CN105797208A - Degradable metal implant for repairing skull and preparation method thereof - Google Patents
Degradable metal implant for repairing skull and preparation method thereof Download PDFInfo
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- CN105797208A CN105797208A CN201610239350.2A CN201610239350A CN105797208A CN 105797208 A CN105797208 A CN 105797208A CN 201610239350 A CN201610239350 A CN 201610239350A CN 105797208 A CN105797208 A CN 105797208A
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/042—Iron or iron alloys
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/32—Phosphorus-containing materials, e.g. apatite
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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
- 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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- 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
- A61L27/58—Materials at least partially resorbable by the body
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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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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Abstract
The invention discloses a degradable metal implant for repairing a skull and a preparation method thereof.The implant is applied to skull injury and plastic surgery for restoration and structurally comprises an implanted net, bone nail holes are formed in the periphery of the implanted net, the implanted net is of a transparent net structure and has bionic radian, the implanted net and the bone nail holes are subjected to surface modification treatment, so that a degradable biological coating is obtained, through the transparent net structure, it is convenient for the lower portion of the implant and peripheral tissues to grow, the degradable biological coating is formed on the surface of the metal implant through a bionic solution method or an ion beam assisted deposition method or a chemical or electrochemical deposition method or an ion implantation method or a plasma spraying method or a laser cladding method and has excellent biological compatibility, biological activity and biological absorbability, the structure is compact, the degradable biological coating and the metal implant are bonded firmly, on one hand, the degradation rate of the degradable metal implant can be controlled, on the other hand, the metal implant can have excellent biological activity and biological compatibility, and a degradation product does not influence generation of new bones.The metal implant has sufficient compression resistance and bending strength, meanwhile has god elasticity and toughness and meets the repairing requirement of the human skull.
Description
Technical field
The invention belongs to technical field of medical instruments, in particular it relates to a kind of skull reparation degradable metal implant and preparation method thereof.
Background technology
Cranioplasty is the defect of skull caused for cerebral trauma or operation of opening cranium etc.; some patients is because decompression or ill skull excise and remain Cranial defect; thus a kind of department of cerebral surgery common surgical that it is repaired; purpose is to solve the problems such as cerebral tissue is not effectively protected by defect of skull region, blood supply disorder and cerebrospinal fluid circulation are abnormal, it can in addition contain solve profile Plastic recovery problem.Because being intended to the repairing to brain tissue, so the material selected, not only require that operation technique is simple and reduces complication; also wanting can be the most moulding; therefore defect of skull needs suitable reconstruction, to provide biomechanical stability, thus reaches brain protection and optimal cosmetic result.
Up to the present, not yet there is a kind of preferably repair materials, both there is excellent mechanical property and biocompatibility, defects with skull regeneration, healing can also be guided simultaneously, and self can be degradable or absorbed, thus realize physiological knitting, the needs of patient are met from aesthetic and psychological aspects.The materials for use in skull-fixing applied at present mainly includes natural biologic material and the big class of synthetic material two.Natural biologic material derives from autologous bone, homogeneous allogenic bone, heterogenous allosome bone, because it is respectively present the deficiencies such as rejection limited, immune, infection risk of drawing materials, the most only limits the use of " filled type " in skull little area defect and transplants.For the large defect of skull, main use synthetic material is repaired.Synthetic material is divided into metal material and nonmetallic materials.Nonmetallic materials include lucite, bone cement and composite, lucite is hard, can heating plastic and drawing materials conveniently, but human body is had stimulation and of long duration after the most aging, it is difficult to reach promising result；Bone cement is moulding soon, but has stimulation to cerebral tissue, and postoperative yielding generation loosens.Conventional metal has tantalum, titanium alloy sheet or corrosion resistant plate, and its plastotype is convenient, but as Permanent implantation thing, its long term physical stimulates, and long-term foreign body stimulates and causes complication, also can cause the chronic inflammatory reaction of local simultaneously.These skulls repair implant can complete its mechanical stability, brain protection and optimal cosmetic result, is preferably able to disappear after self skull grows.Although these metal racks can temporarily meet needs clinically in present stage, but in the long run, develop biodegradable, there is more high-biocompatibility and bioactive skull is repaired implant and had become as a kind of trend.Although degradable high polymer material can use as skull reparation, but its mechanical property is not the best enough, and the catabolite of acidity easily causes acute or chronic inflammation etc..Therefore developing biodegradable skull reparation metal implant is one of important direction becoming the research of present stage cranioplasty.
