Porous implant material

Abstract

A plurality of porous metal bodies which are bonded with each other at bonded-boundary surfaces parallel to a first direction, each of the porous metal bodies 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, 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.

Claims

1. A porous implant material for sponge bone and cortical bone, comprising: a first set of porous metal bodies; and a second set of porous metal bodies having a higher porosity than and bonded to the metal bodies of the first set in an alternating manner, the metal bodies of the first and second sets bonded with each other at bonded-boundary surfaces parallel to a first direction, wherein each of the porous metal bodies 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 the second set of the porous metal bodies 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 a length orthogonal to the bonded-boundary surface in the pores of the second set, the pores formed in the porous metal bodies of the first set are substantially spherical and are more spherical than the pores formed in the second set of porous metal bodies, an entire porosity rate of the implant material is 50% to 92%, and 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 direction, and the compressive strength in the direction parallel to the bonded-boundary surface is 4 to 70 MPa where used as a sponge bone, or 100 to 200 MPa where used as a cortical bone, and a compressive elastic modulus in the direction parallel to the bonded-boundary surface is 1 to 5 GPa where used as the sponge bone, or 5 to 20 GPa where used as the cortical bone.

2. The porous implant material for sponge bone and cortical bone according to claim 1, wherein when the first direction along the bonded-boundary surface is set to an axial direction, a thickness of a cross-sectional surface of at least one porous metal body of the first set in a direction orthogonal to the axial direction is 0.5% to 50% of the cross-sectional surface.

3. The porous implant material for sponge bone and cortical bone according to claim 1, wherein the porous metal bodies are foam metal made by expanding and sintering after forming expandable slurry containing metal powder and expanding agent.

4. The porous implant material for sponge bone and cortical bone according to claim 2, wherein the porous metal bodies are foam metal made by expanding and sintering after forming expandable slurry containing metal powder and expanding agent.

5. The porous implant material for sponge bone and cortical bone of claim 1, wherein the pores of the second set have an oblong shape.

6. The porous implant material for sponge bone and cortical bone of claim 1, wherein the pores of the porous metal bodies are configured to allow infiltration of bone therethrough.

7. The porous implant material for sponge bone and cortical bone according to claim 1, wherein when the first direction along the bonded-boundary surface is set to an axial direction, a proportion of the first set to a total area of a cross-sectional surface perpendicular to the bonded-boundary surface is 0.5% to 50%.

8. The porous implant material for sponge bone and cortical bone according to claim 7, wherein the porous metal bodies are foam metal made by expanding and sintering after forming expandable slurry containing metal powder and expanding agent.

Description

BRIEF DESCRIPTION OF THE DRAWING

(1) FIG. 1 is a perspective view schematically showing an embodiment of porous implant material according to the present invention.

(2) FIG. 2 is a schematic view showing a cross-section of porous metal bodies in the porous implant material shown in FIG. 1.

(3) FIG. 3 is a schematic structural view showing a forming apparatus for producing the porous metal bodies.

(4) FIG. 4 is a plan view schematically showing another embodiment of the porous implant material.

(5) FIG. 5 is a graph showing degrees of dependence of compressive strengths on porosity rates and pore-shapes in the porous implant material of examples.

(6) FIG. 6 is a plan view showing another embodiment of the present invention.

(7) FIG. 7 is a plan view showing another embodiment of the present invention.

(8) FIG. 8 is a perspective view showing another embodiment of the present invention.

(9) FIG. 9 is a schematic structural view showing a substantial part of another forming apparatus for producing the porous metal bodies.

DETAILED DESCRIPTION OF THE INVENTION

(10) Below, embodiments of porous implant material according to the present invention will be explained with reference to drawings.

(11) 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.

(12) 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 FIG. 2: pores 3A in the porous metal bodies 4 with low porosity rate are formed substantially spherically; pores 3B in the porous metal bodies 5 with high porosity rate are formed flat so as to be long along the front surface (i.e., a direction along the bonded-boundary surfaces F, that is a vertical direction in FIG. 2) and short along a direction orthogonal to the front surface (i.e., the thickness direction, that is a horizontal direction in FIG. 2). In this case, each pore 3B is formed so that a length Y along the front surface (i.e., the bounded-boundary surface F) is 1.2 times to 5 times of a length X orthogonal to the front surface (i.e., the bounded-boundary surface F). Hereinafter, the pores are denoted by the reference number 3 when they are not necessary to be distinct; the substantially spherical pores are denoted by the reference symbol 3A and the flat pores are denoted by the reference symbol 3B when they are necessary to be distinct.

(13) 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 FIG. 1, the axial direction C is set vertical; and an area-occupation rate in a horizontal cross-sectional surface orthogonal to the axial direction C (i.e., the occupation rate at an upper surface in FIG. 1) is set to 0.5% to 50%.

(14) 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 FIG. 2 is 1.4 times to 5 times of a strength when compressing in a direction parallel to a direction orthogonal to the axial direction shown by the arrow by a dotted line.

