CN100364618C

CN100364618C - Implantation material for surgery in use for repairing bone

Info

Publication number: CN100364618C
Application number: CNB2004100775622A
Authority: CN
Inventors: 戴萌
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-12-27
Filing date: 2004-12-27
Publication date: 2008-01-30
Anticipated expiration: 2024-12-27
Also published as: CN1795931A

Abstract

The present invention relates to a surgical implant material used for repairing bones. The present invention has the production characteristics that a vacuum plasma spray technique is used, titanium powder coatings with two kinds of particle diameters (from 20 to 50 mu m and from 60 to 160 mu m) and a hydroxyapatite powder(particle diameters of which are from 15 to 55 mu m) coating are sprayed on a metallic surface, the thickness of the titanium powder coating with particle diameters from 20 to 50 mu m is from 20 to 50 mu m, the thickness of the titanium powder coating with particle diameters from 60 to 160 mu m is from 70 to 150 mu m, the thickness of the hydroxyapatite powder coating is from 30 to 100 mu m, a crystal degree of finished hydroxyapatite is larger than 55%, the bonding strength of the titanium layers is larger than 50MPa, and the bonding strength of the hydroxyapatite coating is larger than 15MPa. Thereby, the purposes of convenient manufacture processes, easy production and quality control, high bonding strength of coatings, organically tight bonding with bones of human bodies, etc. are realized.

Description

A kind of implantation material for surgery that is used for repairing bone

Technical field

The invention belongs to medical material tech field, be specifically related to be used for the implantation material for surgery that the bone defect repairing operation is used.

Background technology

The repairing bone material is broadly divided into artificial bone material and human body bone material two big classes in the choice.Human body bone material, especially autologous bone transplanting are performed an operation in addition because of need and are got bone and moulding difficulty, few at present the employing.Artificial bone material mainly contains: lucite (polymethyl methacrylate), silicone rubber, bone cement, hydroxyl apatite bioceramic, metal bone substitute (especially titanium), composite etc.

A disclosed Chinese invention patent application " osteo-implanted body of porous titanium with biological coating and manufacture method thereof " (publication number CN1250820A) is at metal surface spraying titanium-aluminum mixed powder or titanium alloy-aluminum mixed powder, its base material bond strength can reach 25～45MPa, but biocompatibility is poor relatively; Chinese invention patent application " the compound preparation technology of hydro-thermal synthesis of nano the hydroxyl apatite biological painting " (number of applying for a patent: 00113787.5) adopt plasma spraying technology to prepare the initial state coating in the metal surface, and the initial state coating is carried out hydro-thermal synthesize, obtain that internal stress is low, the nanometer needle-like hydroxyapatite of high-purity, high-crystallinity, though coating degree of crystallinity is higher, Bond Strength of Coating is lower; Plasma spraying technology is adopted in Chinese invention patent application " preparation method of artificial joint with bio-active gradient coating " (publication number CN1184626A), the bio-active gradient coating that has graded on metallic matrix spraying composition, structure, it is TiO that its bottom is respectively formed proportioning ₂30～40%wt, biological glass powder 10～20%wt, ZrO ₂%10～20wt, hydroxyapatite 50～70%wt, surface layer are hydroxyapatite 100%wt.Though its bond strength reaches 40MPa, degree of crystallinity is on the low side, and processing technology is also complicated.Chinese invention patent application " biological function gradient composite coating material " (number of patent application 02146114.7) is the using plasma spraying method, metal function gradient coating in four layers of different aperture of metal surface spraying, bottom is the thick dense coatings of 25 μ m, second, three, four layers are respectively hole 10～50 μ m, 50～100 μ m, 100～300 μ m, thickness is 50 μ m, then, spray two-layer biological function gradient coating again, wherein one deck is the HA compacted zone, thickness is 25 μ m, outermost layer is the thick HA+ β-TCP of 50 μ m (respectively accounting for a 50%) layer, from the suitability for industrialized production angle, its processing technology too complex is difficult for realizing producing and carrying out quality control, on its properties of product, its structural design result of six layers has also just solved the technical barrier that monolayer or duplex coating can't resolve basically.