The patent of invention of Patent No. CN201510050828.2 relates to one and has bioactive skull prosthesis and preparation method thereof.There is described in this invention bioactive skull prosthesis and include unmodified skull prosthesis layer, modified skull prosthesis layer and nano fibrous membrane layer the most successively；This invention additionally provides the preparation method of skull prosthesis.By using above-mentioned three-decker, and utilize suitable with human bone hardness, intensity, weight, the poly aryl ether ketone material of good biocompatibility and 3D printing technique, the skull prosthesis mechanical property of this invention is not the best enough, it is impossible to control the degradation rate of degradable metal.
Summary of the invention
In order to overcome above problems of the prior art, the present invention provides a kind of skull reparation degradable metal implant and preparation method thereof, and the degradable biological coating that metal implant surface biological functionalization obtains has biocompatibility, biological activity and the Bioabsorbable of excellence.The degradable biological coating formed by ion-beam assisted deposition, electrodeposition process, chemical gaseous phase deposition, arc deposited, ion implanting, hot spray process, laser cladding, compact structure, it is firmly combined with metal implant, on the one hand the degradation rate of degradable metal can be controlled, on the other hand metal implant is made to have biological activity and the biocompatibility of excellence, catabolite does not affect New born formation, while the metal implant of the present invention possesses enough resistance to compressions and bending strength, it is also equipped with good elasticity and toughness, is suitable for the reparation requirement of human skull.
The present invention provides a kind of skull reparation degradable metal implant, for head injury and Plastic renovation, including implanting net, bone screw holes is arranged on implantation net around, implant net there is penetrating network structure and there is bionical radian, implant net and bone screw holes and obtain degradable biological coating by surface modification treatment.Penetrating network structure is easy to the growth of implant bottom and surrounding tissue.
Preferably, any one during described implantation net and bone screw holes surface use Biomimetic, ion-beam assisted deposition, chemistry or electrochemical deposition method, ion implantation, plasma spraying method or laser cladding carries out surface modification treatment.
Preferably, described degradable biological coating is any one in calcium silicates, apatite or tricalcium phosphate to any of the above-described scheme.
Preferably, described degradable biological coating is any one complex formed with biodegradated polymer materal in calcium silicates, apatite or tricalcium phosphate to any of the above-described scheme.
Preferably, described degradable biological coating layer thickness is 1-20 μm to any of the above-described scheme, and degradable biological coating is 30-100MPa with the bond strength of implantation net.
Preferably, the described interior positive camber implanting net is respectively provided with ± 0 °～the radian of ± 90 ° to any of the above-described scheme.
Preferably, described implantation net thickness is 0.1-1.0mm to any of the above-described scheme.
Preferably, described implantation net gradient thickness is distributed any of the above-described scheme, implant net 1-2 times that interior thickness is edge thickness.
Preferably, in the middle part of described implantation net, 1/5th area thickness are 1-2 times of edge thickness to any of the above-described scheme.
Preferably, in the middle part of described implantation net, 1/5th area thickness are 1.2 times of edge thickness to any of the above-described scheme.
Preferably, in the middle part of described implantation net, 1/5th area thickness are 1.5 times of edge thickness to any of the above-described scheme.
Preferably, in the middle part of described implantation net, 1/5th area thickness are 1.8 times of edge thickness to any of the above-described scheme.
Preferably, the quantity of described bone screw holes is more than four to any of the above-described scheme.
Preferably, the quantity of described bone screw holes is four to any of the above-described scheme.
