WO1997034546A1 - Process for producing a bone substitute material - Google Patents
Process for producing a bone substitute material Download PDFInfo
- Publication number
- WO1997034546A1 WO1997034546A1 PCT/DE1997/000198 DE9700198W WO9734546A1 WO 1997034546 A1 WO1997034546 A1 WO 1997034546A1 DE 9700198 W DE9700198 W DE 9700198W WO 9734546 A1 WO9734546 A1 WO 9734546A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- channels
- ceramic block
- substance
- polymer
- bone substitute
- Prior art date
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
- C04B41/009—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone characterised by the material treated
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- 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
- A61F2/28—Bones
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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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B38/00—Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof
- C04B38/0003—Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof containing continuous channels, e.g. of the "dead-end" type or obtained by pushing bars in the green ceramic product
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
- C04B41/45—Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements
- C04B41/4505—Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements characterised by the method of application
- C04B41/4523—Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements characterised by the method of application applied from the molten state ; Thermal spraying, e.g. plasma spraying
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
- C04B41/80—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone of only ceramics
- C04B41/81—Coating or impregnation
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- 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
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- 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
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- 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
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- 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
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30009—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in fibre orientations
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- 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
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- 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
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- 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
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- 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
- A61F2002/30065—Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
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- 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
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- A61F2002/30199—Three-dimensional shapes
- A61F2002/30261—Three-dimensional shapes parallelepipedal
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- 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
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
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- 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
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- 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
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- 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
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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30795—Blind bores, e.g. of circular cross-section
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0028—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in fibre orientations
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B2111/00—Mortars, concrete or artificial stone or mixtures to prepare them, characterised by specific function, property or use
- C04B2111/00474—Uses not provided for elsewhere in C04B2111/00
- C04B2111/00836—Uses not provided for elsewhere in C04B2111/00 for medical or dental applications
Definitions
- the invention relates to methods for producing a bone replacement material, starting from a highly porous ceramic block.
- the channels are introduced into the ceramic block, the channels are filled with bioabsorbable polymer granules and then the ceramic block with the polymer granules is heated to a temperature above the melting or flow temperature of the polymer granules.
- the polymer granulate melts in the channels and, when it cools down to room temperature, anchors itself in the form of a supporting structure in the pores of the ceramic block adjacent to the bores, thus ensuring the desired mechanical strength without the majority of the pores in the ceramic being removed from it bioresorbable polymer would be closed.
- This ensures that when such a polymer-reinforced ceramic block is inserted into the bone, the contact surface with the bone mainly consists of a pure ceramic surface. This is essential for good biocompatibility of the bone replacement material.
- the temperature to which the ceramic block with the polymer granules is to be heated depends on the selected bioabsorbable polymer. As materials, plastics from the group of polyesters come into question, and from these in particular the Poly ( ⁇ -hydroxyl acids). A temperature range of 180 ° C to 230 ° C is appropriate for this.
- the fumigation process has proven to be advantageous.
- This is a process for shaping thermoplastic materials, in which the thermoplastic material is introduced into a mold cavity in free-flowing form or in the form of a preform, and the viscosity of the plastic is reduced with the aid of supercritical substances to such an extent that the plastic becomes flowable and / or can be deformed.
- the gassing is carried out with one or more gases, possibly also liquefied gases, under high pressure, and they should preferably be in the supercritical state. It can be adjusted in terms of process technology that the polymer takes on a compact or foamed structure within the bores and the adjacent pores.
- the solubility of gases or liquids in polymers is a function of pressure and temperature. It is known that particularly good solubility parameters are achieved when the gas changes to the supercritical state.
- Supercritical gases or liquids are known. These include carbon dioxide, ethylene, propane, nitrogen and water. Depending on the supercritical substance used in each case, the gassing process can be carried out at a pressure in a range from 50 to 800 bar (5 ⁇ 10 6 Pa to 8 ⁇ 10 7 Pa).
- Carbon dioxide is advantageously used for the bone substitute material mentioned, which is preferred for the invention.
- the suitable pressure range is between 50 to 200 bar (5 x IO 6 pa to 2 x 10 7 Pa;.
- biologically active agents such as growth factors, antibiotics, pain-relieving agents, agents which influence cell division and vascularization, coagulating or anti-coagulating agents, immunosuppressive or immunostimulating agents, cytokines, chemical attractiveness, enzymes and combinations of which to be introduced into the bone substitute material.
- biologically active agents such as growth factors, antibiotics, pain-relieving agents, agents which influence cell division and vascularization, coagulating or anti-coagulating agents, immunosuppressive or immunostimulating agents, cytokines, chemical attractiveness, enzymes and combinations of which to be introduced into the bone substitute material.
- the effectiveness and, above all, the mechanisms of action of the said agents are known to the person skilled in the art.
- growth factors can serve to stimulate cells in general and, if appropriate, special cell populations to intensify growth in order to fill up the existing tissue or bone defect as quickly as possible.
