CN1586416A - Absorptive composite bone fracture plate suitable for oral bone fracture fixing and preparing method - Google Patents
Absorptive composite bone fracture plate suitable for oral bone fracture fixing and preparing method Download PDFInfo
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- CN1586416A CN1586416A CN 200410060800 CN200410060800A CN1586416A CN 1586416 A CN1586416 A CN 1586416A CN 200410060800 CN200410060800 CN 200410060800 CN 200410060800 A CN200410060800 A CN 200410060800A CN 1586416 A CN1586416 A CN 1586416A
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Abstract
The absorptive composite bone fracture setting plate suitable for oral bone fracture fixation features that it is made with D, L-lactic acid polymer and hydroxyapatite. The D, L-lactic acid polymer has molecular weight of 50-150 KD and accounts for 70-95 wt%; and the hydroxyapatite has granularity of 5-70 micron and accounts for 5-30 wt%. The absorptive composite bone fracture setting plate has simple preparation process, and is suitable for bone fracture setting and fixing of occlusal surface fracture and oclusal tissue function altering.
Description
Technical field
What the present invention relates to a kind of suitable oral cavity fracture fixation absorbs compound blade plate and preparation method, belongs to oral surgery embedded type bio-medical material preparing technical field in the medical apparatus and instruments.
Background technology
In oral surgery is clinical, cause the reasons such as fracture, jaw facial tissue changing function of human body jaw face, must implement the prosthetic patient of internal fixation and rise year by year because of wound or disease.At present, domestic synthetism location and fixing miniature steel plate or the titanium plate of adopting that is applied to clinical oromaxillo-facial region fracture more, though such material has high mechanical strength and excellent biological compatibility, but the stress that blocks that hinders formation, the fixing head of initial stage callus easily easily causes the secondary fracture, after union of fracture, also need carry out simultaneously second operation and take out miniature steel plate or titanium plate, bring secondary misery and financial burden to the patient like this; Though promoted the application of the internal fixation plate (as polylactic acid, poly-acetic acid and high-molecular copolymer etc.) that can absorb macromolecular material abroad, but because in the macromolecular material degradation process in vivo, progressively be degraded into the small molecular acidity chemical compound, cause the local inflammation that easily produces aseptic of implanting fixing head, therefore, develop a kind of novel suitable oral cavity fracture fixation to absorb compound blade plate extremely urgent.
Summary of the invention
The objective of the invention is to be that oral and maxillofacial surgery fracture or jaw facial tissue changing function carry out the needs of synthetism location and fixing operation treatment, what a kind of suitable oral cavity fracture fixation was provided absorbs compound blade plate and preparation method.
For realizing purpose of the present invention, technical scheme of the present invention is: be fit to the compound blade plate that absorbs of oral cavity fracture fixation, it is characterized in that: it is by poly-D, L lactic acid and hydroxyapatite are formed, poly-D, the molecular weight of L lactic acid is 5～150,000, its weight accounts for 70～95% of composite gross weight; The granularity of hydroxyapatite is 5～70 microns, and weight is 5～30% of composite gross weight.The optimal granularity of hydroxyapatite is 5～30 microns, and optimum weight is 10%.
The preparation method that absorbs compound blade plate that is fit to the oral cavity fracture fixation is: choose molecular weight and be 5～150,000 poly-D, and L lactic acid, its weight accounts for 70～95%, 5～70 microns hydroxyapatite 5～30% of composite gross weight; To gather D, L lactic acid and hydroxyapatite, obtain the homodisperse composite of hydroxyapatite by liquid phase adsorption method, composite passes through thermoplastification then, the temperature of thermoplastification is 50～160 ℃, adopts hot compression molding, punching press shear forming or injection moulding method to make the compound blade plate of absorbing of different contour structures again; 1), hot compression molding: the composite behind the thermoplastification added to carry out hot moulding in the mould, the heating-up temperature scope is 60～160 ℃, optimum temperature range is 100～130 ℃, pressure is 0.10～20MPa, optimal pressure range is 6～10MPa, makes the difform compound blade plate that absorbs through hot moulding; 2), punching press shear forming: the method with hot moulding is processed into flat board with composite earlier, hot pressing temperature is 60～160 ℃, optimum temperature range is 100～130 ℃, pressure is 0.10～20MPa, optimal pressure range is 6～10MPa, and punching press cuts into the compound blade plate of absorbing of various complicated shapes under room temperature state then; 3), injection mo(u)lding: composite is by injection moulding machine, is to inject difform mould under 100～150 ℃ of conditions to make and can absorb compound blade plate in temperature.
