CN106310388A - Developable high-strength high-tenacity biodegradable bone nail and preparation method thereof - Google Patents

Developable high-strength high-tenacity biodegradable bone nail and preparation method thereof Download PDF

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Publication number
CN106310388A
CN106310388A CN201611008325.XA CN201611008325A CN106310388A CN 106310388 A CN106310388 A CN 106310388A CN 201611008325 A CN201611008325 A CN 201611008325A CN 106310388 A CN106310388 A CN 106310388A
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CN
China
Prior art keywords
nail
tenacity
biodegradation
bone nail
preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201611008325.XA
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Chinese (zh)
Inventor
何创龙
禹宝庆
王伟忠
俞斌
苗莹珂
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHANGHAI PUDONG HOSPITAL
Donghua University
National Dong Hwa University
Original Assignee
SHANGHAI PUDONG HOSPITAL
Donghua University
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Application filed by SHANGHAI PUDONG HOSPITAL, Donghua University filed Critical SHANGHAI PUDONG HOSPITAL
Priority to CN201611008325.XA priority Critical patent/CN106310388A/en
Publication of CN106310388A publication Critical patent/CN106310388A/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/028—Other inorganic materials not covered by A61L31/022 - A61L31/026
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18—Materials at least partially X-ray or laser opaque

Abstract

The invention relates to a developable high-strength high-tenacity biodegradable bone nail and a preparation method thereof. The bone nail comprises polycaprolactone PCL, nano-hydroxyapatite and a developing agent. The preparation method comprises the following steps of: dissolving PCL into an organic solvent, stirring at room temperature to obtain a uniform polymer solution, then adding nano-hydroxyapatite and the developing agent, and performing ultrasonic dispersion to obtain a mixed solution; completely volatilizing the solvent of the mixed solution to obtain a mixed material; and melting and extruding the mixed material into a bone nail die, cooling to obtain the d developable high-strength high-tenacity biodegradable bone nail. The prepared degradable bone nail not only has high strength, but also has high tenacity, can bear higher pressure and is difficult to break; the bone nail can conduct X-ray radiography, so as to observe the biodegradation situation of the bone nail after being transplanted into a human body, facilitate a physician to combine and analyze the bone fracture healing situation of a patient and the degradation situation of the bone nail and give best recovery guidance.

