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WO2011071299A2 - Implant - Google Patents

Implant Download PDF

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Publication number
WO2011071299A2
WO2011071299A2 PCT/KR2010/008717 KR2010008717W WO2011071299A2 WO 2011071299 A2 WO2011071299 A2 WO 2011071299A2 KR 2010008717 W KR2010008717 W KR 2010008717W WO 2011071299 A2 WO2011071299 A2 WO 2011071299A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
magnesium alloy
joint
biodegradable
bone
Prior art date
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
Application number
PCT/KR2010/008717
Other languages
English (en)
Korean (ko)
Other versions
WO2011071299A3 (fr
Inventor
구자교
석현광
양석조
김유찬
조성윤
김종택
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
U&I Corp
Original Assignee
U&I Corp
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
Application filed by U&I Corp filed Critical U&I Corp
Priority to EP10836194A priority Critical patent/EP2510957A2/fr
Priority to CN201080055205XA priority patent/CN102639158A/zh
Priority to US13/511,851 priority patent/US20130131814A1/en
Priority to JP2012541956A priority patent/JP2013512069A/ja
Priority to AU2010328804A priority patent/AU2010328804A1/en
Publication of WO2011071299A2 publication Critical patent/WO2011071299A2/fr
Publication of WO2011071299A3 publication Critical patent/WO2011071299A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61F2/30721—Accessories
    • A61F2/30749—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • 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
    • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • 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
    • 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
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2002/4631—Special tools for implanting artificial joints the prosthesis being specially adapted for being cemented

Definitions

  • the present invention relates to an implant.
  • Screws made of polymers are used, but this is a mechanical
  • Japanese Patent Laid-Open Nos. 2002-253665 and 2000-070278 are birthdays made of biodegradable polymers.
  • Japanese Patent Laid-Open Publication No. 1993-049657 attempted to improve artificial joint fusion by using an artificial joint cup movement prevention mechanism made of biodegradable and palate polymers.
  • the present invention aims to provide the following implants:
  • Implants that have a higher initial bending and pull strength than the bone and maintain the initial bending and pull strength until the artificial joint is secured to the bone.
  • the disassembly of the implant fixing the artificial joint to the bone can be controlled at a decomposition rate to maintain the initial mechanical properties of 603 ⁇ 4 or more until the healing period, and the decomposition occurs uniformly from the surface to the inside, A tissue reaction
  • Implants that do not cause eg inflammatory reactions.
  • Implants without side effects from the implant itself and its degradation products iv) Implants without side effects from the implant itself and its degradation products.
  • the implant is secured to the surrounding bone to obtain a secure Resolution
  • the present invention is to fix the artificial joint to the bone, provides an implant comprising a biodegradable magnesium alloy.
  • the implant of the present invention fixes the artificial joint to the bone, and improves the superbonding force and interfacial force between the artificial joint and the bone.
  • the implant of the present invention after binding to the bone, induces the formation of the implant while decomposing the implant.
  • FIG. 1 is a view showing an implant and an artificial joint according to an embodiment of the present invention.
  • Figure 2 is a photograph showing the implant (screw type: arrow) of Example 1 mounted on an artificial joint.
  • Figure 3 is an H & E histological staining picture of the sections 1, 8 and 12 weeks after implantation of the implant of Example 2 to the rat femur.
  • FIG. 4 is an ALP (alkaline phosphatase) showing bone formation and bone growth index by extracting RNA at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after implanting the implant of Example 2 into the femoral section of the rat; Histogram ID-Analysis of the expression of osteocalcin.
  • Figure 5 shows the surface photograph of the biodegradable magnesium alloy of Preparation Example 2. Best Mode for Carrying Out the Invention
  • the implant of the present invention is for fixing an artificial joint to bone, and includes a biodegradable magnesium alloy.
  • the implant plays a role of fixing the artificial joint to the patient during the procedure of the artificial joint. Over time, the implant decomposes inside the bone, leading to bone formation. The area in which the implant is decomposed is filled with bone, which improves the bond between the implant and the artificial joint.
  • the rate of decomposition and bone formation of the implant can be controlled by the amount of biodegradable magnesium alloy.
  • the implant is not particularly limited as long as it can fix the artificial joint to the bone, but is preferably in the form of a screw, bolt, pin, nail and washer (washer).
  • the screw may be a cannula having a hole therein.
  • the washer is used for distributing a load such as a pin.