Beneficial effect of the present invention: under the requirement of satisfying the bone internal fixation, the present invention selects poly-D, and the molecular weight of L lactic acid is 5～150,000, has to be easy to degraded under the intensity that satisfies fixing requirement, and can carry out plastotype as required in the clinical practice.Can absorb compound blade plate material in degradation process, existence because of hydroxyl, make its catabolite show alkalescence, in composite degradation, play neutralization (this effect is better than tricalcium phosphate), and because of the difference of its content, the degradation speed of scalable composite and local acid-base value reduce the aseptic inflammation that composite causes in degradation process, alleviate patient's misery.
1, of the present inventionly absorb compound blade plate material and have excellent biological compatibility, degradable implants.The compound blade plate that absorbs that provides is provided with this composite, have higher mechanical strength can satisfy the fracture healing, be easy to the degraded, in 60～120 ℃ of temperature ranges, be easy to features such as moulding, its bending strength 70～120MPa, satisfy the needs that maxillofacial fracture or jaw facial tissue changing function carry out synthetism location and fixing operation, have excellent curative.
2, the present invention adopts hydroxyapatite as reinforcing material, to improve the mechanical strength that can absorb compound blade plate, satisfies clinical required synthetism location and fixed requirement.Can absorb in the compound blade plate process in preparation, can regulate the percentage composition of hydroxyapatite in the composite, make it to obtain the compound blade plate of absorbing of different performance according to clinical needs.
3, the present invention adopts two kinds of combinations of materials to form can to absorb compound blade plate material, because poly-D, it is acid that L lactic acid degradation in vivo shows, and hydroxyapatite is except that having osteoinductive, existence because of hydroxyl, make its catabolite show alkalescence, in composite degradation, play neutralization (this effect is better than tricalcium phosphate), and because of the difference of its content, the degradation speed of scalable composite and local acid-base value, reduce the aseptic inflammation that composite causes in degradation process, alleviate patient's misery.
4, the present invention adopts methods such as hot moulding, punching press shear forming or injection mo(u)lding to make the compound blade plate of absorbing of different contour structures, and its machine-shaping device is simple, be easy to molding, low production cost, be easy to mechanization produces in batches.
5, of the present invention absorb compound blade plate can be according to the needs of clinical practice, at warm-up time is that 5～50 minutes, temperature are under 60～120 ℃ and the certain external force effect, it is moulding to carry out bending according to clinical needs, to satisfy clinical required synthetism location and fixed needs.
The specific embodiment
The present invention is with poly-D, and L lactic acid and hydroxyapatite are as the raw material of composite, and poly-D, L lactic acid adopt the ring-opening polymerisation method to obtain poly-D, and L lactic acid, its molecular weight are 50,000～150,000; Hydroxyapatite adopts the sedimentation method to synthesize hydroxyapatite, and drying, comminution by gas stream acquisition granularity are 5～70 microns hydroxyapatite again.
Example 1:
The compound blade plate that absorbs that is fit to the oral cavity fracture fixation, it is by poly-D, and L lactic acid and hydroxyapatite are formed, poly-D, the molecular weight of L lactic acid is 50,000, its weight accounts for 70% of composite gross weight; The granularity of hydroxyapatite is 5 microns, and hydroxyapatite is 30% of a composite gross weight.
The preparation method that absorbs compound blade plate that is fit to the oral cavity fracture fixation is: at first choose raw material: molecular weight is 50,000 poly-D, and 70%, 5 micron the hydroxyapatite that L lactic acid accounts for the composite gross weight accounts for 30% of composite gross weight; To gather D, L lactic acid and hydroxyapatite make the hydroxyapatite homodisperse and are adsorbed by liquid phase adsorption method to obtain composite; Composite is after heat is mixed plasticizing, the temperature of thermoplastification is 50～160 ℃, adopt the hot compression molding method to make the compound blade plate of absorbing of different contour structures, its hot compression molding: composite is carried out heat mix plasticizing, it is 50～160 ℃ that heat is mixed plastifying temperature, add to and carry out hot moulding in the mould, the heating-up temperature scope is 60～160 ℃, optimum temperature range is 100～130 ℃, pressure is 0.10～20MPa, optimal pressure range is 6～10MPa, makes the difform internal fixation composite plate that absorbs through hot moulding.Can absorb compound blade plate, be that 5～50 minutes, temperature are that it is moulding to carry out bending according to clinical needs under 60～120 ℃ and the certain external force effect at warm-up time.
