical field
The present invention relates to a kind of body bone tissue internal fixation material, relate in particular to degradable bone fracture internal fixation material of a kind of high strength, the protection of multiple degradation resistant and preparation method thereof.
Background technology
Fracture is a kind of common case clinically, occupies very high ratio in the traumatology department.Its concrete treatment measure have reset, fix, 4 of rehabilitation training and medicine auxiliary treatment.Wherein fixing means is the method that treatment fracture at present, bone injury are extensively taked, and treatment of fractures has also been obtained curative effect preferably.Internal fixation device is treatment fracture, the indispensable medical apparatus and instruments of bone wound.Good fracture inside-fixture should possess following condition: (1) has the good mechanical performance, as higher draw tensile strength, compressive strength, shear strength and preferably fatigue durability, with the near elastic modelling quantity of bone photo etc.; (2) material non-toxic, no heat source response, not carcinogenic, not teratogenesis, do not cause allergic reaction or disturb the immunologic mechanism of human body, but leachable and exudate are low, can not cause the secondary injury; (3) good biological stability guarantees in the healing stage of osseous tissue stable performance guaranteeing good healing, and can impel fracture to heal early.
Adopt the stainless steel metal material as bone fracture internal fixation material for a long time both at home and abroad, this material has obvious defects, mainly shows: (1) elastic modelling quantity is excessive always, stress force shelter reaction is obvious, cause osteoporosis, the osseous tissue indolence causes the secondary fracture easily; (2) biocompatibility is poor, can cause inflammatory reaction; (3) need second operation to take out after the recovery from illness, strengthened patient's misery.
Degradable macromolecule and composite thereof are a big focus of studying both at home and abroad as bone fracture internal fixation material.Along with the prolongation of the time of implantation, material is constantly degraded, and its intensity constantly reduces, and stress is transferred on the skeleton gradually, and then reduces significantly or eliminate stress fully occlusion effect and corresponding osteoporosis; And do not need second operation to take out.The intrinsic product of their catabolite and human body is consistent, finally discharges from respiratory tract and the urethra of human body.But the mechanical property of this class internal fixation material does not reach strong fixing requirement yet, still can not play the effect of pressurization, can not satisfy the fixing requirement of cortical bone fully.In order to improve the mechanical strength of degradability bone fracture internal fixation material, the fiber reinforcement technology is applied on the bone fracture internal fixation material, and has developed a kind of " self-reinforcing " method, namely strengthens with polymer fiber self." yet self-reinforcing " method can only be from single direction reinforcing material intensity, and simultaneously, uncontrollable degraded causes strength loss very fast, and does not have bone conductibility.
Summary of the invention
Not high, the uncontrollable degraded of intensity that the present invention is directed to the existence of degradable bone fracture internal fixation material causes loss of strength problem faster, and the degradable bone fracture internal fixation material of a kind of intensity height, the protection of multiple degradation resistant is provided.
A further object of the present invention provides the preparation method of the degradable bone fracture internal fixation material of a kind of intensity height, the protection of multiple degradation resistant.
The degradable bone fracture internal fixation material of high strength of the present invention, multiple degradation resistant protection is that the composite bed by kernmantle structure and porous surface constitutes; wherein the kernmantle structure is that fibrage with degradation material forms; the surface of every fiber all applies the degradation resistant material; behind several fibrous fibre bundles again at fibre bundle surface-coated one deck degradation resistant material; at last this fibre bundle braiding is formed the kernmantle structure; and at kernmantle surface-coated one deck degradation resistant material, form porous vesicular surface.The kernmantle structure of multiple degradation resistant material protection guarantees that prepared internal fixation material has excellent intensity, and it is little that fracture is recovered the loss of strength in early stage; The composite bed of porous surface provides the growing environment of osteocyte, has bone conductibility.
