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WO2013047999A2 - Implant pouvant être chargé de matériau bioactif et son procédé de fabrication - Google Patents

Implant pouvant être chargé de matériau bioactif et son procédé de fabrication Download PDF

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Publication number
WO2013047999A2
WO2013047999A2 PCT/KR2012/006303 KR2012006303W WO2013047999A2 WO 2013047999 A2 WO2013047999 A2 WO 2013047999A2 KR 2012006303 W KR2012006303 W KR 2012006303W WO 2013047999 A2 WO2013047999 A2 WO 2013047999A2
Authority
WO
WIPO (PCT)
Prior art keywords
insertion hole
implant
bioactive material
pore size
supporting
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/KR2012/006303
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English (en)
Korean (ko)
Other versions
WO2013047999A3 (fr
Inventor
선두훈
김정성
김용화
조유정
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.)
Corentec Co Ltd
Original Assignee
Corentec Co Ltd
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 Corentec Co Ltd filed Critical Corentec Co Ltd
Publication of WO2013047999A2 publication Critical patent/WO2013047999A2/fr
Publication of WO2013047999A3 publication Critical patent/WO2013047999A3/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
    • A61L27/02—Inorganic materials
    • A61L27/04—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
    • A61L27/10—Ceramics or glasses
    • 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
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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 capable of supporting a physiologically active substance used for medical treatment and a method for manufacturing the same, and more particularly, a first structure having a predetermined porosity and a pore size, and surrounding the outer surface of the first structure.
  • a second structure having a porosity and pore size smaller than one structure, an insertion hole formed in one surface of the second structure to extend into the first structure and injecting a bioactive material, and inserted into the insertion hole Including an insert to close the top of the insertion hole, it is possible to easily control the release rate of the bioactive material, and even if the external shock is not easily released or released, it is possible to carry the bioactive material easy to store and transport An implant and a method of manufacturing the same.
  • Implants are artificial devices designed to replace or act as tissues that have been lost, for example implants that are used in human joints, including orthopedic implants, dental implants, spinal cages, knees and hip joints Ore block, bone support and bone graft material used in bone defects. Implants are fabricated using materials such as titanium, titanium alloys, cobalt chromium alloys, etc., which are more difficult to process than other metallic materials but have high biocompatibility, high mechanical strength and bioinert properties to human tissues.
  • the osteogenic growth material on the surface may fall off when applying force or washing for insertion into the body during implantation, and the osteogenic growth material fixed on the surface may Due to the short release period, there is a problem that bone formation is not easy on the surface of the implant used for a long time.
  • the bone growth material or drug injection is made during the implant manufacturing process, there is a limit that the storage and transport conditions of the implant implanted with bone growth material or drugs is limited.
  • the implant in order to fix the bone-forming growth material on the implant or to carry the drug, the implant is manufactured to have a porosity.
  • the conventional method of manufacturing a porous implant requires the use of expensive equipment and increases the manufacturing cost due to the long manufacturing process time.
  • toxic pore precursors or binders remain in the implant.
  • the present invention has been made to solve the above problems,
  • an object of the present invention is to provide an implant capable of supporting a bioactive material which can easily control the release rate of the bioactive material by adjusting the porosity and pore size of the second structure and its manufacturing method.
  • an object of the present invention is to provide an implant capable of supporting a substance and a method of manufacturing the same.
  • Another object of the present invention is to provide an implant and a method for manufacturing the bioactive substance which can be economically supported by storing the bioactive substance in the implant immediately before the implant procedure, thereby facilitating the storage and transportation of the implant.
  • the present invention by increasing the porosity and pore size of the second structure larger than the porosity and pore size of the first structure, the osteogenic cells in the pores inside the second structure while being able to release the bioactive material by the first structure for a long time
  • the purpose of the present invention is to provide an implant and a method for producing the same, which can be bone-formed on the surface and inside.
