CN105167831A - Composite skull plate and manufacturing method thereof - Google Patents
Composite skull plate and manufacturing method thereof Download PDFInfo
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- CN105167831A CN105167831A CN201510464974.XA CN201510464974A CN105167831A CN 105167831 A CN105167831 A CN 105167831A CN 201510464974 A CN201510464974 A CN 201510464974A CN 105167831 A CN105167831 A CN 105167831A
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- skull
- skull plate
- plate body
- cranial bone
- bone plate
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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
- A61B17/688—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for reattaching pieces of the skull
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8085—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Dermatology (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a composite skull plate and a manufacturing method thereof. The composite skull plate is composed of a skull plate body in the shape of an arc-shaped sheet and a reinforcing net embedded in the skull plate body, and the skull plate body is composed of, by total weight, 100 parts of hydroxylapatite, 50-100 parts of polyacrylic alkyl ester, 50-60 parts of EMA resin and 14-18 parts of acrylic alkyl ester. The composite skull plate is non-absorbent, insoluble in water and free of deformation, has quite high chemical stability, has density similar to human bone and is high in safety; even if the skull plate body is broken, fragments of the skull plate body are combined with the reinforcing net, damage to a human body due to the fact that endocranium is pierced is avoided, allergy and rejection reaction caused by the fact that muscle tissue is stimulated by a metal net plate is avoided, and the composite skull plate is convenient for clinical application.
Description
Technical field
The present invention relates to a kind of material for repairing skull.
Background technology
Skull operation, as the defect of skull, reparation and shaping, cranioplasty is the effective ways for the treatment of defect of skull, needs to use a kind of material (artificial material or autologous bone), for the reparation of defects with skull in operation.
The material for repairing skull that current routine adopts is titanium net, or the tablet be made up of the material such as lucite or silicone rubber.During operation, be placed in defect place after reducing according to defect of skull size, the boring silk thread of surrounding or metal material are fixed.The outstanding problem that this kind of Cephalic shadow mask exists is that intensity difference, is unfavorable for the protection at defect of skull position.As the Cephalic shadow mask that number of patent application provides for 201120482438.X, for another example Chinese Patent Application No. is the 201010297116.8 repair of cranial defects titanium nets with anti-stick coating provided, and the Double-layer titanium net for cranioplasty that application number 201120482478.4 and application number 201110173696.4 provide.
In order to overcome above-mentioned defect, also there is patent report, technology disclosed in ZL01341241, this patent adopts carbon fiber and polyether-ether-ketone to carry out compound, prepare a kind of compound compound cranial bone plate, but above-mentioned proprietary material, there is certain defect with the compatibility of human bone material.
Also having technology to report, by metal material and high molecular polymer compound, in order to improve the conjugation of bi-material, adding coupling agent in the material, the material that result in acquisition has certain zest to human body, is unfavorable for the use of human body.
Summary of the invention
The object of this invention is to provide a kind of compound cranial bone plate and preparation method thereof, to overcome the defect that prior art exists, meet the needs of clinical practice.
Compound cranial bone plate of the present invention, is made up of skull plate body and the enhancing net be embedded in described skull plate body of arc-shaped flaky;
The material of described skull plate body is the complex after the solidification of hydroxyapatite, polyacrylic acid alkane ester, EAM resin and alkyl acrylate, and with the material total weight of skull plate body, the parts by weight of each component are:
The material of described enhancing net is titanium, is made up of the twine intersected in length and breadth, and the roughness on described twine surface is Ra=4 ~ 6 μm;
Preparation method of the present invention, comprises the steps:
(1) titanium silk woollen yarn knitting is become enhancing net, in a mold, be suppressed into predetermined shape;
(2) be then placed in the hydrochloric acid of weight concentration 2-5%, 50-80 DEG C of process 10-30 minute, take out, washing, dry, or adopt the method for laser-induced thermal etching to process, or adopt the method for husky mill to process, the roughness on the twine surface described in acquisition is the titanium wire network of Ra=4 ~ 6 μm;
(3) titanium wire network that step (2) obtains is placed in skull plate body mold;
(4) by each component of skull plate bulk material, that inserts step (3) is provided with molding in the skull plate body mold of titanium wire network; Obtain precast body;
(5) then precast body is placed in water and boils 15-20 minute, takes out solidification 8 ~ 12 hours, and washing is dry, can obtain described compound cranial bone plate.
