Patent Application
20130231754
1. Field of the Invention
The present invention relates to material used for an implant implanted intravitally, and in particular, relates to implant material made of porous metal.
Priority is claimed on Japanese Patent Application No. 2010-251432, filed Nov. 10, 2010, the content of which is incorporated herein by reference.
2. Description of the Related Art
Patent Documents 1 to 3 describes implants which are implanted intravitally.
An implant (an intervertebral spacer) described in Patent Document 1 is used by inserted and arranged between centrums from which an intervertebral disk is removed. In order to easily insert the implant and prevent the implant from falling out, the implant includes a spacer body with an upper surface and a lower surface having unique figures.
An implant (a dental implant) described in Patent Document 2 is formed from: a heart material which is formed from solid-columnar titanium or titanium alloy; and a porous layer which is arranged by the heart material. The porous layer is made by sintering a plurality of spherical grains made of titanium or titanium alloy so that a plurality of continuous holes are made between the spherical grains which are bound with each other by sintering. The spherical grains each have a surface layer of gold-titanium alloy, so that the adjacent spherical grains are bound with each other by the surface layers. Accordingly, the implant described in Patent Document 2 is suggested as a small dental implant having high bound strength with a jawbone.
An implant described in Patent Document 3 is made of porous material, and includes a first part with high porosity rate and a second part with low porosity rate. In this case, for example, by inserting the second part of the implant made from absolute high-density material having a titanium-inlay-shape into a hole made at the second part of the implant having a shape of titanium foam in green and sintering them, the second part is adhered by contracting the first part. The second part with low porosity rate is used for implanting or adhesion, so that it can be prevented to waste the grains in implanting or adhesion because of the low porosity rate.
Patent Document 1: Japanese Examined Patent Application, Second Publication No. 4164315
Patent Document 2: Japanese Examined Patent Application, Second Publication No. 4061581
Patent Document 3: Japanese Translation of the PCT International Publication, Publication No. 2009-504207
Since these implants are used for a part of intravital bone, excellent conherence to bone and appropriate strength for assuming a part of bone. However, the strength tends to fail if following the cohesion to bone; on the other hand, the cohesion to bone tends to be poor if following the strength, so that it is difficult to satisfy both of the strength and the cohesion.
The implants described in Patent Documents 2 and 3 are considered to be possible to satisfy the cohesion to bone and the necessary strength since they have a composite construction of the solid-heart material and the porous layer or a composite construction of the first part with high-porosity rate and the second part with low-porosity rate. However, if metal material is used as an implant, since metal material generally has higher strength than that of human bone, the implant may receive most of load on bone, so that stress shielding (i.e., a phenomena in which the vicinity of inserted part of the implant to bone becomes brittle) may arise.
Therefore, it is required for the implants to have the strength equivalent to that of the human bone. However, the human bone has a combined structure of bio-apatite having a dimetric crystal construction with collagen fiber, and has a strength property preferentially oriented along a C-axis direction. Accordingly, it is difficult for the implant to approach the human bone simply by combining the structures as described in Patent Documents.
The present invention is achieved in consideration of the above circumstances, and has an object to provide porous implant material having a strength property approximate to human bone, without arising stress shielding, and which is possible to maintain sufficient bound strength with human bone.
Porous implant material according to the present invention has a plurality of porous metal bodies which are bonded with each other at bonded-boundary surfaces parallel to a first direction, wherein each the porous metal body has a three-dimensional network structure formed from a continuous skeleton in which a plurality of pores are interconnected so as to have a porosity rate different from another porous metal body, the pores formed in at least the porous metal body having the higher porosity rate are formed to have flat shapes which are long along a direction parallel to the bonded-boundary surface and short along a direction orthogonal to the bonded-boundary surface, a length along the bonded-boundary surface is 1.2 times to 5 times of a length orthogonal to the bonded-boundary surface in, the pores, an entire porosity rate of a bonded body of the porous metal bodies is 50% to 92%, a compressive strength compressing in the direction parallel to the bonded-boundary surface is 1.4 times to 5 times of a compressive strength compressing in the direction orthogonal to the bonded-boundary surface.
The porous implant material can be unitarily bonded to bone by infiltrating the bone into the interconnected pores; particularly, it is easier for the bone to be infiltrated in the porous metal body with high porosity rate. Furthermore, since the porous metal body with low porosity rate is bonded, the compressive strength is large in the direction of the bonded-boundary surface. Moreover, even in the porous metal body with low porosity rate, since the pores are formed flat along the bonded-boundary surface, the compressive strength is large in a flat direction. Therefore, in the bonded body, the compressive strength along the bonded-boundary surface is different from the compressive strength orthogonal to the bonded-boundary surface, so that a strength property is anisotropic as human bone. Accordingly, by implanting the porous implant material into a human body with according the anisotropic strength to a directional strength property of human bone, the stress shielding can be efficiently prevented from arising.
