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WO2007148431A1 - Matériau d'implant et son procédé de fabrication - Google Patents

Matériau d'implant et son procédé de fabrication Download PDF

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Publication number
WO2007148431A1
WO2007148431A1 PCT/JP2007/000624 JP2007000624W WO2007148431A1 WO 2007148431 A1 WO2007148431 A1 WO 2007148431A1 JP 2007000624 W JP2007000624 W JP 2007000624W WO 2007148431 A1 WO2007148431 A1 WO 2007148431A1
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WIPO (PCT)
Prior art keywords
orientation
implant material
axis
hard tissue
bone
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/JP2007/000624
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English (en)
Japanese (ja)
Inventor
Takayoshi Nakano
Yukichi Umakoshi
Hideo Nakajima
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University of Osaka NUC
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Osaka University NUC
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Publication date
Application filed by Osaka University NUC filed Critical Osaka University NUC
Priority to JP2008522288A priority Critical patent/JP5153626B2/ja
Publication of WO2007148431A1 publication Critical patent/WO2007148431A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges

Definitions

  • Plant material and method for producing the plant material are Plant material and method for producing the plant material
  • the present invention relates to an implant material and a method for producing the implant material.
  • the present invention relates to an implant material having an anisotropic pore structure and a method for producing the implant material.
  • high-strength materials such as stainless steel alloys, titanium-based metals such as titanium and titanium alloys, and bioactive materials such as apatite sintered body, bioactive glass, and bioactive crystallized glass are known.
  • Patent Document 1 Japanese Patent Laid-Open No. 8-35 7 0 40
  • an object of the present invention is to provide an implant material that can sufficiently prevent the deterioration of the amount and bone quality.
  • the inventors focused on the structure of the original hard tissue existing in the living body, and as a result of earnestly researching the application to the implant material, the inventors found the implant material of the present invention. It came.
  • the implant material of the present invention is characterized by comprising a pore structure having anisotropy.
  • the anisotropy takes into account the orientation direction of crystals in a hard tissue.
  • the orientation direction of the crystal is a running direction of collagen fibers and / or a c-axis direction of a biological avatar.
  • the anisotropy is characterized by considering a blood vessel traveling direction.
  • the anisotropy is characterized by considering the stress load direction of the hard tissue.
  • the anisotropy is characterized by considering a bone near-distal direction.
  • the pore structure is present on the surface of the implant material.
  • the pore structure comprises: It is characterized by not penetrating the implant material.
  • the pore structure penetrates the implant material.
  • a plurality of the pore structures are present.
  • the implant material is selected from polytetrafluoroethylene, a polymer material, a ceramic material, a metal material, an amorphous material, or a mixed material thereof. It is characterized by at least one kind.
  • the amorphous material includes a crystallized portion.
  • a method for producing an implant material according to the present invention is a method for producing an implant material according to any one of claims 1 to 11, wherein the implant material is normal using the crystal orientation. It is characterized by evaluating hard tissue and giving an implant material an anisotropic pore structure considering the orientation.
  • the crystal orientation is measured by an X-ray diffraction method, SEM-EBSP (Scanning Electron
  • TEM-DP Transmission Electron Electron Backscattering Pattern
  • Microscope-Diffraction Pattern Analyzed by at least one selected from the group consisting of analysis by electron diffraction pattern analysis
  • the analysis by the X-ray diffraction method is performed in a minute region.
  • the analysis by the X-ray diffraction method is based on obtaining a diffraction intensity or a diffraction integral intensity of a crystal.
  • the diffraction intensity or the diffraction integrated intensity is obtained on the basis of the orientation with respect to the a-axis, the c-axis, and other directions.
  • the analysis is performed using c-axis a-axis, 0- axis (an orientation other than a-axis and or c-axis), 0- axis (a-axis and and / or c-axis). It is characterized by obtaining at least one kind of diffraction intensity or diffraction integral intensity ratio selected from the group consisting of various orientations including.
  • the orientation is a hydroxyapatite or a biological avatar cocoon orientation.
  • the hard tissue regeneration method of the present invention is characterized in that the hard tissue is regenerated using the implant material of the present invention.
  • the hard tissue formed in the pores of the implant material has a hard orientation so that the orientation of the hard tissue is substantially equal to the orientation of a normal biological hard tissue. It is characterized by regenerating the organization.