Preferably, described implantation net and bone screw holes use biodegradable medical metal material to be made to any of the above-described scheme.
Preferably, described biodegradable medical metal material includes magnesium base alloy, ferrous alloy, Zn-base alloy to any of the above-described scheme.
Preferably, described magnesium base alloy material includes pure magnesium alloy, magnalium, magnesium-manganese alloy, magnesium-zinc alloy, Mg-Zr alloys, magnesium-rare earth alloy, magnesium calcium alloy material to any of the above-described scheme.
Preferably, described ferrous alloy material includes the thio gold of pure iron alloy, iron-carbon alloy, ferrum, ferrotungsten, ferromanganese material to any of the above-described scheme.
Preferably, described Zn-base alloy includes pure kirsite, zinc magnesium alloy material to any of the above-described scheme.
Any of the above-described scheme preferably, weight content < 9%, Zn, weight content all < weight content < weight contents < 3% of 1%, Ca of 5%, Zr of Mn, Si or Re of Al in described magnesium base alloy, ferrous alloy and Zn-base alloy.In in magnesio, iron-based, zinc-base, the content of alloying element should meet the claimed range of bio-medical so that it is catabolite will not cause tissue toxicity to react.
Preferably, described implantation net is network structure to any of the above-described scheme, and the network structure implanting net is made up of at least one in rhombus hole, circular opening, oval hole or XO type hole.Pitch of holes is 5-15mm.
Preferably, the aperture of described bone screw holes is 1-2mm to any of the above-described scheme.
Preferably, described implantation net is provided with four edges and is symmetrical arranged two-by-two any of the above-described scheme.
Preferably, described bone screw holes is symmetricly set on two limits implanting net any of the above-described scheme, and the two other limit implanting net is uniformly provided with V-notch, is conducive to the defect of skull edge that coincide.
Preferably, described implantation net can carry out personalized cutting, plastotype according to required size or shape and not affect repair function any of the above-described scheme.
The invention also discloses the preparation method of a kind of skull reparation degradable metal implant, comprise the following steps:
Step (1), metal implant machine-shaping；
Step (2), the metal implant surface of machine-shaping is used in Biomimetic, ion-beam assisted deposition, chemistry or electrochemical deposition method, ion implantation, plasma spraying method or laser cladding any one carry out surface modification treatment, implant net surface and generate and can improve biocompatibility or osseous tissue induces the degradable biological coating of performance.
Preferably, in described step (2), Biomimetic the metal implant of machine-shaping will put into immersion treatment in bionical solution to any of the above-described scheme, makes plant net surface generate apatite layer.
Any of the above-described scheme is preferably, described step (2) intermediate ion bundle assisted deposition will be put in the vacuum equipment of ion beam assisted depositing the metal implant of machine-shaping, has the calcium phosphor coating of higher Ca/P ratio by joining preparation in HA powder with CaO powder.
Any of the above-described scheme is preferably, in described step (2), electrochemical deposition i.e. uses galvanostatic deposition pattern, and using the metal implant of machine-shaping as the negative electrode of electrochemical reaction, platinized platinum is as anode, the electrolyte of calcium phosphorus mixed solution composition, deposits under the conditions of boiling.
Any of the above-described scheme is preferably, in described step (2) laser cladding will scribble hydroxyapatite metal implant use laser cladding apparatus carry out Laser Cladding Treatment, laser power is 8W, and laser spot diameter is 0.6mm, and laser pulse frequency is set to 2.0Hz.
Any of the above-described scheme preferably, in described step (1) molding mode of metal implant can use a material braiding, laser engraving, machine, mold, weld, cast, in any one method molding.
The present invention provides a kind of skull reparation degradable metal implant and preparation method thereof, for head injury and Plastic renovation, including implanting net, bone screw holes is arranged on implantation net around, implant net there is penetrating network structure and there is bionical radian, implant net and bone screw holes and obtain degradable biological coating by surface modification treatment.Penetrating network structure is easy to the growth of implant bottom and surrounding tissue.