Description

A kind of high-intensity high-tenacity biodegradation nail developed and preparation method thereof
Technical field
The invention belongs to medical instruments field, particularly to a kind of high-intensity high-tenacity biodegradation nail developed and Its preparation method.
Background technology
Nail is the Fracture internal fixaiion apparatus medically commonly used.Prepared by traditional use metal material or ceramic material Nail has the advantage of high-intensity high-tenacity, the fracture fixation reparation being widely used in clinical practice, but this nail is not Can be needed to carry out second operation after patients with fractures fully recovers and be drawn off by body degraded and absorbed, secondary injury can be caused to patient, And the cavity that nail stays after taking out also leaves potential risk of bone fracture to patient.At present, domestic market can drop Solve nail product, the absorbable fracture internal fixation screw (product produced such as Chengdu Dikang Zhongke Biomedical Materials Co., Ltd Standard No.: YZB/ state 5373-2011), this nail is made up of polylactic acid (PDLLA), has preferable biocompatibility, high intensity With good biodegradability.But this product is only applicable to the fracture of non-weight bearing area, osteotomy and arthrodesis, because Poly-lactic acid material toughness is poor, is easily broken off.And, the degradable high polymer majority of composition degradable bone peg is radioparency , invisible under the bad even X-ray of developing performance under X-ray, therefore, it is difficult to be difficult to be sentenced by X-ray during check after surgery The degraded situation of knochenbruch nail, is unfavorable for patient makes optimal rehabilitation instruction.
Polycaprolactone (PCL) be U.S. food Drug Administration (FDA) approval can be used for clinic biodegradation gather One of compound, has good biocompatibility and splendid elasticity, toughness properties, and its fusing point is only 60 DEG C, processes bar Part is gentle, has certain application prospect at degradable biological medical instruments field.
Summary of the invention
The technical problem to be solved be to provide a kind of high-intensity high-tenacity biodegradation nail developed and Its preparation method, this nail not only has high intensity, and has high toughness, can bear bigger pressure and not easy fracture； Available x-ray imaging, to observe the biodegradation situation after nail implants, it is simple to doctor binding analysis patients with fractures heals The degraded situation of situation and nail also gives optimal rehabilitation instruction.
A kind of high-intensity high-tenacity biodegradation nail developed of the present invention, described nail is by biological degradation polyalcohol Polycaprolactone (PCL), nanometer hydroxyapatite and developing agent composition；Wherein, the quality of nanometer hydroxyapatite accounts for the 10 of PCL mass ～80%, the quality of developing agent accounts for the 1～10% of PCL mass.
Described developing agent is iohexol.
A kind of preparation method of the high-intensity high-tenacity biodegradation nail developed of the present invention, including:
(1) PCL is dissolved in organic solvent, be stirred at room temperature, obtain the homogeneous polymer that concentration is 5～20%w/v Solution, is subsequently adding nanometer hydroxyapatite and developing agent, ultrasonic disperse, obtains mixed solution；Wherein, nanometer hydroxyapatite Quality account for the 10～80% of PCL mass, the quality of developing agent accounts for the 1～10% of PCL mass；
(2) the solvent volatilization by the mixed solution obtained in step (1) is clean, obtains mixing material；
(3) mixing melt material extrusion step (2) obtained in nail mould, cooling, obtain can develop high-strength Degree high tenacity biodegradation nail.
In described step (1), organic solvent is dichloromethane, chloroform, oxolane or hexafluoroisopropanol.
The time of described step (1) ultrasonic disperse is 3-5min, makes nanometer hydroxyapatite and developing agent be dispersed in In polymer solution.
In described step (2), volatilization mode is: poured into by mixed solution in evaporating device, and in fume hood, blowing processes and makes greatly After partial solvent volatilization, it is placed under outdoor ventilation environment volatilization 3-5d.
Described blowing is processed as quick blowing and processes.
In described step (3), fusion temperature is 60～70 DEG C.
In described step (3), fusing is extruded as rapid melting extrusion.
Beneficial effect
(1) degradable bone peg prepared by the present invention not only has high intensity, and has high toughness, can bear bigger Pressure and not easy fracture；
(2) degradable bone peg prepared by the present invention contains hydroxyapatite active component, improves nail the most further Intensity, and the one-tenth Bone Defect Repari at position, fixing cavity in nail can be further promoted；
(3) degradable bone peg prepared by the present invention can use x-ray imaging, to observe the biodegradation after nail implants Situation, it is simple to doctor's binding analysis patients with fractures's healing state and the degraded situation of nail also give optimal rehabilitation guidance meaning See.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of the high-intensity high-tenacity biodegradation nail that can develop in the present invention.
Fig. 2 is that (step obtains in (2) for the high-intensity high-tenacity biodegradation nail raw material that can develop in embodiment 1 Product) X-ray development picture.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is expanded on further.Should be understood that these embodiments are merely to illustrate the present invention Rather than restriction the scope of the present invention.In addition, it is to be understood that after having read the content that the present invention lectures, people in the art The present invention can be made various changes or modifications by member, and these equivalent form of values fall within the application appended claims equally and limited Scope.
Embodiment 1
(1) weighing 10g PCL and be dissolved in 100mL chloroform under room temperature stirring preparing concentration is the equal of 10% (w/v) One solution, adds in solution and accounts for the nanometer hydroxyapatite of PCL mass 40% (i.e. 4g) and account for PCL mass 5% (i.e. 0.5g) Iohexol, ultrasonic disperse 5min makes nanometer hydroxyapatite and iohexol dispersed in a polymer solution；
(2) pouring in evaporating device by the mixed solution that step (1) prepares, in fume hood, quick blowing processes and makes major part After solvent volatilization, it is placed under outdoor ventilation environment volatilization 3d, makes chloroform fully volatilize totally；
(3) the mixing material that step (2) is obtained in melt extruder at 65 DEG C rapid melting extrude to nail mould In, cool down and i.e. obtain the high-intensity high-tenacity biodegradation nail that can develop.
Embodiment 2
(1) weighing 15g PCL and be dissolved in 100mL dichloromethane under room temperature stirring preparing concentration is the equal of 15% (w/v) One solution, adds in solution and accounts for the nanometer hydroxyapatite of PCL mass 60% (i.e. 9g) and account for PCL mass 10% (i.e. 1.5g) Iohexol, ultrasonic disperse 5min makes nanometer hydroxyapatite and iohexol dispersed in a polymer solution；
(2) pouring in evaporating device by the mixed solution that step (1) prepares, in fume hood, quick blowing processes and makes major part After solvent volatilization, it is placed under outdoor ventilation environment volatilization 3d, makes dichloromethane fully volatilize totally；
(3) the mixing material that step (2) is obtained in melt extruder at 70 DEG C rapid melting extrude to nail mould In, cool down and i.e. obtain the high-intensity high-tenacity biodegradation nail that can develop.
Embodiment 3
(1) weighing 10g PCL and be dissolved in 100mL oxolane under room temperature stirring preparing concentration is the equal of 10% (w/v) One solution, adds in solution and accounts for the nanometer hydroxyapatite of PCL mass 80% (i.e. 8g) and account for PCL mass 8% (i.e. 0.8g) Iohexol, ultrasonic disperse 5min makes nanometer hydroxyapatite and iohexol dispersed in a polymer solution；
(2) pouring in evaporating device by the mixed solution that step (1) prepares, in fume hood, quick blowing processes and makes major part After solvent volatilization, it is placed under outdoor ventilation environment volatilization 3d, makes oxolane fully volatilize totally；
(3) the mixing material that step (2) is obtained in melt extruder at 65 DEG C rapid melting extrude to nail mould In, cool down and i.e. obtain the high-intensity high-tenacity biodegradation nail that can develop.