  • the orientation of the hard tissue is formed in the hole by supplying a magnetic field to the affected area.
  • a magnetic field to the affected area is applied.
  • the crystal orientation is given in the direction that minimizes the magnetocrystalline anisotropy energy.
  • the crystal orientation direction force is the c-axis direction of the bioapatite.
  • the magnetic field to the affected area is given in a direction of 90 ° ⁇ 45 ° with respect to the traveling direction of the collagen fibers.
  • the magnetic field to the affected area is given in a direction of 90 ° ⁇ 45 ° with respect to the main blood vessel running direction.
  • the magnetic field to the affected area is given in a direction of 90 ° ⁇ 45 ° with respect to the stress load direction of the hard tissue. .
  • the magnetic field to the affected area is given in a direction of 90 ° ⁇ 45 ° with respect to the bone near-far direction of the hard tissue. .
  • the intensity of the magnetic field to the affected area is in the range of 1 to 20 (T).
  • an implant material of the present invention it is possible to provide an implant material that enables early bone entry and early fixation and can reduce adverse effects on surrounding bone.
  • Fig. 1 is a diagram showing an example of an analysis method of the maximum orientation direction.
  • FIG. 2 is a diagram showing the state of diffraction. Specifically, it is a diagram showing the state of diffraction when the optical system is matched with the Bragg condition of 0 0 2 diffraction.
  • FIG. 3 is a diagram showing an example of a precise analysis of the maximum orientation direction.
  • FIG. 4 shows a single-hole implant model for elucidating the dependence of new bone induction on the pore extension direction.
  • FIG. 5 shows the new bone density of regenerated bone. Specifically, the recovery process of new bone density (p Q C T) in the center of the pore is shown.
  • FIG. 6 shows the process of recovery of the new bone BA p orientation at the center of the pore. Specifically, the process of restoring the new bone B A p orientation at the center of the pore is shown.
  • FIG. 7 shows the relationship between bone density and BA p orientation in the pore center. Specifically, it shows the relationship between bone density and B Ap orientation in the center of the pore.
  • FIG. 8 shows an example of a magnetic field applying device for imparting orientation.
  • Superconducting mug Using a net, a magnetic field can be applied in one direction.
  • the implant material of the present invention has a pore structure having anisotropy.
  • the reason for having such an anisotropic pore structure is as follows. In other words, in the past, implant materials have not been studied at all about bone quality, which is a major factor affecting hard tissue, and problems such as fractures occur when implant materials are used. These could not be fully completed. However, as a result of examining the evaluation of the hard tissue according to the knowledge of the present inventors, the hard tissue adopts a structure having anisotropy centered on the orientation, and matches the orientation, or By producing an implant material having the same anisotropy, in other words, a pore structure having substantially the same orientation, it can be made sufficiently good in the subsequent regeneration of the hard tissue. This is because it was made clear.
  • the anisotropy takes into account the orientation direction of crystals in a hard tissue.
  • the present inventors who paid attention to the fact that the structure of a hard tissue, such as bone, has a very strong structure at the nano level, considered the orientation of the crystal, It has been found that if an implant having a porous hole is designed, a good implant material can be provided.
  • the traveling direction of the collagen fiber and / or the c-axis direction of the biological abate (hereinafter also referred to as BAp) can be used as a guide.
  • the traveling direction of the collagen fibers and / or the c-axis direction of the biological abutment ⁇ are almost the same as the principal stress direction on the bone, and almost the same as the preferential traveling direction of the blood vessel.
  • the regenerated bone can form a tissue excellent in both bone mass and bone quality. This is because the formed extension hole is formed approximately equal to the orientation direction of the hard tissue in the living body.
  • the regenerated hard tissue has the same internal structure as that of the original living hard tissue.
  • the anisotropy may be in consideration of the blood vessel traveling direction.
  • the anisotropy may be one that considers the stress load direction of the hard tissue. If the stress loading direction changes after implant insertion, it may be analyzed by computer simulation and the results taken into account. In other words, the stress load direction may change after insertion of the implant material. In such a case, the stress load direction after insertion may be more realistic. You may consider a result. It is also possible to measure the stress load direction after implant insertion once using a small animal such as a model mouse.
  • the orientation orientation of the hard tissue is not known, the orientation may be evaluated using a hard tissue evaluation method described later to reflect the result on the implant material.
