CN101617965A - Preparation method and product of biomedical porous implantation body - Google Patents
Preparation method and product of biomedical porous implantation body Download PDFInfo
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- CN101617965A CN101617965A CN200810115898A CN200810115898A CN101617965A CN 101617965 A CN101617965 A CN 101617965A CN 200810115898 A CN200810115898 A CN 200810115898A CN 200810115898 A CN200810115898 A CN 200810115898A CN 101617965 A CN101617965 A CN 101617965A
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Abstract
Aiming to solve the problems that the mechanical property of the implant is reduced and that the mineralization bone is not easily formed in the implant existing in the technology for preparing the biomedical porous implant, the invention provides a biomedical porous implant and a method for preparing the same. The method comprises the following steps of: interweaving threads of the implant material to form a netty structure; pressing the netty structure into an implant coarse blank with a special shape; sintering the implant coarse blank so as to allow the material threads at cross points in the netty structure to form melting connection to prepare the implant. The plantation body prepared by the method can be used for preparing biomedical porous nickel-titanium alloy implants such as denda, artificial joints and the like and realizing the deep freezing treatment of hemangioma, ecphymata and keloid by carrying liquid nitrogen.
Description
Technical field
The present invention relates to a kind of bio-medical implant technology, the particularly technology of preparing of multiporous biological medical implant.
Background technology
At biomedical sector, often adopt alloy material to make implant, alloy material is normal selects to have the material of characteristics such as good biocompatibility, as using Nitinol more widely.The microstructure of existing bio-medical implant is a loose structure, and promptly implant itself has numerous small holes that are interconnected.Because the existence of this loose structure makes implant itself have certain elasticity and changes the space, thus the mechanical property that makes implant itself and natural bone etc. on every side the organism environment facies mate.In addition, when the aperture of loose structure greater than 0.1mm, interconnecting hole footpath (interface channel size between the hole) is during greater than 0.05mm, implant is in the organism environment behind the certain hour, in the hole, can also form the mineralising bone, this makes and helps human body fluid transmission nutritional labeling by the fixing more reliable of implant, can shorten the convalescence of organism greatly.Porous implant has a wide range of applications in the bio-medical field as the reparation and the replacement surgery embedded material of sclerous tissueses such as bone, joint and tooth.
The method for preparing at present biomedical porous implantation body mainly adopts powder metallurgy method.As the Chinese invention patent 01138916.8 disclosed scheme of utilizing powder metallurgy process to prepare the porous alloy body.Patent of invention: the preparation technology of combustion synthesis of porous nickel-titanium marmem (01138916.8)---with pure titanium valve and nikel powder is that mixed raw material becomes blank; place heating furnace again; preheating under the protection of inert gas atmosphere; when blank reaches the minimum ignition temperature and is lower than 700 ℃; adopt an end of outer hot source point combustion blank; combustion wave spontaneously spreads to the other end, synthesizing porous niti-shaped memorial alloy.Utilize powder metallurgy process to prepare bio-medical Nitinol porous implant, the product purity height, small investment can prepare element complex-shaped, processing difficulties, and processor is few.
But powder metallurgy process prepares biomedical porous implantation body and also has following problem: because pore creating material and binding agent volatilization in smelting process, produce a large amount of micropores on the feasible pore wall that forms, when implant is stressed, these micropore positions cause stress concentration to cause the implant yield strength low easily, the mechanical properties decrease of implant; In addition, powder metallurgy process is not easy to control the implant pore size and the porosity of generation, and this just is unfavorable for forming the mineralising bone in the hole; The 3rd, can not guarantee effectively to be communicated with between the Kong Yukong in the porous implant of powder metallurgic method preparation, this is unfavorable in the transmission of nutritional labeling that implants, and then is unfavorable for the mineralising bone formation.
Summary of the invention
In order to solve implant mechanical properties decrease that existing preparation biomedical porous implantation body technology exists, to be unfavorable for forming the problem of mineralising bone implanting, the invention provides a kind of preparation method of biomedical porous implantation body, can effectively control the connection between porosity, pore size and the hole of porous implant, thereby not only can guarantee the mechanical property of the implant made but also help forming the mineralising bone implanting.