- the use of antibiotics is particularly indicated if there are tissue defects that are large or difficult to clean or if the environment in which the bone substitute material is introduced has a high bacterial load.
- Agents that influence cell division and vascularization also allow rapid regeneration of the tissue or bone defect.
- the addition of coagulating or, if necessary, anti-coagulating agents can be beneficial.
- immunosuppressive agents is particularly indicated if, for example, the healing process would otherwise deteriorate as a result of allergic reactions.
- immunostimulating agents can be advantageous if it is desired to generate an enhanced immune response in the area of the bone replacement material.
- the immigration of various cell populations means that cytokines and chemical acctance can represent a way of largely controlling the healing process.
- the addition of enzymes allows a further modification of the regeneration process and can affect the regenerated or regenerating tissue.
- the gassing process is advantageously carried out at a temperature which is below 37 ° C. Therefore, the addition of thermolabile, biologically active agents is possible without any problems.
- the channels can be closed on at least one side.
- Suitable materials for the highly porous ceramic block are synthetic ceramics, glasses and glass ceramics, or ceramics of natural origin.
- Synthetic ceramics are, for example, hydroxylapatite, ⁇ -tricalcium phosphate and ⁇ -tricalcium phosphate.
- the ceramics of natural origin are made from cattle bones Algae (Algipore ⁇ ) and corals.
- a typical chemical formula for a bioactive glass ceramic is Ca0-P2 ⁇ 5-SiC> 2 •
- Bioresorbable polymer granules which can be used in the present invention are, for example, the poly ( ⁇ -hydroxyl acids) already mentioned above, such as poly (L- Lactide-co-D, L-lactide).
- FIG. 1 schematically with a highly porous ceramic block
- FIG. 2 shows the ceramic block from FIG. 1 with polymer granules filled into the channels
- Figure 3 shows the finished ceramic block
- Figure 4 shows an example of an arrangement of the channels in a ceramic block according to the invention.
- Figure 5 shows another example of the arrangement of the
- channels 20 with a diameter of 2 to 4 mm are drilled in a highly porous ceramic block 10 made of Algipore ⁇ or BioOss * R) .
- the channels 20 are parallel to one another and arranged in rows, only one such row being indicated schematically in FIG.
- polymer granules 30 are filled into these channels 20.
- the ceramic block 10 filled with polymer granules 30 is now heated to 200 ° C. in a heating cabinet.
- the polymer granulate 30 melts in the channels 20, as illustrated in FIG. 3, and forms the desired mechanical structure 40 in the ceramic block 10 after cooling to room temperature. It has been found that a composite bone replacement molded article produced by the method according to the invention exhibits a 100% to 200% higher mechanical strength than the untreated, highly porous ceramic block.
- a ceramic block prepared as in Example 1 is filled with free-flowing polymer granules made of poly ( ⁇ -hydroxyl acids). In a pressure chamber, this filled ceramic block is gassed at room temperature in a carbon dioxide atmosphere at 50 to 200 bar. The carbon dioxide dissolves in the polymer and with it creates a foamed structure within the holes and the adjacent pores.
- channels 20, 24 it can be expedient to design the channels 20, 24 in such a way that they pass through the ceramic block 10 in groups in which the channels each run perpendicular to one another.
- a first row of channels 20 can be formed extending in the top-down direction in the drawing, while a second row of channels 24 are spaced apart such that the channels 24 run perpendicular to the channels 20.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU19237/97A AU1923797A (en) | 1996-03-19 | 1997-01-31 | Process for producing a bone substitute material |
EP97907038A EP0888096A1 (en) | 1996-03-19 | 1997-01-31 | Process for producing a bone substitute material |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE1996110715 DE19610715C1 (en) | 1996-03-19 | 1996-03-19 | Manufacture of bone replacement material |
DE19610715.6 | 1996-03-19 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997034546A1 true WO1997034546A1 (en) | 1997-09-25 |
Family
ID=7788708
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/DE1997/000198 WO1997034546A1 (en) | 1996-03-19 | 1997-01-31 | Process for producing a bone substitute material |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP0888096A1 (en) |
AU (1) | AU1923797A (en) |
DE (1) | DE19610715C1 (en) |
WO (1) | WO1997034546A1 (en) |
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US11638651B2 (en) | 2015-01-27 | 2023-05-02 | K2M, Inc. | Spinal implant |
US10959855B2 (en) | 2017-05-25 | 2021-03-30 | Stryker European Holdings I, Llc | Fusion cage with integrated fixation and insertion features |
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US11701146B2 (en) | 2017-07-07 | 2023-07-18 | K2M, Inc. | Surgical implant and methods of additive manufacturing |
Also Published As
Publication number | Publication date |
---|---|
DE19610715C1 (en) | 1997-06-26 |
AU1923797A (en) | 1997-10-10 |
EP0888096A1 (en) | 1999-01-07 |
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