Example 2:
The compound blade plate that absorbs that is fit to the oral cavity fracture fixation, it is by poly-D, and L lactic acid and hydroxyapatite are formed, poly-D, the molecular weight of L lactic acid is 100,000, its weight accounts for 80% of composite gross weight; The granularity of hydroxyapatite is 20 microns, and hydroxyapatite is 20% of a composite gross weight.
The preparation method that absorbs compound blade plate that is fit to the oral cavity fracture fixation is: at first choose raw material: molecular weight is 100,000 poly-D, and 80%, 20 micron the hydroxyapatite that L lactic acid accounts for the composite gross weight accounts for 20% of composite gross weight; To gather D, L lactic acid and hydroxyapatite make the hydroxyapatite homodisperse and are adsorbed by liquid phase adsorption method to obtain composite; Composite is after heat is mixed plasticizing, the temperature of thermoplastification is 50～160 ℃, adopt punching press shear forming method to make the compound blade plate of absorbing of different contour structures, its punching press shear forming: the method with hot moulding is processed into flat board with composite earlier, hot pressing temperature is 60～160 ℃, and optimum temperature range is 100～130 ℃, and pressure is 0.10～20MPa, optimal pressure range is 6～10MPa, and punching press cuts into the compound blade plate of absorbing of various complicated shapes under room temperature state then.Can absorb compound blade plate, be that 5～50 minutes, temperature are that it is moulding to carry out bending according to clinical needs under 60～120 ℃ and the certain external force effect at warm-up time.
Example 3:
The compound blade plate that absorbs that is fit to the oral cavity fracture fixation, it is by poly-D, and L lactic acid and hydroxyapatite are formed, poly-D, the molecular weight of L lactic acid is 120,000, its weight accounts for 90% of composite gross weight; The granularity of hydroxyapatite is 30 microns, and hydroxyapatite is 10% of a composite gross weight.
The preparation method that absorbs compound blade plate that is fit to the oral cavity fracture fixation is: at first choose raw material: molecular weight is 120,000 poly-D, and 90%, 30 micron the hydroxyapatite that L lactic acid accounts for the composite gross weight accounts for 10% of composite gross weight; To gather D, L lactic acid and hydroxyapatite make the hydroxyapatite homodisperse and are adsorbed by liquid phase adsorption method to obtain composite; Composite is after heat is mixed plasticizing, adopt injection molding forming method to make the compound blade plate of absorbing of different contour structures, its injection mo(u)lding: composite is by injection moulding machine, is to inject difform mould under 100～150 ℃ of conditions to make and can absorb compound blade plate in temperature.
Can absorb compound blade plate, be that 5～50 minutes, temperature are that it is moulding to carry out bending according to clinical needs under 60～120 ℃ and the certain external force effect at warm-up time.
Example 4:
The compound blade plate that absorbs that is fit to the oral cavity fracture fixation, it is by poly-D, and L lactic acid and hydroxyapatite are formed, poly-D, the molecular weight of L lactic acid is 150,000, its weight accounts for 95% of composite gross weight; The granularity of hydroxyapatite is 70 microns, and hydroxyapatite is 5% of a composite gross weight.
The preparation method that absorbs compound blade plate that is fit to the oral cavity fracture fixation is: at first choose raw material: molecular weight is 150,000 poly-D, and 95%, 70 micron the hydroxyapatite that L lactic acid accounts for the composite gross weight accounts for 5% of composite gross weight; To gather D, L lactic acid and hydroxyapatite make the hydroxyapatite homodisperse and are adsorbed by liquid phase adsorption method to obtain composite; Composite is after heat is mixed plasticizing, adopt the hot compression molding method to make the compound blade plate of absorbing of different contour structures, its hot compression molding: composite is carried out heat mix plasticizing, it is 50～160 ℃ that heat is mixed plastifying temperature, adds to and carries out hot moulding in the mould, and the heating-up temperature scope is 60～160 ℃, optimum temperature range is 100～130 ℃, pressure is 0.10～20MPa, and optimal pressure range is 6～10MPa, makes the difform internal fixation composite plate that absorbs through hot moulding.Can absorb compound blade plate, be that 5～50 minutes, temperature are that it is moulding to carry out bending according to clinical needs under 60～120 ℃ and the certain external force effect at warm-up time.