Another object of the present invention provides the implant that adopts above-mentioned porous implant preparation method preparation.
Technical scheme of the present invention is as follows:
The preparation method of biomedical porous implantation body comprises the steps:
A, implant material silk interweaved forms the network structure body;
B, described network structure body is pressed into the implant crude green body of given shape;
C, sintering implant crude green body make material silk formation welding in place, cross point in the network structure body, are prepared into implant.
The realization of steps A comprises following fine division step:
A1, implant material silk is prepared into banded elementary cell, described elementary cell is the spirillum by implant material filament winding system, or the broached-tooth design body of making by bending implant material silk, or the netted pipe that utilizes implant material silk to be woven into;
A2, with the described elementary cell body that is woven into a mesh structure.
The realization of steps A 2 comprises the steps:
Elementary cell is woven into fishing net shape structure, with fishing net shape structure by curling and/or being bent to form described network structure body.
Described implant material is a Nitinol, and the mass ratio of two kinds of elements of titanium nickel is between 0.66～1.2 scope in the described alloy, and the oxygen content of described alloy is less than 500ppm, and phosphorus content is less than 700ppm, and hydrogen content is less than 500ppm.
The diameter of described nitinol alloy wire is 0.1mm-0.5mm.
Described spirochetal pitch is 0.5-3mm, and spiral shell directly is 0.5-3mm; The tooth pitch of described broached-tooth design body is 0.5-3mm, and tooth depth is 0.5-3mm; The caliber of described netted pipe is 0.5-3mm.
Sintering implant crude green body comprises the steps: the implant crude green body is placed vacuum state, 800-1400 ℃ following sintering 1-9 hour, stove is chilled to room temperature then, vacuum is 1.0 * 10
-3-5.0 * 10
-2Pa.
The preparation method of above-mentioned biomedical porous implantation body also comprises the step that forms hydroxyapatite coating layer behind the sintering at implant surfaces.
Adopt the porous implant of method for preparing.
The porosity of above-mentioned porous implant is 35%-85%, and the aperture is 0.05-2mm.
Technique effect of the present invention:
Adopt technical scheme of the present invention, directly utilize implant material silk to make implant by means such as bending, interweave, form the loose structure of implant by above-mentioned means, avoid powder metallurgy process pore creating material volatilization in sintering process on hole wall, to produce micro-pore, and then caused the problem of implant mechanical properties decrease.In addition, method of the present invention can effectively be controlled size and the porosity of implanting body opening in the steps such as implant material silk, compacting that interweave, solved that existing implant porosity, pore-size by the powder metallurgic method preparation is difficult to control and the hole between be communicated with the problem that is difficult to guarantee, thereby solved cause thus be unfavorable for mineralising osteoplastic problem.Adopt technical scheme of the present invention to make the porosity of implant controlled, can realize requiring the implant of the various complicated shapes of preparation according to reality.
The inventive method can be used through the implant that simple compacting forms given shape and hole, uses after also implant can being adhered to overcoat.Implant coating hydroxyapatite coating layer of the present invention can apply on the inner surface of hole, can protect implant effectively, prolongs the service life of implant.
Description of drawings
Fig. 1 is an example of elementary cell of the present invention;
Fig. 2 is second example of elementary cell of the present invention;
Fig. 3 is the 3rd example of elementary cell of the present invention;
Fig. 4 is for utilizing the interlacing example of elementary cell.
The specific embodiment
Describe the method that the present invention prepares biomedical porous implantation body below in detail.
