EP3226811A1 - Espaceur (« spacer ») céramique pour le changement bilatéral d'implants d'épaule, de genou et de hanche suite à une infection - Google Patents

Espaceur (« spacer ») céramique pour le changement bilatéral d'implants d'épaule, de genou et de hanche suite à une infection

Info

Publication number
EP3226811A1
EP3226811A1 EP15805149.0A EP15805149A EP3226811A1 EP 3226811 A1 EP3226811 A1 EP 3226811A1 EP 15805149 A EP15805149 A EP 15805149A EP 3226811 A1 EP3226811 A1 EP 3226811A1
Authority
EP
European Patent Office
Prior art keywords
ceramic
sleeve
placeholder
component
spacer
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.)
Withdrawn
Application number
EP15805149.0A
Other languages
German (de)
English (en)
Inventor
Andreas Rempp
Ralph Autenrieth
Alfons Kelnberger
Roman Preuss
Heinrich Wecker
Tobias Weiss
Javad Parvizi
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.)
Ceramtec GmbH
Original Assignee
Ceramtec GmbH
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 Ceramtec GmbH filed Critical Ceramtec GmbH
Publication of EP3226811A1 publication Critical patent/EP3226811A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A61F2/30724—Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • 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
    • A61F2/3859—Femoral components
    • 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
    • A61F2/389—Tibial components
    • 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
    • A61F2/40—Joints for shoulders
    • A61F2/4014—Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • 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
    • A61F2/40—Joints for shoulders
    • A61F2/4059—Humeral shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/305—Snap connection
    • 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
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2002/30621—Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30624—Hinged joint, e.g. with transverse axle restricting the movement
    • 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
    • A61F2002/30621—Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649—Ball-and-socket joints
    • 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
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30672—Features concerning an interaction with the environment or a particular use of the prosthesis temporary
    • 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
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
    • A61F2002/3615—Heads or epiphyseal parts of femur having a concave shape, e.g. hemispherical cups
    • 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
    • A61F2/32—Joints for the hip
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    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3654—Connections of heads directly to shafts
    • 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
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    • A61F2/4014—Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • A61F2002/4018—Heads or epiphyseal parts of humerus
    • A61F2002/4022—Heads or epiphyseal parts of humerus having a concave shape, e.g. hemispherical cups
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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
    • A61F2/40—Joints for shoulders
    • A61F2/4014—Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • A61F2002/4051—Connections of heads directly to shafts
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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
    • A61F2310/00011—Metals or 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
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • 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
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA

Definitions

  • the invention relates to a spacer ("spacer") made of individual components as joint replacement in the endoprosthetics of the shoulder, the knee and the hip for the temporary surgical treatment of infections in the joint.
  • spacer made of individual components as joint replacement in the endoprosthetics of the shoulder, the knee and the hip for the temporary surgical treatment of infections in the joint.
  • Spacers also called spacers, are known in the field of joint endoprosthetics and are used temporarily to support the healing of bacterial infections, due to endoprosthetic care, and to allow during the healing phase a mechanical minimal functionality of the joint apparatus.
  • a stem or shaft similar to a stem or stem of an artificial hip joint, which supports the spacer in the medullary canal of the femur.
  • a ball segment or ball head capable of articulating to a limited extent (especially with respect to the number of load and motion changes) in the hemisphere of the acetabular cavity remaining after removal of the artificial acetabular cup.
  • the life / application of the spacer ends when the infection healed after a few weeks, the spacer is removed and a new endoprosthesis, if necessary revision endoprosthesis, is used.
  • Previous spacer systems are usually based on PMMA bone cements, which are mixed or filled with antibiotic agents, usually gentamicin and / or vancomecin, and either delivered as prefabricated implants or produced during the surgical operation with provided material mixtures and molds.
  • antibiotic agents usually gentamicin and / or vancomecin
  • the low wear resistance of the materials used in tribological stress restricts the patient extremely in his mobility.
  • the released wear products - cement particles and ceramic particles with which the cements are often filled to increase the strength - may provoke negative biological reactions and increase the risk of wear of the subsequently installed endoprostheses by so-called third-body wear.
  • the low mechanical strength of the temporary spacers compared to regular prostheses means that the patient must limit the load (height of the load and number of load cycles) and thus his mobility extremely, if a failure of the spacer is to be avoided by breakage.
  • the invention has for its object to improve a placeholder or spacer according to the preamble of claim 1 so that an increase of the bone to the spacer and a release of wear products is avoided.
  • the patient should experience essentially no mobility impairment and it should be the wear of the spacer as low as possible, which can lead to insufficient guidance and stability of the joints.
  • the placeholder consists of at least one component of a ceramic or of several ceramic materials, or of a non-ceramic material with a ceramic coating, an increase of the bone to the spacer and a release of wear products is avoided.
  • the patient essentially learns no mobility restrictions and the wear of the spacer is as low as possible, so that no insufficient guidance and stability of the joints occurs.
  • all exposed surfaces of the at least one ceramic component are polished with contact to biological tissue or processed so that their surface roughness Ra is less than 0.35 ⁇ . An increase of the bone is excluded.
  • the at least one ceramic component carries at least in some areas a coating or multiple coatings with one or more antibiotic agents.
  • the placeholder consists in one embodiment of a ceramic shaft with a cantilevered receiving element and on the receiving element is a metallic sleeve attached and on the sleeve, a ceramic ball head is anchored.
  • the placeholder thus consists of the same components as a classic prosthesis.
  • the coupling between the shaft and sleeve and between the sleeve and ball head by a conical clamping connection or the coupling between the shaft and sleeve takes place as a clamping connection based on truncated pyramid geometries or form-fitting based on a square geometry, for. to favor the shaping of the shank by uniaxial dry pressing of ceramic powder or the coupling takes place material or form-fitting using bone cement.
  • the sleeve may also be jammed on the receiving element via one or more stops.
  • the bone engaging portion of the shaft has a rectangular or oval shape in cross section.
  • the placeholder preferably consists exclusively of two components, namely a femoral component of bone cement or of a ceramic material and a tibial component of a ceramic material and the femoral component has two mutually parallel sliding surfaces, which on two Bumps arranged parallel to one another are mounted on the tibial component.
  • the femoral component between the sliding surfaces is closed.
  • the tibial component on the underside opposite the bulges on a right-angled protruding pin which is non-circular in cross-section and preferably has an angular or oval cross-section.
  • the invention thus describes a placeholder (spacer) for the temporary surgical treatment of infections in endoprosthetics, in one or more parts, consisting of one or more ceramic materials in combination with interface modules made of plastic or metal, optionally additionally partially or completely coated with an antibiotic Active substance or antibacterial materials.
  • the coating releases one or more antibiotic agents during the time in the human body, e.g. in the form of a gentamicin-containing palmitate layer - alternatively, the coating may also be in the form of antibiotic-acting metals, e.g. Silver or copper, which prevent bacterial colonization without necessarily release active ingredients.
  • antibiotic-acting metals e.g. Silver or copper
  • the release kinetics of the drug can be adapted to the patient's needs, e.g. by multiple layers with different active ingredient concentration and / or layer thickness, if the release in time dependence of the penetration of the layers by body fluids or by degradation of the layers (biological degradation) and thus drug release from outside to inside.
  • ZTA Zirconia-reinforced aluminum oxide
  • Cerium-stabilized zirconium oxide in which the stabilization of the tetragonal phase of the zirconium oxide is carried out by cerium oxide.
  • non-oxide ceramic materials e.g. Silicon nitride Si3N4 may be used as the ceramic material for this invention.
  • the system is modular and consists of a shaft with attached adapter sleeve and a turn plugged ball head or ball segment head. See the figures.
  • the ceramic ball head resembles the conventional ball end caps of hip endoprosthetics, but meets application-related lower requirements with regard to geometry tolerances and surface quality
  • the diameter of the ceramic ball head 4 is in the range between 48 and 60 mm, as an articulation against the remaining cavity of the removed
  • the functional zone of the articulating sphere of the ball head may be smaller than usual in a hip endoprosthesis (spherical segment).