  • the present invention is harmless to the human body by using no pore precursors or binders at the time of manufacture, and can be produced in a short time at a low temperature using an energization sintering device to support the bioactive material that can reduce the manufacturing cost It is an object of the present invention to provide an implant and a method of manufacturing the same.
  • the present invention is implemented by the embodiment having the following configuration to achieve the above object.
  • an implant capable of supporting a bioactive material comprises: a first structure having a predetermined porosity and a pore size; A second structure surrounding an outer surface of the first structure and having a porosity and a pore size smaller than that of the first structure; Included in one surface of the second structure is formed to extend in the interior of the first structure, the insertion hole is injected with the bioactive material, the bioactive material injected through the insertion hole is primarily in the first structure It is supported by and is discharged to the outside through the second structure over time.
  • the implant capable of supporting the bioactive material according to the present invention further includes an insert inserted into the insertion hole to close the top of the insertion hole; It is characterized in that the active material can be prevented from being discharged through the top of the insertion hole.
  • the first structure has an average pore size of 50 to 1000 ⁇ m, the second structure of 1 to 30 ⁇ m It is characterized by having an average pore size.
  • the physiologically active substance in the implant capable of supporting the physiologically active substance according to the present invention, is characterized in that any one of bone morphogenetic protein, metastatic growth factor, insulin growth factor and drug. .
  • the first structure and the second structure are characterized in that each made of a metal or ceramic material.
  • the insert in the implant capable of supporting the bioactive material according to the present invention, is characterized in that made of any one of a metal, a ceramic and a polymer material.
  • an implant capable of supporting a bioactive material includes: a first structure including an insertion hole formed at a predetermined depth by being embedded in an upper surface thereof; And a second structure surrounding the outer surface of the first structure to expose the upper end of the insertion hole to the outside, the second structure having a predetermined porosity and a pore size, wherein the first structure communicates with the insertion hole and the second structure. Further comprising a hole, the bioactive material injected through the insertion hole is characterized in that it is primarily supported in the insertion hole is discharged to the outside through the communication hole and the second structure in turn over time .
  • the implant capable of supporting the bioactive material according to the present invention further comprises an insert inserted into the insertion hole to close the top of the insertion hole, the physiological injected into the insertion hole It is characterized in that the active material can be prevented from being discharged through the top of the insertion hole.
  • the implant capable of supporting the bioactive material according to the present invention comprises a first structure having a predetermined porosity and pore size; A second structure surrounding an outer surface of the first structure and having a porosity and a pore size greater than that of the first structure; It is embedded in one surface of the second structure is formed to extend in the interior of the first structure, the insertion hole in which the bioactive material is injected; characterized in that it comprises a.
  • an implant capable of supporting a bioactive material according to the present invention further includes an insert inserted into the insertion hole to close an upper end of the insertion hole; It is characterized in that the bioactive material can be prevented from being discharged through the top of the insertion hole.
  • the first structure has a porosity of 1 to 30% and an average pore size of 1 to 30 ⁇ m
  • the second The structure is characterized by having a porosity of 40 to 80% and an average pore size of 100 to 500 ⁇ m.
  • a method of manufacturing an implant capable of supporting a bioactive material includes a first insertion hole, a first structure for manufacturing a first structure having a predetermined porosity and pore size Forming step; A second structure for manufacturing a second structure including a second insertion hole communicating with the first insertion hole and having a porosity and a pore size smaller than that of the first structure and surrounding the first structure after the first structure is manufactured; Forming a structure; And an insert forming step of manufacturing an insert which is inserted into an insertion hole formed by connecting the first insertion hole and the second insertion hole to close an upper end of the insertion hole.
  • the first structure is filled with a raw material made of metal powder or ceramic powder in a mold,
  • a predetermined pressure to the raw material filled in the mold by using the power source is characterized in that the raw material is manufactured by sintering the raw material at a predetermined temperature.