  • considering in the present invention does not mean that the orientation direction or the like of a normal hard tissue is reflected in the pore structure without being deformed as it is. However, it can be modified and changed. “Considering” may be considered to be designed approximately the same. This is because it is practically impossible to reflect exactly the same replication as normal hard tissue in implant material, and it has different properties depending on individual, age, and sex. Also, depending on the location, it is often difficult or impossible to adopt a structure having an orientation orientation similar to that of the hard tissue. For this reason, “considering” means designing the hole close to the orientation of normal hard tissue. Therefore, for example, when designing pores in the direction perpendicular to the orientation direction of hard tissue, it is difficult to say “consider”.
  • the anisotropy is in consideration of a bone near-distal direction.
  • Bone near-distal direction refers to the direction along the longitudinal direction of the bone in the long bone. It means from near to far away from the body.
  • the longitudinal direction of the bone is compared without a precise evaluation of the hard tissue. For example, when the judgment is urgent, the indicator based on the bone near-distal direction is effective.
  • the pore structure may exist on the surface of the implant material (one that does not penetrate), one that penetrates the implant material, or one that stops in the middle even though it is intended to penetrate. This aspect is also possible.
  • the pore structure may be any structure.
  • As the direction of the holes there can be various types, such as those arranged in a specific direction, those preferentially arranged two-dimensionally, those having other arrangements other than random.
  • the pore structure may be either singular or plural, and is not particularly limited as long as the anisotropy of normal hard tissue is taken into consideration. Further, the size of the hole is not particularly limited. For example, from the viewpoint of allowing invasion of bone cells (osteoblasts, osteoclasts, bone cells), the pore size is preferably 50 to 100 Om. Preferably, it is 1 0 0 to 7 0 0 Idm.
  • the material of the implant material is not particularly limited as long as the above-described hard tissue anisotropy is taken into consideration.
  • the implant material should include at least one selected from polytetrafluoroethylene ((Teflon (registered trademark)), polymer material, ceramic material, metal material, amorphous material, or a mixed material thereof.
  • the metal material include pure metals, alloys, intermetallic compounds, etc.
  • the amorphous material may include a partially crystallized portion. Even if it is contained, there is a material called an amorphous material, and examples of the amorphous material include bioglass.
  • examples of the material of the implant material include a hard tissue substitute material.
  • hard tissue substitute materials include ceramic materials typified by apatite, inorganic materials such as alumina and zirconia, and metal materials such as stainless steel, Co-Cr alloys, titanium, alloys and tantalum. Ceramics are Furthermore, it can be divided into bioactive ceramics and bioinert ceramics.
  • examples of biological ceramics include calcium phosphate-based ceramics, silica-based glass, and crystallized glass. As calcium phosphate-based ceramics, hydroxyapatite and tricalcium phosphate are well known, and these are used for artificial tooth roots, skin terminals, metal coating materials, and the like. These various materials can be used as implant materials.
  • the processing method and the like of the implant material are widely known in the technical field, and can be manufactured by applying to the implant material of the present invention by a conventional method.
  • the method for producing an implant material according to the present invention is a method for producing the above-described implant material, and the normal hard tissue is evaluated using the orientation of the crystal, and the orientation It is characterized by imparting an anisotropic pore structure to the implant material in consideration of the properties. That is, in order to impart hard tissue anisotropy to the implant material, it may be necessary to first evaluate normal hard tissue. In such a case, the method of the present invention is effective.
  • the orientation of the crystal is measured by an X-ray diffraction method, SEM-EBSP (Scanning Enlectron
  • the analysis can be performed by at least one selected from the group consisting of materials by analysis of electron diffraction patterns by the Microscope-Difraction Pattern) method.
  • the preparation and preparation of the sample are easy, and the orientation can be determined quantitatively, X-ray diffraction method is preferable.
  • the analysis by the X-ray diffraction method is performed in a minute region. In general, it is more accurate to define the diameter of the incident X-rays than to specify the range of the minute region. In other words, the angle between the X-ray and the sample surface changes to some extent, It is difficult to rigging strictly.
  • the measurement range (small region range) is about 3 to 5 times the incident X-ray diameter. Therefore, a preferable range can be determined using the incident X-ray diameter. From the viewpoint of accurately evaluating the orientation of small parts, the incident X-ray diameter is 10 1! ⁇ 1 country, preferably l O jU ir! ⁇ 1 00 ju m.
