WO1999030672A2 - Materiau de revetement pour protheses et prothese realisee avec ledit materiau - Google Patents

Materiau de revetement pour protheses et prothese realisee avec ledit materiau Download PDF

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Publication number
WO1999030672A2
WO1999030672A2 PCT/EP1998/008184 EP9808184W WO9930672A2 WO 1999030672 A2 WO1999030672 A2 WO 1999030672A2 EP 9808184 W EP9808184 W EP 9808184W WO 9930672 A2 WO9930672 A2 WO 9930672A2
Authority
WO
WIPO (PCT)
Prior art keywords
coating material
prosthesis
modified
mol
prosthesis part
Prior art date
Application number
PCT/EP1998/008184
Other languages
German (de)
English (en)
Other versions
WO1999030672A3 (fr
WO1999030672A8 (fr
Inventor
Wilhelm Aicher
Kurt E. Geckeler
Wolfgang KÜSSWETTER
Original Assignee
Eberhard-Karls-Universität Tübingen Universitätsklinikum
ZIRNGIBL, Friedrich, E.
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 Eberhard-Karls-Universität Tübingen Universitätsklinikum, ZIRNGIBL, Friedrich, E. filed Critical Eberhard-Karls-Universität Tübingen Universitätsklinikum
Priority to EP98965830A priority Critical patent/EP1039939A2/fr
Publication of WO1999030672A2 publication Critical patent/WO1999030672A2/fr
Publication of WO1999030672A8 publication Critical patent/WO1999030672A8/fr
Publication of WO1999030672A3 publication Critical patent/WO1999030672A3/fr

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Classifications

    • 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
    • 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

