WO2019009428A1 - Implant et son procédé de fabrication - Google Patents

Implant et son procédé de fabrication Download PDF

Info

Publication number
WO2019009428A1
WO2019009428A1 PCT/JP2018/025800 JP2018025800W WO2019009428A1 WO 2019009428 A1 WO2019009428 A1 WO 2019009428A1 JP 2018025800 W JP2018025800 W JP 2018025800W WO 2019009428 A1 WO2019009428 A1 WO 2019009428A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
laser light
irradiating
laser
irradiation
Prior art date
Application number
PCT/JP2018/025800
Other languages
English (en)
Japanese (ja)
Inventor
板倉雅彦
清水潔
宇野孝之
片山昌広
Original Assignee
ダイセルポリマー株式会社
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from JP2018115873A external-priority patent/JP2019136472A/ja
Application filed by ダイセルポリマー株式会社 filed Critical ダイセルポリマー株式会社
Priority to EP18827933.5A priority Critical patent/EP3649986B1/fr
Priority to US16/623,906 priority patent/US20210145553A1/en
Priority to CN201880030274.1A priority patent/CN110603012A/zh
Publication of WO2019009428A1 publication Critical patent/WO2019009428A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/80—Preparations for artificial teeth, for filling teeth or for capping teeth
    • A61K6/84—Preparations for artificial teeth, for filling teeth or for capping teeth comprising metals or alloys
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • 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
    • 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