The compound cranial bone plate that the present invention obtains, does not absorb water, also water insoluble, deformation can not be produced, there is very high chemical stability, density and human bone close, safety is high, even if skull plate body is broken, its fragment is also combined with enhancing anastomose, can not puncture cerebral dura mater and produce injury to human body, it also avoid metal otter board irritating muscular tissue simultaneously, produce irritated, rejection, be convenient to clinical application.
Accompanying drawing explanation
Fig. 1 is the structural representation of compound cranial bone plate.
Fig. 2 is for strengthening web frame schematic diagram.
Detailed description of the invention
See Fig. 1 and Fig. 2, compound cranial bone plate of the present invention, is made up of skull plate body 1 and the enhancing net 2 be embedded in described skull plate body 1 of arc-shaped flaky;
The material of described skull plate body 1 is the complex after hydroxyapatite, polyacrylic acid alkane ester, EAM resin, alkyl acrylate solidification;
The material of described enhancing net 2 is titanium, is made up of the twine 201 intersected in length and breadth; The material of described enhancing net is titanium, is made up of the twine 201 intersected in length and breadth, and the roughness on described twine surface is Ra=4 ~ 6 μm;
The thickness of described skull plate body 1 is 2-5mm.
Preferably, described twine diameter be 0.05-0.01mm;
Preferably, mesh is circle, rhombus, rectangle or triangle, and the equivalent diameter of mesh is 1-3mm; Described equivalent diameter refers to when mesh is non-circular, and diameter is the girth/pi of mesh.
Embodiment 1
Preparation compound cranial bone plate as depicted in figs. 1 and 2, wherein:
The material strengthening net is titanium, and be made up of the twine intersected in length and breadth, the roughness on described twine surface is Ra=6 μm; Mesh is circular, and the equivalent diameter of mesh is 1mm;
Formula: (weight)
Preparation method:
(1) titanium silk woollen yarn knitting is become enhancing net, in a mold, be suppressed into predetermined shape;
(2) being then placed on weight concentration is in the hydrochloric acid of 2%, and 80 DEG C process 10 minutes, take out, washing, and dry, the roughness on the twine surface described in acquisition is the titanium wire network of Ra=4 μm;
(3) titanium wire network that step (2) obtains is placed in skull plate body mold;
(4) by each component of skull plate bulk material, fully mix the titanium wire network that is provided with being filled in step (2) and be placed in the molding of skull plate body mold; Obtain precast body;
(5) then precast body is placed in water and boils 15 minutes, then takes out, solidifies 12 hours, and washing is dry, can obtain described compound cranial bone plate.
Detection method:
The method adopting following standard to specify detects:
1 firming body bending strength:
Detect by GB1449-2005 regulation, be greater than 30MPa.
2 biology performances:
2.1 cell toxicity test
Detect according to the lixiviating solution test method specified in GB/T16886.5-2003, cell-cytotoxic reaction≤1 grade.
2.2 sensitization test (STT)
Carry out, without anaphylaxis according to the maximal dose sensitization test (STT) method specified in GB/T16886.10-2005.
2.3 genetic toxicity test
Undertaken by the Salmonella reversion test specified in GB/T16886.3-2008, micronucleus test method, Salmonella reversion test: result is negative; Cell chromosome tertogenicity test: result is negative; By the cell chromosome tertogenicity test specified in GB/T16886.3-2008, micronucleus test: result is negative.
2.4 endosseous implant tests
Undertaken by GB/T16886.6-1997 regulation, result judges to press YY0305-1998, total toxicity ratio 1 ~ 0 grade (≤1).
2.5 intradermoreaction tests
Undertaken by GB/T16886.10-2005 regulation, the difference of test specimen and solvent control mean score should be not more than 1.0.