  • the artificial joint is not particularly limited as long as it can replace the joint of the human body, but it is preferably selected from the group consisting of hip bone joint, knee joint, shoulder joint, elbow joint, wrist joint, ankle joint, finger joint and toe joint.
  • the biodegradable magnesium alloy may be represented by the following formula (1). ⁇ Formula 1>
  • A is manganese (Mn), cobalt (Co), nickel (Ni), chromium (Cr), copper (Cu), cadmium (Cd), zirconium (Zr), silver (Ag), gold (Au), palladium (Pd ), Platinum (Pt), rhenium (Re), iron (Fe), zinc (), molybdenum (Md), niobium (Nb), tantalum (Ta), titanium ( ⁇ , strontium (Sr), silicon (Si), It is 1 type (s) or 2 or more types selected from the group which consists of phosphorus (P) and selenium (Se).
  • the biodegradable magnesium alloy may be represented by the following formula (2).
  • X is zirconium (Zr), molybdenum (Mo), niobium (Nb), tantalum (Ta), titanium (Ti), strontium (Sr), crumb (Cr), manganese (Mn), zinc (Zn), silicon (Si ), Phosphorus (P), nickel (Ni) and iron (Fe) is selected from the group of 1 or 2 or more.
  • the implant of the present invention can determine the amount of Ca and X within the above range in consideration of the required strength and the rate of extinction of the filling metal.
  • X contains nickel (Ni). Nickel reduces the toxicity of biodegradable implants and facilitates corrosion rate control. At this time, the nickel content is preferably 100 ppm or less, more preferably 50 ppm or less.
  • the iron content is preferably lOOOOppm or less, and more preferably 500ppm or less. At this time, if the iron content is included in the above range, the iron is not dissolved in the magnet and exists as an independent factor to increase the corrosion rate of magnesium.
  • the biodegradable magnesium alloy is composed of magnesium (Mg) and impurities, and the impurities are made of manganese (Mn) and a mixture of iron (Fe), nickel (Ni) and iron (Fe) and nickel (Ni). Including one selected from the group, the impurity content is more than 0 parts by weight or less based on 100 parts by weight of the magnet, (iron 6), nickel (Ni), iron (Fe) and nickel (Ni) 1 species selected from the group consisting of the compound / manganese (Mn) may be greater than or equal to 5 or less.
  • ⁇ the 1 type chosen from the group which consists of a mixture of iron ⁇ , nickel (Ni), iron (Fe), and nickel (Ni) ⁇ / manganese (Mn) more than 0.2 or less.
  • nickel (Ni), selected from the group consisting of iron (Fe) and nickel (Ni) 1 type ⁇ / manganese (Mn) satisfies the above-mentioned range, the decomposition rate is extremely low in vivo and the corrosion resistance is improved. This may allow implants to exist for longer periods in vivo.
  • the impurities include nickel (Ni) and manganese (Mn).
  • Nickel (Ni) causes human allergic reactions and increases the rate of corrosion of pure Mg. Therefore, the nickel content is more preferably 100 ppm or less, most preferably 50 ppm or less.
  • the biodegradable magnesium alloy is represented by the following formula (3), with respect to the total weight, Ca is greater than 0 to 23% by weight; Y is greater than 0 and less than or equal to 10 weight percent; And Mg may be a magnet alloy including the remaining amount.
  • Y is Mn or Zn.
  • biodegradable magnesium alloy represented by Chemical Formula 3 satisfies the above-described range, it is possible to provide a biodegradable implant in which mechanical properties and corrosion resistance are improved at the same time, and brittle fracture does not occur.
  • the magnesium alloy represented by the formula (3) is preferably based on the total weight, Ca is more than 0 to 23% by weight, Y is 1 to 5% by weight and Mg is the residual amount, more preferably The Ca is more than 0 and 23% by weight or less, X is 0.1 to 3% by weight and Mg is the balance. The reason is that when the same corrosion rate is implemented in consideration of possible side effects of impurities, it is advantageous that the content of impurities is small.
  • biodegradable implant of the present invention the biodegradable magnesium alloy; And a magnet composite in which one or more selected from the group consisting of metals, ceramics and polymers are mixed.
  • the biodegradable magnesium alloy included in the implant of the present invention can perform a surface coating.
  • corrosion products may be generated on the surface of the magnesium alloy to delay the decomposition rate.
  • the surface coating may be performed with a ceramic and / or a polymer.