  • the orientation direction of the crystal may be observed.
  • the orientation direction of the crystal can be specified to such an extent that it can be compared with a normal hard structure, It is not limited. Therefore, for example, when the orientation is examined by X-ray diffraction method, SEM-EBSP method, TEM-DP method, etc., the one with the largest peak may be used, the one with the second or third peak or those Other than those may be used. These can be changed or modified as appropriate depending on the nature of the hard tissue, bone mass, disease severity, type of hard tissue such as long bone, short bone, and flat bone, various sites, etc. A comparative analysis can be made.
  • the orientation direction is a crystal in the hard tissue.
  • the orientation direction having the maximum value or the maximum value is preferable.
  • the hard tissue is a bone slice.
  • the bone section is not particularly limited, but can be obtained by one type selected from the group consisting of bone biopsy needles, bone saws, bones only, duel, sharp blades, cutting tools, etc. Can do. Bone biopsy needles have been widely used for analysis of hard tissues in the past, and the use of bone sections collected using the bone biopsy needles is a preferred embodiment for quick and precise evaluation.
  • this method is particularly effective when the axial direction to be measured is not clear. Therefore, in addition to bone biopsies, even for bone sections whose axial direction to be measured is unclear, this method can be used to quickly and accurately evaluate hard tissue and It is possible to design implant materials.
  • the orientation orientation can be determined by analyzing in-plane anisotropy of the hard tissue.
  • the orientation orientation is quickly determined by rotating the sample and continuously measuring the in-plane orientation.
  • the degree of orientation parallel to a specific axis is high. Therefore, for example, when a bone section is collected using a bone biopsy needle as described above, since the bone axis is perpendicular to the bone biopsy direction, 360 degrees with the direction of the sampled sample taken as the central axis. It can be installed on a rotatable jig and the continuous profile of diffraction information can be analyzed by X-ray diffraction. If the detector is two-dimensional and can be detected simultaneously, the analysis time will be faster. However, analysis is possible in the 0th and 1st dimensions, although analysis time is required.
  • the analysis of the in-plane anisotropy is performed in an in-plane anisotropic manner on a plane parallel to the bone axis direction of the hard tissue or a plane within a range of ⁇ 90 degrees in the bone axis direction. This is done by analyzing sex.
  • the orientation direction can be quickly identified, which is preferable from this viewpoint.
  • the shape of the bone is indefinite (when it is not cylindrical), it is possible to detect an orientation with high orientation in the plane of rotation by determining the axis and rotating the axis.
  • the analysis can be performed by obtaining the diffraction intensity of the crystal by the X-ray diffraction method.
  • the diffraction intensity can be determined based on the orientation with respect to the a-axis, c-axis, and other orientations.
  • the analysis condition is that the Bragg angle (which is the angle between the incident X-ray and the diffracted X-ray with respect to the diffractive surface to satisfy the diffraction condition) is determined so that the orientation of the 3-axis and c-axis can be judged
  • the angle between the incident direction of the line and the sample surface can be set, and the sample can be swung further.
  • the state of the regenerated hard tissue or diseased hard tissue can be evaluated.
  • This utilizes the fact that in this evaluation method, the crystal orientation of the hard tissue varies greatly depending on the type of bone, such as long bone, short bone, and flat bone, and various sites.
  • the analysis is performed by analyzing the G-axis, c-axis / (orientation other than the a-axis and / or c-axis), c-axis (a-axis, and / or c-axis) This is done by obtaining at least one diffraction intensity or diffraction integral intensity ratio selected from the group consisting of (azimuth). That is, if the numerator is c axis, any denominator can be used.
  • c axis (a axis + c axis), c axis / axis + (other directions other than a axis and c axis) ⁇ , c axis / G axis + (other than a axis and c axis) Other directions) ⁇ , c axis (a direction other than a axis and / or c axis), c axis (a axis, c axis, and other directions other than these), and the like.
  • the diffraction intensity ratio for example, evaluate only the diffraction intensity based on the orientation with respect to the a-axis, c-axis, and other orientations. May be.
  • the X-ray diffraction method for example, in addition to the diffraction intensity ratio of (002) / (310), (002) / ⁇ (21 1) + (1 1 2) + (300) ⁇
  • a method of measuring only (002) diffraction three-dimensionally at the same location and mapping in this case, the average of the three-dimensional diffraction intensity is normalized to 1, the maximum intensity and half-value width
  • the orientation direction may be determined.
