WO2002070031A1 - Materiau de substitution osseuse et procede pour produire un implant de substitution osseuse - Google Patents

Materiau de substitution osseuse et procede pour produire un implant de substitution osseuse Download PDF

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Publication number
WO2002070031A1
WO2002070031A1 PCT/EP2001/012867 EP0112867W WO02070031A1 WO 2002070031 A1 WO2002070031 A1 WO 2002070031A1 EP 0112867 W EP0112867 W EP 0112867W WO 02070031 A1 WO02070031 A1 WO 02070031A1
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WIPO (PCT)
Prior art keywords
implant
bone
bone replacement
filler particles
biocompatible
Prior art date
Application number
PCT/EP2001/012867
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German (de)
English (en)
Inventor
Katja Tangermann
Jochen Bauer
Original Assignee
BLZ Bayerisches Laserzentrum Gemeinnützige Forschungsgesellschaft mbH
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Publication of WO2002070031A1 publication Critical patent/WO2002070031A1/fr

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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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • 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
    • 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
    • A61L27/443—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with carbon fillers
    • 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
    • A61L27/446—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/141—Processes of additive manufacturing using only solid materials
    • B29C64/153—Processes of additive manufacturing using only solid materials using layers of powder being selectively joined, e.g. by selective laser sintering or melting
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • 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
    • A61F2002/30065—Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30952—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30968—Sintering
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/3097—Designing or manufacturing processes using laser
    • 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
    • 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
    • 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
    • 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
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses

Definitions

  • the invention relates to a bone replacement material, in particular for the care of bone defects after surgical interventions, a method for producing a bone replacement implant from such a bone replacement material and a bone implant itself.
  • the present invention is in the field of implant medicine related to bone defects such as e.g. after tumor resection, trauma treatment or in the reconstruction of congenital malformations.
  • the main areas of application are defects in the skull and orbital roof and all other bone defects that require reconstructive or functional interventions on the patient. This results in the following development goals for the development of so-called "Taylored Implants":
  • the body's own (autogenous) and foreign (alloplastic) materials are used in the reconstruction and care of bony defects.
  • the use of the body's own bone or cartilage has the disadvantage that a second operation at a further point of the patient is necessary to remove the autogenous material. This can usually affect the donor region of the fibula, rib or iliac crest. There is an additional burden on the patient. Another limitation is the amount of graft material available.
  • a disadvantage also lies in the unpredictable process of remodeling and dismantling transplanted bones, which after a few years leads to renewed surgical interventions on the patient if the transplant is completely dismantled.
  • the decisive factor in the care of bone defects is primarily the accuracy of fit to the defect edges.
  • the surgical field which is restricted by the sterile cover, does not allow a comprehensive assessment of the contour during the operation. The exact individual adjustment is therefore limited.
  • Computed tomography can be used to precisely measure bony structures and the resulting 3D data can be used for implant production. Based on these data sets, individual hip endoprostheses and cranioplasties are already made from titanium using computer aided design and manufacturing (CAD / CAM).
  • CAD / CAM computer aided design and manufacturing
  • metal implant and bone tissue due to the strongly varying modulus of elasticity of metal implant and bone tissue (Ti: 110 GPa, bone: cancellous 0.5-3 GPa, cortical 10-25 GPa), bone degradation can occur as a result of the so-called "stress shielding" effect .
  • Another disadvantage of using metals is that they belong to the group of inert materials, so that, as a rule, no non-positive connection between the implant and the recipient tissue can form. The metal implant is therefore fixed to the bone using screws and plates.
  • the object of the present invention is to provide a bone replacement material which enables a non-positive connection to the bone, the modulus of elasticity of which is adapted to that of the bone, and which is achieved by a quick and simple method individually shaped, patient-specific endoprostheses must be processed.
  • the core of the invention is the selection of the materials involved in the bone substitute material according to the invention, which represent an optimal compromise in view of the very different tasks.
  • the starting point is a mixture of a biocompatible, laser-sinterable polymer material as the matrix material and filler particles made of inorganic, non-metallic materials such.
  • B. ceramic powder A polymer / ceramic compound in powder form is also possible.
  • the inorganic fillers are at least bioinert or preferably bioactive, such as. B. osteoinductive or osteoconductive.
  • plastics such as. B. polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride, polyamide, polyurethane, polysulfone, polysiloxane or polytetrafluoroethylene.
  • PEEK polyether ether ketone
  • Suitable for the filler particles include Calcium phosphates, biocompatible glass particles, as are commercially available under the "Bioglas” brand, or carbon particles. These particles can be in the form of fibers, spheres, whiskers or platelets. Their particle size is preferably in the range from 0.1 to 200 ⁇ m, which also applies to the particle size of the powdery raw material in the production of a bone replacement implant according to the invention.
  • the filler particles preferably have a weight fraction of 5 to 80% based on the total amount of material.
  • the method according to claim 6 for producing a bone replacement implant from the bone replacement material according to the invention is based on the method of laser beam sintering known in connection with the so-called "rapid prototyping".
  • the laser beam sintering is a generative process that can be used to produce components directly from a 3D data set.
  • complex component structures including undercuts can be produced at short notice.
  • the workpiece is created by applying a material.
  • the decisive advantage of laser beam sintering of plastics is the high flexibility with which complex and individually shaped component structures can be manufactured within a very short time. In this respect, this method is also excellently suited for the production of a bone replacement implant, since such workpieces must always be individually manufactured.
  • the filler particles in the matrix material made of the biocompatible polymer material in such a way that these filler particles are only partially embedded in the matrix material on the implant surface.
  • bioactive fillers such as calcium phosphates or the aforementioned biocompatible glass particles
  • no permanent anchoring is necessary by means of fixing agents, since the filler particles lying there achieve a positive connection between the bone and the implant attached to it.
  • Further functions of the filler particles are that the mechanical properties of the bone substitute material, such as elastic modulus, strength and creep behavior, can be adapted to the surrounding bone tissue due to their proportion in the matrix material.
  • inorganic fillers are advantageous for making the polymeric implant visible on X-ray images, but the imaging diagnostics are not disturbed by these fillers.
  • the inorganic filler particles have a positive effect on the shrinkage behavior of the matrix material, in which a ch shrinkage is largely prevented.
  • the implants made from the bone substitute material therefore have a high degree of dimensional accuracy.
  • FIG. 1 is a perspective, partially enlarged schematic representation of a bone replacement implant
  • Fig. 2 is a schematic, extremely enlarged partial section through the interface between the bone replacement implant and the surrounding bone tissue, and
  • FIG. 3 shows a basic illustration of a laser sintering system for producing a bone replacement implant.
  • a laser-sintered bone replacement implant 1 consists of a matrix material 2 and filler particles 3 embedded therein.
  • the matrix material is polyethene ether ketone (PEEK), the property profile of which is outstandingly designed for use as a matrix material.
  • PEEK is characterized by excellent mechanical properties, high chemical resistance and thus long-term resistance as well as high radiation and wear resistance. In this respect, this material is well suited for use in an aggressive body environment.
  • Another advantage of this material, which is not very sensitive to external influences, lies in its easy sterilizability. The suitability of this material for the medical field is also documented by the existing FDA (American Food and Drug Association) approval.
  • PEEK like all plastics, is assigned to the group of bio-inert materials, i.e. that the implant cannot make any connection with the bone tissue.
  • the modulus of elasticity from PEEK with 3.7 GPa is in the lower modulus of elasticity of the human bone (cancellous bone: 0.5-3 GPa; Compacta: 10-25 GPa), with an elastic modulus adapted to the bone in load-bearing endoprostheses must be set.
  • the problems associated with this are solved by the filler particles 3.
  • Bioactive fillers based on calcium phosphates have emerged as particularly suitable.
  • the calcium phosphate group includes, for example, the osteoinductive hydroxyapatite (Ca 10 (PO) 6 (OH)) and the osteoconductive, fully absorbable tricalcium phosphate (Ca 3 (P0 4 ) 2 ). Both materials are already used in medicine as synthetic bone material in mostly granular form for the filling of bone defects. Hydroxyapatite is the inorganic mineral phase in the tooth (98% by weight) and bone (60-70% by weight). Due to their low strength, hydroxyapatite implants are only suitable for non-load-bearing applications with small bone defects.
  • the modulus of elasticity and thus the strength of the material are adapted and adjusted to the particular application.
  • the modulus of elasticity stated above increases from pure PEEK to 30 GPa of the mixture when 30% technical glass is added. With the addition of 30% carbon, a modulus of elasticity of 20 GPa is achieved.
  • the only partial embedding of the filler particles 3 in the area S of the implant 1 creates a point of contact for the ingrowth of bone tissue 4.
  • This growth of the bone tissue 4 to the filler particles 3 creates a non-positive connection between the implant 1 and the bone tissue 4, as is shown in FIG. 2 by the scliraffur lines extending from the bone tissue 4 into the filler particles 3.
  • the three-dimensional geometry data for the implant 1 are determined by suitable measurement methods, such as, for example, computer tomography, and in a corresponding CAD / CAM system 13 entered.
  • the corresponding data are read in and processed in a suitable manner so that the entire sintering process can be controlled fully automatically.
  • the laser beam is now guided over a scanner mirror 14 controlled by the CAD / CAM system 13 and a corresponding focusing lens 15 over the top layer of the powder 8.
  • the matrix material 2 and the filler particles 3 are sintered together by melting and glued.
  • the building platform 10 is then moved downward by the layer thickness 9, which can be 10-250 ⁇ m depending on the powder grain size, and a new layer of powder material 8 is applied from the application container 7. Again, a certain area of this layer is scanned by the laser 5 in accordance with the CAD data of the implant 1 and the polymer material and the filler particles are sintered together. There is also a firm connection with the previously sintered layer. This process is repeated successively until the entire implant 1 is completed.
  • thermoplastic material used for the matrix material has good absorption in the wavelength range of the laser 5 so that the amount of energy required to melt the materials can be absorbed.
  • the heating of the material in the application container 7 and in the installation space 11 is necessary to just below the glass transition temperature Tg or, in the case of partially crystalline powders, to just above the crystallite melting temperature Tm.
  • hydroxyapatite over laser beam sintering has several advantages:
  • the structured surface of the laser-sintered implant 1 has a stimulating effect on a positive connection with the surrounding area Bone tissue 4, in contrast to metallic implants, there are no complications or artifacts in the imaging diagnosis via X-ray, CT or MW, quick and direct implant creation from a 3D data record (CT data), patient-specific, individual endoprosthesis geometry, shortening the operating time and the burden on the patient.
  • CT data 3D data record