  • the surface coating is performed with ceramics.
  • the surface of the biodegradable magnesium alloy When the biodegradable magnesium alloy is immersed in a bio simulation solution or a saline solution, the surface of the biodegradable magnesium alloy may be coated with a corrosion product.
  • the corrosion product is a ceramic
  • the ceramic may be magnesium oxide, calcium phosphate.
  • it may be further coated with a polymer.
  • the type of the polymer is the same as that of the polymer described later.
  • the polymer used to coat the surface of the biodegradable magnet alloy with a polymer is not particularly limited as long as it is used in the art.
  • the polymer may be poly (L-lactide), poly (glycol ide), poly (DL-lact ide), poly (dioxanone), poly (DL-l act ide-co L— lactide), poly (DL-lact It is preferable to use ide-co-glycol ide), poly (glycol ide one co-tr imethylene carbonate), poly (L-lact ide-co-glycol ide), poly (e—caprolactone) or polymers thereof.
  • Magnesium alloy contained in the implant of the present invention is that the surface treatment desirable.
  • the surface treatment is preferably shot peening or sand blasting.
  • the biodegradable magnet alloy may be applied to the ultrasonic wave.
  • Application of ultrasonic wave to the biodegradable magnesium sum has an advantage of increasing the corrosion rate in the living body and thus eliminating the implant in a shorter time.
  • the biodegradable magnet alloy may lead to a porous structure, or the biodegradable magnesium alloy may be layered on the porous structure.
  • the implant of the present invention may further comprise a porous structure in addition to the biodegradable magnesium alloy.
  • the pore size of the porous structure may be adjusted according to the field used using conventional methods in the art, but is preferably 200 to 500 / im. When the pore size satisfies the above-mentioned range, blood vessels that are responsible for supplying nutrients, minerals and ions easily pass through the pores.
  • the porosity of the porous structure is preferably 5 to 95%.
  • the porosity refers to the volume ratio occupied by the pores in the total volume.
  • the porosity may increase the strength of the porous structure by lowering the porosity when the required strength of the object to be applied is high.
  • the porous structure is a metal such as high strength tantalum, or simply serves to fill the cavity of the missing bone, it is irrelevant to increase the porosity.
  • the porous structure may be at least one selected from the group consisting of metals, ceramics, and polymers.
  • the porous structure is a metal, it is preferably at least one member selected from the group consisting of titanium or a titanium alloy, cobalt-crumb alloy and stainless steel.
  • the porous structure is ceramic, it is preferable that it is one kind ⁇ phase selected from the group consisting of Calciu, Phosphate, alumina, zirconia, and magnesia.
  • the polystructure is a polymer, polyethylene, polylactic acid (PLA), polyglycolic acid (PGA), and copolymers thereof PLGA, Poly (L-lactide), poly (glycol ide), poly (DL-lact ide), poly (dioxanone), poly (DL-lact ide-co L-lact ide), poly (DL-lact ide-co-glycol ide), poly (glycol ide-co-trimethylene carbonate), It is preferably at least one member selected from the group consisting of poly (L-lact ide-co-glycol ide), poly (e-caprolactone) and polymers thereof.
  • the porous structure is the polymer described above, an acid that may be decomposed in a living body is generated to cause a pH to be lowered.
  • the effect of increasing the pH of magnesium and the decomposition of magnesium can be expected, and additional effects of arbitrarily controlling the pH in vivo can be expected by controlling the decomposition rate of the polymer and magnesium. have.
  • the implant of the present invention may further include a substance that may help adhesion of cells, induce or promote angiogenesis, bone formation.
  • the material include BMP (bone morphogenic protein) -2, BMP-4, BMP-6, BMP-7, IGF (insulin like growth fadtor) -1, IGF-2, f ibroblast growth factor (FGF), PDGF ( platelet derived growth factor, other transforming growth factor I J3, VEGF (vascular endothelial growth factor), fibronectin (f ibronectin), and one or more selected from the group consisting of vitronectin.
  • Figure 1 is a view showing an implant and artificial joint according to an embodiment of the present invention.
  • the artificial joint 10 and the implant 20 are combined.
  • the implant 20 is in the form of a screw, but is not limited thereto.
  • the method of manufacturing an implant according to an embodiment of the present invention may include a) providing the biodegradable magnesium alloy, and b) molding the biodegradable magnesium alloy.
  • the step a) is preferably a step of melting and providing the biodegradable magnesium alloy.