The advantage that the present invention has the following aspects:
1. having biodegradability, the most existing non-degradable metallic prosthetic implant, the skull that degradable metal material makes is repaired implant and gradually can be degraded after reaching dummy purpose, Chronic inflammation will not be caused to react.
2. biomechanical stability is good, and for relative degradable high polymer material, the skull that degradable metal material makes is repaired implant and had higher specific strength, can effectively protect cerebral tissue.And the plasticity of metal excellence can be utilized, change the shape of implant at any time, and keep the state after plastotype, it is to avoid phenomenons such as subsiding occurs.
3. the biological functional of coating, metal implant surface obtains biological functional coating, has on the one hand efficiently controlled the biodegradation rate of implant, has made implant have more preferable biocompatibility and osseous tissue induced growth characteristic simultaneously.
4. simple in construction, can shift to an earlier date prefabricated different model, can on-the-spot cutting, it is also possible to personalized customization, uses 3-D scanning technology to scan at the defect of patient, collects data, then use computer software modeling, prepare the implant more mated with patient.
Accompanying drawing explanation
Fig. 1 is an embodiment structural representation of degradable metal implant；
Fig. 2 is another embodiment structural representation of degradable metal implant；
Fig. 3 is another embodiment structural representation of degradable metal implant.
Detailed description of the invention
In order to be best understood from technical scheme and advantage, below by way of detailed description of the invention, the present invention will be further described.
The present invention provides a kind of skull reparation degradable metal implant and preparation method thereof, for head injury and Plastic renovation, including implanting net 1, bone screw holes 2 is arranged on implantation net 1 around, implant net 1 there is penetrating network structure and there is bionical radian, implant net 1 and bone screw holes 2 obtains degradable biological coating by surface modification treatment.Penetrating network structure is easy to the growth of implant bottom and surrounding tissue; meet the reparation requirement of human skull; and degradation rate can be controlled by surface-functionalized process; obtain good biological activity and biocompatibility; and promote the regeneration of defect of skull, healing; can progressively degrade after completing biomechanical stability, brain protection and cosmetic result, absorbed or discharge.In the specific implementation, degradable metal implant can use by monolayer, or two-layer combination of the above uses.
Implanting net 1 thickness is 0.1-1.0mm, thick for edge thickness 1-2 times in middle part, and the thick structural stability that can play a protective role and can maintain whole implant in middle part prevents from subsiding；Having bionical radian, inside has penetrating network structure, and Symmetry Edge designs at least 4 bone screw holes 2 and is beneficial to fixing, and another Symmetry Edge is beneficial to the defect of skull edge that coincide.
The material of skull reparation degradable metal implant uses the biodegradable metal medically used at present, including magnesium base alloy material (including pure magnesium alloy, magnalium, magnesium-manganese alloy, magnesium-zinc alloy, Mg-Zr alloys, magnesium-rare earth alloy, magnesium calcium alloy material), ferrous alloy material (including the thio gold of pure iron alloy, iron-carbon alloy, ferrum, ferrotungsten row, ferromanganese material) and Zn-base alloy (including pure kirsite, zinc magnesium alloy material).In in magnesium base alloy, ferrous alloy, Zn-base alloy, the content of alloying element should meet the claimed range of bio-medical, make its catabolite that tissue toxicity will not be caused to react, wherein aluminum Al weight content < 9%, Zn, Mn, Si or RE weight content < 5%, the weight content < 1% of Zr；The weight content < 3% of Ca.Alloy representative such as magnesium base alloy material Mg-6Zn, LAE442, AM60, WE43, LA91, ZK21, Mg-1Ca etc., ferrous alloy material such as Fe, Fe-2W, Fe-Mn, Fe-0.5cnt,
Fe-W etc., Zn-base alloy such as Zn, Zn-1Mg etc..