The preparation method of the degradable bone fracture internal fixation material of high strength of the present invention, the protection of multiple degradation resistant specifically comprises the steps:
(1) the degradation resistant materials A is dissolved in is mixed with certain density casting solution B in the appropriate solvent;
(2) at surface-coated one deck casting solution B of the biodegradable fiber material C of certain fiber number, dry solidification;
Described fibre number is 50～700dtex;
(3) fiber that step (2) is obtained is twisted with the fingers a burst back through 1～5 time and is formed fibre bundle D, then at fibre bundle D surface-coated one deck casting solution B, dry solidification;
(4) the fibre bundle D that step (3) is obtained pulls out by the guide wheel of high-speed knitter from bobbin with the speed of 1～10m/min and guides the braiding point into, and braiding obtains kernmantle;
(5) degradation resistant materials A and organic pore former are dissolved in are mixed with certain density casting solution E in the appropriate solvent;
(6) casting solution E is coated in the hollow kernmantle surface that step (4) obtains, places the water coagulation forming then, obtain bone fracture internal fixation material.
Described degradation resistant materials A refers to for fibrous material, the slower material of degrading, specifically refer to the copolymer of the different D-lactic acid of proportion of composing (LLA) and glycolic (GA), wherein D-lactic acid (LLA) is 85～99: 1～15 with the mass ratio of glycolic (GA) in copolymer;
Solvent is oxolane among described casting solution B and the E, acetone or ethyl acetate;
The concentration of described casting solution B is 10～50%;
Described biodegradable fiber material C is the copolymer of D-lactic acid (LLA) and glycolic (GA), and wherein D-lactic acid (LLA) is 60～80: 20～40 with the mass ratio of glycolic (GA) in copolymer;
Described organic pore former is Polyethylene Glycol, and molecular weight is 200～20000;
The mass ratio of described degradation resistant material and organic pore former is 20～40: 2～8;
The concentration of described casting solution E is 10～50%.
Beneficial effect of the present invention:
(1) bone fracture internal fixation material of the present invention as supporting construction, has very high initial strength with kernmantle;
(2) bone fracture internal fixation material of the present invention has multiple degradation resistant protective layer, and loss of strength is slow;
(3) bone fracture internal fixation material of the present invention top layer has loose structure, and the growing environment of osteocyte is provided, and has bone conductibility;
(4) support of the present invention all adopts biocompatible degradation material, to blood vessel and body tissue not damaged, has eliminated antigenicity and immunity, does not need to carry out anticoagulant after the use.
Specific embodiment
Embodiment 1
(1) will gather (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 85: 15) and be dissolved in that to be made into mass concentration in the ethyl acetate be 30% film liquid, being coated in fiber number then is the fiber surface of poly-(lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 60: 40 in the copolymer) of 200dtex, and dry solidification;
(2) fiber is twisted with the fingers a burst back through 2 times and is formed fibre bundle, then at fibre bundle surface-coated one strata (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 85: 15 in the copolymer) (the film liquid of preparation in the step 1), and dry solidification;
(3) fibre bundle is pulled out by the guide wheel of high-speed knitter from bobbin with the speed of 1m/min guide the braiding point into, braiding obtains kernmantle;
(4) will gather (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 85: 15 in the copolymer) and Polyethylene Glycol (molecular weight is 500) and be dissolved in that to be mixed with mass concentration in the ethyl acetate be 10% casting solution, wherein, poly-(lactic acid-ethanol) is 20: 2 with the mass ratio of Polyethylene Glycol;
(5) casting solution that step (4) is made is coated in the kernmantle surface that step (3) obtains, and places the water coagulation forming then, obtains bone fracture internal fixation material.
The performance test results sees Table 1, and hydrolyzation sample is that the sample that will prepare places 20 weeks of phosphate buffer, takes out dry back test mechanical property.