  • the present invention relates to an implant suitable for bonding to a living tissue and a method of manufacturing the same.
  • An implant made of titanium or a titanium alloy is known as an implant for bonding to a living tissue.
  • the implant is required to have both connectivity and strength with bones, teeth, etc. in order to be present in the living body by being combined with living tissues such as bones, teeth etc. From such viewpoints, as described in the following document, in addition, an implant having a porous structure at a binding site with a living tissue is known.
  • Patent No. 5920030 is an invention of a porous implant material, which uses a porous metal body having a three-dimensional network structure in which a plurality of pores communicate with one another, which is formed by a continuous skeleton, and a metal powder And producing a foamed slurry containing the foaming agent and the foaming agent (Claim 1, paragraph 0013).
  • Japanese Patent Application Publication No. 2009-254581 is an invention of an implant for a living body, including a surface portion which is a bonding portion to a living tissue, and a core portion inside the surface portion, and the surface portion is formed with pores. It is described that the porous sintered body is made of metal (Claim 1).
  • JP-A-2014-161520 is an invention of an implant and a method of manufacturing the same, and it is described that a titanium base material is subjected to shot blasting and electrolytic treatment (claim 1).
  • Japanese Patent No. 5326164 is an invention of a biomaterial and a method for producing the same, and it is described that a biomaterial having a porous structure is manufactured using a molded body made of a thin plate laminate having a porous structure as a mold ( Claim 1, paragraph numbers 0025, 0026).
  • Non-patent document "Creating bone tissue compatible implant with nano pulse laser” (Masatani Mizutani, General Research Development Grant AF-2011212, Tohoku University graduate School of Engineering), bone tissue with nano pulse laser Techniques for creating compatible implants are described. Summary of the invention
  • An object of the present invention is to provide an implant that can be used in living tissue and a method of manufacturing the same.
  • the present invention relates, in one embodiment, to an implant used for bonding to a living tissue including bone or teeth, comprising a metal selected from titanium or titanium alloy, cobalt chromium alloy, tantalum,
  • a surface portion of a portion connected to a living tissue including a bone or a tooth has a porous structure.
  • the porous structure is formed in the thickness direction, a trunk hole having an opening on the coupling surface side, and an open hole comprising branch holes formed in a direction different from the inner wall surface of the trunk hole from the trunk hole; It has an internal space formed in the thickness direction and not having an opening on the side of the coupling surface, Furthermore, the present invention provides an implant comprising a tunnel connection path connecting the open hole and the internal space, and a tunnel connection path connecting the open holes.
  • the present invention provides, in another embodiment, a method for producing the above implant, which comprises the step of forming a porous structure in the surface layer of the implant,
  • the step of forming a porous structure in the surface layer of the implant is a step of irradiating a surface including the surface layer with a laser beam
  • a method of manufacturing an implant wherein the step of irradiating the laser light is a step of continuously irradiating the laser light so as to be a straight line, a curved line, or a combination of a straight line and a curved line.
  • the present invention provides, in yet another embodiment, a method for producing the above implant, which comprises the step of forming a porous structure in the surface layer of the implant,
  • the step of forming a porous structure in the surface layer of the implant is a step of irradiating a surface including the surface layer with a laser beam
  • the step of irradiating the laser light is a step of irradiating the laser light so that the irradiated portion and the non-irradiated portion are alternately generated when irradiating the laser light to be a straight line, a curved line or a combination of a straight line and a curved line.
  • a method of manufacturing an implant is provided.
  • the implant of the present invention has good connectivity with living tissue including bone or teeth due to the presence of the porous structure in the surface layer.
  • FIG. 1 (a), (b) is sectional drawing which shows the example of the porous structure of the implant surface layer part of this invention.
  • 2 (a) to 2 (c) are cross-sectional views showing an example of the porous structure of the surface layer portion of the implant of the present invention different from FIG.
  • FIG. 3 is explanatory drawing of one Embodiment of the laser beam irradiation process in the manufacturing method of the implant of this invention.
  • FIG. 4 is explanatory drawing of one Embodiment of the laser beam irradiation process in the manufacturing method of the implant of this invention.
  • FIG. 5 is a SEM photograph (129 ⁇ ) of a plate surface of pure titanium after laser light irradiation in Example 1.
  • FIG. 6 is a SEM photograph (137 ⁇ ) of a plate surface of pure titanium after laser light irradiation in Example 2.
  • FIG. 7 is a SEM photograph (110 times) of the surface of a plate of 64 titanium after laser light irradiation in Example 3.
  • FIG. 8 is a SEM photograph of the plate surface of pure titanium after laser light irradiation in Example 5.
  • FIG. 9 is a SEM photograph of the plate surface of pure titanium after laser light irradiation in Example 7.