  • the second structure is filled with the first structure and the raw material in a mold, and using an energization sintering device It is characterized by being manufactured by sintering the raw material at a predetermined temperature by applying a predetermined pressure to the raw material which is filled in the mold and located outside the first structure and energizing the raw material.
  • the present invention can achieve the following effects by the configuration and combination, the use relationship described above in the present embodiment.
  • the present invention is effective to support the bioactive material and release the bioactive material to the outside for a long time.
  • the present invention has the effect of easily controlling the release rate of the bioactive material by adjusting the porosity and pore size of the second structure.
  • the present invention since the bioactive material is not supported on the surface of the implant, but on the first structure inside the implant, there is an effect that the bioactive material is not easily released or released even in the external impact that may occur during the implantation process or transport process have.
  • the present invention can support the bioactive material in the implant immediately before the implant procedure, it is easy to store and transport the implant has an economic effect.
  • the present invention by increasing the porosity and pore size of the second structure larger than the porosity and pore size of the first structure, the osteogenic cells in the pores inside the second structure while being able to release the bioactive material by the first structure for a long time
  • the purpose of the present invention is to provide an implant and a method of manufacturing the same, the bone is formed on the surface and inside.
  • the present invention is harmless to the human body by using no pore precursor or a binder at the time of manufacture, it can be produced in a short time at a low temperature by using an energization sintering device has the effect of reducing the manufacturing cost.
  • FIG. 1 is a perspective view showing a state in which a bioactive material is supported on an implant according to an embodiment of the present invention.
  • Figure 2 is an exploded perspective view of an implant according to an embodiment of the present invention.
  • Figure 3 is an exploded longitudinal cross-sectional view of an implant according to an embodiment of the present invention.
  • Figure 4 is a reference diagram for explaining the process of supporting the bioactive material in the implant according to an embodiment of the present invention.
  • FIG. 5 is an exploded perspective view of an implant according to another embodiment of the present invention.
  • FIG. 6 is an exploded longitudinal cross-sectional view of an implant according to another embodiment of the present invention.
  • Figure 7 is an exploded longitudinal cross-sectional view of an implant according to another embodiment of the present invention.
  • FIG. 8 is a schematic view of the energizing and sintering apparatus used in the method for manufacturing an implant according to an embodiment of the present invention.
  • FIG. 9 is a flow chart showing a method of manufacturing an implant according to an embodiment of the present invention.
  • FIG. 1 is a perspective view showing a state in which a bioactive material is supported on an implant according to an embodiment of the present invention
  • Figure 2 is an exploded perspective view of the implant according to an embodiment of the present invention
  • Figure 3 is an embodiment of the present invention
  • Figure 4 is a reference diagram for explaining the process of supporting the bioactive material in the implant according to an embodiment of the present invention.
  • an implant 1 capable of supporting a bioactive material includes a first structure 11 having a predetermined porosity and pore size; A second structure (12) surrounding an outer surface of the first structure (11) and having a porosity and a pore size smaller than that of the first structure (11); An insertion hole 13 formed in one surface of the second structure 12 to extend in the first structure 11 and into which a bioactive material is injected; Insert 14 is inserted into the insertion hole 13 to close the upper end of the insertion hole 13, including, the bioactive material injected through the insertion hole 13 is the insertion hole 13 and It is primarily supported on the first structure 11 and is characterized in that it is gradually discharged to the outside through the second structure 12 over time.
  • the first structure 11 is a porous structure having a predetermined three-dimensional shape having a predetermined porosity and pore size, and primarily supports the bioactive material introduced through the insertion hole 13 to be described later.
  • the first structure 11 has a relatively large porosity and pore size to support a large amount of bioactive material, preferably has a porosity of 40 to 80% and an average pore size of 50 to 1000 ⁇ m.