In this case, if a ratio of the length along the bonded-boundary surface and the length orthogonal to the bonded-boundary surface is lower than 1.2, the strength may be insufficient; if the ratio is more than 5, the pores are too low so that infiltration of bone may be too slow and the bonding may be insufficient.
If the entire porosity rate is lower than 50%, the filtration of bone is slow, so that a bound function is insufficient. If the entire porosity rate is higher than 92%, the compressive strength is low, so that function as an implant of supporting bone is insufficient.
By bonding the plurality of porous metal bodies, various block-like materials can be easily made.
Furthermore, in a case in which the porous implant material formed as described above is utilized as an implant, it is possible to add a porous metal body which is bonded at a bonded-boundary surface with a different direction from the direction parallel to the first direction if required.
In the porous implant material according to the present invention, when the first direction along the bonded-boundary surface is set to an axial direction, it is preferable that an area-occupation rate of the porous metal body having the lower porosity rate in a cross-sectional surface orthogonal to the axial direction be 0.5% to 50%.
By implanting the porous implant material with according the axial direction thereof to an axial direction of bone, it can be utilized along with the strength property of bone. In this case, if the area-occupation rate is lower than 0.5% in the porous metal body with low porosity rate, the strength of the porous implant material tends to be insufficient; if higher than 50%, the infiltration of bone is slow, so that it tends to take long for the implant to be ossified.
In the porous implant material according to the present invention, it is preferable that the porous metal bodies be foam metal made by expanding and sintering after forming expandable slurry containing metal powder and expanding agent.
The foam metal can be made so as to have the three-dimensional network structure of the continuous skeleton and the pores, and can be controlled in the porosity rate at a wide range by foam of the expanding agent. Therefore, the foam metal can be appropriately utilized according as an intended part.
Moreover, in the foam metal, an opening rate at a surface can be controlled independently of the entire porosity rate. Therefore, by raising a metallic density at the surface (i.e., reducing the opening rate), strength along the bonded-boundary surface is improved, so that anisotropic property can be easily added in combination with the strength property by the flat shape of the pores.
A producing method of porous implant material according to the present invention has steps of: forming a bonded body by bonding a plurality of porous metal bodies, having three-dimensional network structures formed from continuous skeletons in which a plurality of pores are interconnected, at bonded-boundary surfaces along a first direction, and making the pores in at least the porous metal body having a higher porosity rate so as to have flat shapes by compressing the bonded body in a direction orthogonal to the bonded-boundary surface.
According to the porous implant material of the present invention, since the porous metal bodies with low porosity rate are bonded and the flat pores are made in the porous metal bodies with high porosity rate, the porous implant material has the strength property with anisotropic near to human bone. Therefore, by utilizing the porous implant material with according the anisotropic strength to the direction of bone, the stress shielding can be efficiently prevented from arising. Furthermore, it is easy for bone to infiltrate by the interconnected pores, so that the cohesion to bone can be sufficiently maintained.
Below, embodiments of porous implant material according to the present invention will be explained with reference to drawings.
Porous implant material 1 of the present embodiment is made by laminating, a plurality of plate-like porous metal bodies 4 and 5 of foam metal having three-dimensional network structure formed from a continuous skeleton 2 in which a plurality of pores 3 are interconnected, at bonded-boundary surfaces F parallel to a first direction. In the illustrated example, the porous metal bodies 4 with low porosity rate and the porous metal bodies 5 with high porosity rate are laminated alternately. The foam metal constructing the porous metal bodies 4 and 5 is made by expanding and sintering after forming expandable slurry containing metal powder and expanding agent and the like into a sheet-shape as described later. In the foam metal, the pores 3 are open at a front surface, a back surface, and a side surface. The foam metal is made close at the vicinity of the front surface and the back surface with respect to a center part of a thickness direction.
The porous implant material 1 made by laminating the porous metal bodies 4, 5 of the foam metal has an entire porosity rate of 50% to 92%. As schematically shown in
In the porous implant material 1, the first direction along the bonded-boundary surface F is set to an axial direction C when implanting into a living body. The porous metal bodies 4 with low porosity rate is made so that an area-occupation rate in a cross-sectional surface orthogonal to the axial direction C is set in a range of 0.5% to 50% in the entire porous metal bodies 4 with low porosity rate. For example, in
As a bonded body of the porous metal bodies 4, 5, strength when compressing in a direction parallel to the axial direction C (i.e., a longitudinal direction of the pores 3B) shown by the arrow by a continuous line in
Next, a producing method of the porous implant material 1 will be explained.