  • FIG. 10 is a SEM photograph of the plate surface of pure titanium after laser light irradiation in Example 8.
  • FIG. 11 is a SEM photograph of the surface of a plate of 64 titanium after laser light irradiation in Example 9.
  • FIG. 12 is a SEM photograph of the plate surface of 64 titanium after laser light irradiation in Example 11.
  • FIG. 13 is a SEM photograph of the plate surface of 64 titanium after laser light irradiation in Example 12.
  • FIG. 14 is an X-ray CT scan photograph of the plate surface of 64 titanium after laser light irradiation in Example 13, (a) is a cross-sectional photograph parallel to the scanning direction of the laser light, (b) is the laser light It is a cross-sectional photograph perpendicular to the scanning direction.
  • FIG. 15 is an SEM photograph of a tantalum plate surface after laser light irradiation in Example 14.
  • FIG. 16 is an SEM photograph of a tantalum plate surface after laser light irradiation in Example 15.
  • FIG. 15 is an SEM photograph of a tantalum plate surface after laser light irradiation in Example 14.
  • FIG. 17 is a SEM photograph of the surface of a tantalum plate after laser light irradiation in Example 16.
  • FIG. 18 is an SEM photograph of a tantalum plate surface after laser light irradiation in Example 17.
  • FIG. 19 is an SEM photograph of a tantalum plate surface after laser light irradiation in Example 18.
  • the implant of the present invention is used to connect with living tissue including bone or teeth.
  • Examples of the implant include artificial hip joints (stems, cups), artificial joints such as artificial knee joints, for fracture fixation (plates, screws), artificial tooth roots and the like.
  • the implant of the present invention comprises a metal selected from titanium (pure titanium), a titanium alloy, a cobalt chromium alloy, and tantalum. Titanium alloys and cobalt chromium alloys are used as medical (including dental) titanium alloys and cobalt chromium alloys.
  • a cobalt chromium alloy Ichrome (manufactured by IDS Co., Ltd.), Premier Cast Hard (manufactured by Denken High Dental Co., Ltd.), or the like can be used.
  • the implant is one in which the surface layer of the portion to be joined with a living tissue including bone or teeth has a porous structure.
  • the porous structure includes a trunk hole having an opening on the side of the joint surface and an open hole formed in the thickness direction, and a branch hole formed in a direction different from the inner wall surface of the trunk hole to the trunk hole; It has an internal space formed in the thickness direction and not having an opening on the side of the joint surface, and further connects a tunnel connection path connecting the open hole and the internal space with the open hole. It has a tunnel connection.
  • the porous structure of the surface layer portion of the implant is, for example, a porous structure as shown in FIGS. 1 (a) and 1 (b) and FIGS. 2 (a) to 2 (c). It is the same as the porous structure shown.
  • the surface layer portion of the implant 10 has an open hole 30 having an opening 31 on the side of the joint surface 12 with the living tissue.
  • the open hole 30 includes a trunk hole 32 having an opening 31 formed in the thickness direction, and a branch hole 33 formed in a direction different from the inner wall surface of the trunk hole 32 from the trunk hole 32.
  • One or more branch holes 33 may be formed.
  • the surface layer portion of the implant 10 has an internal space 40 without an opening on the side of the joint surface 12 with the living tissue.
  • the interior space 40 is connected to the open hole 30 by a tunnel connection 50.
  • the surface layer portion of the implant 10 may have an open space 45 in which a plurality of open holes 30 are integrated, and the open space 45 is formed by integrating the open hole 30 and the internal space 40. It may be done.
  • One open space 45 has a larger internal volume than one open hole 30.
  • many open holes 30 may be one and the groove-shaped open space 45 may be formed.
  • the open hole 30 and the internal space 40 may be connected by the tunnel connection path 50 as shown in FIGS. 2A and 2B, and may be open as shown in FIG. 2C.
  • the holes 30 may be connected by the tunnel connection path 50.
  • the inner spaces 40 as shown in FIG. 2A may be connected by a tunnel connection line 50.
  • the surface layer portion having the porous structure of the implant preferably has a depth ranging from 10 to 1000 ⁇ m from the surface to the depth of the open hole.
  • the porous structure formed in the surface layer of the implant of the present invention is a complex structure as shown in FIG. 1 and FIG. 2, so that the complex porous structure acts to enhance the bonding between bone and implant. It is expected to do.
  • a method of manufacturing the implant of the present invention will be described.
  • a surface including the surface layer portion is irradiated with laser light to form a porous structure.
  • the first laser beam irradiation method is known, and the patent 5774246, the patent 5701414, the patent 5860190, the patent 5890054, the patent 5959689, the Japanese patent 2016-43413, a special It can carry out similarly to the continuous irradiation method of the laser beam described in the open 2016-36884 gazette and Unexamined-Japanese-Patent No. 2016-44337 gazette.
  • the energy density needs to be 1 MW / cm 2 or more.
  • the energy density at the time of laser beam irradiation can be determined from the laser beam output (W) and the laser beam (spot area (cm 2 ) ( ⁇ ⁇ [spot diameter / 2] 2 ). density is preferably 2 ⁇ 1000MW / cm 2, more preferably 10 ⁇ 800MW / cm 2, 10 ⁇ 700MW / cm 2 is more preferred.