Definitions

  • the invention relates to a coating material for prostheses and a prosthesis part.
  • cemented prostheses In the case of endoprostheses, a rough distinction is made between cemented prostheses and cementless implanted prostheses.
  • cemented prosthesis a prosthesis section is firmly connected to the wall of a cavity created in a bone using a cement layer.
  • cementless implants bone material grows against the surface of the prosthesis.
  • the prostheses are made from a metal, usually titanium, in view of their high mechanical strength.
  • osteogenic cells in the bone material adhere less well to metal surfaces. It has therefore already been proposed to provide the surface of prostheses or implants made of metal with an outer layer of hydroxylapatite. Hydroxyapatite is an inorganic material related to bone material, which has a favorable influence on the waxing-up kinetics of the implant. The rapid growth of osteogenic cells on the coated prosthesis surface accelerates the mobilization of patients after operations.
  • prostheses coated with hydroxyapatite have the disadvantage that cracks or surface detachments can occur between the mineral outer layer and the metallic base body of the prosthesis. This has a negative effect on the strength of the corresponding implants in the bone.
  • plastic materials of this type do not promote the growth of bone cells, but rather display a more inert, some even a non-biocompatible behavior.
  • the object is achieved in the case of a coating material in that it is formed from an organic polymer material which has a firm bond with the al forms from which the prosthesis is made, and that the organic polymer material is chemically modified such that an increase in bone cells thereon is increased compared to the prosthesis material.
  • the object is achieved in that the outer layer consists of such a coating material.
  • the coating material is selected from the materials epoxy resins, epoxy resins modified with acetethylamine or chromosulfuric acid, glutardialdehyde, polyvinyl acetates, polyacrylonitriles, polyhydroxybutyrates, polyacrylates, polyoxymethylenes, polystyrenes, polyethylenes, polyethylenes, paraffins, polymethylols , Acetyl celluloses, nitrocelluloses, polyvinylpyrrolidones.
  • These materials are outstandingly suitable as coating materials for the common materials from which base bodies of prosthesis parts are made, but these materials can also serve as base bodies themselves. These materials can already be modified in such a way that an increase in bone cells is increased, or they must be additionally modified in order to increase this increase even further.
  • the chemical modification is carried out by introducing functional groups into the polymer materials.
  • This chemical modification can take place wet-chemical or plasma-chemical.
  • the modification is carried out by including biocompatible materials in the polymer material.
  • the polymer material as such essentially serves to form the firmly adhering bond with the base of the prosthesis.
  • the biocompatible materials enclosed in the polymer material then promote ingrowth into the organism. It is particularly advantageous if the enclosed materials are osteocompatible, they then specifically promote the growth of bone cells on the prosthesis material.
  • the coating material is an epoxy resin which is modified with 0.01 to 1.0 mol / mol, preferably with 0.3 to 0.8 mol / mol, most preferably with 0.5 mol / mol acetethylamines.
  • a prosthesis part which is coated with such materials ensures sufficient mechanical stability and a rapid and firmly adhering growth of the bone cells on the prosthesis.
  • the free surface of the outer layer of the prosthesis part can be treated by a plasma discharge, in particular with a treatment plasma that contains oxygen.
  • the surface can also be treated with microwaves.
  • the outer layer can carry a surface layer made of a material which is selected from the group of hydroxyapatite, proteins, in particular albumin, trypsin, pepsin, collagen.
  • This measure has the advantage that a particularly tissue-friendly surface is present at the immediate interface with the growing bone material and thus an increase in the outer layer is further promoted by interposing this surface layer.
  • this surface layer is treated by plasma discharge.
  • This measure has the advantage that the additional treatment of the surface layers results in further promotion of rapid and intensive growth.
  • the prosthesis base body is made of metal, preferably titanium, a ceramic material or a fiber / plastic composite material.
  • the prosthesis itself is formed from the materials that also build the coating material. In order to promote the growth, only the outside has to be modified or activated accordingly.
  • Figure 1 a side view of a femoral stem prosthesis
  • Figure 2 a transverse section through the shaft portion of the prosthesis shown in Figure 1 after insertion or ingrowth in a femur on an enlarged scale.
  • a total of 10 femoral stem prosthesis is designated. It consists of a prosthesis part 12 cast from metal, which in the exemplary embodiment shown has an essentially rectangular transverse cross section, is curved like a sickle and tapers towards the free end.
  • the prosthesis part 12 carries, via a molded pin 14, a joint ball 16 made of ceramic with a polished surface.
  • the prosthesis part 12 consists of a titanium prosthesis base body 18, to which an outer layer 20 made of an organic plastic material is applied.
  • the outer layer 20 is in the vicinity of its surface by a TCPL treatment (tissue culture plasma treatment; Low pressure plasma treatment) has been treated.
  • TCPL treatment tissue culture plasma treatment; Low pressure plasma treatment
  • This treatment gives the surface chemical modifications and reactive centers as well as biocompatible behavior.
  • This part of the outer layer 20 is shown in the drawing as a separate intermediate layer 22.
  • Possible materials for the outer layer 20 are: epoxy resins, epoxy resins which are modified with 0.1 to 1.0 mol / mol acetethylamine (AEM), preferably 0.3 to 0.8 mol / mol AEM, again preferably contain about 0.5 mol / mol AEM; Epoxy resins modified with chromosulfuric acid (CrSS); Glutardialdehyde (GDA); Polyvinyl acetates (PVAC), polyacrylonitriles (PAN); Polyhydroxybutyrates (PHB); Polycarbonate (PA); Polyoxymethylene (POM); Polyacrylates (PA); Polyvinylchloride (PVC); Polyethylenes (PE); Acetyl celluloses; Nitrocelluloses; Polyethylene glycol 400 diacryl (PEG4-D); Methyl methacrylate (PMMA); Polyvinyl pyrolidone (PVP).
  • AEM chromosulfuric acid
  • GDA Glutardialdehyde
  • PVAC
  • Suitable materials for the surface layer 24 are initially the materials already listed in connection with the outer layer 20 (applied as a thinner layer), furthermore the following particularly tissue-friendly, in particular bone-friendly, materials: hydroxyapatite; Proteins, especially albumin, trypsin, pepsin, collagen.
  • the free surface of the outer layer 20 (and possibly the surface layer 24) is preferably modified by a TCPL action. This consists in subjecting the surface to a plasma treatment, the plasma being enriched with, for example, 20-50% oxygen.
  • FIG. 2 shows in the right half the prosthesis part 12 immediately after insertion into a cavity 32 created in the cancellous bone 28 of a femur 30.
  • the left half of FIG. 2 shows the conditions after the prosthesis part 12 has grown in.
  • the one between the wall of the cavity Intermediate spaces 32 and the outer surface of the prosthesis part 12 are filled with regrown cancellous tissue 34 (shown more densely dotted). This adheres firmly to the surface of the prosthesis part, so that the prosthesis part is firmly connected to the femur 30.
  • Normal cell culture petri dishes (surface-treated molded parts made of polystyrene (PS)) were coated on the inside with the polymer or the polymers to be tested (outer layer 20 and surface layer 24). The surface of the layer was subjected to the secondary treatment described above (e.g. plasma, acid).
  • PS polystyrene
  • the dishes prepared in this way were additionally UV-sterilized and inoculated with SAOS-2 osteosarcoma cells.
  • the cells were in normal full medium, enriched with serum (20% FCS in Doubl. mod. ass. Medium (DMEM)) with antibiotics and vitamin additives for 7 days at 37 ° C and 5% C0 2 incubated.
  • the vitality of the cells after incubation was measured in the MTT assay (formazan formation).
  • the number of cells is measured via the metabolic enzyme dehydrogenase produced by the mitochondria. This catalyzes with a test substance contained in the assay in such a way that a color change is obtained. Its intensity is a measure of the vitality of the cells and indirectly the number of cells.
  • This plasma chemical surface modification can partly be replaced by using moderately polar plastics. Even such cells can still achieve cell growth of 80% of that of plasma-treated polystyrene, which means that these plastics are around 30% higher than untreated polystyrene.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un matériau de revêtement pour prothèses, qui se caractérise en ce qu'il consiste en un matériau polymère organique qui forme un composite avec le matériau dans lequel est réalisée la prothèse. Le matériau polymère organique peut être modifié par voie chimique, de manière à pouvoir augmenter la croissance de cellules osseuses dessus, par rapport au matériau constituant la prothèse.
PCT/EP1998/008184 1997-12-15 1998-12-14 Materiau de revetement pour protheses et prothese realisee avec ledit materiau WO1999030672A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP98965830A EP1039939A2 (fr) 1997-12-15 1998-12-14 Materiau de revetement pour protheses et prothese realisee avec ledit materiau