Claims (5)
1. be fit to the compound blade plate that absorbs of oral cavity fracture fixation, it is characterized in that: it is by poly-D, and L lactic acid and hydroxyapatite are formed, poly-D, and the molecular weight of L lactic acid is 5～150,000, its weight accounts for 70～95% of composite gross weight; The granularity of hydroxyapatite is 5～70 microns, and its weight is 5～30% of composite gross weight.
2. suitable oral cavity according to claim 1 fracture fixation absorb compound blade plate, it is characterized in that: poly-D, the molecular weight of L lactic acid is 5～150,000, its weight accounts for 90% of composite gross weight; The granularity of hydroxyapatite is 5～30 microns, and its weight is 10% of composite gross weight.
3. be fit to the preparation method that absorbs compound blade plate of oral cavity fracture fixation, it is characterized in that: choose molecular weight and be 5～150,000 poly-D, L lactic acid, its weight accounts for 70～95%, 5～70 microns hydroxyapatite 5～30% of composite gross weight; To gather D, L lactic acid and hydroxyapatite, obtain the homodisperse composite of hydroxyapatite by liquid phase adsorption method, composite passes through thermoplastification then, the temperature of thermoplastification is 50～160 ℃, adopts hot compression molding, punching press shear forming or injection moulding method to make the compound blade plate of absorbing of different contour structures again; 1), hot compression molding: the composite behind the thermoplastification added to carry out hot moulding in the mould, the heating-up temperature scope is 60～160 ℃, and pressure is 0.10～20MPa, makes the difform compound blade plate that absorbs through hot moulding; 2), punching press shear forming: the method with hot moulding is processed into flat board with composite earlier, and hot pressing temperature is 60～160 ℃, and pressure is 0.10～20MPa, and punching press cuts into the compound blade plate of absorbing of various complicated shapes under room temperature state then; 3), injection mo(u)lding: composite is by injection moulding machine, is to inject difform mould under 100～150 ℃ of conditions to make and can absorb compound blade plate in temperature.
4. the preparation method that absorbs compound blade plate of suitable oral cavity according to claim 3 fracture fixation is characterized in that: in the hot compression molding, carry out hot moulding in the mould, optimum temperature range is 100～130 ℃, and optimal pressure range is 6～10Mpa.
5. the preparation method that absorbs compound blade plate of suitable oral cavity according to claim 3 fracture fixation is characterized in that: in the punching press shear forming, the hot pressing optimum temperature range is 100～130 ℃, and the hot pressing optimal pressure range is 6～10Mpa.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410060800 CN1586416A (en) | 2004-09-06 | 2004-09-06 | Absorptive composite bone fracture plate suitable for oral bone fracture fixing and preparing method |
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| CN 200410060800 CN1586416A (en) | 2004-09-06 | 2004-09-06 | Absorptive composite bone fracture plate suitable for oral bone fracture fixing and preparing method |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008021921A3 (en) * | 2006-08-17 | 2008-05-22 | Warsaw Orthopedic Inc | Medical implant sheets useful for tissue regeneration |
| CN102266593A (en) * | 2011-07-27 | 2011-12-07 | 长春圣博玛生物材料有限公司 | Absorbable internal fracture fixing piece |
| CN102355863A (en) * | 2009-01-16 | 2012-02-15 | 卡波菲克斯整形有限公司 | Composite material bone implant |
| US8545866B2 (en) | 2004-10-29 | 2013-10-01 | Smith & Nephew, Inc. | Bioabsorbable polymers |