  • the physiologically active substance is bone formation such as transforming growth factor, Insulin-like growth factor, bone morphogenetic protein, which promotes the proliferation and differentiation of osteoblasts forming bone. It includes drugs such as growth substances and antibiotics, and in addition to the concept that the implant (1) includes all the substances that can act physiologically to the implanted body.
  • the second structure 12 is a porous structure surrounding the outer surface of the first structure 11 and having a porosity and a pore size smaller than that of the first structure 11.
  • the second structure 12 is implanted when the implant 1 is implanted.
  • the outer surface of the structure 12 is in contact with the surrounding bone tissue.
  • the second structure 12 has a relatively small porosity and pore size so as to release the bioactive material supported on the first structure 11 to the outside for a long time, Preferably it has a porosity of 1 to 30% and a pore size of 1 to 30 ⁇ m.
  • the second structure 12 forming the outer shape of the implant 1 is illustrated as having a cylindrical shape, but this is only an example and according to the purpose of the implant 1, the second structure 12. May have various shapes.
  • the first structure 11 and the second structure 12 may be made of the same or different materials, preferably the first structure 11 and the second structure 12 is made of a metal or ceramic material,
  • the metal is titanium, titanium alloy, cobalt chromium, cobalt chromium alloy, tantalum, tantalum alloy, niobium, niobium Any one or more metals selected from the group consisting of niobium alloys and titanium nitrides can be used, and the ceramics include tricalcium phosphate, hydroxideyapatite, and zirconia. And one or more ceramics selected from the group consisting of alumina (Alumina) can be used.
  • the insertion hole 13 is embedded in one surface of the second structure 12 is formed in the interior of the first structure 11 is a configuration in which a bioactive material is injected, has a predetermined shape but preferably cylindrical It has a shape.
  • the insertion hole 13 is formed by communicating a first insertion hole 131 formed in the first structure 11 and a second insertion hole 132 formed in the second structure 12.
  • the bioactive material injected through the insertion hole 13 is primarily supported in the first structure 11 and gradually discharged to the outside through the second structure 12 over time. Let's take a look at
  • the insert 14 is inserted into the insertion hole 13 to close the upper end of the insertion hole 13, the bioactive material injected into the insertion hole 13 is the upper end of the insertion hole 13 To prevent it from being discharged.
  • the insert 14 is formed of a non-porous material having a shape corresponding to the insertion hole 13 and having a dense structure so as to securely close the upper end of the insertion hole 13, and preferably the first Metal, ceramic, or biocompatible polymer forming the structure 11 and the second structure 12 may be used.
  • the polymer is a polyglycolic acid, D, L-polylactic acid (D, L-polylactic acid), L-polylactic acid (L-polylactic acid), polycaprolactone (Polycaprolactone), air of lactic acid and glycolic acid
  • Poly (lactic-co-glycolic acid) and poly (glycolide-cocaprolactone) copolymers [poly (glycolide-cocaprolactone)] and the like can be used.
  • the present invention injects the bioactive material (a) into the implant (1) with a syringe (b) and the like, and inserts the insert 14 into the insertion hole 13 by the simple operation of the bioactive material ( There is a characteristic that can support a).
  • the present invention is capable of supporting the physiologically active material in the implant (1) immediately before the procedure of the implant (1), there is a feature that is easier to store and transport compared to the implant bearing the physiologically active material in the manufacturing process.
  • the present invention since the bioactive material is not supported on the surface of the implant, but on the first structure inside the implant, the bioactive material is not easily released or released even in the external impact that may occur during the procedure or transport of the implant There is this.
  • the inside of the implant (1) has a higher pressure than the surrounding bone tissue so that the bioactive material is discharged to the surrounding bone tissue do.
  • the bioactive material is discharged by the second structure 12 in contact with the surrounding bone tissue.
  • the second structure 12 has a relatively small porosity and pore size, so that the bioactive material may be released into the surrounding bone tissue for a long time. Can be.
  • the second structure 12 having a specific porosity and pore size can be easily manufactured according to the purpose. There is a characteristic that can control the release rate of the active material.