Summary of the invention

The bone defect repairing operation is more general, and just operation is implemented itself easily, but when selecting the repairing bone material, consider kposthesis after the embedded material compatibility good, have or not rejection, better coincide the outward appearance perfection with synthetism; The intensity of material is enough big; Aging, distortion that patching material is difficult for, material should have the effect of induced osteogenesis and conduction skeletonization, can degrade gradually and is replaced from the body area of new bone, and its intensity such as does not reduce at factor in this process.Now viewpoint think ideal repairing bone material should: 1. no cytotoxicity; 2. do not have or reduced immunogenicity; 3. can be moulding arbitrarily; 4. has sufficient intensity and toughness; 5. nonmagnetic; 6. can be in body solidified forming; 7. more easily prepare and apply; 8. be convenient to CT and MRI scanography; 9. biodegradable and can be replaced from the body area of new bone within a certain period of time.

Composite is that the material with different degradation characteristics or mechanical property carries out compound, concentrate the feature performance benefit of each component, abandon weak point separately, have one-component or structure material incomparable performance advantage, make material possess the combination property advantage, realize that better it is in the intravital treatment function of people.Thereby composite can be the tissue repair engineering provides performance more superior new material, has represented repairing bone Development of Materials direction.

Technical scheme of the present invention is: on the sheet metal surface, adopt the vacuum plasma spray coating technology, spray the titanium valve and the hydroxylapatite powder [Ca of two kinds of particle diameters ₁₀(PO ₄) ₆(OH) ₂, be called for short HA] and coating, elder generation is at the titanium valve of metal surface spraying particle diameter 30～50 μ m, coating layer thickness 20～50 μ m spray the titanium valve of particle diameter 60～160 μ m, coating layer thickness 70～150 μ m then, spray the hydroxylapatite powder of particle diameter 15～55 μ m at last, coating layer thickness 30～100 μ m.Above-mentioned sheet metal is meant metal materials such as titanium, molybdenum, cobalt, chromium, nickel, titanium alloy, nickel alloy.Above-mentioned implantation material for surgery can be made lamellar or the net lamellar that is used for flat bone defect repairings such as skull.

This its hydroxylapatite crystal degree＞55% of surgical implant finished product that is used for repairing bone, titanium layer bond strength＞50MPa, hydroxyapatite coating layer bond strength＞15MPa.Thereby realized easy, the easy enforcement production of processing technology and carried out quality control that the anchoring strength of coating height is with the organic purpose such as combine closely of human body bone formation.

The present invention is making full use of hydroxyl apatite bioceramic [Ca ₁₀(PO ₄) ₆(OH) ₂, be called for short HA] have with human body bone and tooth in similar chemical composition and the crystal structure of main mine material, be the main inorganic composition of skeleton tissue, can combine with skeleton tissue formation chemical bond.Organize compatible fully, calcium, phosphorus composition can produce slight dissolving in body, dissolved calcium, phosphorus and from the calcium in the blood plasma, phosphorus in material and bone contact surface deposition, form the abundant layer of calcium phosphorus, the calcium of this layer, phosphorus exist with the crystal form similar to HA crystal in the osseous tissue, conduct skeletonization, constitute the good generation chemical bond that is connected with osseous tissue.And titanium has light specific gravity, mechanical strength is big, stretching resistance intensity height, chemical property is stable, nontoxic to human body, unlikely inflammation, sensitization not, retain unlikely corrosion the in the body for a long time, aging, cracked and absorb, the X line can penetrate, do not hinder cranium brain X ray examination, do not hinder EEG (electrocardiogram) examination yet, to the X ray examination, CT and magnetic resonance imaging image do not produce pseudo-shadow, the titanium source, make, moulding easy, intensity is moderate, hardness is lower, the elastic modelling quantity of its elastic modelling quantity and people's bone is approaching, do not cause the stress barrier, under the basis and preceding topic of advantages such as the bone reconstruction in healing that helps fracturing and healing later stage and function reconstruction,, there are two substantially according to human body repairing bone composite, the quality and technical index that also is most critical requires: anchoring strength of coating wants big, coating degree of crystallinity wants height to carry out the science design, adopt the vacuum plasma spray coating technology, two kinds of particle diameter (20～50 μ m in the spraying of metal surface, 60～160 μ m) titanium valve and hydroxylapatite powder (particle diameter 15～55 μ m) coating, titanium valve coating layer thickness 20～50 μ m of particle diameter 20～50 μ m, the titanium valve coating layer thickness of particle diameter 60～160 μ m is 70～150 μ m, the hydroxylapatite powder coating layer thickness is at 30～100 μ m, hydroxylapatite crystal degree＞55% of finished product, titanium layer bond strength＞50MPa, hydroxyapatite coating layer bond strength＞15MPa, thereby realized that processing technology is easy, implement easily to produce and quality control, anchoring strength of coating is big, and the degree of crystallinity height is with the organic purpose such as combine closely of human body bone formation.