At first, adopt implant material silk material to make banded elementary cell.The material of implant is a titanium alloy in the present embodiment, the composition scope of Nitinol is that the mass percent of two kinds of elements of titanium nickel is between 0.66～1.2 scope, the oxygen content of Nitinol is less than 500ppm, phosphorus content is less than 700ppm, hydrogen content is less than 500ppm, the Nitinol that above-mentioned parameter limits has good super-elasticity, can satisfy the requirement of bio-medical.The shape of elementary cell can be but be not limited to Fig. 1 to shape shown in Figure 3, concrete operation method be with diameter be the nitinol alloy wire of 0.1mm-0.5mm to turn to pitch be 0.5-3mm, spiral shell directly constitute implant for the taenidium of 0.5-3mm elementary cell, as shown in Figure 1.The preparation method of second kind of elementary cell is the elementary cell that the nitinol alloy wire of 0.1mm-0.5mm is converted into the zigzag structure formation implant of tooth pitch 0.5-3mm, tooth depth 0.5-3mm, as shown in Figure 2.The preparation method of the third elementary cell be the nitinol alloy wire with 0.1mm-0.5mm to be woven into diameter be the elementary cell that the netted pipe of 0.5-3mm constitutes implant, as shown in Figure 3.Preferred nitinol alloy wire diameter dimension also comprises 0.2mm, 0.3mm and 0.4mm.Preferred pitch, spiral shell footpath size also comprise 1mm, 1.5mm and 2mm.Preferred tooth pitch, tooth depth size also comprise 1mm, 1.5mm and 2mm.The diameter of preferred netted pipe (caliber) size also comprises 1mm, 1.5mm and 2mm.Such as background technology part introduction, because the size of interface channel forms mineralising bone important influence for finally whether being beneficial between implant aperture and hole, therefore, above-mentioned diameter and the preferred of elementary cell relative dimensions to nitinol alloy wire all is provided with for the size that realizes favourable hole.Curvature when for example the diameter of above-mentioned preferred nitinol alloy wire can make the bending of alloy silk is more suitable for forming the size in above-mentioned hole.
The second, with the elementary cell body that is woven into a mesh structure, be about to banded elementary cell coiling, level is arranged and is formed monolayer holey thin slice (similar fishing net shape).Fig. 4 has shown and a kind of elementary cell has been woven into the example of monolayer holey thin slice, with the elementary cell coiling, forms the monolayer holey thin slice of square crossing, and the gap between the alloy silk should specifically be determined according to the size of the implantation body opening of final needs.Monolayer holey thin slice is closely curled formation network structure body.
Except the elementary cell method that interweaves that Fig. 4 shows, can also exempt the step that shape sheet is curled by directly elementary cell being woven into the netted structure in space.For example elementary cell is interweaved and form the network structure body of similar Bird's Nest structure.
By following process, above-mentioned network structure body can be processed into difform implant, in the present embodiment above-mentioned network structure body is put into mould and suppress the implant that forms given shape.The pressure of compacting is between 20MPa-30MPa, and the press time is 20-30 minute.Pressing process can be controlled the size and the structure in final porous implant hole, and concrete grammar is to control by macro-control compacting network structure body compacting distance.Compacting back implant is because the characteristic of nitinol alloy wire itself, rebound phenomenon can appear in the shape of implant and size (size in microcosmic hole and macro-size), in order to address this problem, can calculate contingent springback capacity in advance, in pressing process, this springback capacity can be eliminated by overvoltage (promptly having more certain surplus than predetermined compacting distance).The above-mentioned difform implant that forms through processing can directly be used, and also can carry out using as implant after the intensive treatment to its surface again.
The 3rd, the implant crude green body after the compacting is carried out sintering.Agglomerating main purpose is to form welding in the cross point that interlacing nitinol alloy wire forms.As place, two sections nitinol alloy wire cross points, two sections alloy silks just overlap in this cross point, be subjected to being easy to take place relative slip after the external force, the size in the hole that this just makes the alloy silk interweave to form easily changes, and then bigger variation can take place in the shape of whole implant and structure, and this is unfavorable for that very implant brings into play due usefulness.By sintering, make two sections alloy silks in the fusion of place, cross point, it is moving to make the alloy silk be difficult for that string takes place, the shape of implant and Stability Analysis of Structures.
The present invention will in the service life that can improve implant, can adopt prior art at porous implant surface applied hydroxyapatite coating layer of the present invention through the implant surfaces coating hydroxyapatite coating layer of above-mentioned processing.The described surface that is coated with application layer comprises the inner surface in the hole of macroscopic outer surface of implant and microcosmic.Two end surfaces and a side surface of macroscopic outer surface such as columned implant; The hole of microcosmic is meant the pore structure of porous implant inside, owing to be communicated with between the Kong Yukong, the surface that therefore coating can be coated to the implant endoporus forms overcoat.
Below by five examples implant preparation method of the present invention is described.