The porous metal bodies 4, 5 forming the porous implant material 1 are produced by for expandable slurry containing metal powder, expanding agent and the like into a sheet-shape by Doctor Blade method or the like, dehydrating the sheet so as to make a green sheet, and expanding the green sheet after a degreasing process and a sintering process. Furthermore, a plurality of green sheets with different mix amounts of the expanding agent from each other are made. These green sheets are layered and sintered so as to make a layered body of the porous metal bodies 4, 5. Then, by pressing or rolling the layered body to compress in a layered direction, the porous implant material 1 is produced.
The expandable slurry is obtained by kneading metal powder, binder, plasticizer, surfactant, and expanding agent with water as solvent.
As metal powder, for example, powder of metal or oxide thereof which is biologically innocuous for is used, such as pure titanium, titanium alloy, stainless steel, cobalt chromium alloy, tantalum, niobium, or the like. These powders can be produced by hydrogenate-dehydrogenate method, atomize method, chemical process method or the like. An average particle size of these powders is preferably 0.5 μm to 50 μm. These powders are contained in the slurry at 30% by mass to 80% by mass.
As the binder (i.e., a water-soluble resin binder), methyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl methylcellulose, carboxymethylcellulose ammonium, ethyl cellulose, polyvinyl alcohol or the like can be used.
The plasticizer is added in order to plasticize a compact obtain by fanning the slurry. As the plasticizer, for example, polyalcohols such as ethylene glycol, polyethylene glycol, glycerin and the like, oils and fats such as sardine oil, rapeseed oil, olive oil and the like, ethers such as petroleum ether and the like, and esters such as diethyl phthalate, di-n-butyl phthalate, diethylhexyl phthalate, dioctyl phthalate, sorbitan monooleate, sorbitan trioleate, sorbitan palmitate, sorbitan stearate and the like can be used.
As the surfactant, anion surfactants such as alkyl benzene sulfonate, α-olefin sulfonate, alkyl ester sulfate, alkyl ether sulfate, alkane sulfonate and the like, nonionic surface-active agent such as polyethylene glycol derivatives, polyhydric alcohol derivatives and the like, and ampholytic active agent and the like can be used.
As the expanding agent, agent which can form pores in the slurry by generating gas can be used. For example, volatile organic solvents such as pentane, neopentane, hexiane, isohexane, isoheptane, benzene, octane, toluene and the like, that is, anti-soluble hydrocarbon-system organic solvent having carbon number of 5 to 8 can be used. It is preferably that the expanding agent be contained in the expandable slurry by 0.1 to 5% by weight.
The green sheet is formed for the porous metal bodies 4, 5 using the forming apparatus 20 shown in
The forming apparatus 20 forms a sheet by Doctor Blade Method, is provided with: a hopper 21 in which the expandable slurry S is stored; a carrier sheet 22 transferring the expandable slurry S supplied from the hoper 21; rollers 23 supporting the carrier sheet 22; a blade (a doctor blade) 24 forming the expandable slurry S on the carrier sheet 22 at a prescribed thickness; a constant-temperature high-humidity chamber 25 in which the expandable slurry S is expanded; and a dehydrate chamber 26 in which the expanded slurry is dehydrated. A lower surface of the carrier sheet 22 is supported by a supporting plate 27.
Forming Process of Green Sheet
In the forming apparatus 20, at first, the expandable slurry S is charged in the hopper 21 so as to supply the expandable slurry S on the carrier sheet 22 from the hopper 21. The carrier sheet 22 is supported by the rollers 23 rotating to the right in the illustration and the supporting plate 27 so that an upper surface thereof is moved rightward in the illustration. The expandable slurry S supplied on the carrier sheet 22 is moved along with the carrier sheet 22, and formed into plate-shape by the blade 24.
Next, the plate-shape expandable slurry S is expanded in the constant-temperature high-humidity chamber 25 with a prescribed condition (ex., is 30° C. to 40° C. of temperature, 75% to 95% of humidity) with being moved for, for example, 10 minutes to 20 minutes. Subsequently, the expanded slurry S expanded in the constant-temperature high-humidity chamber 25 is dehydrated in the dehydrate chamber 26 with a prescribed condition (ex., 50° C. to 70° C. of temperature) with being moved for, for example, 10 minutes to 20 minutes. As a result, a spongiform green sheet G is obtained. Two types of the green sheets G are produced so as to have different extents of foaming.