  • energy density, or increase or decrease the output of the laser beam, the laser beam spot diameter Can be adjusted to fall within the above range by increasing or decreasing.
  • the output of the laser light is preferably 4 to 4000 W, more preferably 50 to 2500 W, still more preferably 150 to 2000 W, and still more preferably 150 to 1000 W. It is preferable to do.
  • the beam diameter is preferably 5 to 80 ⁇ m, but it is preferable to adjust it to the above-mentioned energy density in combination with the output of the laser beam within the above-mentioned range.
  • the laser beam irradiation rate is preferably 2,000 to 20,000 mm / sec, more preferably 2,000 to 18,000 mm / sec, and still more preferably 3,000 to 15,000 mm / sec.
  • the wavelength is preferably 500 to 11,000 nm.
  • the defocusing distance is preferably ⁇ 5 to +5 mm, more preferably ⁇ 1 to +1 mm, and still more preferably ⁇ 0.5 to +0.1 mm.
  • the defocusing distance may be a laser irradiation with a constant set value, or may be a laser irradiation while changing the defocusing distance. For example, at the time of laser irradiation, the defocusing distance may be reduced, increased, or periodically increased or decreased.
  • the number of repetitions (the total number of laser beam irradiations for forming one hole) is preferably 1 to 50 times, more preferably 5 to 30 times, and still more preferably 5 to 20 times.
  • the irradiation so as to alternately generate the irradiated portion and the non-irradiated portion of the laser light includes an embodiment in which the irradiation is performed as shown in FIG.
  • FIG. 3 shows a state where irradiation is performed so that non-irradiated portions 102 of the laser light alternately occur between the irradiated portions 101 of the laser light and the irradiated portions 101 of the laser light adjacent to each other to form a dotted line as a whole. It shows. At this time, the same portion can be repeatedly irradiated to form one dotted line in appearance as shown in FIG. The number of repetitions can be, for example, 1 to 20 times.
  • the irradiated part of the laser light may be the same, or by making the irradiated part of the laser light different (shifting the irradiated part of the laser light), the entire metal piece is roughened You may When the same portion of the laser light is irradiated and irradiated a plurality of times, it is irradiated like a dotted line, but the irradiated portion of the laser light is shifted, that is, the portion of the laser light is not irradiated at first. When the irradiation portions are repeatedly shifted and irradiated so as to overlap, even when the irradiation is performed in a dotted line, the irradiation is finally performed in a solid line state.
  • the metal compact is continuously irradiated with laser light, the temperature of the irradiated surface rises, and there is a possibility that deformation such as warpage may occur in a compact with a small thickness, so it is necessary to take measures such as cooling. May be However, as shown in FIG. 3, when the laser irradiation is performed in a dotted line shape, the irradiated portion 101 of the laser light and the non-irradiated portion 102 of the laser light are alternately generated, and the non-irradiated portion 102 of the laser light is cooled. When the irradiation of the laser beam is continued, deformation such as warpage is less likely to occur even with a compact having a small thickness, which is preferable.
  • the same effect can be obtained because the laser beam is irradiated in a dotted line shape.
  • the laser light irradiation method is a method of irradiating the surface of the implant 110 in one direction as shown in FIG. 4 (a) or a method of irradiating the surface of the implant 110 from both directions as shown by a dotted line in FIG. It can be used.
  • a laser beam as shown to FIG. 4 (a) and FIG. 4 (b)
  • it can also be irradiated so that it may become a continuous line by shifting and irradiating the irradiation part of a laser beam as mentioned above.
  • the method of irradiating so that the dotted line irradiation part of a laser beam may cross may be used.
  • the crossing angle at this time is not particularly limited, but can be, for example, in the range of 45 ° to 90 °, and irradiation can also be performed so that the solid lines cross in the above-described manner.
  • irradiation may be alternately performed in the cross direction, or irradiation may be performed in the cross direction a plurality of times after irradiation in only one direction a plurality of times.
  • the same number may be irradiated, or different numbers may be irradiated.
  • the distance b1 between the dotted lines after irradiation can be adjusted according to the area to be irradiated of the metal molded body, etc., but can be, for example, in the range of 0.01 to 5 mm.
  • Adjust the length (L1) of the irradiated part 101 of the laser light and the length (L2) of the non-irradiated part 102 of the laser light shown in FIG. 3 to be in the range of L1 / L2 1/9 to 9/1. can do.
  • the length (L1) of the laser beam irradiated portion 101 is preferably 0.05 mm or more in order to roughen to a complicated porous structure, 0.1 to 10 mm is more preferable, and 0.3 to 7 mm Is more preferred.
  • the second laser beam irradiation method is Method of irradiating a laser beam so that the irradiated part and the non-irradiated part are alternately generated by using a combination of a galvano mirror and a galvano controller and pulsing the laser light continuously oscillated from the laser oscillator by the galvano controller Or, using a fiber laser device in which a direct modulation type modulator that directly converts laser drive current is connected to a laser power source, and using a method of irradiating a laser beam so that an irradiated part and an unirradiated part are alternately generated. It can be implemented.