  • FIG. 5 is an exploded perspective view of an implant according to another embodiment of the present invention
  • Figure 6 is an exploded longitudinal cross-sectional view of the implant according to another embodiment of the present invention.
  • an implant 2 capable of supporting a bioactive material may include a first structure 21 including an insertion hole 211 formed at a predetermined depth by being embedded in an upper surface thereof. )Wow;
  • the upper surface of the insertion hole 211 surrounds the outer surface of the first structure 21 so as to be exposed to the outside, the second structure 22 having a predetermined porosity and pore size and is inserted into the insertion hole 211 is And an insert 23 closing an upper end of the insertion hole 211
  • the first structure 21 further includes a communication hole 212 communicating the insertion hole 211 and the second structure 22.
  • the bioactive material injected through the insertion hole 211 is first supported in the insertion hole 211 and passes through the communication hole 212 and the second structure 22 in turn over time It is characterized in that it is discharged to the outside.
  • the first structure 21 is a non-porous structure having a dense tissue, and carries a bioactive material.
  • the first structure 11 has a predetermined shape, preferably has a cylindrical shape, and is made of a material such as a conventional nonporous implant.
  • the first structure 21 preferably has a porosity of less than 1%.
  • the first structure 21 includes a configuration such as the insertion hole 211, the communication hole (212).
  • the insertion hole 211 is formed to be embedded in a predetermined depth on the upper surface of the first structure 21, the insertion hole 211 is injected with a bioactive material is carried.
  • the communication hole 212 is configured to communicate the insertion hole 211 and the second structure 22, the bioactive material injected into the insertion hole 211 is the second structure (through the communication hole 212) 22).
  • the second structure 22 is a porous structure surrounding the outer surface of the first structure 21 so that the upper end of the insertion hole 211 is exposed to the outside, having a predetermined porosity and pore size, the implant (2)
  • the outer surface of the second structure 22 is in contact with the surrounding bone tissue during implantation.
  • the second structure 22 has a relatively small porosity and pore size so as to release the bioactive material supported on the first structure 21 to the outside for a long time, Preferably it has a porosity of 1 to 30% and a pore size of 1 to 30 ⁇ m.
  • the insert 23 is inserted into the insertion hole 211 to close the upper end of the insertion hole 211, the bioactive material injected into the insertion hole 211 is the upper end of the insertion hole 211 To prevent it from being discharged. Since the insert 23 performs the same role as the insert 14 described above, a detailed description thereof will be omitted.
  • the implant (2) is inserted using a syringe like the implant (1) described with reference to FIGS.
  • the bioactive material is injected into the hole 211 and the insert 23 is inserted into the insertion hole 211, the bioactive material is supported in the implant 2.
  • the implant (2) loaded with a bioactive material is implanted in the body, the pressure of the inside of the implant (2) is higher than the surrounding bone tissue, so the bioactive material carried in the insertion hole (211) is a communication hole (212) Through the flow to the second structure 22 is discharged to the outside through the pores of the second structure (22).
  • FIG. 7 is an exploded longitudinal sectional view of an implant according to another embodiment of the present invention.
  • an implant 3 capable of supporting a bioactive material may include a first structure 31 having a predetermined porosity and a pore size, and a structure of the first structure 31.
  • the first structure 31 is a porous three-dimensional porous structure having a predetermined porosity and pore size, relatively small porosity and pore so that the bioactive material introduced through the insertion hole 33 to be described later can be released for a long time It has a size, and preferably has a porosity of 1 to 30% and an average pore size of 1 to 30 ⁇ m.
  • the second structure 32 is a porous structure that surrounds the outer surface of the first structure 31 and has a porosity and a pore size larger than that of the first structure 31.
  • the second structure 32 is implanted when the implant 3 is implanted.
  • the outer surface of the structure 32 is in contact with the surrounding bone tissue.