  • the step a) may be a step of melting and providing the biodegradable magnesium in an inert gas atmosphere or a vacuum atmosphere such as argon (Ar) that does not react with the magnet.
  • the magnesium may be melted by various methods such as resistance heating by generating electricity by applying electricity to a resistor, induction heating by flowing a current through an induction coil, or by laser or focused light. It may be a step of providing.
  • the resistance heating method of the above-mentioned melting method is the most economical. It is preferable to stir the molten alloy (hereinafter, molten metal) so that the ball impurities are well mixed when the biodegradable magnesium alloy is melted.
  • the step a) comprises the steps of a-1) preparing a porous structure; And a-2) laminating pores of the porous structure with the biodegradable magnesium alloy.
  • the porous structure may be one selected from the group consisting of metals, ceramics and polymers.
  • the step a ⁇ 1) is as follows.
  • the metal is made of powder or wire.
  • the metal made of the powder or wire is made of green preform.
  • a sintering method and a method in which the sintering method is modified may be used.
  • the production method of the preform using the sintering method is as follows.
  • the metal made of the powder or wire is put in a container or pressed with an appropriate force of less than lOOMPa to have a weak strength, and the metal having such a weak strength is 2/10 to 9/10 of the melting point of the metal. Maintained at the temperature of the powder or wires to combine to prepare a preform having a mechanical strength.
  • the manufacturing method using a method in which the sintering method is modified is as follows.
  • the metal made of the powder or wire is contained in a conductive container such as graphite, and a high current flows through the conductive container to Heat is generated instantaneously at the contact portion to form a sintered body to produce a preform.
  • the step a1 1) is as follows.
  • the metal is made of powder or wire.
  • the polymer is mixed with the metal made of powder or wire, and the polymer is decomposed and extinguished at low temperature in the process of raising the silver degree, and the metal made of powder or wire is sintered from silver and preform having appropriate mechanical strength.
  • the porosity and the strength of the sintered body are determined according to the sintering temperature, the pressing force, the mixing ratio of the polymer and the metal, and appropriate conditions can be selected as necessary.
  • the sintering temperature depends on the type of material used to prepare the porous structure, and in general, about 1/2 to 9/10 of the melting point of the porous structure is preferable. Although sintering occurs even if no pressure is applied during sintering, the higher the pressure, the faster the sintering proceeds. However, as the pressing force increases, additional costs such as device cost and mold cost are required, so it is better to select an appropriate pressure.
  • the a-1) step is equal to 'it follows.
  • the polymer surface is plated with precious metals such as gold, platinum, and Pd. Thereafter, the polymer may be removed to prepare a metal porous structure having better biocompatibility.
  • the step a-1 is as follows.
  • a water-soluble salt and a metal powder are mixed and molded at high temperature to prepare a preform.
  • the water-soluble salt is one or more selected from the group consisting of NaN0 2 , KN0 2 , NaN0 3 , NaCl, CuCl, ⁇ 3 ⁇ 4, C1, LiCl, ⁇ ⁇ 3, PbCl 2 , MgCl 2 , CaCl 2 and BaCl 3 desirable.
  • the preform is pressed at a temperature of 2/10 to 9/10 of the melting point of the metal powder.
  • the metal powders are bonded to each other by atomic transfer to form a structure, and form a composite containing a water-soluble salt therein.
  • the metal porous structure may be manufactured by injecting a blowing agent that generates gas after completely melting the metal material.
  • the step a-1 is as follows.
  • the surface of the porous polymer is plated with metal using an electrolyte solution containing metal ions.
  • the metal ion is not particularly limited, but is preferably one or more selected from the group consisting of Ti, Co, Cr and Zr.
  • the polymer may be removed by reducing the temperature to prepare a porous metal structure.
  • the step a_2) is as follows.
  • ceramic fine powder and binder polymer are mixed.
  • the mixture is coated on the surface of the framework structure of a foam material made of a removable material such as polyurethane and then dried to form a porous structure. After that, increase the temperature When the polymer is burned and removed near the combustion temperature of the polymer, and the silver is further increased, the remaining ceramics are sintered with each other to produce a porous structure having mechanical strength.
  • the ceramic fine powder is preferably at least one selected from the group consisting of hydroxyapatite (HA), zirconia and alumina.