  • a pulse wave laser by pulse excitation is generally called a normal pulse.
  • the second laser beam irradiation method is different from the continuous wave laser used in the first laser irradiation method, but the energy density, laser beam irradiation speed, laser beam output, wavelength, beam diameter (spot The diameter) and the defocusing distance can be implemented in the same manner as the first laser irradiation method.
  • the duty ratio is adjusted and the irradiation is performed.
  • the duty ratio corresponds to L1 / (L1 + L2) when using L1 (length of irradiated portion of laser beam) and L2 (length of non-irradiated portion of laser beam) shown in FIG. It can be selected from the range of 10 to 90%.
  • the length (L1) of the laser beam irradiated portion 101 is preferably 0.05 mm or more in order to roughen to a complicated porous structure, preferably 0.1 to 10 mm, and 0.3 to 7 mm. More preferable.
  • Lasers used in the first laser irradiation method and the second laser irradiation method may be known ones, for example, YVO 4 laser, fiber laser (single mode fiber laser, multi mode fiber laser), excimer laser, Carbon dioxide gas laser, ultraviolet laser, YAG laser, semiconductor laser, glass laser, ruby laser, He-Ne laser, nitrogen laser, chelate laser, dye laser can be used.
  • YVO 4 laser fiber laser (single mode fiber laser, multi mode fiber laser), excimer laser, Carbon dioxide gas laser, ultraviolet laser, YAG laser, semiconductor laser, glass laser, ruby laser, He-Ne laser, nitrogen laser, chelate laser, dye laser can be used.
  • the metal forming body is subjected to the laser so as to satisfy the above energy density and irradiation speed.
  • the surface of the metal compact melts and partially evaporates, thereby forming a porous structure of complex structure (FIGS. 1 and 2).
  • thermo conductivity is 100 W / m ⁇ k or more
  • a non-irradiated surface of a laser beam of an implant and titanium or titanium alloy constituting the implant, cobalt chromium alloy, tantalum A method of contacting with a substrate (for example, a glass plate) made of a material having a thermal conductivity smaller than that of the metal selected from the above can be applied.
  • JP-A-2016-78090 can be applied to the method (i), and the method described in JP-A-2016-124024 can be applied to the method (ii).
  • the method (i) can suppress the temperature rise by radiating the heat generated when the laser beam is irradiated to the implant made of a metal selected from titanium or titanium alloy, cobalt chromium alloy, and tantalum.
  • the method (ii) can suppress the heat radiation generated when the laser beam is irradiated to the implant made of a metal selected from titanium or titanium alloy, cobalt chromium alloy, and tantalum.
  • the method (i) can suppress changes in pore size, depth and shape
  • the method (ii) can suppress changes in pore size, depth and shape. Can be promoted.
  • the size, depth and shape of the hole can be adjusted by selectively using the method (i) and the method (ii).
  • the manufacturing method of this invention When irradiating a laser beam by the manufacturing method of this invention, it can irradiate, supplying the assist gas chosen from air, oxygen, nitrogen, argon, and helium.
  • the assist gas chosen from air, oxygen, nitrogen, argon, and helium.
  • control of the depth, size and orientation (the direction of the opening of the hole) of the hole can be assisted, and further, the formation of carbide can be suppressed,
  • the surface quality can be controlled. For example, selection of argon gas can prevent surface oxidation, selection of oxygen can promote surface oxidation, and selection of nitrogen gas can prevent oxidation and improve surface hardness.
  • the hole orientation can be adjusted by adjusting all of the following requirements (a) to (g) or requirements (a) to (h): It is preferable to control the orientation of the openings of the holes, the size of the holes and the depth of the holes.
  • (A) Irradiation Direction and Angle of Laser Light By fixing the irradiation direction of the laser light to a specific direction and a specific angle, the formed holes can be oriented.
  • the irradiation angle is preferably 45 to 90 degrees with respect to the laser beam irradiation surface (implant surface).
  • the laser beam irradiation rate is preferably 2,000 to 20,000 mm / sec, more preferably 2,000 to 18,000 mm / sec, and 2,000 to 15,000 mm / sec, 3 It is more preferably 1,000 to 15,000 mm / sec.
  • the energy density is preferably 1 MW / cm 2 or more.
  • the energy density at the time of laser beam irradiation can be determined from the laser beam output (W) and the laser beam (spot area (cm 2 ) ( ⁇ ⁇ [spot diameter / 2] 2 ). density is more preferably 2 ⁇ 1000MW / cm 2, more preferably 10 ⁇ 800MW / cm 2, more preferably 50 ⁇ 700MW / cm 2, more preferably 100 ⁇ 500MW / cm 2, the 100 ⁇ 300MW / cm 2 More preferably, the higher the energy density, the deeper and the larger the holes.
  • the number of repetitions (the number of irradiations of the total laser light for forming one line) is preferably 1 to 40 times, more preferably 5 to 30 times, Twenty times is even more preferred.
  • the holes (grooves) formed along the line become deeper and larger as the number of repetitions increases, and the holes (grooves) formed along the lines become shallower as the number of repetitions decreases. It becomes smaller.
  • the focusing distance is preferably ⁇ 5 to +5 mm, more preferably ⁇ 1 to +1 mm, and still more preferably ⁇ 0.5 to +0.1 mm.
  • the defocusing distance may be a laser irradiation with a constant set value, or may be a laser irradiation while changing the defocusing distance. For example, at the time of laser irradiation, in addition to decreasing or increasing the defocusing distance, it may be increased or decreased periodically.
