WO2024251877A1 - Prothèse d'articulation de genou orthopédique - Google Patents

Prothèse d'articulation de genou orthopédique Download PDF

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Publication number
WO2024251877A1
WO2024251877A1 PCT/EP2024/065610 EP2024065610W WO2024251877A1 WO 2024251877 A1 WO2024251877 A1 WO 2024251877A1 EP 2024065610 W EP2024065610 W EP 2024065610W WO 2024251877 A1 WO2024251877 A1 WO 2024251877A1
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WO
WIPO (PCT)
Prior art keywords
contact
implant part
bone
coating
surface areas
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/EP2024/065610
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German (de)
English (en)
Inventor
Berna Richter
Rachel LANG
Thomas Grupp
Julius DOHM
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.)
Aesculap AG
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Aesculap AG
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 Aesculap AG filed Critical Aesculap AG
Priority to AU2024286530A priority Critical patent/AU2024286530A1/en
Publication of WO2024251877A1 publication Critical patent/WO2024251877A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • 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
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—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
    • B33Y80/00—Products made by additive manufacturing
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C28/00—Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
    • C23C28/04—Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings of inorganic non-metallic material
    • C23C28/044—Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings of inorganic non-metallic material coatings specially adapted for cutting tools or wear applications
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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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    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
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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
    • A61F2002/30922—Hardened surfaces
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30929—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having at least two superposed coatings
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30932—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for retarding or preventing ingrowth of bone tissue
    • A—HUMAN NECESSITIES
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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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
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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
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00419—Other metals
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    • A—HUMAN NECESSITIES
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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
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00419—Other metals
    • A61F2310/00485—Coating made of zirconium or Zr-based alloys
    • A—HUMAN NECESSITIES
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    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction

Definitions

  • the invention relates to an orthopedic knee joint prosthesis with a metallic femoral implant part, with a metallic tibial implant part, and with a meniscus replacement part, which forms a sliding partner for the femoral implant part and is held on the tibial implant part, wherein the femoral implant part has surface areas facing the bone and in contact with the bone in the implanted state, wherein the femoral implant part has articulating condylar surface areas in sliding contact with the meniscus replacement part as a sliding partner in the implanted state, wherein the tibial implant part has surface areas facing the bone and in contact with the bone in the implanted state, wherein the tibial implant part has surface areas in contact with the meniscus replacement part in the implanted state, wherein the femoral implant part and the tibial implant part each have surface areas in the implanted state that are not in contact with the bone and not with the meniscus replacement part but are in soft tissue contact, wherein the femoral implant part has a
  • Such a knee joint prosthesis is already known from EP 2 051 666 B1, in which it was proposed to form articulating condylar surface areas of the femolar implant part that are in sliding contact with the meniscus replacement part and also surface areas on the tibial implant part that are in contact with the meniscus replacement part with a hardening and wear-reducing coating.
  • This hardening and wear-reducing coating is in particular multi-layered and comprises in particular ceramic layers that prove to be particularly wear-resistant in sliding contact with corresponding articulation surfaces of the meniscus replacement part. They also prevent or reduce the release of metal ions from the interior of the femoral or tibial implant part as a result of the articulating sliding contact.
  • the object of the present invention is to achieve, on the one hand, optimal anchoring of the metallic implant material in the bone, starting from a knee joint prosthesis of the type mentioned at the beginning, and, on the other hand, to achieve unproblematic contact with surrounding soft tissue.
  • femoral implant part and in particular also the tibial implant part are manufactured additively by metallic 3D printing, that the femoral implant part and/or the tibial implant part have a three-dimensionally porous surface structure formed by metallic 3D printing in the surface areas facing the bone for the bone to grow into the implant part, and that the femoral implant part and/or the tibial implant part are placed on the surface areas not connected to the bone and not connected to the meniscus replacement part in Surface areas which are in contact with the soft tissue but are at least partially provided with a coating by means of which the surface roughness of these surface areas is reduced.
  • the surface roughness is lower than that of the uncoated surface areas of the implant part under consideration produced by 3D printing and also lower than that of the surface areas of the implant part under consideration facing the bone.
  • an optimization of preferably all of the surface areas of the implant part under consideration mentioned at the beginning is achieved with regard to their respective specific function in the implanted state of the prosthesis.
  • the implant parts are advantageously produced for this purpose in an additive manufacturing process by metallic 3D printing, manufactured, whereby a certain surface roughness that is formed in this way can be smoothed out by applying the coating.
  • the coating can advantageously prevent or reduce the formation of biofilms caused by bacteria by using suitable materials, such as zirconium nitride (ZrN).
  • suitable materials such as zirconium nitride (ZrN).
  • ZrN zirconium nitride
  • the surface roughness of the surface areas not in contact with the bone and not with the meniscus replacement part, but in soft tissue contact and provided with the coating is greater than or equal to a surface roughness of the articulating condylar surface areas in sliding contact provided with the hardening and wear-reducing coating.
  • the surface areas in soft tissue contact in the femoral implant part and/or in the tibial implant part are designed to be as smooth as possible.
  • the surface roughness of the surface areas not in contact with the bone and not with the meniscus replacement part but in soft tissue contact and provided with the coating is at most 0.50 gm, in particular at most 0.40 gm, in particular at most 0.30 gm and in particular at least 0.04 gm, in particular at least 0.05 gm and in particular at least 0.10 gm, measured as Ra according to DIN/ISO 21920-3.
  • the coating that reduces surface roughness. It is advantageous if the coating on the surface areas that are not in contact with the bone or the meniscus replacement part, but are in contact with the soft tissue, is produced using a PVD (Physical Vapour Deposition) process. This allows a very uniform and thin coating to be produced in a process-stable manner. It is particularly advantageous if the coating has a coating thickness of 3.5 - 6.0 ⁇ m, which can be measured and determined in accordance with DIN/ISO 26423.
  • PVD Physical Vapour Deposition
  • Ceramic materials such as zirconium nitride (ZrN), chromium nitride (CrN) or chromium carbonitride (CrCN) are suitable for the coating, which can preferably be multi-layered.
  • the coating can be bonded to the implant part using an adhesion-promoting layer, particularly based on cobalt-chromium or titanium.
  • the tibial implant part has a three-dimensional porous surface structure in the surface areas facing the bone for the bone to grow into the implant part and that the tibial implant part has a coating at least in some areas on the surface areas not in contact with the bone and not with the meniscus replacement part but in contact with the soft tissue, by means of which the surface roughness of these surface areas is reduced.
  • this enables the tibial implant part to be securely anchored in the bone and, on the other hand, the surrounding soft tissue in the area of the tibial implant part is less irritated by the smooth formation of the surface in contact with the soft tissue.