(15) Next, a producing method of the porous implant material 1 will be explained.

(16) 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.

(17) The expandable slurry is obtained by kneading metal powder, binder, plasticizer, surfactant, and expanding agent with water as solvent.

(18) 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 m to 50 m. These powders are contained in the slurry at 30% by mass to 80% by mass.

(19) 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.

(20) The plasticizer is added in order to plasticize a compact obtain by forming 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.

(21) As the surfactant, anion surfactants such as alkyl benzene sulfonate, -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.

(22) 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.

(23) The green sheet is formed for the porous metal bodies 4, 5 using the forming apparatus 20 shown in FIG. 3 from the expandable slurry S prepared as described above.

(24) 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.

(25) Forming Process of Green Sheet

(26) 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.

(27) 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.

(28) Layering and Sintering Process

(29) 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.

(30) 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.

(31) Compression Process

(32) 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.

(33) 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.

(34) 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.

(35) 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 FIG. 2) is higher than the strength when being compressed orthogonal to the bonded-boundary surfaces F (i.e., in the thickness direction shown by the arrow by the dotted line in FIG. 2).

(36) 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.

(37) 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.

(38) 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.

(39) FIG. 4 shows another embodiment. In the abovementioned embodiment, the porous metal bodies 4, 5 are formed into plate-shapes and layered. In a porous implant material 11 this embodiment, the porous metal body 4 with lower porosity rate formed into a columnar-shape is surrounded by the porous metal body 5 with higher porosity rate, so that the porous implant material is formed into a columnar-shape. Therefore, the bonded-boundary surface F is formed as a cylindrical surface. The axial direction C agrees with a longitudinal direction of the columnar-shape.

(40) 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.

(41) 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.

Examples

(42) 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 m, 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.

(43) 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.

(44) FIG. 5 is a graph showing degrees of dependence of the compressive strengths on the porosity rates and pore-shapes. With respect to different ratios of lengths Y of pores parallel to a compressed surface by the rolling machine to lengths X orthogonal to the compressed surface, the layered bodies having different porosity rates were made and the strengths were measured with adding compression load parallel to the longitudinal direction of the pores.

(45) 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.

(46) The compressive strengths were measured according to JIS H 7920 (Method for Compressive Test of Porous Metals).

(47) As shown in FIG. 5, in a case in which the area-occupation rate of the porous metal bodies with lower porosity rate was 5%, the prolate degree was 3.2 (i.e., Y:X=3.2:1), and the porosity rate was 72%: the compressive strength when compressed in the direction parallel to the front surface was 48 MPa; and the compressive strength when compressed in the direction orthogonal to the front surface was 28 MPa. Therefore, the strength when compressed in the direction parallel to the front surface is about 1.7 times of that when compressed in the direction orthogonal to the front surface.

(48) 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.

(49) 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.

(50) 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.

(51) When a plurality of porous metal bodies are bonded, various configurations may be carried out as shown in FIGS. 6 to 8 besides the configurations in which the plate-shape porous metal bodies are layered as the above embodiments. In these drawings, the porous metal bodies each having the different porosity rates are denoted by the same reference symbols as in FIG. 1; that is, the porous metal bodies with lower porosity rates are denoted by the reference symbol 4, and the porous metal bodies with higher porosity rates are denoted by the reference symbol 5. For example, in a porous implant material 12 shown in FIG. 6, the plurality of columnar-shaped porous metal bodies 5 with lower porosity rate than in FIG. 4 are provided; in a porous implant material 13 shown in FIG. 7, the porous metal bodies 4 with low porosity rate and the porous metal body 5 with high porosity rate are multiply arranged concentrically; and in a porous implant material 14 shown in FIG. 8, the porous metal body 4 with low porosity rate is formed into a cross-shaped block, and the porous metal bodies 5 with high porosity rate which are formed into rectangular blocks are combined at four corners of the porous metal body 4. In the producing processes, the porous implant materials can be made by winding a plate-shape porous metal body around a particular metal body, or by rounding a plate-shape porous metal body. Prolate direction of the pores is illustrated as C-direction in FIG. 8. The prolate directions of the pores in FIGS. 6, 7 are orthogonal to pages.

(52) 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 FIG. 6 and FIG. 7 can be compressed in the radial direction by rolling the bonded bodies of the porous metal bodies as the embodiment shown in FIG. 4. Also, the compression process can be carried out in the state of the green sheets before sintering, or after sintering.

(53) 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.

(54) 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 FIG. 9.

(55) 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.

INDUSTRIAL APPLICABILITY

(56) 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.

DESCRIPTION OF REFERENCE SYMBOLS

(57) 1 porous implant material 2 skeleton 3, 3A, 3B pore 4 porous metal body with low porosity rate 5 porous metal body with high porosity rate 11 porous implant material 12 to 14 porous implant material F bonded-boundary surface C axial direction