Example 1
Cut-off directly is 40: 60 nitinol alloy wire for 0.1mm, titanium nickel mass ratio, it is turned to pitch is that 1mm, spiral shell directly constitute elementary cell for the taenidium of 1mm, formation monolayer holey thin slice is arranged in the elementary cell square crossing, closely curl monolayer holey thin slice then and form the network structure body, the network structure body is put into mould, become the implant crude green body after the compacting.Applied pressure is 20MPa when suppressing in the present embodiment, and the press time is 10 minutes.
Under 20 ℃, be 1: 1 acetone and dehydrated alcohol mixed solvent ultrasonic cleaning implant crude green body 20 minutes, handled 20 minutes with mixed acid then that the mixed acid volume ratio is HF: HNO with the mixed volume ratio
3: H
2O=1: 2: 3, use washed with de-ionized water afterwards.This is conventional surface clean step, removes the impurity on alloy silk surface.
Then (vacuum is 5.0 * 10 in 800 ℃ of vacuum with the implant crude green body
-2Pa) sintering is 9 hours under, and stove is chilled to room temperature and obtains implant of the present invention.
Be 1: 1 NaOH and supersaturation Ca (OH) subsequently with the implant behind the sintering at the mixed volume ratio
2Boiling was handled 8 hours in the mixed solution, and wherein the concentration of NaOH is 5M.This is conventional alkali treatment means, and purpose is to make alloy silk rough surface, is beneficial to the follow-up coating that forms from the teeth outwards.
At last implant is carried out cathodic electrochemical deposition, electrolyte is by 1.0 * 10
-3M Ca (NO)
3With 1.0 * 10
-3MNaH
2PO
4Form, the pH value of electrolyte is 6.1.Control voltage 20V, temperature is 70 ℃, and sedimentation time is 0.1h, and electrochemical deposition promptly obtains the bio-medical porous Nitinol implant that the surface has hydroxyapatite after finishing, and its porosity is 50%, pore size is 0.05-1mm.
Example 2
Cut-off directly is 45: 55 nitinol alloy wire for 0.1mm, titanium nickel mass ratio, it is converted into tooth pitch is that 1mm, tooth depth are the broached-tooth design formation elementary cell of 1mm, formation monolayer holey thin slice is arranged in the elementary cell square crossing, closely curl monolayer holey thin slice then and form the network structure body, the network structure body is put into mould, take out the implant crude green body after the compression moulding.Applied pressure is 25MPa when suppressing in the present embodiment, and the press time is 5 minutes.
Under 35 ℃, be 1: 1 acetone and dehydrated alcohol mixed solvent ultrasonic cleaning implant crude green body 22 minutes, handled 40 minutes with mixed acid then that the mixed acid volume ratio is HF: HNO with the mixed volume ratio
3: H
2O=1: 2: 3, use washed with de-ionized water afterwards.
Then (vacuum is 5.0 * 10 in 1200 ℃ of vacuum with the implant crude green body
-3Pa) sintering is 4 hours under, and stove is chilled to room temperature and obtains implant of the present invention; Be 1: 1 NaOH and supersaturation Ca (OH) subsequently with implant at the mixed volume ratio
2Boiling was handled 6 hours in the mixed solution, and wherein the concentration of NaOH is 10M.At last implant is carried out cathodic electrochemical deposition, electrolyte is by 6.0 * 10
-4M Ca (NO)
3With 6.0 * 10
-4M NaH
2PO
4Form, pH value is 7.0, control voltage 10V, and temperature is 80 ℃, and sedimentation time is 2h, and electrochemical deposition promptly obtains the bio-medical porous Nitinol implant that the surface has hydroxyapatite after finishing, and its porosity is 60%, pore size is 0.05-1.5mm.
Example 3
Cut-off directly is 45: 55 nitinol alloy wire for 0.1mm, titanium nickel mass ratio, it is woven into the netted pipe formation elementary cell that diameter is 1mm, formation monolayer holey thin slice is arranged in the elementary cell square crossing, closely curl monolayer holey thin slice then and form the network structure body, the network structure body is put into mould, take out the implant crude green body after the compression moulding.Applied pressure is 30MPa in the present embodiment, and the press time is 8 minutes.
