CN103536346A - Manufacturing method of orthopaedic fixing device - Google Patents
Manufacturing method of orthopaedic fixing device Download PDFInfo
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- CN103536346A CN103536346A CN201310493091.2A CN201310493091A CN103536346A CN 103536346 A CN103536346 A CN 103536346A CN 201310493091 A CN201310493091 A CN 201310493091A CN 103536346 A CN103536346 A CN 103536346A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
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- Orthopedic Medicine & Surgery (AREA)
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Abstract
The invention provides a manufacturing method of an orthopaedic fixing device. The manufacturing method includes steps of a), manufacturing a mould so that the cross section of the manufactured orthopaedic fixing device contacting with the spine is an arc matched with the spine; b), forming a plurality of fixing holes in the orthopaedic fixing device and at two ends of the same and setting the fixing holes in parallel arrangement; c), placing biodegradable high-polymer materials into the mould, pressing and molding.
Description
Technical field
The present invention relates to the manufacture method of orthopedic medical device technical field, particularly a kind of Orthopedic fixation device.
Background technology
Spinal fracture or accept the patient of spinal column position operation, after operative site resets, need to fix with clamping plate, then be wound around with binder.Traditional clamping plate surface of using is clinically planar structure, has certain difference with the arcuate structure at vertebra position, the long-time situation of using easily appearance displacement, slippage, and then affect recovery effects, increased patient's misery.
Summary of the invention
For this reason, the present invention proposes a kind of manufacture method of Orthopedic fixation device, can eliminate fully one or more problems that restriction and defect due to prior art cause.
Additional advantages of the present invention, object and characteristic, a part will be elucidated in the following description, and another part will be significantly or be acquired from enforcement of the present invention by the investigation of the explanation to below for those of ordinary skill in the art.By the structure of pointing out especially in the description at word and claims and accompanying drawing, can realize and obtain the object of the invention and advantage.
The preparation method that the invention provides a kind of Orthopedic fixation device, is characterized in that, described method specifically comprises the following steps:
A) make mould, the transverse section of the side that the Orthopedic fixation device that makes to make contacts with vertebra is the arc matching with vertebra;
B) on described Orthopedic fixation device, offer a plurality of fixing holes, described a plurality of fixing holes lay respectively at the two ends of described Orthopedic fixation device, arrange with transverse axis;
C) Biodegradable polymer material is put into mould, compression molding.
Preferably, the quantity of fixing hole is more than 4 or 4.
Preferably, the arc place diameter of a circle of described step in a) is 8cm, and arc length is 1.5cm, and central angle is 21.6 degree.
Preferably, described step b), Biodegradable polymer material is the mixture of PLLA or PLLA and HA.
Preferably, in the mixture of described PLLA and HA, the weight ratio of PLLA and HA is 8: 1～11: 1.
Preferably, at described step b) also comprise that before the mixture of PLLA or PLLA and HA is heated to 180 ℃～200 ℃ also to be stirred.
Preferably, described HA is through PLLA grafting and modifying.
Preferably, described step b) in, compression molding is specially at 180 ℃～200 ℃, and mold pressing 2min～3min under 9.5MPa～11MPa, is then cooled to 115 ℃～125 ℃, insulation 1min～2min, then to be cooled to room temperature be molding.
The present invention is directed to the structure of human vertebra, be made into and there is the shape with certain radian matching with vertebra, the shape of the spinal column of effectively fitting, the stability of reconstruction and recovery spinal column, prevents adhesion, slippage displacement, alleviates patient's misery; And this Orthopedic fixation device adopts Biodegradable polymer material to make, and has good biocompatibility and wearability, can Preserving time in human body, finally can complete biodegradable, without second operation, take out.
Accompanying drawing explanation
The schematic appearance of the Orthopedic fixation device that Fig. 1 provides for a kind of specific embodiment of the present invention;
Fig. 2 is the cross sectional representation of Orthopedic fixation device in Fig. 1;
The cross sectional representation of the Orthopedic fixation device that Fig. 3 provides for the another kind of specific embodiment of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing, the specific embodiment of the present invention is described further.
Please refer to Fig. 1 and Fig. 2, the schematic appearance of the Orthopedic fixation device that Fig. 1 provides for a kind of specific embodiment of the present invention, Fig. 2 is the cross sectional representation of Orthopedic fixation device in Fig. 1.Orthopedic fixation device provided by the invention, the arc of the transverse section of the side 1 contacting with vertebra for matching with vertebra, as preferably, arc place diameter of a circle is 8cm, arc length is 1.5cm, central angle is 21.6 degree, and cross section shape as shown in Figure 3 is also fine certainly, as long as the side 1 contacting with vertebra is arc.And this Orthopedic fixation device is made by the composite of Biodegradable polymer material PLLA (poly (l-lactic acid)) or PLLA and HA (hydroxyapatite).