  • the coupling between the shaft and sleeve and between the sleeve and the ball head by conical clamping connections can also be designed as a clamp connection based on truncated pyramid geometries or positively on
  • the coupling can also be material or form-fitting using intra-operatively on Kursdem bone cement (possibly including antibiotic agent such as gentamicin) take place
  • the sleeve consists of an established implant alloy such as TiAl6V4, CoCrMo, stainless steel or pure titanium - alternatively, the sleeve may also consist of a biocompatible polymer, eg PE, XPE, Vitamin E XPE, PEEK, PEKK, PMMA
  • neck jump or “neck length”
  • sleeves made of polymer materials do not have a purely frictional connection (e.g., a conical clamp connection), but additionally have one or more stops which become active upon reaching a predefined stress condition in the clamp connection due to the associated relative displacement
  • the more bone-sparing is the spacer depending on the extracted, infected system (maintaining the existing bony bearing) and / or subsequently to be implanted new or revision system (maintaining the created bony bearing in the process) from an economic point of view can also one Reduced variety of forms are offered, which is based on established, market-leading systems - alternatively, a unitary geometry would also be possible, which allows high quantities with low diversity
  • the ceramic shaft has a collar on the proximal part, which provides additional support and thus contributes to both
  • a dense ceramic coating can be applied to an established hip stem made of a metallic material, so that the stem is sufficiently similar to a full ceramic stem with respect to the surface or its chemical, physical and biological properties in order to sufficiently increase osseointegration and bacterial colonization to reduce.
  • Figure 1 shows a spacer according to the invention or spacer 1, consisting of a shaft 2 with a cantilever receiving element 13 for a sleeve 3 and a head 4.
  • the shaft 2 and the head 4 are made of a ceramic.
  • the sleeve 3 consists in this embodiment of a metal. So that the shaft 2 is implantable against rotation in the bone, it has a rectangular or oval shape in cross-section.
  • FIG. 2 shows the shaft 2 alone. At the marked point A1, it has an anatomical design. At the marked point A2, the shaft has large radii. In area A3 there are only soft transitions in cross section. The shaft has a maximum cross section of 14 * 14 mm in the area A4.
  • Figure 3 shows different sizes of the shaft 2.
  • Figure 4 shows conventional ball heads 5 in comparison to the ball heads 4 for the spacers including the sleeves 3.
  • the ball heads 4 are larger than the conventional ball heads 5 for hip prostheses.
  • the surface roughness Ra of the shaft 2 after sintering is preferably 0.25 to 0.35.
  • the ball head 4 of the spacer 1 has a surface roughness of preferably 0.1 ⁇ .
  • FIGS. 5a, 5b show the state of the art in knee joint prostheses.
  • This prosthesis consists of a ceramic femoral component 6, a PE component 7 and a ceramic tibia component 8.
  • FIG. 5a shows the prosthesis implanted and FIG. 5b not yet implanted.
  • FIGS. 6 and 7 show spacers according to the invention for the knee.
  • FIG. 6 a shows a femoral component 9 made of bone cement, which is mounted on a tibial component 10 according to the invention made of a ceramic.
  • the tibial component 10 consists essentially of a rectangular plateau of a ceramic with bulges 15 on which the femoral component 9 is mounted with its sliding surfaces 14.
  • the tibial component 10 on a pin 1 1 On its underside, the tibial component 10 on a pin 1 1, which is shaped out of round for security against rotation, for example, has an angular or oval cross-section.
  • Both the femoral component 9 and the tibial component 10 are anchored in the bone with bone cement.
  • FIGs 7a and 7b an alternative spacer is shown.
  • the femoral component 12 in this embodiment consists of a ceramic, such as the tibial component 10.
  • the tibial component 10 is formed identically with the tibial component 10 according to FIG. 6b.
  • the femur component 9, 12 of the spacer has a simplified geometry, oriented on existing spacers made of PMMA materials-alternatively, a universal geometry can be realized which represents the average of the inner contour of the most common implant systems on the market or the Minimai geometry (minimum material condition) of an overlay of these systems •
  • the tibial component 10 is realized in the form of a simplified ceramic plateau, where the joint space is realized by inserting one or more stackable spacer plates
  • the spacer plates are made of ceramic or a low abrasion polymer, e.g. PE, XPE, Vitamin E-XPE, where the polymer could additionally be filled with one or more antibiotic agents released in vivo
  • the articulating components can be produced by known manufacturing methods, e.g. uniaxial or isostatic dry pressing, cutting shaping, single or multi-stage sintering (hot isostatic pressing possible but possibly not necessary), grinding and polishing in the sintered state, which reduces grinding and polishing due to lower requirements on tolerances and surface finishes or sub-steps if necessary can be omitted. Shaping of the articulating components could also be accomplished by ceramic injection molding (CIM or LIM).
  • CIM ceramic injection molding
  • the surface of the ceramic shaft is mechanically reworked by grinding and / or vibratory finishing and / or polishing in such a way that the surface is as smooth as possible, which does not osseointegrate as little or as little as possible into the bone, and if necessary obstructs the bacterial colonization sufficient adhesion of the coating allows.
  • the metallic sleeve 3 is advantageously produced cost-saving by deep drawing from sheet metal blanks.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un espaceur (« spacer ») (1) constitué de composants individuels (2, 3, 4, 9, 10, 12) formant prothèse articulaire dans la pose de prothèses d'épaule, de genou et de hanche dans le cadre du traitement chirurgical temporaire des infections touchant l'articulation. On évite ainsi toute croissance de l'os sur l'espaceur et toute libération de produits d'usure. La mobilité du patient n'est sensiblement pas réduite et l'usure de l'espaceur est aussi limitée que possible par le fait que l'espaceur (1) est fabriqué en au moins un composant constitué d'un matériau céramique ou de plusieurs matériaux céramiques, ou en un matériau non céramique recouvert de céramique.
EP15805149.0A 2014-12-05 2015-12-03 Espaceur (« spacer ») céramique pour le changement bilatéral d'implants d'épaule, de genou et de hanche suite à une infection Withdrawn EP3226811A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014225026 2014-12-05
PCT/EP2015/078460 WO2016087561A1 (fr) 2014-12-05 2015-12-03 Espaceur (« spacer ») céramique pour le changement bilatéral d'implants d'épaule, de genou et de hanche suite à une infection