The degradable metal implant of the present invention passes through surface modifying treatment, obtain degradable biological coating, on the one hand controlling the degradation rate of degradable metal, on the other hand make implant have biological activity and the biocompatibility of excellence, the catabolite of whole implant does not affect New born formation.While whole implant possesses enough resistance to compressions and bending strength, it is also equipped with good elasticity and toughness, is suitable for the reparation requirement of human skull.The most existing non-degradable metallic prosthetic implant, the skull that degradable metal material makes is repaired implant and gradually can be degraded after reaching dummy purpose, Chronic inflammation will not be caused to react；Biomechanical stability is good; relatively for degradable high polymer material; the skull that degradable metal material makes is repaired implant and is had higher specific strength; can effectively protect cerebral tissue; and the plasticity of metal excellence can be utilized; change the shape of implant at any time, and keep the state after plastotype, it is to avoid phenomenons such as subsiding occurs；The biological functional of coating, metal implant surface obtains biological functional coating, has on the one hand efficiently controlled the biodegradation rate of implant, has made implant have more preferable biocompatibility and osseous tissue induced growth characteristic simultaneously；Simple in construction, can shift to an earlier date prefabricated different model, can on-the-spot cutting, it is also possible to personalized customization, uses 3-D scanning technology to scan at the defect of patient, collects data, then use computer software modeling, prepare the implant more mated with patient.
The detailed description of the invention of the present invention be described in detail below:
Embodiment 1:Mg-1Ca alloy, argyle design, Biomimetic
(1) the Mg-1Ca alloy selected, machining obtains the implantation net 1 that 0.5mm is thick, implanting 1/5th area thickness in the middle part of net 1 is 1.0mm, the aperture of bone screw holes 2 is 1.2mm, implant and be uniformly provided with V-notch 3 on two Symmetry Edges of net 1, to implant net 1 a size of 30 × 30mm thin slice, prepare curved surface, the inside and outside curved surface implanting net 1 has ± radian of 30 °.
Laser engraving diamondwise pierced pattern, as it is shown in figure 1, implant to be put into ultrasonic cleaning 10min in acetone, then ultrasonic cleaning 10min in ethanol, ultrasonic cleaning 10min the most in deionized water, it is dried.
(2) bionical solution (the anhydrous CaCl of SILVER REAGENT of 37 DEG C it is placed in2(100mg/L) be dissolved in DPBS, preparation calcic DPBS solution) in soak 12 hours, after taking-up in deionized water rinse after, be dried.The thickness of surface apatite is 10 μm, is 40Mpa with the bond strength of matrix.
According to the method for the present invention and use the metal implant that Mg-1Ca alloy obtains, the Mg-1Ca alloy of selection is compact texture or loose structure.
In the specific implementation, the present invention also provides for the using method of a kind of skull reparation degradable metal implant, and degradable metal implant can use by monolayer, or two-layer combination of the above uses.When being two-layer such as degradable metal implant, ground floor degradable metal implant, selecting Mg-1Ca alloy is loose structure, the loose structure of Mg-1Ca alloy is for medicament-carried, generating surface apatite after medicament-carried in bionical solution, not only act as the preliminary effect closing medicine, apatite is loose structure simultaneously, can be used for medicament-carried, the loose structure of Mg-1Ca alloy and surface apatite can be used in carrying similar and different medicine；Surface apatite top is additionally provided with one layer of degradable metal implant, it is second layer degradable metal implant, now, can be as required, the Mg-1Ca alloy that degradable metal implant is selected is compact texture or loose structure, when for compact texture, Mg-1Ca alloy then can not be used for medicament-carried, when for loose structure, then can be used to medicament-carried, simultaneously, the surface apatite that its surface generates in bionical solution may also be used for medicament-carried, the loose structure of Mg-1Ca alloy and surface apatite can be used in carrying similar and different medicine, ground floor degradable metal implant and the medicine or identical or different of second layer degradable metal implant carrying, can be used for patient is carried out intermittent therapy or continued treatment.
Have the advantage that
1, specific strength is high.Relatively for degradable high polymer material, the skull repairing body that magnesium alloy materials makes has higher specific strength, can effectively protect cerebral tissue.And the plasticity of metal can be utilized, change the shape of dummy at any time, and the state after plastotype can be kept, it is to avoid phenomenons such as subsiding occurs.