2.6 acute systemic toxicity
Undertaken by GB/T16886.11-2011 regulation, should react without Acute systemic toxicity.
2.7 sub-chronic systemic toxicity tests
Undertaken evaluating sub-chronic systemic toxicity by GB/T16886.11-2011 regulation, should without obvious sub-chronic systemic toxic reaction.
Embodiment 2
Preparation compound cranial bone plate as depicted in figs. 1 and 2, wherein:
The material strengthening net is titanium, and be made up of the twine intersected in length and breadth, the roughness on described twine surface is Ra=6 μm; Mesh is triangle, and the equivalent diameter of mesh is 3mm;
Formula: (weight)
Preparation method:
(1) titanium silk woollen yarn knitting is become enhancing net, in a mold, be suppressed into predetermined shape;
(2) then adopted the method for laser-induced thermal etching to process, the roughness on the twine surface described in acquisition is the titanium wire network of Ra=6 μm;
(3) titanium wire network that step (2) obtains is placed in skull plate body mold;
(4) by each component of skull plate bulk material, fully mix the titanium wire network that is provided with being filled in step (2) and be placed in the molding of skull plate body mold; Obtain precast body;
(5) then precast body is placed in water and boils 20 minutes, then takes out, solidifies 8 hours, and washing is dry, can obtain described compound cranial bone plate.
Detection method:
The method adopting following standard to specify detects:
1 firming body bending strength:
Detect by GB1449-2005 regulation, be greater than 30MPa.
2 biology performances:
2.1 cell toxicity test
Detect according to the lixiviating solution test method specified in GB/T16886.5-2003, cell-cytotoxic reaction≤1 grade.
2.2 sensitization test (STT)
Carry out, without anaphylaxis according to the maximal dose sensitization test (STT) method specified in GB/T16886.10-2005.
2.3 genetic toxicity test
Undertaken by the Salmonella reversion test specified in GB/T16886.3-2008, micronucleus test method, Salmonella reversion test: result is negative; Cell chromosome tertogenicity test: result is negative; By the cell chromosome tertogenicity test specified in GB/T16886.3-2008, micronucleus test: result is negative.
2.4 endosseous implant tests
Undertaken by GB/T16886.6-1997 regulation, result judges to press YY0305-1998, total toxicity ratio 1 ~ 0 grade (≤1).
2.5 intradermoreaction tests
Undertaken by GB/T16886.10-2005 regulation, the difference of test specimen and solvent control mean score should be not more than 1.0.
2.6 acute systemic toxicity
Undertaken by GB/T16886.11-2011 regulation, should react without Acute systemic toxicity.
2.7 sub-chronic systemic toxicity tests
Undertaken evaluating sub-chronic systemic toxicity by GB/T16886.11-2011 regulation, should without obvious sub-chronic systemic toxic reaction.
Claims (7)
1. compound cranial bone plate, is characterized in that, is made up of skull plate body and the enhancing net be embedded in described skull plate body of arc-shaped flaky;
The material of described skull plate body, with the material total weight of skull plate body, the parts by weight of each component are:
2. compound cranial bone plate according to claim 1, is characterized in that, the material of described enhancing net is titanium, is made up of the twine intersected in length and breadth.
3. compound cranial bone plate according to claim 2, is characterized in that, the roughness on described twine surface is Ra=4 ~ 6 μm.
4. compound cranial bone plate according to claim 3, is characterized in that, described twine diameter be 0.05-0.01mm.
5. compound cranial bone plate according to claim 4, is characterized in that, mesh is circle, rhombus, rectangle or triangle, and the equivalent diameter of mesh is 1-3mm.
6. the compound cranial bone plate according to any one of Claims 1 to 5, is characterized in that, the thickness of described skull plate body is 2-5mm.