Layering and Sintering Process
The two types of green sheets G obtained as above are degreased and sintered in a state of being layered alternately so that the layered body of the porous metal bodies 4, 5 is formed. Specifically, the binder in the green sheets G are removed (dehydrated) under a condition in vacuum, 550° C. to 650° C. of temperature for 25 minutes to 35 minutes, and then further sintered under a condition in vacuum, 700° C. to 1300° C. for 60 minutes to 120 minutes.
The layered body of the porous metal bodies 4, 5 as obtained above has three-dimensional network structures formed from continuous skeletons in which a plurality of pores 3 are interconnected. The porous metal bodies 4, 5 are produced by foaming and sintering the green sheet molded on the carrier sheet 22 so that densities at vicinities of a surface being in contact with the carrier sheet 22 and the counter surface thereof, that is, the densities at the vicinities of a front surface and a back surface, are closer than that of a center part along a thickness direction to have high metallic density. In the porous metal bodies 4, 5, the pores 3 are open at the front surface and the back surface. Therefore, also in the layered body of the porous metal bodies 4, 5, the pores 3 are interconnected from the front surface to the back surface.
Compression Process
Next, the layered body of the porous metal bodies 4, 5 is compressed in the thickness direction (i.e., layered direction) by pressing or rolling at a prescribed pressure.
By the compression process, the porous metal body 5 with higher porosity rate is compressed antecedently. Accordingly, the inner pores 3B are pressed so as to have oblong shapes long along the front surface (i.e., along the bonded-boundary surface) and short to orthogonal to the front surface (i.e., along the thickness direction). If the pores 3B are oblong, as the porous metal body 5, a compressive strength is higher when compressed in a longitudinal direction of the oblong shape than a compressive strength when compressed orthogonal to the longitudinal direction of the oblong shape. In addition, the porous metal body 4 with lower porosity rate is almost not pressed in the compression process, so that the pores 3A are maintained substantially spherically; however, the porous metal body 4 may be slightly pressed.
Furthermore, the porous metal bodies 4, 5 have the high density in the vicinities of the front surface and the back surface thereof. Therefore, the layered body thereof has the higher density in the vicinities of the bonded-boundary surfaces F than at the center part between the bonded-boundary surfaces F.
In the layered body, the porous metal bodies 4 with lower porosity rate are bonded, the pores 3B in the porous metal bodies 5 with higher porosity rate are pressed so as to have oblong shaped long along the bonded-boundary surfaces F, and the density is high in the vicinities of the bonded-boundary surfaces F. Therefore, the strength when being compressed in the bonded-boundary surfaces F (i.e., in the direction shown by the arrow by the continuous line in
Next, the layered body of the porous metal material bodies 4, 5 is cut into a desired shape. An axial direction C is set as a first, direction along the bonded-boundary surfaces F. The layered body is cut so that, in a cross section orthogonal to the axial direction C, an occupation area by the porous metal bodies 4 with low porosity rate is 0.5% to 50% of a total area.
In the porous implant material 1 as produced above, owing to the porosity having the porosity rate of 50% to 92% in total, it is easy to infiltrate for bone when the porous implant material 1 is used as an implant, so that the cohesion to the bone is excellent. Moreover, since the compressive strength is anisotropic; and the porous implant material 1 has the strength property near to the human bone. Therefore, when the porous implant material 1 is used as a part of the bone, by implanting into a human body with according the anisotropic strength to a directional strength property of the human bone, the stress shielding can be efficiently prevented from arising. Specifically, it is preferable that the axial direction C along the bonded-boundary surfaces F of the porous implant material 1 agree with a C-axis direction of the bone.
The human bone is structured from a sponge bone at the center part thereof and a cortical bone surrounding the sponge bone. When the porous implant material is used as the sponge bone, the compressive strength in the axial direction C is preferably 4 to 70 MPa; and an elastic module of the compression is preferably 1 to 5 GPa. When the porous implant is used as the cortical bone, the compressive strength in the axial direction C is preferably 100 to 200 MPa, and the elastic module of the compression is preferably 5 to 20 GPa. In each case, it is preferable that the compressive strength in the axial direction C be directional so as to be 1.4 times to 5 times of the compressive strength of the compressive strength in the direction orthogonal to the axial direction C.