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Materials Engineering (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Composite Materials (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Manufacturing & Machinery (AREA)
  • Optics & Photonics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un matériau de substitution osseuse, servant notamment à combler des lésions osseuses résultant d'opérations. Ce matériau est principalement composé d'un matériau matriciel (2),qui est constitué d'une matière plastique, notamment thermoplastique, biocompatible et pouvant être frittée par laser, et de particules de charge (3), qui sont constituées de matières notamment bio-actives ou bio-inertes, non métalliques et inorganiques, et qui sont au moins partiellement intégrées audit matériau matriciel (2).
PCT/EP2001/012867 2000-11-09 2001-11-07 Materiau de substitution osseuse et procede pour produire un implant de substitution osseuse WO2002070031A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10055465A DE10055465A1 (de) 2000-11-09 2000-11-09 Knochenersatzwerkstoff und Verfahren zur Herstellung eines Knochenersatz-Implantats
DE10055465.2 2000-11-09

Publications (1)

Publication Number Publication Date
WO2002070031A1 true WO2002070031A1 (fr) 2002-09-12

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US9833788B2 (en) 2004-03-21 2017-12-05 Eos Gmbh Electro Optical Systems Powder for layerwise manufacturing of objects
CN111526896A (zh) * 2017-10-06 2020-08-11 帝斯曼知识产权资产管理有限公司 制备骨引导性聚合物制品的方法和由此制备的骨引导性聚合物制品
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EP1402016A2 (fr) * 2001-05-30 2004-03-31 Porex Technologies Corporation Materiaux poreux fonctionnalises et leurs applications dans des dispositifs medicaux
EP1402016A4 (fr) * 2001-05-30 2006-02-08 Porex Int Corp Materiaux poreux fonctionnalises et leurs applications dans des dispositifs medicaux
CN100360193C (zh) * 2002-12-24 2008-01-09 凯瑟琳·卡多雷尔 医学或兽医学材料及其制造方法和应用
US8313087B2 (en) 2004-03-21 2012-11-20 Eos Gmbh Electro Optical Systems Powder for rapid prototyping and associated production method
US9833788B2 (en) 2004-03-21 2017-12-05 Eos Gmbh Electro Optical Systems Powder for layerwise manufacturing of objects
US8710144B2 (en) 2004-03-21 2014-04-29 Eos Gmbh Electro Optical Systems Powder for layerwise manufacturing of objects
EP2115043B1 (fr) 2007-04-05 2017-05-31 EOS GmbH Electro Optical Systems Poudre de paec, destinée à être utilisée en particulier dans un procédé de fabrication par couches d'un objet tridimensionnel et procédé de fabrication dudit objet
US9144628B2 (en) 2007-09-11 2015-09-29 Solvay Specialty Polymers Usa, Llc Prosthetic devices
US9539361B2 (en) 2007-09-11 2017-01-10 Solvay Specialty Polymers Usa, L.L.C. Prosthetic devices
US8592531B2 (en) 2007-09-11 2013-11-26 Solvay Advanced Polymers, L.L.C. Prosthetic devices
CN103959359A (zh) * 2011-10-03 2014-07-30 克利夫兰临床医学基金会 合成骨模型及提供其的方法
CN111526896A (zh) * 2017-10-06 2020-08-11 帝斯曼知识产权资产管理有限公司 制备骨引导性聚合物制品的方法和由此制备的骨引导性聚合物制品
US11400184B2 (en) 2017-10-06 2022-08-02 Dsm Ip Assets B.V. Method of making an osteoconductive polymer article and an osteoconductive polymer article thus made
US12016977B2 (en) 2017-10-06 2024-06-25 Dsm Ip Assets B.V. Method of making an osteoconductive fibrous article and a medical implant comprising such osteoconductive fibrous article

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