  • only the diffraction of (002) may be performed. In this case In spite of being extremely simplified, they are generally capable of obtaining a good evaluation.
  • the relative orientation can be analyzed by taking the ratio.
  • the intensity of other diffraction lines it is possible to evaluate the orientation with respect to the a-axis, the G-axis, and other directions. Using these diffraction intensities and orientations, hard tissues can be evaluated.
  • the crystallinity can be evaluated by measuring the half width of each diffraction line.
  • the half width is the width of the diffraction peak at a position where the intensity is halved, and is a unit of angle. A larger width means lower crystallinity.
  • the crystallinity is determined by the size of the crystallite and the lattice strain. When the crystallite is small and the lattice strain is large, the crystallinity decreases (the half-value width increases).
  • it can be done by changing the sample orientation to be evaluated three-dimensionally and the X-ray incident angle, and measuring the diffraction intensity of a specific diffraction line from multiple directions. If you want to know the orientation of the c-axis, use a Bragg angle (2-seat) force Cu-K characteristic X-ray as the incident X-ray, and use a diffraction line around 26 °.
  • Crystal orientation usually means that unit structures (microcrystals) constituting a polymer solid are arranged in a certain direction. Orientation is the plane orientation found in polyethylene films (for example, the c-axis is in the plane of the film and there is no other orientation). ), Uniaxial orientation (the c-axis is oriented in the fiber direction), spiral orientation found in cotton and hemp (the C-axis has a certain inclination with the fiber orientation), and double orientation (with a certain crystal plane Parallel to a certain plane including the fiber axis. Therefore, the hard tissue can be evaluated by examining the orientation of the normal hard tissue and the orientation of the hard tissue substitute material and comparing the two.
  • the orientation of hydroxyapatite cocoon which is a representative component of hard tissue, is examined, and the hard tissue can be evaluated by comparing the normal one with the diseased one during regeneration. it can.
  • this evaluation method it is possible to further evaluate bone mass, observation of tissue specimen, composition analysis, infrared absorption (IR) analysis, hardness, measurement of mechanical properties such as fracture stress, elastic modulus, etc. it can.
  • IR infrared absorption
  • the implant material is designed in consideration of the anisotropy.
  • the implant material is designed in consideration of the anisotropy.
  • it is possible to form a tissue excellent in both bone mass and bone quality.
  • the hard tissue regeneration method of the present invention regenerates hard tissue using the implant material of the present invention described above. That is, the above-described implant material of the present invention has a hole structure having anisotropy, and the hole structure is designed to be approximately equal to the orientation of the biological hard tissue.
  • a hard tissue is regenerated using a material, it is possible to regenerate an excellent tissue having a strength similar to that of the original biological hard tissue. That is, in the present invention, it is possible to regenerate the hard tissue so that the orientation of the hard tissue formed in the pores of the implant material of the present invention is substantially equal to the orientation of the normal biological hard tissue. is there.
  • the method for regenerating hard tissue is not particularly limited.
  • reproduction can be performed minimally invasively without damaging the skin or the like.
  • a magnetic field may be used instead of applying stress. That is, in a preferred embodiment of the method for regenerating a hard tissue of the present invention, the orientation of the hard tissue is formed in the hole of the implant material by supplying a magnetic field to the affected area.
  • the magnetic field to the affected area is applied in a direction that minimizes the magnetocrystalline anisotropy energy with respect to the crystal orientation.
  • the direction that minimizes the magnetocrystalline anisotropy energy is preferably 90 ° ⁇ 45 ° with respect to the crystal orientation.
  • the orientation direction of the crystal is preferably the c-axis direction of the biological avatar ⁇ . This is because the c-axis direction of the bioapatite is oriented in a direction parallel to the longitudinal direction of the bone, so that it is possible to give an orientation substantially equal to the orientation of the original biohard tissue based on this. .
  • the stress direction and orientation direction of the normal tissue may be different. Therefore, it is within the range of 90 ° ⁇ 45 °.
  • the range is not limited to this range depending on the degree of defect, etc., and the range is appropriately set so that the above-described original mechanical function can be exhibited. It can be set. Therefore, depending on the case, it may be good if it is outside the above 90 ° ⁇ 45 ° range.
  • the magnetic field to the affected area is applied in a direction of 90 ° ⁇ 45 ° with respect to the running direction of the collagen fibers.