Under 50 ℃, be 1: 1 acetone and dehydrated alcohol mixed solvent ultrasonic cleaning implant crude green body 27 minutes, handled 50 minutes with mixed acid then that the mixed acid volume ratio is HF: HNO with the mixed volume ratio
3: H
2O=1: 2: 3, use washed with de-ionized water afterwards.
Then (vacuum is 1.0 * 10 in 1250 ℃ of vacuum with the implant crude green body
-3Pa) sintering is 2 hours under, and stove is chilled to room temperature and obtains implant of the present invention; Be 1: 1 NaOH and supersaturation Ca (OH) subsequently with implant at the mixed volume ratio
2Boiling was handled 8 hours in the mixed solution, and wherein the concentration of NaOH is 8M.At last implant is carried out cathodic electrochemical deposition, electrolyte is by 3.0 * 10
-4M Ca (NO)
3With 8.0 * 10
-5M NaH
2PO
4Form, pH value is 5.5, control voltage 8V, and temperature is 90 ℃, and sedimentation time is 8h, and electrochemical deposition promptly obtains the bio-medical porous Nitinol implant that the surface has hydroxyapatite after finishing, and its porosity is 80%, pore size is 0.1-2mm.
Example 4
Cut-off is 50: 50 nitinol alloy wires for 0.5mm, titanium nickel mass ratio directly, it is turned to pitch is that 3mm, spiral shell directly constitute elementary cell for the spirillum of 3mm, formation monolayer holey thin slice is arranged in the elementary cell square crossing, closely curl monolayer holey thin slice then and form the network structure body, the network structure body is put into mould, take out the implant crude green body after the compression moulding.Applied pressure is 30MPa in the present embodiment, and the press time is 5 minutes.
Under 60 ℃, be 1: 1 acetone and dehydrated alcohol mixed solvent ultrasonic cleaning implant crude green body 30 minutes, handled 60 minutes with mixed acid then that the mixed acid volume ratio is HF: HNO with the mixed volume ratio
3: H
2O=1: 2: 3, use washed with de-ionized water afterwards.
Then (vacuum is 2.0 * 10 in 1400 ℃ of vacuum with the implant crude green body
-2Pa) sintering is 1 hour under, and stove is chilled to room temperature and obtains implant of the present invention; Be 1: 1 NaOH and supersaturation Ca (OH) subsequently at the mixed volume ratio
2Boiling was handled 5 hours in the mixed solution, and wherein the concentration of NaOH is 10M.At last implant is carried out cathodic electrochemical deposition, electrolyte is by 1.0 * 10
-4M Ca (NO)
3With 5.0 * 10
-5M NaH
2PO
4Form, pH value is 7.2, control voltage 1V, and temperature is 100 ℃, and sedimentation time is 10h, and electrochemical deposition promptly obtains the bio-medical porous Nitinol implant that the surface has hydroxyapatite after finishing, and its porosity is 80%, pore size is 0.5-2mm.
Example 5
This example is that with the difference of example 4 titanium nickel mass ratio is 55: 45 in the nitinol alloy wire.
The implant of the present invention's preparation can be used for making tooth root and artificial joint, can also carry the deep cooling treatment that liquid nitrogen is carried out hemangioma, vegetation, keloid.The implant that the present invention makes can form the mineralising bone in the hole, form good binding with osseous tissue, compares with traditional implant, can make easier length such as freshman bone tissue, vascular system in hole, shortens patient's convalescence greatly.
Should be pointed out that the above specific embodiment can make those skilled in the art more fully understand the present invention, but do not limit the present invention in any way.Therefore, although this description has been described in detail the present invention with reference to embodiment,, it will be appreciated by those skilled in the art that still and can make amendment or be equal to replacement the present invention; And all do not break away from the technical scheme and the improvement thereof of spirit of the present invention and technical spirit, and it all should be encompassed in the middle of the protection domain of patent of the present invention.
Claims (10)
1, the preparation method of biomedical porous implantation body is characterized in that comprising the steps:
A, implant material silk interweaved forms the network structure body;
B, described network structure body is pressed into the implant crude green body of given shape;
C, sintering implant crude green body make material silk formation welding in place, cross point in the network structure body, are prepared into implant.
