CN109692363A - A kind of preparation of the fixed device of lower chin bone reparation - Google Patents
A kind of preparation of the fixed device of lower chin bone reparation Download PDFInfo
- Publication number
- CN109692363A CN109692363A CN201711004202.3A CN201711004202A CN109692363A CN 109692363 A CN109692363 A CN 109692363A CN 201711004202 A CN201711004202 A CN 201711004202A CN 109692363 A CN109692363 A CN 109692363A
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- CN
- China
- Prior art keywords
- magnesium
- base metal
- lower chin
- composite polymer
- chin bone
- 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.)
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Classifications
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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
-
- 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
- A61L31/022—Metals or alloys
-
- 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular 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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/04—Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Neurology (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Materials For Medical Uses (AREA)
Abstract
The device for being used to repair fixed lower chin bone for being coated with and constituting through composite polymer material the invention discloses a kind of part made by degradable magnesium Base Metal.Belong to biodegradable material field.It mainly solves the disadvantage that repair fixed lower chin bone Biocompatibility difference in clinical use and needs second operation to take out without degradability.So that composite polymer material is coated on magnesium-base metal piece surface using the air-dried method of solution lifting and prepares good biocompatibility, the fixed device of the regulatable lower chin bone reparation of degradation time.
Description
Technical field
The present invention relates to a kind of use that the part made by degradable magnesium Base Metal is constituted through composite polymer material coating
In the device for repairing fixed lower chin bone.Belong to biodegradable material field.
Background technique
Currently, the lower fixed device of chin reparation used in clinic is substantially made of metal material or high molecular material.Its
Used in metal material be entirely non-degradable material, the overwhelming majority is fabricated by magnesium-base metal.By polymerization high score
The fixed device of lower chin reparation of sub- material manufacture, is usually made of polyether-ether-ketone or polylactic acid, wherein polyether-ether-ketone can not drop
Solution, polylactic acid can degrade.From the point of view of the current clinical product service condition manufactured to both materials, clinic can be substantially met
It is required that but there is also some limitations and potential problems.Such as the reparation of chin under children, because pediatric patient bone is still
Incomplete development is mature, if using non-degradable material as fixed material is repaired, just influences whether the bone of pediatric patient
Development forms development and hinders, causes problem at a specified future date.Further more, the product that the degradable poly lactate material of clinical use manufactures now,
Since polylactic acid can discharge lactic acid monomer in degradation process in human body, causes body tissue that acidic environment is locally presented, lead
It causes tissue hydrops and inflammatory reaction occurs, influence therapeutic effect, even need to take out implants when serious.It can by upper simple analysis
See, repairing field in lower chin bone at present still not only has good biocompatibility without a kind of, but also has degradability, simultaneously
It is also fixed to meet clinical demand with the controllable lower chin bone reparation of degradation time.
In recent years, there is research boom because having degradability and superior bio compatibility again in magnesium-base metal material.
Research to magnesium-base metal correlated performance at present and evaluation are highly developed.Many performances show that magnesium-base metal has clinic
Application many advantages be but found through experiments that, magnesium-base metal there is also degrade it is too fast, cannot be with the bone tissue reparation time
The problem of matched.In addition, medical degradable polymerization macromolecule material is ratified by FDA and CFDA in clinical use many years,
The material has degradable in vivo, and degradation time can be regulated and controled with the variation of molecular weight, while its final product of degrading
For water and carbon dioxide, human body will not be caused finally to influence.By clinical many years using discovery, this quasi polymer, which is removed, to be had
Outside above-mentioned advantage, there is also some the problem of biocompatibility is described above, therefore affect the use of the material.
Content according to the present invention is exactly using excellent possessed by magnesium-base metal and degradable polymerization high molecular material
Gesture eliminates the disadvantage of both materials by physical mixed, coated method, then combines the two and is used to make newly
The fixed device of the reparation of the degradable lower chin bone of type.The fixed device of the lower chin bone reparation made through the invention, not only can solve
The non-degradable problem of above-mentioned fixed device, also can solve that magnesium-base metal material degradation is too fast and polymerization macromolecule material in vivo
Caused aseptic inflammation problem in degradation process.
Specifically, the characteristic that the present invention utilizes magnesium-base metal itself that can degrade, by the way that degradable polymerization macromolecule is molten
The appearance of magnesium-base metal part is wrapped up one layer of degradable polymerization by the method for solving and being coated on the part made of magnesium-base metal
Macromolecule is made first to be contacted and the method for polymerization macromolecule of degrading after in part implantation human body using body fluid, delays body fluid and magnesium-based
Metal contact time, reach solves the problems, such as magnesium-base metal degrade it is too fast, in addition polymerization macromolecule have molecular size range and
The characteristic that degradation time is positively correlated achievees the purpose that degradation is controllable by adjusting the molecular size range of polymerization macromolecule.Meanwhile
By the way that certain magnesium salts is added in polymerization macromolecule, while so that polymerization macromolecule decomposites monomer during degradation
Also there is magnesium salts precipitation, thus can make in situ polymerization macromolecule monomer in conjunction with magnesium salts, neutralize polymerization macromolecule monomer
The variation of caused internal pH value, tissue reaction caused by eliminating because of acid reaction solve general height in degradation process
Aseptic inflammation problem in molecular material bring body.