  • the orientation direction may be different, so 90 degrees above
  • the range is ⁇ 45 degrees.
  • the range is not limited to this range depending on the degree of deficiency, and the range can be set as appropriate so that the above-described original mechanical functions can be exhibited. Therefore, depending on the case, it may be good if it is out of the above 90 ° ⁇ 45 ° range.
  • the magnetic field to the affected area is applied in a direction of 90 degrees ⁇ 45 degrees with respect to the blood vessel running direction. It is virtually impossible to set exactly vertical
  • the stress direction and orientation direction of normal tissue may differ, so the above range of 90 ° ⁇ 45 ° is used.
  • the range is not limited to this range depending on the degree of deficiency or the like, but can be set as appropriate so that the above-described original dynamic functions can be exhibited. Therefore, depending on the case, it may be good if it is out of the above 90 ° ⁇ 45 ° range.
  • the magnetic field to the affected area is applied in the direction of 90 degrees ⁇ 45 degrees with respect to the stress load direction of the hard tissue.
  • the stress direction and orientation direction of normal tissue may differ when an implant material is inserted.
  • the range is 90 degrees ⁇ 45 degrees, but it is not limited to this range depending on the degree of loss, etc., and the range can be set appropriately so that the above-mentioned original mechanical functions can be exhibited. is there. Therefore, depending on the case, it may be good if it is outside the range of 90 ° ⁇ 45 °.
  • the magnetic field to the affected area is applied in the direction of 90 ° ⁇ 45 ° with respect to the direction of bone near-distal direction of the hard tissue.
  • the stress direction and orientation direction of normal tissue also differ.
  • the range can be set as appropriate. Therefore, depending on the case, it may be good if it is out of the range of 90 ° ⁇ 45 °.
  • the strength of the magnetic field to the affected area is in the range of 1 to 20 (T). Preferably there is.
  • the magnetic field effect on the affected area is applied for 1 to 12 hours from the viewpoint of efficiently and reducing the time for hindering life. If the desired orientation can be obtained even in a short time, the magnetic field can be applied in a short time. You can stop it.
  • One embodiment of the present invention includes a magnetic field supply means 1 and a unit 2 as shown in FIG.
  • the magnetic field supply means for supplying the magnetic field to the affected area is not particularly limited, and examples thereof include a permanent magnet, an electromagnet, a superconducting magnet, a water-cooled copper magnet, and combinations thereof. That is, the magnetic field supply means is not particularly limited as long as it can supply a magnetic field and the direction of the magnetic field B can be specified. This is because the collagen travel direction and the c-axis direction of the biological properties ⁇ have been found to be oriented almost perpendicular to the magnetic field. This is because, in the present invention, it has a specific orientation, and if the direction of the magnetic field B can be specified as the magnetic field supply means, the orientation of the tissue in the living body can be controlled. As the magnetic field supply means, a permanent magnet, an electromagnet, a superconducting magnet, a water-cooled copper magnet, or a hybrid of both is preferable from the viewpoint that it is easy to generate a magnetic field in a specific direction.
  • FIG. 8 shows an example of a magnetic field application device for imparting orientation.
  • FIG. 8 shows a case where the magnetic field (B) is applied in a direction perpendicular to and parallel to the longitudinal direction of the rat tibia. That is, 4 in FIG. 8 shows the case where the longitudinal direction of the rat tibia and the magnetic field are perpendicular, and 5 in FIG. 8 shows the case where the longitudinal direction of the rat tibia and the magnetic field are parallel.
  • the direction of the biological avatar c-axis and the traveling direction of the collagen fibers are oriented. Therefore, the direction of the bioapatite c-axis or the traveling direction of the collagen fibers is arranged in the same direction as the longitudinal direction of the tibia.
  • the magnetic field may be applied in a direction substantially perpendicular to the longitudinal direction of the tibia using the device of the present invention.
  • Fig. 8 is an example in which a magnetic field is applied in one direction.
  • the direction of irradiation in this case, the rat tibia
  • the application direction relative orientation relative to the specific direction of the hard tissue.
  • the orientation orientation was determined for the actual human femur (contributor) and the ushi femur, and the hard tissue was evaluated.
  • a hollow cylindrical bone biopsy needle is inserted almost perpendicularly to the bone axis, and a cylindrical bone sample is collected.