Claims (7)

1. the high-intensity high-tenacity biodegradation nail that a kind can be developed, it is characterised in that described nail by polycaprolactone (PCL), Nanometer hydroxyapatite and developing agent composition；Wherein, the quality of nanometer hydroxyapatite accounts for the 10～80% of PCL mass, development The quality of agent accounts for the 1～10% of PCL mass.
A kind of high-intensity high-tenacity biodegradation nail developed the most according to claim 1, it is characterised in that described Developing agent is iohexol.
3. a preparation method for the high-intensity high-tenacity biodegradation nail that can develop, including:
(1) PCL is dissolved in organic solvent, is stirred at room temperature, obtains the homogeneous polymer solution that concentration is 5～20%w/v, It is subsequently adding nanometer hydroxyapatite and developing agent, ultrasonic disperse, obtains mixed solution；Wherein, the matter of nanometer hydroxyapatite Amount accounts for the 10～80% of PCL mass, and the quality of developing agent accounts for the 1～10% of PCL mass；
(2) the solvent volatilization by the mixed solution obtained in step (1) is clean, obtains mixing material；
(3) mixing melt material step (2) obtained is extruded to nail mould, cooling, obtains the high intensity that can develop high Toughness biodegradation nail.
The preparation method of a kind of high-intensity high-tenacity biodegradation nail developed the most according to claim 3, it is special Levying and be, in described step (1), organic solvent is dichloromethane, chloroform, oxolane or hexafluoroisopropanol.
The preparation method of a kind of high-intensity high-tenacity biodegradation nail developed the most according to claim 3, it is special Levying and be, the time of described step (1) ultrasonic disperse is 3-5min.
The preparation method of a kind of high-intensity high-tenacity biodegradation nail developed the most according to claim 3, it is special Levying and be, in described step (2), volatilization mode is: poured into by mixed solution in evaporating device, and in fume hood, blowing processes and makes greatly After partial solvent volatilization, it is placed under outdoor ventilation environment volatilization 3-5d.
The preparation method of a kind of high-intensity high-tenacity biodegradation nail developed the most according to claim 3, it is special Levying and be, in described step (3), fusion temperature is 60～70 DEG C.
CN201611008325.XA 2016-11-16 2016-11-16 Developable high-strength high-tenacity biodegradable bone nail and preparation method thereof Pending CN106310388A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107737377A (en) * 2017-10-11 2018-02-27 深圳维度生物医疗科技有限公司 It is a kind of develop for the biodegradable Bone Defect Repari of 3D printing and reconstruction biomaterialses and preparation method thereof
CN110639067A (en) * 2019-10-16 2020-01-03 四川大学 Composite material for processing miniature bone retention nail and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101209355A (en) * 2007-12-25 2008-07-02 暨南大学 Preparation of material for bone plate, bone peg and bone block
CN102247622A (en) * 2011-06-10 2011-11-23 东华大学 Degradable fiber-enhanced polycaprolactone degradable bone nail and preparation method thereof through solution method
CN204394657U (en) * 2014-12-29 2015-06-17 上海市浦东医院 A kind of internal fixation bar of fracturing for fracture around joint and short tubular bone
CN104906640A (en) * 2015-06-15 2015-09-16 东华大学 Developable biodegradable medical strapping tape and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101209355A (en) * 2007-12-25 2008-07-02 暨南大学 Preparation of material for bone plate, bone peg and bone block
CN102247622A (en) * 2011-06-10 2011-11-23 东华大学 Degradable fiber-enhanced polycaprolactone degradable bone nail and preparation method thereof through solution method
CN204394657U (en) * 2014-12-29 2015-06-17 上海市浦东医院 A kind of internal fixation bar of fracturing for fracture around joint and short tubular bone
CN104906640A (en) * 2015-06-15 2015-09-16 东华大学 Developable biodegradable medical strapping tape and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107737377A (en) * 2017-10-11 2018-02-27 深圳维度生物医疗科技有限公司 It is a kind of develop for the biodegradable Bone Defect Repari of 3D printing and reconstruction biomaterialses and preparation method thereof
CN110639067A (en) * 2019-10-16 2020-01-03 四川大学 Composite material for processing miniature bone retention nail and preparation method thereof

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Application publication date: 20170111