Embodiment 2
(1) will gather (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 99: 1) and be dissolved in that to be made into mass concentration in the ethyl acetate be 20% film liquid, being coated in fiber number then is the fiber surface of poly-(lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 80: 20 in the copolymer) of 300dtex, and dry solidification;
(2) fiber is twisted with the fingers a burst back through 2 times and is formed fibre bundle, then at fibre bundle surface-coated one strata (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 99: 1 in the copolymer) (the film liquid of preparation in the step 1), and dry solidification;
(3) fibre bundle is pulled out by the guide wheel of high-speed knitter from bobbin with the speed of 10m/min guide the braiding point into, braiding obtains kernmantle;
(4) will gather (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 99: 1 in the copolymer) and Polyethylene Glycol (molecular weight is 800) and be dissolved in that to be mixed with mass concentration in the ethyl acetate be 50% casting solution, wherein, poly-(lactic acid-ethanol) is 40: 8 with the mass ratio of Polyethylene Glycol;
(5) casting solution that step (4) is made is coated in the kernmantle surface that step (3) obtains, and places the water coagulation forming then, obtains bone fracture internal fixation material.
The performance test results sees Table 1, and hydrolyzation sample is that the sample that will prepare places 20 weeks of phosphate buffer, takes out dry back test mechanical property.
Embodiment 3
(1) will gather (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 90: 10) and be dissolved in that to be made into mass concentration in the ethyl acetate be 50% film liquid, being coated in fiber number then is the fiber surface of poly-(lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 70: 30 in the copolymer) of 300dtex, and dry solidification;
(2) fiber is twisted with the fingers a burst back through 2 times and form fibre bundle, then at fibre bundle surface-coated one strata (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 90: 10 in the copolymer) (the film liquid of preparation in the step 1), and dry solidification;
(3) fibre bundle is pulled out by the guide wheel of high-speed knitter from bobbin with the speed of 5m/min guide the braiding point into, braiding obtains kernmantle;
(4) will gather (lactic acid-ethanol) (mass ratio of lactic acid and glycolic is 90: 10 in the copolymer) and Polyethylene Glycol (molecular weight is 2000) and be dissolved in that to be mixed with mass concentration in the ethyl acetate be 20% casting solution, wherein, poly-(lactic acid-ethanol) is 30: 5 with the mass ratio of Polyethylene Glycol;
(5) casting solution that step (4) is made is coated in the kernmantle surface that step (3) obtains, and places the water coagulation forming then, obtains bone fracture internal fixation material.
The performance test results sees Table 1, hydrolyzation sample be will preparation sample as for 20 weeks in the phosphate buffer, take out dry back test mechanical property.
Table 1 sample mechanical property
| ? | Hydrolysis front curve intensity/MPa | Hydrolysis 20 all bending strength/MPa |
| Embodiment 1 | 245 | 146 |
| Embodiment 2 | 350 | 215 |
| Embodiment 3 | 286 | 187 |
Claims (9)
1. the degradable bone fracture internal fixation material of a high strength, the protection of multiple degradation resistant, it is characterized in that this internal fixation material is made of the composite bed of kernmantle structure and porous surface, wherein the kernmantle structure is to form with the biodegradable fiber braiding, the surface of every fiber all applies the degradation resistant material, behind several fibrous fibre bundles again at fibre bundle surface-coated one deck degradation resistant material, at last this fibre bundle braiding is formed the kernmantle structure, and at kernmantle surface-coated one deck degradation resistant material, form porous vesicular surface; It is little that the kernmantle structure of multiple degradation resistant material protection guarantees that prepared internal fixation material has excellent intensity, fracture is recovered the loss of strength in early stage; The composite bed of porous surface provides the growing environment of osteocyte, has bone conductibility.
2. the degradable bone fracture internal fixation material of a kind of high strength according to claim 1, the protection of multiple degradation resistant is characterized in that the employed biodegradable fiber of described kernmantle is the copolymer of D-lactic acid (LLA) and glycolic (GA).