  • the specimen center does not match the ⁇ 2- axis rotation center. Move the sample to the ⁇ 2- axis rotation center on the y 2 axis.
  • the sample center does not coincide with the X-ray diffraction center ( ⁇ -axis rotation center), so the X and ⁇ axes on the normal jig are moved to the ⁇ -axis rotation center (for each special jig). .
  • the sample surface is actually matched to the diffraction center.
  • Figure 1 shows an example of the maximum orientation orientation analysis method.
  • Right view in FIG. 1 shows the count of [Phi 2 your capital of the diffracted X-rays, a left view that was plotted Bok whereas the [Phi 2.
  • ⁇ 2 has a peak around 26 °, indicating that this is consistent with the maximum orientation of the bone long axis.
  • the two-dimensional PSPC equipped with this diffraction apparatus has a dimension in the 2S direction, it is possible to simultaneously detect diffraction lines other than symmetrical diffraction.
  • the (310) plane that causes such diffraction is a plane that is tilted about 7 ° from the sample plane (Fig. 2).
  • 002 diffraction detected when the optical system is matched to the Bragg condition of 310 diffraction is also a surface that is tilted 7 ° from the sample surface. From this, the incident angle ⁇ is swung from 13 to 20 degrees.
  • Fig. 3 shows an example of analysis of actual precision measurement.
  • Fig. 3 shows an example of analysis using 2D PSPC. Because it is two-dimensional, it appears in a ring shape. If you take a profile for 20, it will look like a white line. Note that the profile is reversed left and right because the center of the ring is 0 degrees. From the 20 profile file obtained in this way, after removing the background, the integrated intensity of the 002 and 310 diffraction peaks is calculated, and the ratio is taken to obtain the degree of orientation G-axis orientation. In this case, the intensity ratio can be determined to be 13.6 from this diffraction integrated intensity ratio. The diffraction peak can be analyzed using the maximum intensity, but in the embodiment, the analysis is performed using the integrated intensity. In essence, there is no big difference, but when the crystallinity is low (when the crystallite size is small), more accurate analysis is possible.
  • the two-dimensional PSPC of the diffraction device used in the present invention also has a dimension in the tilt direction (direction), it is also possible to obtain diffraction information from the crystal plane tilted in the tilt direction with respect to the incident X-ray from the sample surface. Is possible. Therefore, by integrating ⁇ 7 °, which is the same as the tilt with respect to the X-ray incident direction, 002, It is possible to obtain a 20 profile based on diffraction information from the crystal plane that is within ⁇ 7 ° from the sample plane for both 310 planes. This means that an analysis that is (almost) equivalent to the sample in-plane rotation ( ⁇ -axis rotation) in normal reflection measurements is possible. (Equivalent analysis is possible despite the fact that ⁇ axis rotation is impossible due to the mounting of special jigs).
  • the long tube bone (normal ⁇ disease) along the bone axis direction that has been accumulated so far, Diagnose whether or not it is a diseased bone.
  • an implant material was designed in consideration of the orientation of the hard tissue, and the regeneration state was examined using the implant material.
  • a defect was introduced into the long bone (rat tibia), an implant with one hole in one direction was inserted into it, and the anisotropy of the bone microstructure was Depending on the direction of the hole, (1) the speed of introduction of new bone, (2) the stress shielding effect due to the presence or absence of stress (stress shielding effect: bone resorption occurs when stress shielding occurs in living bone) Examined.
  • FIG. 4 shows a single-hole implant model for elucidating the dependence of new bone induction on the pore extension direction. This is intended to actively induce bone through pores, taking into account the anisotropy of bone tissue.
  • 10-week-old SD rat female tibia (longitudinal bone) Cortical diaphysis A 2 country ⁇ hole is drilled in the center, and a unidirectional single-hole implant is inserted there, and the insertion direction is collagen fiber apatite c-axis Preferred orientation direction (longitudinal direction of bone, near distance)
  • the implant made of Teflon (registered trademark) or Ti (CP-Ti, 2 types) having a unidirectional elliptical columnar hole was placed in parallel or vertically along the (central direction).
  • the elliptical hole was used to adjust the indentation depth into the cortical bone, and the actual thickness of the cortical bone is about 0.5, so 0.5 countries ⁇ .5 countries
  • the prismatic part of this corresponds to the original cortical bone.