2, osseous tissue inducing properties.In the pure magnesium of degradable and magnesium alloy simulated body fluid in vitro, research shows to increasingly generate the class bone phosphate of rich magnesium, it has also been found that magnesium alloy has the characteristic promoting and inducing bone growth in animal experiment, the present invention combines the good biocompatibility of degradable biological pottery and the advantage of induction osseous tissue simultaneously, on the one hand efficiently controlled the biodegradation infiltration rate of repairing body, made dummy have more preferable biocompatibility and osseous tissue induced growth characteristic simultaneously.
3, safe, practical property is good.Magnesium is the macroelement being only second to calcium, sodium and potassium in human body, and everyone daily requirement amount of being grown up is more than 350mg, and it participates in internal a series of metabolic processes.Finally it is corroded under degradable magnesium and magnesium alloy physiological environment in vivo and degrades and be absorbed by organisms or metabolism, its catabolite is mainly the magnesium ion of needed by human body, magnesium is needed by human body macroelement, other alloying element contents contained are all within the scope of bio-medical, selected degradable high polymer material is also the most conventional, therefore it is safe for using the pure magnesium after present invention process and magnesium alloy to prepare the medical embedded device of controlled degradation, has the biggest advantage and application prospect.
Embodiment 2
Fe-30Mn-1C alloy, circular, ion-beam assisted deposition
(1) the Fe-30Mn-1C alloy selected, machining obtains the implantation net 1 that 0.5mm is thick, implanting 1/5th area thickness in the middle part of net 1 is 1.5 times of edge thickness, i.e., implanting 1/5th area thickness in the middle part of net 1 is 0.6mm, the aperture of bone screw holes 2 is 1.2mm, the size implanting net 1 is 30 × 30mm thin slice, prepare curved surface, the inside and outside curved surface implanting net 1 has the ± radian of 45 °, the circular pierced pattern of laser engraving, as shown in Figure 2, implant is put into ultrasonic cleaning 10min in acetone, ultrasonic cleaning 10min the most in ethanol, last ultrasonic cleaning 10min in deionized water, it is dried.
(2) Fe-30Mn-1C alloy implant is put into the vacuum equipment of ion beam assisted depositing, by joining preparation in HA powder with 37%CaO powder, there is the calcium phosphor coating of higher Ca/P ratio.Use electron-beam evaporator and the ion gun of bulbous end degree of lip-rounding formula.Before deposition, substrate 120V, 2A ar-ion beam sputter clean 20min, it is thus achieved that suitably vacuum (basic pressure 2 × 10 7Torr).Through the ion beam bombardment of 20min, the water vapor flux of evaporation generates on electron-beam evaporator, and deposits to certain thickness on rotary plate.In deposition, base reservoir temperature keep below 100 DEG C.Take some sample and at 250 DEG C of annealing 2h and immerse 30min in 100 DEG C of deionized waters.Taking out, 37 DEG C of drying baker are vacuum dried 48 hours.
Embodiment 3
Pure Zn, XO, electrochemical deposition method
(1) pure Zn metal is selected, machining obtains 0.5mm thickness and implants net 1, implanting 1/5th area thickness in the middle part of net 1 is 1.5 times of edge thickness, i.e. implanting 1/5th area thickness in the middle part of net 1 is 7.5mm, the aperture of bone screw holes 2 is 2mm, implant net 1 a size of 30 × 30mm thin slice, prepare curved surface, the inside and outside curved surface implanting net 1 has the ± radian of 60 °, and laser engraving becomes XO intermittent pattern, as shown in Figure 3, implant is put into ultrasonic cleaning 10min in acetone, ultrasonic cleaning 10min the most in ethanol, the most in deionized water ultrasonic cleaning 10min, be dried.