  • Step a-1 may be a method of modifying or combining the above-described method of manufacturing a porous structure, or a method of manufacturing a porous structure in which the porosity of the inside and the outside is controlled by applying a part of a heterogeneous material. In the latter method, it is possible to produce a porous structure having high or low porosity on the inside and high porosity on the outside.
  • Step a-2 the method of immersing the porous structure in the melt of the biodegradable magnesium alloy, the method of fixing the porous structure and the molten solution of magnesium to fill the pores, and from the two methods from the outside
  • One type selected from the group consisting of a method in which the molten biodegradable magnesium is layered between pores of the porous structure more easily by applying a pressure of 1 atm or more may be used.
  • the molten biodegradable magnesium alloy may be heated to remove the contaminants on the surface or the porous structure so as not to solidify during the filling of the pores so that the molten magnet can easily fill the pores.
  • the step a-2) may be as follows.
  • magnesium is vaporized by maintaining it at a high temperature, preferably at 700 ° C. or higher, and then the magnesium vapor is deposited on the pore surface while passing between the pores of the porous structure. Stratifying the pores.
  • the step a-2) may be as follows.
  • the magnesium after dissolving a salt containing magnesium in a liquid, the magnesium may be adsorbed to the pore surface of the porous structure while passing the porous structure through the liquid.
  • only some of the pores of the porous structure may be filled without completely filling the magnesium alloy.
  • the unmung magnesium is removed from the porous structure and only a part of the magnesium It can remain to produce a composite with magnesium impregnated in some of the pores.
  • the magnesium lamination rate for each position of the porous structure pores may be controlled differently.
  • the implant containing the polymer and biodegradable magnesium alloy is mixed with the biodegradable magnesium alloy powder and the polymer in the volume fraction of the range of 5:95 to 95: 5 and then heated to 150 to 500 ° C. 1 to 100 atm It is preferable to produce an implant comprising a biodegradable magnesium alloy by a method of pressing in the range of.
  • the above condition is a polymer porous structure- It is only desirable manufacturing conditions for implants comprising biodegradable magnesium alloys, and even under conditions deviating from the above conditions, the polymer porous structure—implants containing biodegradable magnesium alloys is not molded, so the right of the present invention may be changed by changing the manufacturing conditions. Cannot be violated.
  • the shape of the implant after molding is not particularly limited as long as it can fix the artificial joint to the bone, but is preferably a form selected from the group consisting of screws, bolts, pins and nails.
  • the cooling method can be used for the purpose of improving the mechanical strength of the magnet alloy.
  • a method of immersing the crucible containing the molten magnet in water may be used.
  • a cooling method of spraying the molten magnesium using an inert gas such as argon may be used.
  • the spraying cooling method can be cooled at a much higher rate to show very fine texture.
  • casting small size magnets may cause a large number of pores (black parts) inside, so be careful.
  • the extrusion method is used for the purpose of making the structure of magnesium uniform and improving mechanical performance.
  • the extrusion method is preferably made at 300 to 450 ° C.
  • the extrusion of the magnesium may be performed within 10: 1 to 30: 1 reduction ratio (extrusion ratio) before and after extrusion.
  • the extrusion ratio increases, the microstructure of the extruded material becomes uniform, and there is an advantage in that defects formed during casting are easily removed. In this case, it is preferable to increase the capacity of the extrusion apparatus.
  • the metal processing method is not particularly limited as long as it is a metal processing method known in the art.
  • the molten magnesium is poured directly into a mold processed in a form close to the final product, manufactured by a thickener such as rod or plate, and then milled or milled, and magnesium alloy is produced. And a method of producing the final product shape by press forging with a large force.
  • the inventors of the present invention insert the biodegradable implant of the present invention directly into the bone, and at the same time, the bone tissue grows into the disassembled implant at the same time as the implant is biodegraded to strengthen the strength of the bone and repair the lost bone tissue. Proved to be possible.
  • the components of the contents shown in Table 1 were charged to a crucible having an internal diameter of 50 countries made of stainless steel (SUS 410). Subsequently, argon gas is poured around the crucible so that iron, nickel, manganese, aluminum and magnesium in the crucible do not come into contact with the air, and the crucible temperature is raised from about 700 ° C to 750 ° C using a resistance furnace. Nickel, aluminum, manganese and magnesium were melted. The crucible was shaken and stirred so that molten iron, nickel, aluminum, manganese and magnesium could be mixed well with each other. A fully molten magnesium alloy was prepared to prepare a magnesium alloy in the solid state. In addition, when engraving, the crucible was immersed in water (20 ° C) for the purpose of improving the mechanical strength of the magnet, so that the molten magnesium alloy was rapidly etched.