7. the preparation method of the compound cranial bone plate according to any one of claim 1 ~ 6, is characterized in that, comprise the steps:
(1) titanium silk woollen yarn knitting is become enhancing net, in a mold, be suppressed into predetermined shape;
(2) be then placed in the hydrochloric acid of weight concentration 2-5%, 50-80 DEG C of process 10-30 minute, take out, washing, dry, or adopt the method for laser-induced thermal etching to process, or adopt the method for husky mill to process, the roughness on the twine surface described in acquisition is the titanium wire network of Ra=4 ~ 6 μm;
(3) titanium wire network that step (2) obtains is placed in skull plate body mold;
(4) by each component of skull plate bulk material, that inserts step (3) is provided with molding in the skull plate body mold of titanium wire network; Obtain precast body;
(5) then precast body is placed in water and boils 15-20 minute, takes out solidification 8 ~ 12 hours, and washing is dry, can obtain described compound cranial bone plate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510464974.XA CN105167831A (en) | 2015-07-31 | 2015-07-31 | Composite skull plate and manufacturing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510464974.XA CN105167831A (en) | 2015-07-31 | 2015-07-31 | Composite skull plate and manufacturing method thereof |
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| CN105167831A true CN105167831A (en) | 2015-12-23 |
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| CN201510464974.XA Pending CN105167831A (en) | 2015-07-31 | 2015-07-31 | Composite skull plate and manufacturing method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111867515A (en) * | 2018-01-31 | 2020-10-30 | 弹性钛合金植入物有限责任公司 | Self-fixating mesh implant based on titanium wire and bioabsorbable polymer |
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| CN1618412A (en) * | 2004-08-24 | 2005-05-25 | 上海倍尔康生物医学科技有限公司 | Technique for making restitution skull and jawbone by using biological artificial bone material combined with CAD/CAM technology |
| CN1795931A (en) * | 2004-12-27 | 2006-07-05 | 戴萌 | Implantation material for surgery in use for repairing bone |
| US20060224242A1 (en) * | 2003-04-16 | 2006-10-05 | Porex Surgical, Inc. | Craniofacial implant |
| CN1923299A (en) * | 2006-09-15 | 2007-03-07 | 北京吉马飞科技发展有限公司 | Titanium material personalized skull-jaw facial bone renovation unit and preparation method thereof |
| CN101559240A (en) * | 2008-04-17 | 2009-10-21 | 杨立群 | Skull repairing material and preparation method thereof |
| CN103549990A (en) * | 2013-10-11 | 2014-02-05 | 江苏百得医疗器械有限公司 | PEEK cranioplasty screen |
| CN203564382U (en) * | 2013-12-04 | 2014-04-30 | 赵殿东 | Compound skull repair mesh |
-
2015
- 2015-07-31 CN CN201510464974.XA patent/CN105167831A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060224242A1 (en) * | 2003-04-16 | 2006-10-05 | Porex Surgical, Inc. | Craniofacial implant |
| CN1618412A (en) * | 2004-08-24 | 2005-05-25 | 上海倍尔康生物医学科技有限公司 | Technique for making restitution skull and jawbone by using biological artificial bone material combined with CAD/CAM technology |
| CN1795931A (en) * | 2004-12-27 | 2006-07-05 | 戴萌 | Implantation material for surgery in use for repairing bone |
| CN1923299A (en) * | 2006-09-15 | 2007-03-07 | 北京吉马飞科技发展有限公司 | Titanium material personalized skull-jaw facial bone renovation unit and preparation method thereof |
| CN101559240A (en) * | 2008-04-17 | 2009-10-21 | 杨立群 | Skull repairing material and preparation method thereof |
| CN103549990A (en) * | 2013-10-11 | 2014-02-05 | 江苏百得医疗器械有限公司 | PEEK cranioplasty screen |
| CN203564382U (en) * | 2013-12-04 | 2014-04-30 | 赵殿东 | Compound skull repair mesh |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111867515A (en) * | 2018-01-31 | 2020-10-30 | 弹性钛合金植入物有限责任公司 | Self-fixating mesh implant based on titanium wire and bioabsorbable polymer |
| CN111867515B (en) * | 2018-01-31 | 2024-01-30 | 钛合金纺织品公司 | Self-anchoring mesh implant based on titanium wire and bioabsorbable polymer |
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Application publication date: 20151223 |
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