  • the hardening and wear-reducing coating of the articulating surface areas in sliding contact with the meniscus replacement part is explained below. It proves to be advantageous if the hardening and wear-reducing, in particular multi-layered coating of the articulating condylar surface areas in sliding contact comprises a ceramic surface, in particular made of or based on zirconium nitride (ZrN).
  • ZrN zirconium nitride
  • the hardening and wear-reducing coating of the articulating condylar surface areas in sliding contact is designed in several layers and is connected to the implant part via an adhesion-promoting layer, in particular based on titanium.
  • the hardening and wear-reducing coating contains layers based on Chromium nitride (CrN) and/or based on chromium carbonitride (CrCN) and/or based on zirconium nitride (ZrN).
  • the hardening and wear-reducing coating has a top layer based on zirconium nitride (ZrN) and inner layers based on chromium nitride (CrN) or chromium carbonitride (CrCN), whereby several inner layers based on chromium nitride (CrN) and chromium carbonitride (CrCN) can alternate.
  • ZrN zirconium nitride
  • CrN chromium nitride
  • CrCN chromium carbonitride
  • the coating that reduces the surface roughness in the soft tissue contact area it is advantageous if the coating of the surface areas that are not in contact with the bone and not with the meniscus replacement part but are in soft tissue contact is bonded to the implant part via a titanium-based adhesion-promoting layer.
  • the coatings are bonded to a base material of the relevant implant part via different bonding layers. It would be conceivable that the bonding layer in the hardening and wear-reducing coating is based on cobalt-chromium or titanium, and that the bonding layer in the coating that reduces surface roughness in the soft tissue contact area is based on titanium. However, both coatings can also be bonded via the same titanium-based bonding layer.
  • the meniscus replacement part has a polymer-based sliding surface, in particular polyethylene-based, which is in contact with the articulating condylar surface areas of the femoral implant part.
  • the meniscus replacement part can also be made entirely of polymer.
  • the metallic femoral implant part and the metallic tibial implant part are manufactured additively.
  • Additive manufacturing in the form of metallic 3D printing is suitable for the manufacture of complex and particularly filigree structures that would be difficult or impossible to manufacture using injection molding or casting technology.
  • additive manufacturing is advantageous in that it can be used to manufacture any closed and/or three-dimensionally porous structures, including surface structures. can be produced.
  • an implant part both a preferably essentially closed articulating surface area and a three-dimensionally porous surface area in contact with the bone can be produced in the same implant part.
  • the three-dimensionally porous surface area on the respective implant part can therefore be produced by additive manufacturing in the form of metallic 3D printing, without an additional porous layer having to be added to the implant part.
  • an implant part in question can be formed with a three-dimensional bar structure in the area of bone contact, whereby the three-dimensional bar structure can extend inwards from the outer shell surface to any depth. In this way, however, a deep penetration of the bone tissue into the implant part can be achieved, which enables a lasting tight fit of the implant part and thus of the prosthesis.
  • a certain surface roughness inherent in 3D printing can then be reduced in the soft tissue contact area by applying the roughness-reducing coating.
  • the metallic femoral implant part and/or the metallic tibial implant part is additively manufactured from titanium or titanium alloy.
  • Titanium or titanium alloy is ideal for the direct formation of surface areas facing the bone and in contact with the bone, as bone grows well into and onto surfaces formed from titanium or titanium alloy.
  • the natural surface roughness formed by 3D printing is also beneficial for this purpose.
  • a titanium alloy in particular an alpha or beta titanium alloy, for example T16-A14-V or Ti-24Nb-4 Zr-8Sn, can be used.
  • the tribological properties of titanium surfaces can be improved and, as already mentioned at the beginning, undesirable bone growth in the soft tissue contact area can be prevented or at least inhibited.
  • the subject matter of the invention is also considered to be a respective implant part, i.e. a femoral implant part and/or a tibial implant part, which has a three-dimensionally porous surface structure in the area of bone contact in the surface areas facing the bone for the bone to grow into the implant part and which has a coating at least in some areas on the surface areas not in contact with the bone and not with the meniscus replacement part but in contact with soft tissue, by means of which a surface roughness of these surface areas is reduced.
  • a respective implant part i.e. a femoral implant part and/or a tibial implant part, which has a three-dimensionally porous surface structure in the area of bone contact in the surface areas facing the bone for the bone to grow into the implant part and which has a coating at least in some areas on the surface areas not in contact with the bone and not with the meniscus replacement part but in contact with soft tissue, by means of which a surface roughness of these surface areas is reduced.
  • Figure 1 is an exploded view of an embodiment of an orthopedic knee joint prosthesis according to the invention with a femoral implant part, a tibial implant part and a meniscus replacement part that can be fixed to the tibial implant part;
  • Figure 2 is a schematic, simplified sectional view of the femoral implant part
  • Figure 3 is a side view of the tibial implant part with partial cross-section
  • Figure 4 is a top view of the tibial implant portion in the direction of arrow IV in Figure 3;
  • Figure 5 is a bottom view in the direction of arrow V in Figure 3;