3. the preparation method of the degradable bone fracture internal fixation material of a high strength, the protection of multiple degradation resistant is characterized in that described preparation method comprises the steps:
(1) the degradation resistant materials A is dissolved in is mixed with certain density casting solution B in the appropriate solvent;
(2) at surface-coated one deck casting solution B of the biodegradable fiber material C of certain fiber number, dry solidification;
Described fibre number is 50～700dtex;
(3) fiber that step (2) is obtained is twisted with the fingers a burst back through 1～5 time and is formed fibre bundle D, then at fibre bundle D surface-coated one deck casting solution B, dry solidification;
(4) the fibre bundle D that step (3) is obtained pulls out by the guide wheel of high-speed knitter from bobbin with the speed of 1～10m/min and guides the braiding point into, and braiding obtains kernmantle;
(5) degradation resistant materials A and organic pore former are dissolved in are mixed with certain density casting solution E in the appropriate solvent;
(6) casting solution E is coated in the hollow kernmantle surface that step (4) obtains, places the water coagulation forming then, obtain bone fracture internal fixation material.
4. the preparation method of the degradable bone fracture internal fixation material of a kind of high strength according to claim 3, multiple degradation resistant protection; it is characterized in that described degradation resistant materials A refers to respect to the slower material of employed fibrous material degraded; specifically refer to the copolymer of the different D-lactic acid of proportion of composing (LLA) and glycolic (GA), wherein D-lactic acid (LLA) is 85～99: 1～15 with the mass ratio of glycolic (GA) in copolymer.
5. the preparation method of the degradable bone fracture internal fixation material of a kind of high strength according to claim 3, multiple degradation resistant protection; it is characterized in that described biodegradable fiber material C is the copolymer of D-lactic acid (LLA) and glycolic (GA), wherein D-lactic acid (LLA) is 60～80: 20～40 with the mass ratio of glycolic (GA) in copolymer.
6. the preparation method of the degradable bone fracture internal fixation material of a kind of high strength according to claim 3, the protection of multiple degradation resistant is characterized in that solvent is oxolane, acetone or ethyl acetate among described casting solution B and the E.
7. the preparation method of the degradable bone fracture internal fixation material of a kind of high strength according to claim 3, the protection of multiple degradation resistant is characterized in that organic pore former is Polyethylene Glycol among the described casting solution E, and molecular weight is 200～20000.
8. the preparation method of the degradable bone fracture internal fixation material of a kind of high strength according to claim 3, multiple degradation resistant protection is characterized in that the mass ratio of degradation resistant material and organic pore former is 20～40: 2～8 among the described casting solution E.
9. the preparation method of the degradable bone fracture internal fixation material of a kind of high strength according to claim 3, the protection of multiple degradation resistant is characterized in that described casting solution (B and E) mass concentration is 10～50%.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106794280A (en) * | 2014-10-14 | 2017-05-31 | 安东尼奥·桑布瑟蒂 | For the absorbable device of osteanagenesis |
| CN110903082A (en) * | 2019-11-26 | 2020-03-24 | 杭州电子科技大学 | Gradient composite bar and manufacturing method thereof |
| CN111803713A (en) * | 2020-05-29 | 2020-10-23 | 广州新诚生物科技有限公司 | Woven film, woven bag and weaving method |
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| US4512038A (en) * | 1979-04-27 | 1985-04-23 | University Of Medicine And Dentistry Of New Jersey | Bio-absorbable composite tissue scaffold |
| EP0146398A2 (en) * | 1983-12-19 | 1985-06-26 | Southern Research Institute | Method of producing biodegradable prothesis and products therefrom |
| FR2573979B1 (en) * | 1984-12-04 | 1987-01-02 | Ceraver | LIGAMENT OR PROSTHETIC TENDON BASED ON CARBON FIBERS |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106794280A (en) * | 2014-10-14 | 2017-05-31 | 安东尼奥·桑布瑟蒂 | For the absorbable device of osteanagenesis |
| CN110903082A (en) * | 2019-11-26 | 2020-03-24 | 杭州电子科技大学 | Gradient composite bar and manufacturing method thereof |
| CN110903082B (en) * | 2019-11-26 | 2022-05-20 | 杭州电子科技大学 | Gradient composite bar and manufacturing method thereof |
| CN111803713A (en) * | 2020-05-29 | 2020-10-23 | 广州新诚生物科技有限公司 | Woven film, woven bag and weaving method |
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