Polylactic acid PLA is a kind of biological degradation polyalcohol of good biocompatibility, be divided into PLLA (poly (l-lactic acid)) and PDLA (poly-D-ALPHA-Hydroxypropionic acid), human body only has the LDH of metabolism Pfansteihl, therefore only have the PLLA can be by the complete metabolism of human body, and do not produce the metabolite of any toxic side effect, be a kind of material of complete green, it is poisoning that the excessive absorption of PDLA likely causes that metabolism disorder even causes, so the present invention selects PLLA.
The composites of PLLA and HA has good biocompatibility and Bioabsorbable, in the PLLA that the present invention uses and the composite of HA, the weight ratio of PLLA and HA is preferably 8: 1～and 11: 1, the general HA that uses nanorize, HA is preferably the grafting and modifying through small component PLLA, grafting refers on macromolecular chain passes through the suitable side chain of chemical bonds or the reaction of functional side group, by grafting, can improve macromolecular material performance, and crosslinking technology is well known in the art.
The preparation method of Orthopedic fixation device provided by the invention comprises:
A) make the mould of this Orthopedic fixation device, the arc of the transverse section of the side that the Orthopedic fixation device that makes to make contacts with vertebra for matching with vertebra, specifically can be with reference to figure 1.
B) Biodegradable polymer material is put into mould, compression molding.Biodegradable polymer material is preferably the mixture of PLLA or PLLA and HA, in the mixture of PLLA and HA the weight ratio of PLLA and HA be preferably 8: 1～11: 1.
As preferably, before above Biodegradable polymer material is put into mould, also comprise the mixture of PLLA or PLLA and HA is heated to 180 ℃～200 ℃ and stirring and evenly mixing, this is owing to using organic solvent in the preparation process of PLLA, therefore in the PLLA of finished product, always have residual solvent, by heating and stirring and residual solvent can be removed, prevent from generating bubble in the fixing head of last molding, PLLA and HA fully can also be mixed in addition, this process can be carried out in torque rheometer.More than, in preparation, HA is preferably the grafting and modifying through small component PLLA.
Biodegradable polymer material heating is mixed, remove after residual solvent, the material mixing is put into mould, at 180 ℃～200 ℃, mold pressing 2min～3min under 9.5MPa～11MPa, is then cooled to 115 ℃～125 ℃, for extending the crystallization time of PLLA, improve its degree of crystallinity and be incubated again 1min～2min, be then cooled to the fixing head that room temperature can be taken out molding.
Embodiment 1:
First prepare mould.Then PLLA is heated in torque rheometer to 180 ℃ and stirring and evenly mixing.Take out PLLA and put into mould, at 190 ℃, mold pressing 2.5min under 9.5MPa, is then cooled to 120 ℃, and insulation 1.5min, is then cooled to the fixing head that room temperature is taken out molding.Through detecting, the impact strength of the Orthopedic fixation device obtaining is 7.8 ± 0.94KJ/m
2.This Orthopedic fixation device is implanted in animal body and is tested, and the impact strength of transplanting after 7 months is 6.99 ± 1.42KJ/m
2.In addition, offer a plurality of fixing holes on described Orthopedic fixation device, described a plurality of fixing holes lay respectively at the two ends of described Orthopedic fixation device, arrange with transverse axis; The quantity of fixing hole is more than 4 or 4.
Embodiment 2:
First prepare mould.Then the PLLA that is 9: 1 by weight ratio and HA are heated to 190 ℃ and stirring and evenly mixing in torque rheometer.Take out the mixture of PLLA and HA and put into mould, at 195 ℃, mold pressing 2min under 10MPa, is then cooled to 118 ℃, and insulation 1min, is then cooled to the fixing head that room temperature is taken out molding.
Through detecting, the impact strength of the Orthopedic fixation device obtaining is 7.46 ± 0.4KJ/m
2.This Orthopedic fixation device is implanted in animal body and is tested, and the impact strength of transplanting after 7 months is 14.75 ± 0.9KJ/m
2.
Embodiment 3:
First prepare mould.HA is carried out to grafting and modifying with micromolecule PLLA, g-HA, the PLLA that is then 10: 1 by weight ratio and g-HA are heated to 200 ℃ and stirring and evenly mixings in torque rheometer.Take out the mixture of PLLA and g-HA and put into mould, at 190 ℃, mold pressing 2.5min under 10.5MPa, is then cooled to 120 ℃, and insulation 1min, is then cooled to the fixing head that room temperature is taken out molding.
Through detecting, the impact strength of the Orthopedic fixation device obtaining is 9.9 ± 3.17KJ/m
2.This Orthopedic fixation device is implanted in animal body and is tested, and the impact strength of transplanting after 7 months is 21.1 ± 2.85KJ/m
2.