  • the defocusing distance is negative (-) (when focused on the inside of the surface of the metal molding), the hole is deep and large.
  • the defocus distance is preferably -1 to +0.5 mm, more preferably -0.5 to -0.05 mm, and still more preferably -0.3 to -0.05 mm.
  • the relationship between the thermal conductivity of the implant and the substrate on which the implant is placed when irradiating laser light As described above, the method of placing the implant on a substrate having a high thermal conductivity and the method of placing the implant on a substrate having a low thermal conductivity
  • the hole structure can be adjusted by selecting.
  • the thermal conductivity relationship may be such that the thermal conductivity of the implant ⁇ the thermal conductivity of the substrate.
  • the line interval of laser light is the interval of b1 in FIG. 4 (a) or (b).
  • the line interval of the laser beam is preferably 0.01 to 3 mm, more preferably 0.01 to 1 mm, still more preferably 0.03 to 0.5 mm, and still more preferably 0.03 to 0.1 mm.
  • the line spacing may be the same for all line spacings, or may be different for some or all of the line spacings.
  • the line spacing is narrow, the adjacent lines are also thermally affected, so the holes become large, the shape of the holes becomes complicated, and the depth of the holes tends to be deep, but the thermal effects become too large In some cases, an appropriate hole shape may not be formed. If the line spacing is large, the holes will be smaller, the shape of the holes will not be complicated and the holes will tend to be less deep, but the processing speed can be increased.
  • Duty ratio is preferably 10 to 90%, more preferably 30 to 80%.
  • the output of the laser beam is preferably 4 to 4000 W, more preferably 50 to 2000 W, further preferably 150 to 1000 W, still more preferably 150 to 500 W, and still more preferably 150 to 300 W. If the other laser light irradiation conditions are the same, the larger the output, the deeper and the larger the hole, and the smaller the output, the shallower and the smaller the hole.
  • the wavelength is preferably 500 to 11,000 nm.
  • Example 3 Using a laser apparatus described below, an area of 20 mm ⁇ 6 mm was continuously irradiated with laser light under the conditions shown in Table 1 with respect to a plate of 64 titanium (30 mm long, 30 mm wide, 1.5 mm thick).
  • the magnitude relationship of the thermal conductivity (100 ° C.) of pure titanium, 64 Ti, steel plate, glass plate and copper plate is copper> steel plate> pure titanium> 64 Ti> glass in descending order.
  • FIG. 5 Example 1
  • FIG. 6 Example 2
  • FIG. 7 Example 3
  • the living tissue including bones and teeth seems to be most easily intruded into the inside of the hole in FIG.
  • the more complex structure of the pore structure as shown in FIGS. 5 and 7, may eventually increase the bonding strength between the bone (tooth) and the implant.
  • Examples 4 to 8 Using the same laser apparatus as in Examples 1 and 2, laser light is continuously applied to an area of 5 mm ⁇ 10 mm under the conditions shown in Table 2 for a plate of pure titanium (60 mm long, 10 mm wide, 2 mm thick) Irradiated.
  • Example 8 irradiation was performed in the longitudinal direction of the pure titanium plate and in the direction orthogonal thereto.
  • the number of lines in the length direction was 63
  • the number of lines in the orthogonal direction was 125. Irradiation was performed in each direction. Specifically, 63 line irradiations were performed 10 times at a line interval of 0.08 mm in the length direction. After that, 125 line irradiations were performed 10 times at a line interval of 0.08 mm in the orthogonal direction.
  • FIG. 8 The surface photograph (SEM photograph) of the plate of pure titanium after laser light irradiation is shown in FIG. 8 (Example 5), FIG. 9 (Example 7), and FIG. 10 (Example 8).
  • Examples 9 to 13 Using the same laser apparatus as in Examples 1 and 2, laser light is continuously applied to an area of 5 mm long ⁇ 10 mm wide under the conditions shown in Table 3 with respect to a plate of 64 titanium (90 mm long, 10 mm wide, 2 mm thick) Irradiated.
  • FIG. 11 The surface photograph (SEM photograph) of the plate of 64 titanium after the laser light irradiation is shown in FIG. 11 (Example 9), FIG. 12 (Example 11), and FIG. 13 (Example 12).
  • FIG. 14 (a) (a cross-sectional photograph parallel to the scanning direction of the laser beam), FIG. Shown in the cross-sectional photograph perpendicular to the direction).
  • the maximum depth of the hole determined from the X-ray CT scan was 380 ⁇ m.
  • Test Example 1 Pure titanium plate (not irradiated with laser light), Pure titanium plate after laser light irradiation in Examples 4 to 6, 64 titanium plate (not irradiated with laser light), 64 titanium after laser light irradiation in Examples 9 to 11 Composition analysis of the plate was performed by SEM-EXD. The results are shown in Table 4.
  • Examples 14 to 18 Using a laser apparatus described below, a tantalum plate (50 mm long, 50 mm wide, 1.5 mm thick) was continuously irradiated with laser light in the area of 5 mm long ⁇ 10 mm wide under the conditions shown in Table 5. Assist gas was not used.
  • the implant of the present invention can be used as an artificial hip joint (stem, cup), an artificial joint such as an artificial knee joint, for fracture fixation (plate, screw), an artificial tooth root and the like.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plastic & Reconstructive Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Dentistry (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Prostheses (AREA)
  • Laser Beam Processing (AREA)