The specific embodiment

Describe the present invention in detail below by embodiment, but invention is not limited in this.

Embodiment 1:

Get one of titanium mesh plate, big or small 10mm * 10mm * 0.6mm at first, adopts acetone, ethanol to carry out ultrasonic cleaning successively, removes greasy dirt, after drying up, uses AL ₂O ₃Carry out blasting treatment, then, send into the vacuum plasma spray coating chamber and carry out spray treatment.The titanium valve of particle diameter 20～50 μ m on the titanium mesh plate surface sprays successively, coating layer thickness 20～50 μ m spray the titanium valve of particle diameter 60～160 μ m, coating layer thickness 70～150 μ m then, spray the hydroxylapatite powder of particle diameter 15～55 μ m at last, coating layer thickness 30～100 μ m.Cooling back row analytical test, its hydroxylapatite crystal degree 60%, titanium layer bond strength 55MPa, hydroxyapatite coating layer bond strength 20MPa, quality and technical index meet and exceed standard-requireds such as ISO 13779-2, ISO 5832-2 fully.

Embodiment 2:

Get one of titanium alloy (Ti-6AL-4V), long 200mm, diameter 20mm.At first, adopt acetone, ethanol to carry out ultrasonic cleaning successively, remove greasy dirt, after drying up, use AL ₂O ₃Carry out blasting treatment, then, send into the vacuum plasma spray coating chamber and carry out spray treatment.The titanium valve of particle diameter 20～50 μ m on the titanium mesh plate surface sprays successively, coating layer thickness 20～50 μ m spray the titanium valve of particle diameter 60～160 μ m, coating layer thickness 70～150 μ m then, spray the hydroxylapatite powder of particle diameter 15～55 μ m at last, coating layer thickness 30～100 μ m.Cooling back row analytical test, its hydroxylapatite crystal degree 60%, titanium layer bond strength 55MPa, hydroxyapatite coating layer bond strength 20MPa, quality and technical index meet and exceed standard-requireds such as ISO 13779-2, ISO 5832-2 fully.

Claims

1. implantation material for surgery that is used for repairing bone, the titanium valve and the hydroxylapatite powder coating of two kinds of particle diameters in sheet metal or the spraying of net material surface, it is characterized in that adopting the vacuum plasma spray coating technology to spray the titanium valve of particle diameter 20～50 μ m at sheet metal or net material surface, coating layer thickness 20～50 μ m, spray the titanium valve of particle diameter 60～160 μ m again, coating layer thickness 70～150 μ m, the hydroxylapatite powder of outermost layer spraying particle diameter 15～55 μ m, coating layer thickness 30～100 μ m.

2. the implantation material for surgery that is used for repairing bone according to claim 1 is characterized in that sheet metal or net material are meant titanium, molybdenum, cobalt, chromium, nickel, titanium alloy or nickel alloy metal material.

3. the implantation material for surgery that is used for repairing bone according to claim 1 is characterized in that implantation material for surgery is made lamellar or the net lamellar that is used for the skull defect repairing.