Comparing embodiment 1 to 3, impact strength before being implanted by Orthopedic fixation device with in the data of the impact strength after 7 months that implants, can see, after adding HA, Orthopedic fixation device impact strength after implanting is improved, especially with PLLA, HA is carried out after grafting and modifying, the impact strength of the Orthopedic fixation device making is 9.9 ± 3.17KJ/m
2be significantly improved, after implanting 7 months, impact strength obtains larger raising, reaches 21.1 ± 2.85KJ/m
2.The introducing of visible HA and g-HA particle has improved the body internal stability of PLLA, adds the shape of fitting with vertebra, can effectively help the stability of restore intravertebral, alleviates patient suffering.
Above content is only preferred embodiment of the present invention, for those of ordinary skill in the art, according to thought of the present invention, all will change in specific embodiments and applications, and this description should not be construed as limitation of the present invention.
Claims (8)
1. a preparation method for Orthopedic fixation device, is characterized in that, described method specifically comprises the following steps:
A) make mould, the transverse section of the side that the Orthopedic fixation device that makes to make contacts with vertebra is the arc matching with vertebra;
B) on described Orthopedic fixation device, offer a plurality of fixing holes, described a plurality of fixing holes lay respectively at the two ends of described Orthopedic fixation device, arrange with transverse axis;
C) Biodegradable polymer material is put into mould, compression molding.
2. the preparation method of Orthopedic fixation device according to claim 1, is characterized in that, the quantity of fixing hole is more than 4 or 4.
3. the preparation method of Orthopedic fixation device according to claim 1, is characterized in that, the arc place diameter of a circle of described step in a) is 8cm, and arc length is 1.5cm, and central angle is 21.6 degree.
4. the preparation method of Orthopedic fixation device according to claim 1, is characterized in that, described step b) in Biodegradable polymer material be the mixture of PLLA or PLLA and HA.
5. the preparation method of Orthopedic fixation device according to claim 4, is characterized in that, in the mixture of described PLLA and HA, the weight ratio of PLLA and HA is 8: 1～11: 1.
6. the preparation method of Orthopedic fixation device according to claim 5, is characterized in that, at described step b) also comprise that before the mixture of PLLA or PLLA and HA is heated to 180 ℃～200 ℃ also to be stirred.
7. the preparation method of Orthopedic fixation device according to claim 5, is characterized in that, described HA is through PLLA grafting and modifying.
8. the preparation method of Orthopedic fixation device according to claim 7, it is characterized in that, described step b) in, compression molding is specially at 180 ℃～200 ℃, mold pressing 2min～3min under 9.5MPa～11MPa, then be cooled to 115 ℃～125 ℃, insulation 1min～2min, then to be cooled to room temperature be molding.
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| CN201310493091.2A CN103536346A (en) | 2013-10-18 | 2013-10-18 | Manufacturing method of orthopaedic fixing device |
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| CN201310493091.2A CN103536346A (en) | 2013-10-18 | 2013-10-18 | Manufacturing method of orthopaedic fixing device |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997031517A2 (en) * | 1995-03-27 | 1997-08-28 | Sdgi Holdings, Inc. | Spinal fusion implants and tools for insertion and revision |
| WO2001049191A1 (en) * | 2000-01-06 | 2001-07-12 | Spinal Concepts, Inc. | System and method for stabilizing the human spine with a bone plate |
| CN2631438Y (en) * | 2003-06-09 | 2004-08-11 | 王岩 | Absorbable fixing plate for cervical vertebrae front |
| CN1663538A (en) * | 2004-03-01 | 2005-09-07 | 王岩 | Vetebrae anterior biological osteogenesis-inducing type internal fixing device |
| CN101716095A (en) * | 2009-12-30 | 2010-06-02 | 中国科学院长春应用化学研究所 | Orthopedic internal fixation plate and preparation method thereof |
| CN202761426U (en) * | 2012-09-26 | 2013-03-06 | 汕头大学医学院第一附属医院 | Medical bone-protecting plate |
-
2013
- 2013-10-18 CN CN201310493091.2A patent/CN103536346A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997031517A2 (en) * | 1995-03-27 | 1997-08-28 | Sdgi Holdings, Inc. | Spinal fusion implants and tools for insertion and revision |
| WO2001049191A1 (en) * | 2000-01-06 | 2001-07-12 | Spinal Concepts, Inc. | System and method for stabilizing the human spine with a bone plate |
| CN2631438Y (en) * | 2003-06-09 | 2004-08-11 | 王岩 | Absorbable fixing plate for cervical vertebrae front |
| CN1663538A (en) * | 2004-03-01 | 2005-09-07 | 王岩 | Vetebrae anterior biological osteogenesis-inducing type internal fixing device |
| CN101716095A (en) * | 2009-12-30 | 2010-06-02 | 中国科学院长春应用化学研究所 | Orthopedic internal fixation plate and preparation method thereof |
| CN202761426U (en) * | 2012-09-26 | 2013-03-06 | 汕头大学医学院第一附属医院 | Medical bone-protecting plate |
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Application publication date: 20140129 |