2,, it is characterized in that the realization of steps A comprises following fine division step according to the preparation method of the described biomedical porous implantation body of claim 1:
A1, implant material silk is prepared into banded elementary cell, described elementary cell is the spirillum by implant material filament winding system, or the broached-tooth design body of making by bending implant material silk, or the netted pipe that utilizes implant material silk to be woven into;
A2, with the described elementary cell body that is woven into a mesh structure.
3,, it is characterized in that the realization of steps A 2 comprises the steps: according to the preparation method of the described biomedical porous implantation body of claim 2
Elementary cell is woven into fishing net shape structure, with fishing net shape structure by curling and/or being bent to form described network structure body.
4, according to the preparation method of the described biomedical porous implantation body of claim 2, it is characterized in that described implant material is a Nitinol, the mass ratio of two kinds of elements of titanium nickel is between 0.66～1.2 scope in the described alloy, the oxygen content of described alloy is less than 500ppm, phosphorus content is less than 700ppm, and hydrogen content is less than 500ppm.
5, according to the preparation method of the described biomedical porous implantation body of claim 4, the diameter that it is characterized in that described nitinol alloy wire is 0.1mm-0.5mm.
6, according to the preparation method of the described biomedical porous implantation body of claim 5, it is characterized in that described spirochetal pitch is 0.5-3mm, spiral shell directly is 0.5-3mm; The tooth pitch of described broached-tooth design body is 0.5-3mm, and tooth depth is 0.5-3mm; The caliber of described netted pipe is 0.5-3mm.
7, according to the preparation method of the described biomedical porous implantation body of claim 4, it is characterized in that sintering implant crude green body comprises the steps: the implant crude green body is placed vacuum state, 800-1400 ℃ following sintering 1-9 hour, stove is chilled to room temperature then, vacuum is 1.0 * 10
-3-5.0 * 10
-2Pa.
8,, it is characterized in that also comprising the step that forms hydroxyapatite coating layer behind the sintering at implant surfaces according to the preparation method of the described biomedical porous implantation body of claim 4.
9, adopt the porous implant of the described method preparation of one of claim 1-8.
10, according to the described porous implant of claim 9, the porosity that it is characterized in that described porous implant is 35%-85%, and the aperture is 0.05-2mm.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103300945A (en) * | 2013-06-06 | 2013-09-18 | 上海交通大学 | Medical porous composite material |
| CN103599560A (en) * | 2013-11-05 | 2014-02-26 | 上海交通大学 | Medical titanium/magnesium composite material and preparation method thereof |
| CN105999397A (en) * | 2016-06-22 | 2016-10-12 | 苏州大学 | Application of mineralized three-dimensional porous graphene material in bone defect filler |
| US11145850B2 (en) | 2016-06-22 | 2021-10-12 | Soochow University | Soft neural electrode based on three-dimensional porous graphene foam material and use of three-dimensional porous graphene foam material to prepare bone defect filler |
-
2008
- 2008-06-30 CN CN200810115898A patent/CN101617965A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103300945A (en) * | 2013-06-06 | 2013-09-18 | 上海交通大学 | Medical porous composite material |
| CN103599560A (en) * | 2013-11-05 | 2014-02-26 | 上海交通大学 | Medical titanium/magnesium composite material and preparation method thereof |
| CN103599560B (en) * | 2013-11-05 | 2015-04-15 | 上海交通大学 | Medical titanium/magnesium composite material and preparation method thereof |
| CN105999397A (en) * | 2016-06-22 | 2016-10-12 | 苏州大学 | Application of mineralized three-dimensional porous graphene material in bone defect filler |
| CN105999397B (en) * | 2016-06-22 | 2019-02-19 | 苏州大学 | Application of the three-dimensional porous grapheme material of mineralising in bone defect filler |
| US11145850B2 (en) | 2016-06-22 | 2021-10-12 | Soochow University | Soft neural electrode based on three-dimensional porous graphene foam material and use of three-dimensional porous graphene foam material to prepare bone defect filler |
| US11862786B2 (en) | 2016-06-22 | 2024-01-02 | Soochow University | Three-dimensional porous graphene foam material to prepare bone defect filler |
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Open date: 20100106 |