Abstract

[Problème] Fournir un implant médical présentant une bonne biocompatibilité. [Solution] La présente invention concerne un implant utilisé pour jonction à un tissu biologique, comprenant un os et des dents, l'implant étant constitué d'un métal choisi parmi le titane ou un alliage de titane, un alliage de cobalt et de chrome, et le tantale. Une couche de surface de la partie de l'implant qui est jointe à un tissu biologique, comprenant un os et des dents, présente une structure poreuse. La structure poreuse comprend un trou de tronc qui est formé dans la direction de l'épaisseur du trou et comporte une ouverture sur le côté de face de jonction, des trous ouverts constitués par des trous de ramification formés de façon à s'étendre depuis des parois internes du trou de tronc dans différentes directions par rapport au trou de tronc, et un espace intérieur qui est formé dans la direction d'épaisseur traversante et ne comprend pas d'ouverture sur le côté de face de jonction, ainsi que des trajets de liaison de tunnel qui relient les trous ouverts et l'espace intérieur, et un trajet de liaison de tunnel qui relie les trous ouverts.
PCT/JP2018/025800 2017-07-07 2018-07-09 Implant et son procédé de fabrication WO2019009428A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP18827933.5A EP3649986B1 (fr) 2017-07-07 2018-07-09 Implant et son procédé de fabrication
US16/623,906 US20210145553A1 (en) 2017-07-07 2018-07-09 Implant and method for manufacturing same
CN201880030274.1A CN110603012A (zh) 2017-07-07 2018-07-09 植入物及其制造方法

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
JP2017-133498 2017-07-07
JP2017133498 2017-07-07
JP2017219912 2017-11-15
JP2017-219912 2017-11-15
JP2018-025671 2018-02-16
JP2018025671 2018-02-16
JP2018-115873 2018-06-19
JP2018115873A JP2019136472A (ja) 2017-07-07 2018-06-19 インプラントとその製造方法

Publications (1)

Publication Number Publication Date
WO2019009428A1 true WO2019009428A1 (fr) 2019-01-10

Family

ID=64950109

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2018/025800 WO2019009428A1 (fr) 2017-07-07 2018-07-09 Implant et son procédé de fabrication

Country Status (2)

Country Link
TW (1) TW201914622A (fr)
WO (1) WO2019009428A1 (fr)

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5326164B2 (fr) 1972-08-28 1978-07-31
JPS571414B2 (fr) 1976-12-09 1982-01-11
JPS5920030B2 (ja) 1979-10-09 1984-05-10 アキレス株式会社 柔軟性、耐久性に優れた合成皮革
JPS63160662A (ja) * 1986-12-23 1988-07-04 川崎製鉄株式会社 骨親和性に優れた金属材表面の処理方法
JP2009254581A (ja) 2008-04-16 2009-11-05 Toyo Advanced Technologies Co Ltd 生体用インプラント及びその製造方法
JP2014161520A (ja) 2013-02-25 2014-09-08 Shiga Prefecture インプラントおよびその製造方法
JP5774246B2 (ja) 2013-03-26 2015-09-09 ダイセルポリマー株式会社 金属成形体の粗面化方法
JP5860190B2 (ja) 2013-07-18 2016-02-16 ダイセルポリマー株式会社 複合成形体
JP2016036884A (ja) 2014-08-08 2016-03-22 ダイセルポリマー株式会社 研磨材
JP2016043413A (ja) 2014-08-19 2016-04-04 ダイセルポリマー株式会社 金属成形体の粗面化方法
JP2016044337A (ja) 2014-08-25 2016-04-04 ダイセルポリマー株式会社 複合成形体の製造方法
JP2016078090A (ja) 2014-10-20 2016-05-16 ダイセルポリマー株式会社 表層部に多孔構造を有する金属成形体の製造方法
JP2016124024A (ja) 2015-01-08 2016-07-11 ダイセルポリマー株式会社 表層部に多孔構造を有する金属成形体の製造方法