  • the second structure 32 has a relatively large porosity and pore size so that osteogenic cells can be easily introduced into not only the surface of the implant 3, but also preferably 40 to 80% and 100 to 500 It has a pore size of ⁇ m.
  • the insertion hole 33 is embedded in one surface of the second structure 32 is formed in the interior of the first structure 31 and the bioactive material is injected, the insert 34 is the insertion hole Is inserted into (33) is a configuration for closing the upper end of the insertion hole (33). Since the insertion hole 33 and the insert 34 play the same role as the insertion hole 13 and the insert 14 described above, a detailed description thereof will be omitted.
  • the bioactive material is injected into the insertion hole 33 and the insert 34 is inserted into the insertion hole 33, the bioactive material is supported in the implant 3.
  • the implant (3) loaded with a bioactive material is implanted in the body, since the pressure inside the implant (3) is higher than the surrounding bone tissue, the bioactive material carried in the insertion hole 33 is the first structure (31) And is discharged to the outside through the pores of the second structure (32).
  • the present invention is characterized in that bone is formed not only on the surface but also on the inside while releasing the bioactive material for a long time, thereby improving the union between the implant 3 and the surrounding bone tissue.
  • Figure 8 is a schematic diagram of the energizing and sintering apparatus used in the method for manufacturing an implant according to an embodiment of the present invention
  • Figure 9 is a flow chart showing a method for manufacturing an implant according to an embodiment of the present invention.
  • the energization and sintering device 5 is a device for applying a pressure to the raw material 6 made of powder inserted therein and directly through electricity to sinter the raw material 6 at a predetermined temperature to make a product, and the casing 51. , A mold 52, a punch 53, a pressing means 54, a power supply unit 55, a control unit (not shown), and the like.
  • the casing 51 forms an outer shape of the energization and sintering device 5 and accommodates the mold 52 and the punch 53 therein, and the inside of the casing 51 is maintained in a vacuum state when manufacturing the product.
  • the mold 52 is configured to accommodate a raw material 6 such as metal powder or ceramic powder, which is a raw material of a product, and is inserted into the casing 51.
  • the mold 52 includes a hollow 521 penetrated up and down, and the punch 53 is installed on the upper and lower ends of the hollow 521 so that the punch 53 can move up and down.
  • the raw material 6 is located in the space S formed by the hollow 521 and the punch 53, so that the product is manufactured, and thus the shape of the hollow 521 and the punch 53 is deformed. Products of various shapes can be produced.
  • the mold 52 is formed of an electrically heat-resistant material such as graphite, tungsten oxide or tungsten.
  • the punch 53 is installed in the upper and lower ends of the hollow 521 of the mold 52 so as to be movable, respectively, and is coupled to the pressing means 54 to be described later at the end of the punch 53.
  • the punch 53 is formed of an electrically heat-resistant material such as graphite, tungsten oxide or tungsten.
  • the pressing means 54 is connected to the punch 53, and provides a driving force for allowing the punch 53 to move up and down in the hollow 521 of the mold 52.
  • the power supply unit 55 is configured to generate electricity so that electricity can flow to the raw material 6 in the mold 52, the power supply unit 55 is the pressing means 54, punch 53, the mold 52 Is electrically connected). When the power supply unit 55 is operated to allow electricity to be supplied to the raw material 6 in the mold 52, heat is generated to sinter the raw material 6.
  • the control unit (not shown) is configured to control the overall operation of the energization and sintering device 5, by operating the pressing means 54 to press the raw material 6 or to operate the power supply unit 54 to the raw material 6 It plays a role in making electricity flow.
  • the manufacturing method of the implant (1) capable of supporting the bioactive material according to an embodiment of the present invention includes a first insertion hole 131, constant porosity and pore
  • the first structure forming step 1 is a step of manufacturing a first structure 11 including a first insertion hole 131 and having a predetermined porosity and pore size.
  • a step S12 and a sintering step S13 are included.