The porous implant material 11 is produced by: Miming two types the green sheet having the different porosity rate by Doctor Blade Method as described above; combining the green sheet for the porous metal body 5 with higher porosity rate with the green sheet for the porous metal body 4 with lower porosity rate by winding; sintering in the combination so as to make a columnar-shaped sintered body; and compressing the sintered body in a radial direction thereof by rolling. By compressing the sintered body by rolling, the pores in the porous metal body 5 with higher porosity rate are pressed radially so as to have oblong-shapes which are bent along the longitudinal direction and a circumferential direction of the columnar-shape.
Therefore, the porous implant material 11 has the higher compressive strength in the longitudinal direction of the columnar-shape (i.e., along the axial direction C) as compared with the compressive strength in the radial direction. Therefore, the porous implant material 11 is implanted so that the axial direction C agrees with the strength property of the bone.
The green sheets were made by the expanding slurry method, and then the porous metal bodies were made from the green sheets. As material, metal powder of titanium having an average particle size of 20 pm, polyvinyl alcohol as a binder, glycerin as a binder, alkyl benzene sulfonate as surfactant, and heptane as expanding agent are kneaded with water as solvent, so that slurry was made. The slurry was formed into a plate-shape and dehydrated, so that the green sheets were made. In this case, by varying mixing ratio or the like of the expanding agent in the slurry, two types of the green sheets were produced so as to have different porosity rate after foaming. Subsequently, the two types of the green sheets were layered alternately, degreased and sintered, so that layered body of the porous metal bodies was obtained.
The layered bodies of the porous metal bodies were compressed by a rolling machine, and cut so that an area-occupation rate of the porous metal bodies with lower porosity rate were 1% or 5%. Finally, pieces of implant material were produced. As comparative examples, non-layered implant material was produced by sintering a sheet of the green sheet.
Prolate degree of the pores in each sample was obtained by: selecting five to ten pores in which the shapes thereof were easy to be certified in a photo image by an optical microscope; calculating the prolate degrees from lengths Y and X of the selected pores from the photo image; and averaging the prolate degrees.
The compressive strengths were measured according to JIS H 7920 (Method for Compressive Test of Porous Metals).
As shown in
It was considered that: if the area-occupation rate was small, the compressive strength was low and a difference between the strength along the front surface and the strength orthogonal to the front surface was small; however, by adjusting the porosity rate appropriately, appropriate implants having a wide range of the compressive strength can be produced.
The present invention is not limited to the above-described embodiments and various modifications may be made without departing from the scope of the present invention.
For example, in the above embodiments, two types of the porous metal bodies having the different porosity rates, i.e., the porous metal bodies with higher porosity rate and the porous metal bodies with lower porosity rate, are bonded. However, three or more types of porous metal bodies each having different porosity rate may be bonded.
When a plurality of porous metal bodies are bonded, various configurations may be carried out as shown in
As a bonding method, a method in which the porous metal bodies are each sintered, and then assembled and diffusion-bonded, can be accepted besides the method in which the green sheets are assembled and then sintered. When compressing, the bonded bodies having the columnar configuration shown in
In each case, it is important that the bonded-boundary surfaces F are parallel to the first direction. Consequently, in combination with the directional strength of the compressed pores, the compressive strength along the direction parallel to the bonded-boundary surface F can be higher than the compressive strength along the direction orthogonal to the bonded-boundary surface F. Moreover, when using as an implant, another porous metal body can be added that is bonded at a bonded-boundary surface along the other direction than the direction parallel to the prolate direction of the pores (i.e., parallel to the first direction) as appropriate if the directivity of the intended strength can be maintained.
When forming the slurry into a sheet-shape by Doctor Blade Method, the green sheets can be formed in a layered state by supplying expandable slurries each having different mixing rate of the expanding agent in a layered state from a plurality of hoppers as shown in
Furthermore, a method of decompression-foaming can be accepted besides the method of expanding and forming by Doctor Blade Method. Specifically, pores and dissolved gas are once removed from the slurry, and then the slurry is stirred while adding gas, so that expandable slurry is made into a state in which bubble nucleus of the added gas are made and distributed therein. Subsequently, the slurry including the bubble nucleus is decompressed to a prescribed pressure and maintained at pre-cooling temperature higher than freezing point and lower than boiling point of the slurry at the prescribed pressure, so that the bubble nucleus are expanded and the slurry in which volume thereof is increased by the expansion of the bubble nucleus is vacuum-freeze dried. By sintering the green body obtained as abovementioned, porous sintered body can be produced.
The implant material of the present invention can be used which is implanted into a living body as an implant such as an intervertebral spacer, a dental implant and the like.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2010-251432 | Nov 2010 | JP | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/JP2011/075950 | 11/10/2011 | WO | 00 | 5/8/2013 |