In short, disclosed in this invention by the way that degradation material to be applied in combination and made by simple process
The fixed loading amount of the lower chin bone reparation of work, not only has the properties of product of institute's normal use in existing clinic, also having can drop completely
Solution, degradation time are controllable, and the preferably advantages such as biocompatibility, for lower chin doctor do not change existing operation habit with
Bigger selectivity is provided under the premise of clinical effectiveness, while can also be patient, and especially young patient eliminates because solid
Determine bring potential risk in device prolonged stay body.
Summary of the invention
The present invention provides a kind of for the fixed use of lower chin bone reparation, degradable fixation device.It is specific as follows:
1, the fixed device of the craniofacial bone reparation is made of the part that magnesium-base metal material and composite polymer material make.
(1) magnesium-base metal material therein is pure magnesium or magnesium alloy.It is preferred that can be magnesium zinc calcium alloy.
(2) composite polymer material therein is the composite material of degradable polymerization high molecular material and magnesium salts, storage
For 5wt%~50wt% of magnesium-base metal material and composite polymer material total amount；Magnesium salts is magnesia, magnesium phosphate, magnesium carbonate
One kind, account for composite polymer material storage be 0.5wt%~5wt%.Magnesium salts is preferably magnesia.
(3) degradable polymerization high molecular material therein is polyacrylamide.It is preferred that degradable polymerization high molecular material is
Polylactic acid (PLA).
2, the fixed device of the lower chin bone reparation, it is characterized in that the part of magnesium-base metal material production is by composite polymer material
Coating, it is coated with a thickness of 0.05~2mm.
3, the fixed device of the lower chin bone reparation is made of various parts, and design of part can be plate with holes, screw, T-type
Fastener, hole gasket, band tooth gasket, pole, lead screw.Wherein, plate with holes and screw, T-type fastener can be used in combination；Pad with holes
It piece, screw rod and/or can be used in combination with tooth gasket and/or pole.Wherein metal plate with holes with a thickness of 0.5~4mm, it is long or
Width is 5~300mm, and the diameter in hole is 0.5~30mm, and the diameter of T-type fastener and screw is 0.5~10mm, and the length of screw is 1
~20mm；Diameter with tooth gasket and hole gasket is 6~30mm；Lead screw and diameter of the rod are 1~5mm, length is 10~
200mm。
Specific embodiment
Embodiment one
It is 40mm, 6mm, 1mm with the machined length of producing of magnesium zinc calcium alloy, and is the hole 2mm with diameter
Plate, then make of magnesium zinc calcium alloy the screw of a length of 4mm, diameter 2mm.Made plate and screw through light decorations cleaning after drying to
With.Taking 5g molecular weight is that the l-polylactic acid of 12KDa is dissolved in 100ml methylene chloride, after mixing evenly again by the magnesia of 0.5g
It is slowly dissolved in the solution, is uniformly distributed in magnesia in solution through ultrasound.It will be with the plate of the machined completion of magnesium zinc calcium alloy
With screw it is weighed after, be soaked in the lifting of the PLA solution 5 of mixed oxidization magnesium~after ten minutes and air-dry, impregnated again after dry
In solution, until whole weight is the 5% of the weight of plate to terminate to impregnate, after clean 3 times with ethyl alcohol, drying and packaging simultaneously irradiation sterilization
It completes.
Embodiment two
It is 80mm, 80mm, 1mm with the machined length of producing of pure magnesium, and is the plate in the hole 2mm with diameter, then
The screw of a length of 4mm, diameter 2mm are made of pure magnesium.Made plate and screw is dried stand-by after light decorations cleaning.Take 5g molecule
Amount is that the l-polylactic acid of 22KDa is dissolved in 100ml chloroform, and the magnesium carbonate of 0.25g is slowly dissolved the solution again after mixing evenly
In, magnesium carbonate is uniformly distributed in solution through ultrasound.By with the plate of the machined completion of pure magnesium and screw it is weighed after, be soaked in
It lifts and air-dries behind PLA solution 20~30 minutes of mixed carbonic acid magnesium, be soaked in solution again after dry, until whole weight
For after the weight 10% of raw sheet or screw terminate impregnate, after clean 3 times with ethyl alcohol, drying and packaging and irradiation sterilization completion.
Claims (3)
1. a kind of fixed device of lower chin bone reparation is the part group made by magnesium-base metal material and composite polymer material
At.
2. as described in claim 1, magnesium-base metal material therein is pure magnesium or magnesium alloy.
3. as described in claim 1, composite polymer material therein be it is degradable polymerization high molecular material and magnesium salts it is compound
Material, storage are 5wt%~50wt% of magnesium-base metal material and composite polymer material total amount；Magnesium salts is magnesia, phosphorus
One kind of sour magnesium, magnesium carbonate, the storage for accounting for composite polymer material is 0.5wt%~5wt%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711004202.3A CN109692363A (en) | 2017-10-24 | 2017-10-24 | A kind of preparation of the fixed device of lower chin bone reparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711004202.3A CN109692363A (en) | 2017-10-24 | 2017-10-24 | A kind of preparation of the fixed device of lower chin bone reparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109692363A true CN109692363A (en) | 2019-04-30 |
Family
ID=66229454
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711004202.3A Pending CN109692363A (en) | 2017-10-24 | 2017-10-24 | A kind of preparation of the fixed device of lower chin bone reparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109692363A (en) |
-
2017
- 2017-10-24 CN CN201711004202.3A patent/CN109692363A/en active Pending
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Application publication date: 20190430 |