  • the mold and punch preparation step (S11) is a step of preparing a mold and a punch forming a space in which the raw material is inserted to have a specific shape, the raw material is located in the space formed by the mold and punch as the product is manufactured By modifying the shape of the mold and the punch, the first structure 11 of various shapes may be manufactured.
  • the raw material filling step (S12) is a step of filling the raw material into the mold prepared in the mold and the punch preparation step (S11), inserting the raw material into the hollow of the mold and punching the punch at the top and bottom of the hollow, respectively Combine.
  • metal powder and / or ceramic powder having a size of 10 to 2000 ⁇ m may be used, and the raw material may have a spherical or irregular shape.
  • the metal powder is titanium, titanium alloy, cobalt chromium, cobalt chromium alloy, tantalum, tantalum alloy, niobium, Any one or more metal powder selected from the group consisting of niobium alloy and titanium nitride may be used.
  • the ceramic powder may be any one or more ceramic powders selected from the group consisting of tricalcium phosphate, hydroxyapatite, zirconia, and alumina.
  • the sintering step (S13) is a step of manufacturing the first structure 11 by applying a predetermined pressure to the raw material filled in the mold using an energizing and sintering device and energizing the raw material to sinter the raw material at a predetermined temperature.
  • the raw material is pressurized and electricity is flowed to the punch, the mold and the raw material, so that the raw material is locally dissolved and combined. That is, the first structure 11 in which the plurality of pores is formed is manufactured.
  • the sintering step (S13) it is preferable to apply a pressure of 100 to 2000kgf / cm2, sintered at a temperature of 800 to 1400 °C, to generate electricity of a current of 500 to 2000A and a voltage of 3 to 7V.
  • the second structure forming step (S2) includes a second insertion hole 132 communicating with the first insertion hole 131 after manufacturing the first structure 11 and the first structure 11.
  • the mold and punch preparation step (S21), the raw material and the first structure filling step (S22), sintering Step S23 is included.
  • the mold and punch preparation step (S21) is a step of preparing a mold and a punch forming a space in which the raw material and the first structure 11 are inserted to have a specific shape. Since the raw material and the first structure 11 are placed in a space formed by a mold and a punch, a product is manufactured, the second structure 12 having various shapes desired to be manufactured by modifying the shape of the mold and the punch can be manufactured. Can be.
  • Filling the raw material and the first structure is a step of filling the raw material and the first structure 11 in the mold, inserting the raw material and the first structure 11 in the hollow 121 of the mold and the hollow Combine punches to the top and bottom of the shank respectively.
  • the sintering step (S23) is filled in the mold using an energizing and sintering device and while applying a predetermined pressure to the raw material located outside the first structure 11 and energizing the raw material to sinter the raw material at a predetermined temperature
  • a step of manufacturing the second structure 12 is performed. remind
  • the raw material positioned on the outside of the first structure 11 is pressurized and electricity is flowed through the punch, the mold, and the raw material, the raw material is locally dissolved and combined. That is, the second structure 12 having a plurality of pores is manufactured.
  • the sintering step it is preferable to apply a pressure of 100 to 2000kgf / cm2, to sinter at a temperature of 800 to 1400 °C, to generate electricity of a current of 500 to 2000A and a voltage of 3 to 7V.
  • the insert forming step S3 is inserted into an insertion hole 13 formed by the first insertion hole 131 and the second insertion hole 132 communicating with each other, thereby closing an upper end of the insertion hole 13. To prepare a step.
  • the pressurizing means is operated to pressurize the raw material located on the outside of the first structure at 500 kgf / cm 2 and generate a 5V voltage and 1700 A current to sinter the raw material to 1100 ° C., as shown in FIGS. 1 to 3.
  • a porous second structure is formed to enclose the first structure of the type as shown.