  • Figure 6 shows schematically an additively manufactured three-dimensional porous metallic structure of an implant portion for the ingrowth of bone tissue
  • Figure 7 schematically illustrates a multilayer coating.
  • Figure 1 shows an exploded view of an orthopedic knee joint prosthesis, designated overall by the reference symbol 2, with a femoral implant part 4, a tibial implant part 6 and a meniscus replacement part 8, which can typically be anchored to the tibial implant part 6.
  • the femoral implant part 4 comprises a not shown
  • the femoral implant part 4 comprises surface areas 14 that are not in contact with the bone and not with the meniscus replacement part 8, but are in soft tissue contact. These are surface areas 14 that are outside the articulating sliding contact with the meniscus replacement part, in particular surface areas 14 that flank the femoral implant part 4 horizontally on the sides.
  • the tibial implant part 6 also has surface areas 16 facing the bone of the lower leg (tibia) and in contact with the bone. Furthermore, the tibial implant part 6 comprises surface areas 18 in contact with the meniscus replacement part 8, and finally the tibial implant part 6 also has surface areas 20 that are not in contact with the bone and not with the meniscus replacement part 8, but are in soft tissue contact.
  • the femoral implant part 4 has at least one dome- or shaft-shaped projection 22 and the tibial implant part 6 has an elongated projection 24, which each serve to engage and anchor to the femur or lower leg bone.
  • the projection 24 of the tibial implant part 6 is also connected to a disc-shaped plateau part 26 of the tibial implant part 6.
  • the disk-shaped plateau part 26 comprises, facing away from the bone and facing the meniscus replacement part 8, a flatly extending recess 28 for inserting and in particular locking the complementary region 28 of the meniscus replacement part 8.
  • the femoral implant part 4 as well as the tibial implant part 6 are each formed with a three-dimensionally porous surface structure 30 or 32 in the area of their bone contact.
  • this three-dimensionally porous surface structure 30 and 32 extends macroscopically over at least 0.5 mm and in particular up to 20 mm, in particular up to 15 mm and in particular up to 10 mm in the depth direction into the respective implant part 4 or 6, which are each preferably manufactured using additive manufacturing processes.
  • the meniscus replacement part 8 forms, as a sliding partner to the femoral implant part 4, three-dimensionally shaped sliding surface areas 34 which are essentially complementary in shape to the condylar surface areas 12 of the femoral implant part 4 and which, like the entire meniscus replacement part 8, are made of a polymer, in particular polyethylene.
  • the Meniscus replacement part 8 in sliding contact with articulating condylar surface areas 12 a hardening and wear-reducing, in particular multi-layered
  • Coating 38 on This coating comprises several ceramic layers as well as a cover layer , for example and preferably based on zirconium nitride as well as an adhesion-promoting layer on the base material of the femoral implant part 4 (described below by way of example in connection with Figure 7).
  • the hardening and wear-reducing coating 38 can be designed in detail as described in EP 2 051 666 B1, so that the relevant content of this publication with regard to the structure of the hardening and wear-reducing coating is incorporated by reference into the present application.
  • a corresponding hardening and wear-reducing coating 50 is present on the surface area 18 of the tibial implant part 6 that is in contact with the meniscus replacement part 8. This is advantageous because, despite the holding connection, in particular the locking connection, between the meniscus replacement part 8 and the tibial implant part 6, micro-movements take place between these components.
  • the present invention proposes to provide soft tissue contact
  • Surface areas 14 of the femoral implant part 4 and surface areas 20 of the tibial implant part 6 outside the contact area with the bone and the meniscus replacement part are to be provided with a smoothing coating 52 or 54, by means of which a surface roughness of these surface areas 14, 20 in contact with the soft tissue is reduced.
  • the aim is to achieve a surface that is as smooth as possible so that relative movements do not lead to the introduction of frictional energy into the soft tissue, or at least lead to a significantly lower introduction of frictional energy into the soft tissue, which could prove to be problematic.
  • this coating 52 or 54 which reduces the surface roughness, is only deposited on outer webs, struts or ribs of the structure during application using the PVD process in the event of an unintentional coating of three-dimensionally porous surface areas 10 or 16 of the implant parts 4, 6 that are in contact with bone, which does not noticeably hinder the anchoring of bone material in the three-dimensionally porous structure.
  • the same layer structure can be used to form the smoothing coating 52, 54, i.e. the coating which reduces the surface roughness, as is used to produce the hardening and wear-reducing coating 38 and 50 of the articulating condylar surface areas 12 of the femoral implant part 4 and the meniscus replacement part 8. facing surface areas 18 of the tibial implant part 6.
  • Figure 7 shows schematically and by way of example a multi-layer structure which is equally suitable for the construction of the respective hardening and wear-reducing coating 38, 50 and for the smoothing coating 52, 54.
  • a base material 60 of the respective implant part 4 or 6 and an adhesion-promoting layer 62 which is only 30 to 200 x 10-9 m thick, in particular based on titanium.
  • several ceramic layers 64 are provided, in particular made of two alternating materials.
  • a ceramic surface layer 66 is provided, in particular based on zirconium nitride.
  • this layer structure can be used both as a hardening and wear-reducing coating 38, 50 and as a smoothing coating 52, 54 exclusively in soft tissue contact.