Patent Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5326164B2 (fr) 1972-08-28 1978-07-31
JPS571414B2 (fr) 1976-12-09 1982-01-11
JPS5920030B2 (ja) 1979-10-09 1984-05-10 アキレス株式会社 柔軟性、耐久性に優れた合成皮革
JPS63160662A (ja) * 1986-12-23 1988-07-04 川崎製鉄株式会社 骨親和性に優れた金属材表面の処理方法
JP2009254581A (ja) 2008-04-16 2009-11-05 Toyo Advanced Technologies Co Ltd 生体用インプラント及びその製造方法
JP2014161520A (ja) 2013-02-25 2014-09-08 Shiga Prefecture インプラントおよびその製造方法
JP5774246B2 (ja) 2013-03-26 2015-09-09 ダイセルポリマー株式会社 金属成形体の粗面化方法
JP5860190B2 (ja) 2013-07-18 2016-02-16 ダイセルポリマー株式会社 複合成形体
JP5890054B2 (ja) 2013-07-18 2016-03-22 ダイセルポリマー株式会社 複合成形体の製造方法
JP5959689B2 (ja) 2013-07-18 2016-08-02 ダイセルポリマー株式会社 複合成形体の製造方法
JP2016036884A (ja) 2014-08-08 2016-03-22 ダイセルポリマー株式会社 研磨材
JP2016043413A (ja) 2014-08-19 2016-04-04 ダイセルポリマー株式会社 金属成形体の粗面化方法
JP2016044337A (ja) 2014-08-25 2016-04-04 ダイセルポリマー株式会社 複合成形体の製造方法
JP2016078090A (ja) 2014-10-20 2016-05-16 ダイセルポリマー株式会社 表層部に多孔構造を有する金属成形体の製造方法
JP2016124024A (ja) 2015-01-08 2016-07-11 ダイセルポリマー株式会社 表層部に多孔構造を有する金属成形体の製造方法

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ASRI, R.I.M. ET AL: "Corrosion and surface modification on biocompatible metals: A review", MATERIALS SCIENCE AND ENGINEERING C, vol. 77, August 2017 (2017-08-01), pages 1261 - 1274, XP085028532, ISSN: 0928-4931, DOI: 10.1016/j.msec.2017.04.102 *
MIZUTANI, MASAYOSHI ET AL.: "High functionalization of Dental Implant with laser fabrication", JOURNAL OF THE JAPAN SOCIETY FOR PRECISION ENGINEERING, vol. 81, no. 12, 2015, pages 1073 - 1077, XP055658963, ISSN: 1882-675x, DOI: 10.2493/jjspe.81.1073 *
MIZUTANI, MASAYOSHI: "Creation of bone tissue-compatible implant by means of nano pulse laser", REPORT OF GRANT-SUPPORTED RESEARCHES, THE ARMADA FOUNDATION, vol. 27, pages 158 - 163, ISSN: 2434-0723 *
See also references of EP3649986A4 *

Also Published As

Publication number Publication date
TW201914622A (zh) 2019-04-16

Similar Documents

Publication Publication Date Title
JP4997452B2 (ja) レーザ加工装置、骨の接合方法、インプラント材、インプラント材製造方法およびインプラント材製造装置
US20110183292A1 (en) Material with a repetitive pattern of micro-features for application in a living organism and method of fabrication
JP2019063875A (ja) 金属成形体の粗面化方法
JP6510296B2 (ja) 金属成形体の粗面化方法
JP2019136472A (ja) インプラントとその製造方法
JP2019034131A (ja) インプラントの製造方法
Miller et al. Laser micromachining for biomedical applications
Swift et al. Heat generation in hydroxyapatite-coated implants as a result of CO2 laser application
Um et al. Recent advances in selective laser–material interaction for biomedical device applications
KR20200026475A (ko) 레이저를 이용한 아파타이트 피막 형성방법
WO2019009428A1 (fr) Implant et son procédé de fabrication
CN108555437A (zh) 一种定向调控生物金属材料表面细胞生长的激光加工方法
JP7164919B2 (ja) 表層部が多孔構造を有している金属成形体とその製造方法
Beltrán Bernal et al. Laser in bone surgery
JP6989328B2 (ja) 金属成形体表面の粗面化方法
JP7250235B2 (ja) 金属成形体および金属成形体の粗面化方法
KR102115225B1 (ko) 단일 공정 적층성형 다공성 부품 제조방법
Panova et al. Application of lasers and laser processing technologies in modern dentistry: A review
WO2005070151A2 (fr) Distributions d'energie electromagnetique pour decoupage mecanique a induction electromagnetique
JP6590399B2 (ja) 医療機器材料の製造方法及び医療機器材料
JP6479414B2 (ja) 医療機器材料の製造方法及び医療機器材料
Beltran Bernal Laser and wave-guides system for endoscopic/fiberscopic laser surgery
Kiani et al. High-Energy Nanosecond Laser Pulses for Synthesis of Better Bone Implants
Sener Biomedical optics and lasers
Bartsch et al. Discover Mechanical Engineering

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18827933

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2018827933

Country of ref document: EP

Effective date: 20200207