  • Test purpose Measurement of average pore size of the first and second structures
  • the average pore size of the first structure and the second structure of Examples 1 to 6 was measured and shown in Table 1 below. The average pore size was cut into the specimens prepared in Examples 1 to 6 by the SEM and averaged pore size.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Ceramic Engineering (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un implant, qui peut être chargé de matériau bioactif et qui est utilisé à des fins médicales, et son procédé de fabrication, l'implant comportant : une première structure ayant une porosité et une dimension de pore uniformes ; une seconde structure enfermant la surface externe de la première structure et ayant une porosité et une dimension de pore qui sont plus petites que la porosité et la dimension de pore de la première structure ; un trou d'insertion qui est encastré dans une surface de la seconde structure et formé de telle sorte qu'il s'étend dans la première structure de façon à ce qu'un matériau bioactif puisse être injecté dans celui-ci ; un élément d'insertion est introduit dans le trou d'insertion pour fermer la partie supérieure de celui-ci, le taux de libération du matériau bioactif pouvant être facilement régulé, et le matériau bioactif n'étant pas facilement délogé, ni libéré, même par des impacts externes, assurant que l'implant est facile à stocker et à porter.
PCT/KR2012/006303 2011-09-28 2012-08-08 Implant pouvant être chargé de matériau bioactif et son procédé de fabrication Ceased WO2013047999A2 (fr)

Applications Claiming Priority (2)

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KR10-2011-0098214 2011-09-28
KR1020110098214A KR101265783B1 (ko) 2011-09-28 2011-09-28 생리활성물질의 담지가 가능한 임플란트 및 그 제조방법

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WO2013047999A2 true WO2013047999A2 (fr) 2013-04-04
WO2013047999A3 WO2013047999A3 (fr) 2013-05-23

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KR102219852B1 (ko) * 2018-12-07 2021-02-25 주식회사 메디팹 중공형 케이지(hollow cage)를 포함하는 생체적합 구조체 및 이의 제조방법
US11738123B2 (en) 2019-06-05 2023-08-29 Korea Institute Of Science And Technology Implant having controlled generation rate of reactive oxygen species and method of controlling generation of reactive oxygen species using the same
KR102252691B1 (ko) * 2019-06-05 2021-05-17 한국과학기술연구원 활성산소 종의 발생속도가 제어되는 임플란트 및 이를 이용한 활성산소 종의 발생 제어 방법.
KR102568192B1 (ko) * 2021-04-07 2023-08-22 주식회사 코렌텍 이종 다공성 구조가 적용된 보강 임플란트

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JP4172883B2 (ja) 1999-09-08 2008-10-29 Ｈｏｙａ株式会社 薬物徐放用担体および薬物徐放用担体の製造方法
TW200800298A (en) * 2000-01-27 2008-01-01 Zentaris Ag Compressed microparticles for dry injection
GB0115320D0 (en) * 2001-06-22 2001-08-15 Univ Nottingham Matrix
KR100429000B1 (ko) * 2001-08-14 2004-04-28 한국과학기술원 약물이 봉입된 다공성 생분해성 고분자 지지체의 제조방법
US8435560B2 (en) * 2006-12-28 2013-05-07 Dow Corning Corporation Polynuclear microcapsules
KR100847395B1 (ko) 2007-02-20 2008-07-18 재단법인서울대학교산학협력재단 약물-고분자 복합재 적층 시스템을 이용한 약물전달체의제조 방법
US8815273B2 (en) * 2007-07-27 2014-08-26 Boston Scientific Scimed, Inc. Drug eluting medical devices having porous layers
KR100950287B1 (ko) 2008-07-07 2010-04-09 제로켐 주식회사 의료용 임플란트
KR101182736B1 (ko) * 2010-02-17 2012-09-13 연세대학교 산학협력단 코어-쉘 형태의 나노섬유 지지체 및 이의 제조방법

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WO2013047999A3 (fr) 2013-05-23
KR101265783B1 (ko) 2013-05-20

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