  • biodegradable magnesium alloy of Preparation Example 1 was ground to provide a powder having an average particle diameter of 50 (3 ⁇ 4mu (hereinafter referred to as biodegradable magnesium alloy powder)).
  • Biodegradable magnesium alloy powder and biodegradable polymer were mixed at a volume ratio of 85:15. Then pressurized at 200 ° C, 5 atmospheres. Then, the process to prepare a screw-type implant.
  • FIG. 2 is a view showing an artificial joint equipped with an implant prepared in Example 1.
  • an implant (arrow) mounted on an artificial joint (trade name: Optigen, E & E Co., Ltd.) is well illustrated.
  • the implant was processed to the extent that it can be placed in the rat.
  • a male SD rat of 200 g body weight was used as an experimental animal.
  • a hole was formed in the femur of the rat according to a normal procedure using an implant motor.
  • the implant prepared in Example 2 was placed in the implant.
  • Rats were sacrificed at 1 week, 8 weeks, and 12 weeks after implantation, and bone specimens were collected using a chainsaw for histological examination.
  • the collected bone fragments were fixed in 10% neutral formalin, decalcified in 10% nitric acid and 10% sodium citrate for 2 days, and then dehydrated and paraffin-fixed according to 4-6 ⁇ specimens.
  • the specimens were stained with hemaroxylin-eosin to observe histological findings under an optical microscope.
  • Example 2 As shown in Figure 3, the first week the magnesium alloy prepared in Example 2 The boundaries of the implant rod were clearly distinguished from the surrounding tissues, but bone formation was observed at 8 weeks and filled with new bone and fibrotic tissue at 12 weeks.
  • a male SD rat weighing 200 g was used as an experimental animal, and the autogenous bone (using the pelvic bone of the rat, a), the magnesium alloy implant of Example 2 (b), pure magnesium (manufacturer: Ti ⁇ inco Metals, material: MP21 -31-31, Detailed composition: 99.98% ingot, c) and AZ91 (trade name, d) were implanted, except that the rats were sacrificed at 1, 2, 4, 8, and 12 weeks after implantation.
  • MRNA was collected from the bone specimens in a conventional manner to analyze the expression of ALP (alkaline phosphatase) and osteocalcin (0C), which represent bone formation and growth index, and are shown in FIG. 4.
  • the magnesium alloy implant of the present invention is decomposed to induce bone formation, and the implant implant portion disassembled in the end is replaced with new bone, as a result of the bone and the implant is combined, resulting in a strong between the implant and the bone in the long term. It clearly suggests that it can be used to improve implant and bone bonding in that it can maintain binding force.
  • FIG. 5 shows the surface photograph of the biodegradable magnesium alloy of Preparation Example 2.
  • the biodegradable magnesium alloy located above is before the surface treatment
  • the biodegradable magnesium alloy located below is after the surface treatment.
  • the biodegradable magnesium alloy of Preparation Example 2 before the surface treatment is glossy (top), the biodegradable magnesium alloy of Preparation Example 2 after the surface treatment is not glossy (bottom).
  • the surface treatment was shot peening.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un implant qui fixe une articulation artificielle sur l'os d'un patient, et qui contient des alliages de magnésium biodégradables.
PCT/KR2010/008717 2009-12-07 2010-12-07 Implant Ceased WO2011071299A2 (fr)

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EP10836194A EP2510957A2 (fr) 2009-12-07 2010-12-07 Implant
CN201080055205XA CN102639158A (zh) 2009-12-07 2010-12-07 植入物
US13/511,851 US20130131814A1 (en) 2009-12-07 2010-12-07 Implant
JP2012541956A JP2013512069A (ja) 2009-12-07 2010-12-07 インプラント
AU2010328804A AU2010328804A1 (en) 2009-12-07 2010-12-07 Implant

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KR20090120346 2009-12-07

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CN109097649A (zh) 2012-06-26 2018-12-28 百多力股份公司 镁合金、其制造方法及其用途
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US20130131814A1 (en) 2013-05-23
EP2510957A2 (fr) 2012-10-17
KR20110065390A (ko) 2011-06-15
WO2011071299A3 (fr) 2011-11-10
AU2010328804A1 (en) 2012-07-05
JP2013512069A (ja) 2013-04-11

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