| CN104546103A (en) * | 2015-01-20 | 2015-04-29 | 深圳市博立生物材料有限公司 | Absorbable intraosseous fixing device with biological activity and plasticity and forming method |
| US9101427B2 (en) | 2010-06-07 | 2015-08-11 | Carbofix Orthopedics Ltd. | Self tapping insert |
| US9526549B2 (en) | 2012-01-16 | 2016-12-27 | Carbofix Orthopedics Ltd. | Bone screw with insert |
| CN106691567A (en) * | 2016-12-19 | 2017-05-24 | 苏州西脉新诚生物科技有限公司 | High-strength and absorbable internal fixation bone plate for fracture |
| CN106823018A (en) * | 2016-12-19 | 2017-06-13 | 兰州西脉记忆合金股份有限公司 | High-intensity absorbable bone fracture internal fixation material |
| CN108339161A (en) * | 2018-03-13 | 2018-07-31 | 武汉理工大学 | A kind of personalization Degradable bone fracture plate and preparation method thereof |
| US10154867B2 (en) | 2010-06-07 | 2018-12-18 | Carbofix In Orthopedics Llc | Multi-layer composite material bone screw |
| US10617458B2 (en) | 2015-12-23 | 2020-04-14 | Carbofix In Orthopedics Llc | Multi-layer composite material bone screw |
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2004
- 2004-09-06 CN CN 200410060800 patent/CN1586416A/en active Pending
Cited By (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9387274B2 (en) | 2004-10-29 | 2016-07-12 | Smith & Nephew, Inc. | Bioabsorbable polymers |
| US9173981B2 (en) | 2004-10-29 | 2015-11-03 | Smith & Nephew, Inc. | Bioabsorbable polymers |
| US8545866B2 (en) | 2004-10-29 | 2013-10-01 | Smith & Nephew, Inc. | Bioabsorbable polymers |
| WO2008021921A3 (en) * | 2006-08-17 | 2008-05-22 | Warsaw Orthopedic Inc | Medical implant sheets useful for tissue regeneration |
| US8524265B2 (en) | 2006-08-17 | 2013-09-03 | Warsaw Orthopedic, Inc. | Medical implant sheets useful for tissue regeneration |
| US8709055B2 (en) | 2009-01-16 | 2014-04-29 | Carbofix Orthopedics Ltd. | Composite material bone implant |
| CN102355863A (en) * | 2009-01-16 | 2012-02-15 | 卡波菲克斯整形有限公司 | Composite material bone implant |
| US10028777B2 (en) | 2009-01-16 | 2018-07-24 | Carbofix Orthopedics Ltd. | Composite material bone implant |
| CN102355863B (en) * | 2009-01-16 | 2014-09-17 | 卡波菲克斯整形有限公司 | Composite material bone implant |
| US9101417B2 (en) | 2009-01-16 | 2015-08-11 | Carbofix Orthopedics Ltd. | Composite material bone implant |
| US10849668B2 (en) | 2010-06-07 | 2020-12-01 | Carbofix Orthopedics Ltd. | Composite material bone implant |
| US9370388B2 (en) | 2010-06-07 | 2016-06-21 | Carbofix Orthopedics Ltd. | Composite material bone implant |
| US9101427B2 (en) | 2010-06-07 | 2015-08-11 | Carbofix Orthopedics Ltd. | Self tapping insert |
| US10154867B2 (en) | 2010-06-07 | 2018-12-18 | Carbofix In Orthopedics Llc | Multi-layer composite material bone screw |
| US9974586B2 (en) | 2010-06-07 | 2018-05-22 | Carbofix Orthopedics Ltd. | Composite material bone implant |
| CN102266593A (en) * | 2011-07-27 | 2011-12-07 | 长春圣博玛生物材料有限公司 | Absorbable internal fracture fixing piece |
| US9526549B2 (en) | 2012-01-16 | 2016-12-27 | Carbofix Orthopedics Ltd. | Bone screw with insert |
| CN104546103A (en) * | 2015-01-20 | 2015-04-29 | 深圳市博立生物材料有限公司 | Absorbable intraosseous fixing device with biological activity and plasticity and forming method |
| US10617458B2 (en) | 2015-12-23 | 2020-04-14 | Carbofix In Orthopedics Llc | Multi-layer composite material bone screw |
| CN106691567A (en) * | 2016-12-19 | 2017-05-24 | 苏州西脉新诚生物科技有限公司 | High-strength and absorbable internal fixation bone plate for fracture |
| CN106823018A (en) * | 2016-12-19 | 2017-06-13 | 兰州西脉记忆合金股份有限公司 | High-intensity absorbable bone fracture internal fixation material |
| CN108339161A (en) * | 2018-03-13 | 2018-07-31 | 武汉理工大学 | A kind of personalization Degradable bone fracture plate and preparation method thereof |
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