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

Abstract

L'invention concerne une prothèse d'articulation de genou orthopédique (2) ayant une partie d'implant fémoral (4) métallique, une partie d'implant tibial (6) métallique et une partie de remplacement de ménisque (8) ; selon l'invention, il est proposé que la partie d'implant fémoral (4) et en particulier également la partie d'implant tibial (6) sont fabriquées de manière additive par impression 3D métallique, que la partie d'implant fémoral (4) et/ou la partie d'implant tibial (6) ont/a une structure de surface poreuse tridimensionnelle (30, 32) formée par l'impression 3D, dans des régions de surface (10, 16) faisant face à l'os, pour permettre l'incorporation de l'os dans la partie d'implant (4, 6), et que la partie d'implant fémoral (4) et/ou la partie d'implant tibial (6) ont/a au moins dans certaines zones un revêtement (52, 54) dans des régions de surface (14, 20) non en contact avec l'os et non en contact avec la partie de remplacement de ménisque (8) mais en contact avec un tissu mou, ce revêtement permettant de réduire la rugosité de surface de ces régions de surface (14, 20).
PCT/EP2024/065610 2023-06-06 2024-06-06 Prothèse d'articulation de genou orthopédique Ceased WO2024251877A1 (fr)

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AU2024286530A AU2024286530A1 (en) 2023-06-06 2024-06-06 Orthopaedic knee joint prosthesis

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DE102023114759.5 2023-06-06
DE102023114759.5A DE102023114759A1 (de) 2023-06-06 2023-06-06 Orthopädische Kniegelenkprothese

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CN120168177A (zh) * 2025-03-18 2025-06-20 北京力达康科技有限公司 一种膝关节假体

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DE102024126035A1 (de) 2024-09-11 2026-03-12 Aesculap Ag Tibia-Implantat

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EP2051666B1 (fr) 2006-08-16 2011-10-26 Ionbond AG Olten Implant et procédé de production d'un implant
RU2433803C1 (ru) * 2010-04-28 2011-11-20 Общество с ограниченной ответственностью "ИЛЬКОМ" Модульный эндопротез коленного сустава
US8642112B2 (en) 2008-07-16 2014-02-04 Zimmer, Inc. Thermally treated ceramic coating for implants
US10272177B2 (en) * 2014-06-13 2019-04-30 Acuitive Technologies, Inc. Joint replacement or joint resurfacing devices, systems and methods
US20190358041A1 (en) * 2009-05-21 2019-11-28 Depuy Ireland Unlimited Company Prosthesis with surfaces having different textures and method of making the prosthesis
AU2021222575A1 (en) * 2020-02-19 2022-10-13 DePuy Synthes Products, Inc. Coated implant and method of making the same

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Publication number Priority date Publication date Assignee Title
US20230096615A1 (en) 2020-02-19 2023-03-30 DePuy Synthes Products, Inc. Metallic orthopaedic implant and method of making the same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2051666B1 (fr) 2006-08-16 2011-10-26 Ionbond AG Olten Implant et procédé de production d'un implant
US8642112B2 (en) 2008-07-16 2014-02-04 Zimmer, Inc. Thermally treated ceramic coating for implants
US20190358041A1 (en) * 2009-05-21 2019-11-28 Depuy Ireland Unlimited Company Prosthesis with surfaces having different textures and method of making the prosthesis
RU2433803C1 (ru) * 2010-04-28 2011-11-20 Общество с ограниченной ответственностью "ИЛЬКОМ" Модульный эндопротез коленного сустава
US10272177B2 (en) * 2014-06-13 2019-04-30 Acuitive Technologies, Inc. Joint replacement or joint resurfacing devices, systems and methods
AU2021222575A1 (en) * 2020-02-19 2022-10-13 DePuy Synthes Products, Inc. Coated implant and method of making the same

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120168177A (zh) * 2025-03-18 2025-06-20 北京力达康科技有限公司 一种膝关节假体

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