EP3166536A1 - Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite - Google Patents

Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite

Info

Publication number
EP3166536A1
EP3166536A1 EP15732279.3A EP15732279A EP3166536A1 EP 3166536 A1 EP3166536 A1 EP 3166536A1 EP 15732279 A EP15732279 A EP 15732279A EP 3166536 A1 EP3166536 A1 EP 3166536A1
Authority
EP
European Patent Office
Prior art keywords
porous
knee joint
joint replacement
replacement according
bone
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
EP15732279.3A
Other languages
German (de)
English (en)
French (fr)
Inventor
Roman Preuss
Marita Raschke
Peter STRÖTGEN
Tobias Weiss
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 EP3166536A1 publication Critical patent/EP3166536A1/de
Ceased 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
    • 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
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • 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
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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
    • 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
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    • A61F2/3859—Femoral components
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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
    • A61F2/38—Joints for elbows or knees
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
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    • A61L27/32—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
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    • 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
    • A61L27/52—Hydrogels or hydrocolloids
    • 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
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04—Homopolymers or copolymers of ethene
    • C08L23/06—Polyethene
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00—Compositions of proteins; Compositions of derivatives thereof
    • 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
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30769—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth madreporic
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • 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
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction

Definitions

  • the invention relates to a knee joint replacement with a femoral component and a tibial component, each having a front side forming the joint and a rear side facing the bone and having a polyethylene (PE) liner.
  • PE polyethylene
  • the current state of the art for replacement of the knee joint provides for over 90% cemented endoprostheses.
  • the bone cement adheres very well to the strongly roughened surfaces of the metallic endoprostheses (CoCrMo or Ti alloys), but dissolves over time due to the action of the aqueous environment in the human body on the component (so-called "debonding")
  • Micro-movements of the knee endoprostheses on the bone cement quiver and the progressive subcritical crack growth of the bone cement due to the dynamic loading of the joint shatters the bone cement over time, resulting in abrasion particles which enter the surrounding tissue and also in the sliding surface of the bone
  • the resulting bone cement as well as PE abrasion usually leads to a biological reaction of the surrounding tissue resulting in local inflammation and osteolysis (regression of the bone) to aseptic loosening of the Implants can lead.
  • This mechanism is indispensable for cemented knee endoprostheses and also explains why the average life of a cemented knee joint endopros
  • Cementless knee endoprostheses represent an alternative with great potential for longer prosthesis service life.
  • Metal knee joint endoprostheses that are frequently provided with a likewise metallic osseointegrative coating, which is the direct ingrowth of the knee joint endoprostheses, are currently established on the market Bone in the implant surface allows.
  • Such metal-free knee joint components combine the advantages of a biocompatible, allergy-friendly material and low wear of the sliding pair with excellent osseointegration.
  • An inventive knee joint replacement with a femoral component and a tibial component, each with a front side forming the joint and a back side facing the bone and with a polyethylene (PE) liner is characterized in that the femoral component and the tibial component consist of a full ceramic and with porous osseointegrative bone-facing Rear of both components.
  • the femoral component and the tibial component are each made of a ceramic sintered shaped body, wherein the sintered shaped bodies have a porous layer on their rear side facing the bone.
  • the porous bone-facing rear side is formed by applying a ceramic slip and spacers (pore-forming agent) on the base body (component) in the green state. About the sintering process, a compound of the layer is achieved with the body. Burning out the placeholders during sintering creates an open - pored structure with a fissured surface, which advantageously supports bone ingrowth and ingrowth. See also EP 1 268 364 A1.
  • the ceramic slip consists of the same material as the ceramic base body.
  • the complete implant, including the coating is completely free of metals and advantageous in terms of allergic reactions.
  • the porous bone-facing rear side is formed by foaming a ceramic slip and spacers (pore formers) on the base body (component) in the green state.
  • the porous bone-facing rear side can also be formed by joining a dense molding with a porous ceramic molding in the sintered state.
  • the porous molding can be made by foaming ceramic Slurry and sintering or infiltration of a porous carrier material with slip and sintering arise.
  • the joining is preferably carried out by soldering or gluing. This type of coating in combination with a ceramic base body is metal-free advantageous in terms of allergic reactions.
  • the integrated porous osseointegrative bone-facing back may also be formed by 2K injection molding (dense phase and porous or pore-forming phase) and sintering. This type of coating in combination with a ceramic base body is metal-free.
  • the porous bone-facing rear side can preferably be given additional functionality by further coating, such as a higher rate of integration or antibacterial effects. Integration speed is the time of ingrowth with the bone. This can preferably be achieved with Biogläsern, Hydroxilapatit, functionalized proteins or hydrogels.
  • the porous bone-facing rear side is formed by applying a porous metallic biocompatible layer on the already sintered ceramic base body (see EP 1 052 949 B1).
  • Figure 1 shows a total ceramic knee joint endoprosthesis consisting of femoral component 1, a tibial component 2 and ziwscheneaudem polyethylene (PE) liner 3 in the implanted state.
  • the porous bone-facing back is identified by the reference numeral 4.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ceramic Engineering (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
EP15732279.3A 2014-07-09 2015-07-01 Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite Ceased EP3166536A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014213356 2014-07-09
PCT/EP2015/064924 WO2016005235A1 (de) 2014-07-09 2015-07-01 Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite

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EP3166536A1 true EP3166536A1 (de) 2017-05-17

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EP15732279.3A Ceased EP3166536A1 (de) 2014-07-09 2015-07-01 Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite

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Country Link
US (1) US20170252168A1 (ru)
EP (1) EP3166536A1 (ru)
JP (1) JP2017521160A (ru)
KR (1) KR20170028977A (ru)
CN (1) CN106659571A (ru)
AU (1) AU2015286968A1 (ru)
DE (1) DE102015212258A1 (ru)
RU (1) RU2017104139A (ru)
WO (1) WO2016005235A1 (ru)

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CN110755681B (zh) * 2019-10-31 2023-09-08 吉瑞骨科有限公司 一种金属和陶瓷复合的关节假体及其制作方法

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JPS6485644A (en) * 1987-09-28 1989-03-30 Asahi Optical Co Ltd Preparation of ceramics composite
JPH03267055A (ja) * 1990-03-16 1991-11-27 Koshino Nariko 人工膝関節の脛骨側コンポーネント
WO1992002470A1 (de) 1990-08-06 1992-02-20 Stora Feldmühle Aktiengesellschaft Sinterformkörper und seine verwendung
US5609641A (en) * 1995-01-31 1997-03-11 Smith & Nephew Richards Inc. Tibial prosthesis
DE19755536A1 (de) 1997-12-13 1999-06-17 Ceramtec Ag Hüftgelenkspfanne
DE10015614B4 (de) 2000-03-29 2009-02-19 Ceramtec Ag Gesinterter Formkörper mit poröser Schicht auf der Oberfläche sowie Verfahren zu seiner Herstellung und seine Verwendungen
WO2006053044A1 (en) * 2004-11-10 2006-05-18 Dynamet Technology, Inc. Fine grain titanium-alloy article and articles with clad porous titanium surfaces
WO2007123861A2 (en) * 2006-04-18 2007-11-01 University Of Florida Prosthetic device
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DE102007020471A1 (de) * 2007-04-27 2008-11-06 Ceramtec Ag Innovative Ceramic Engineering Sinterformkörper
ITTO20070373A1 (it) * 2007-05-29 2008-11-30 Torino Politecnico Coppa acetabolare ceramica monoblocco per protesi d'anca.
US8642112B2 (en) * 2008-07-16 2014-02-04 Zimmer, Inc. Thermally treated ceramic coating for implants
US8388887B2 (en) * 2010-04-12 2013-03-05 Biomet Manufacturing Corp. Methods for making textured ceramic implants
DE102011005424A1 (de) * 2010-10-29 2012-05-03 Mathys Ag Bettlach Keramik-Endoprothese mit keramischer Beschichtung und Verfahren zu dessen Herstellung
US9237950B2 (en) * 2012-02-02 2016-01-19 Biomet Manufacturing, Llc Implant with patient-specific porous structure
EP2879725B1 (de) * 2012-07-30 2020-09-16 CeramTec GmbH Mehrkomponenten-fügen von plastischen zubereitungen zur herstellung von medizinprodukten mit funktioneller oberfläche

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RU2017104139A (ru) 2018-08-10
DE102015212258A1 (de) 2016-01-14
KR20170028977A (ko) 2017-03-14
RU2017104139A3 (ru) 2018-12-28
WO2016005235A1 (de) 2016-01-14
CN106659571A (zh) 2017-05-10
AU2015286968A1 (en) 2017-02-16
US20170252168A1 (en) 2017-09-07
JP2017521160A (ja) 2017-08-03

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