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EP3226811A1 true EP3226811A1 (fr) 2017-10-11

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EP15805149.0A Withdrawn EP3226811A1 (fr) 2014-12-05 2015-12-03 Espaceur (« spacer ») céramique pour le changement bilatéral d'implants d'épaule, de genou et de hanche suite à une infection

Country Status (8)

Country Link
US (1) US20170340445A1 (fr)
EP (1) EP3226811A1 (fr)
JP (1) JP2017536214A (fr)
CN (1) CN107223041A (fr)
BR (1) BR112017010111A2 (fr)
DE (1) DE102015224150A1 (fr)
RU (1) RU2017123560A (fr)
WO (1) WO2016087561A1 (fr)

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DE102016009730A1 (de) * 2016-07-28 2018-02-01 Forschungszentrum Jülich GmbH Verfahren zur Verstärkung von transparenten Keramiken sowie Keramik
DE102017107621A1 (de) * 2017-04-10 2018-10-11 Ilias Efthimiou Reibbelagkörper
GR20180100146A (el) * 2018-04-04 2019-11-28 Βλαχος, Ιωαννης Ηλια Συστημα κεραμικης αρθροπλαστικης επιφανειας
US20210145549A1 (en) * 2019-11-14 2021-05-20 Biomet 3I, Llc Implant placement assist system
JP7090186B2 (ja) * 2020-03-20 2022-06-23 ヘレウス メディカル ゲーエムベーハー スペーサを製造するための装置及び方法
RU202061U1 (ru) * 2020-04-09 2021-01-28 Иван Михайлович Ефремов Форма для изготовления головки монополярного спейсера тазобедренного сустава

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EP0562782A3 (en) * 1992-03-24 1994-05-25 Smith & Nephew Richards Inc Dual composition coupler for modular medical implants
ITVI20000025U1 (it) * 2000-04-07 2001-10-07 Tecres Spa Dispositivo distanziatore temporaneo per il trattamento chirurgico del ginocchio
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FR2898039B1 (fr) * 2006-03-03 2008-06-27 Ceravic Sas Soc Par Actions Si Implant provisoire comprenant deux actifs.
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Also Published As

Publication number Publication date
CN107223041A (zh) 2017-09-29
RU2017123560A (ru) 2019-01-10
JP2017536214A (ja) 2017-12-07
WO2016087561A1 (fr) 2016-06-09
BR112017010111A2 (pt) 2017-12-26
US20170340445A1 (en) 2017-11-30
DE102015224150A1 (de) 2016-06-09

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