  • the Young's modulus along the longitudinal direction of the cortical bone is about 10 GPa, about 0.5 GPa for Teflon (registered trademark), and about 10 GPa for Ti. Therefore, when a unidirectional hole is embedded parallel to the bone axis, a stress shielding effect can be considered for Ti in the long term, but not for Teflon (registered trademark).
  • Fig. 5 shows the changes in bone density (volumetric bone density by pQCT method) at the center of the directional pore with age after implantation.
  • the density of the new bone to be introduced differs greatly depending on the difference in the embedding direction between parallel and vertical.
  • the density of new bone is high, and at 4 weeks and 8 weeks, the bone density is statistically significantly higher, and the average value is higher at other weeks of age.
  • BA p collagen biocapacitor
  • FIG. 6 shows the process of restoring the new bone BA p orientation at the center of the pore.
  • the bone quality was evaluated based on the orientation of the biological abatite (BAp) along the pore direction by micro-area X-ray diffraction. Not only bone mass (bone density) but also BAp G-axis orientation shows a tendency to recover preferentially in the parallel case over the vertical case.
  • BAp biological abatite
  • the collagen apatite ⁇ is oriented, and along the long bone axis, which is the direction of extension of the main blood vessels, the bone quality is preferentially restored and approaches the bone quality of normal bone that is not absorbed early. ing.
  • the orientation is lower than that of the parallel, but it shows a higher value than the non-orientation. Therefore, the formation of the hole in one direction does not increase the anisotropy of the microstructure of the new bone to some extent Can be controlled.
  • the c-axis orientation value in this figure is about 2. In other words, it is possible to impart a higher orientation of about 4 to 5 by introducing holes in one direction.
  • FIG. 7 shows the relationship between bone density and BA p orientation in the pore center.
  • Irradiation was performed only for 2 hours a day, and the formation of trabecular bone was observed.
  • orientation of the collagen apatite ⁇ was shown in the direction of trabecular extension, so the direction of trabecular extension was investigated.
  • the bone microstructure in the initial stage of bone regeneration showed anisotropy according to the pore structure of the implant material, and the trabecular direction was perpendicular to the magnetic field. This indicates that the anisotropy of bone microstructure similar to that of normal bone can be given from the early stage of bone regeneration.
  • bone can be introduced, fixed, and fixed for a long period of time at an earlier stage by creating an anisotropic implant hole in accordance with the anisotropy of the bone microstructure.
  • This is a revolutionary technology.
  • image-based stress calculation using images such as CT (FEM: Finite Element Method, etc.)
  • design the implant hole direction in the optimal direction Is also possible.
  • orientation is imparted using a magnetic field.
  • the present invention can be expected to contribute to the treatment of hard tissue diseases, the field of regenerative medicine and dentistry (in particular, orthopedic surgery, brain surgery, and dentistry) and basic medicine.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un matériau d'implant permettant de prévenir de manière suffisante la réduction et la dégradation de l'os. Ce matériau d'implant est caractérisé en ce qu'il présente une structure poreuse anisotrope. Selon un mode de réalisation préféré, il est caractérisé en ce que l'anisotropie est déterminée selon l'orientation du cristal dans le tissu dur. L'invention concerne également un procédé de fabrication du matériau d'implant décrit ci-dessus, caractérisé en ce qu'il comprend l'évaluation du tissu dur normal en utilisant les propriétés d'orientation des cristaux et la mise en place d'une structure poreuse anisotrope déterminée en considérant l'orientation d'un matériau d'implant.
PCT/JP2007/000624 2006-06-20 2007-06-12 Matériau d'implant et son procédé de fabrication Ceased WO2007148431A1 (fr)

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Cited By (1)

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JP2015516243A (ja) * 2012-05-14 2015-06-11 モーブライフ・ナムローゼ・フエンノートシャップＭｏｂｅｌｉｆｅ Ｎ．Ｖ． インプラント可能な骨増生部およびインプラント可能な骨増生部を製造するための方法

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JP2003111832A (ja) * 2001-10-09 2003-04-15 Univ Osaka 硬組織代替材料及びその製造方法
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015516243A (ja) * 2012-05-14 2015-06-11 モーブライフ・ナムローゼ・フエンノートシャップＭｏｂｅｌｉｆｅ Ｎ．Ｖ． インプラント可能な骨増生部およびインプラント可能な骨増生部を製造するための方法

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