(2) using galvanostatic deposition pattern, electric current density controls as 1.0mA/cm2Left and right；Using pure Zn metal as the negative electrode of electrochemical reaction, electrode is selected platinized platinum；Electrolyte is the CaCl of 10-4mol/l2And Na2HPO4Mixed solution, PH regulate between 5.5-7.0, boiling under the conditions of deposit, sedimentation time is 10-30 minute.Taking out, 37 DEG C of drying baker are vacuum dried 48 hours, it is thus achieved that degradable biological coating layer thickness be 15 μm.
Embodiment 4
Zn-1Mg alloy, oval, laser cladding
(1) Zn-1Mg metal is selected, machining obtains 1.0mm thickness and implants net 1, a size of 50 × 50mm thin slice, implanting 1/5th area thickness in the middle part of net 1 is 1.8mm, prepares curved surface, the inside and outside curved surface implanting net 1 has the ± radian of 80 °, laser engraving ovalisation pattern, puts into ultrasonic cleaning 10min in acetone, then ultrasonic cleaning 10min in ethanol by implant, last ultrasonic cleaning 10min in deionized water, is dried.
(2) adjusting laser cladding apparatus parameter, laser power is 8W, laser spot diameter is set to 0.6mm, laser pulse frequency is set to 2.0Hz.The intravascular stent scribbling hydroxyapatite is placed in laboratory table and carries out Laser Cladding Treatment by setup parameter.Taking out, 37 DEG C of drying baker are vacuum dried 48 hours.
It should be noted that various embodiments above is only in order to illustrate technical scheme, it is not intended to limit；Although the present invention being described in detail with reference to foregoing embodiments, it will be understood by those within the art that: the technical scheme described in foregoing embodiments still can be modified by it, or the most some or all of technical characteristic is carried out equivalent；And these amendments or replacement, do not make the essence of appropriate technical solution depart from the scope of various embodiments of the present invention technical scheme.
Claims (10)
1. a skull reparation degradable metal implant, for head injury and Plastic renovation, it is characterized in that, including implanting net, bone screw holes is arranged on implantation net around, implant net there is penetrating network structure and there is bionical radian, implant net and bone screw holes and obtain degradable biological coating by surface modification treatment.
2. skull reparation degradable metal implant as claimed in claim 1, it is characterized in that, described implantation net and bone screw holes surface use in Biomimetic, ion-beam assisted deposition, chemistry or electrochemical deposition method, ion implantation, plasma spraying method or laser cladding any one carry out surface modification treatment.
3. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that described degradable biological coating is any one in calcium silicates, apatite or tricalcium phosphate.
4. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that described degradable biological coating is any one complex formed with biodegradated polymer materal in calcium silicates, apatite or tricalcium phosphate.
5. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that described degradable biological coating layer thickness is 1-20 μm, and degradable biological coating is 30-100MPa with the bond strength of implantation net.
6. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that the interior positive camber of described implantation net is respectively provided with ± 0 °～the radian of ± 90 °.
7. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that described implantation net thickness is 0.1-1.0mm.
8. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that described implantation net gradient thickness is distributed, implant net 1-2 times that interior thickness is edge thickness.
9. skull reparation degradable metal implant as claimed in claim 1, it is characterised in that in the middle part of described implantation net, 1/5th area thickness are 1-2 times of edge thickness.
10. a skull reparation preparation method for degradable metal implant, comprises the following steps:
Step (1), metal implant machine-shaping；
Step (2), the metal implant surface of machine-shaping is used in Biomimetic, ion-beam assisted deposition, chemistry or electrochemical deposition method, ion implantation, plasma spraying method or laser cladding any one carry out surface modification treatment, implant net surface and generate and can improve biocompatibility or osseous tissue induces the degradable biological coating of performance.
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| CN201610239350.2A CN105797208A (en) | 2016-04-18 | 2016-04-18 | Degradable metal implant for repairing skull and preparation method thereof |
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| CN115533122A (en) * | 2022-12-01 | 2022-12-30 | 四川工程职业技术学院 | Iron-based alloy body and forming method and application thereof |
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