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19755334.6 1997-12-15
DE1997155334 DE19755334A1 (de) 1997-12-15 1997-12-15 Beschichtungsmaterial für Prothesen und hiermit beschichtetes Prothesenteil

Publications (3)

Publication Number Publication Date
WO1999030672A2 true WO1999030672A2 (fr) 1999-06-24
WO1999030672A8 WO1999030672A8 (fr) 1999-07-29
WO1999030672A3 WO1999030672A3 (fr) 1999-09-02

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/008184 WO1999030672A2 (fr) 1997-12-15 1998-12-14 Materiau de revetement pour protheses et prothese realisee avec ledit materiau

Country Status (3)

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EP (1) EP1039939A2 (fr)
DE (1) DE19755334A1 (fr)
WO (1) WO1999030672A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001045595A2 (fr) * 1999-12-17 2001-06-28 Cartificial A/S Dispositif prothetique
US7229545B2 (en) 2000-06-21 2007-06-12 Biomet Deutschland Gmbh Process for the coating for metallic implant materials
WO2016048155A1 (fr) 2014-09-26 2016-03-31 Dsm Ip Assets B.V. Composition médicale

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009103720A1 (fr) * 2008-02-18 2009-08-27 Dsm Ip Assets B.V. Revêtement sur métal

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB990126A (en) * 1961-10-23 1965-04-28 Haeger Potteries Inc Prosthetic parts and method of making same
WO1987005038A1 (fr) * 1986-02-17 1987-08-27 Commonwealth Scientific And Industrial Research Or Materiaux implantables
US4795475A (en) * 1985-08-09 1989-01-03 Walker Michael M Prosthesis utilizing salt-forming oxyacids for bone fixation
US4927676A (en) * 1988-07-01 1990-05-22 Becton, Dickinson And Company Method for rapid adherence of endothelial cells onto a surface and surfaces prepared thereby
US5308704A (en) * 1991-08-20 1994-05-03 Sony Corporation Cell adhesive material and method for producing same
US5324591A (en) * 1987-03-06 1994-06-28 Geo-Centers, Inc. Deep ultraviolet photolithographically defined ultra-thin films for selective cell adhesion and outgrowth and method of manufacturing the same and devices containing the same
WO1995019796A1 (fr) * 1994-01-21 1995-07-27 Brown University Research Foundation Implants biocompatibles

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB990126A (en) * 1961-10-23 1965-04-28 Haeger Potteries Inc Prosthetic parts and method of making same
US4795475A (en) * 1985-08-09 1989-01-03 Walker Michael M Prosthesis utilizing salt-forming oxyacids for bone fixation
WO1987005038A1 (fr) * 1986-02-17 1987-08-27 Commonwealth Scientific And Industrial Research Or Materiaux implantables
US5324591A (en) * 1987-03-06 1994-06-28 Geo-Centers, Inc. Deep ultraviolet photolithographically defined ultra-thin films for selective cell adhesion and outgrowth and method of manufacturing the same and devices containing the same
US4927676A (en) * 1988-07-01 1990-05-22 Becton, Dickinson And Company Method for rapid adherence of endothelial cells onto a surface and surfaces prepared thereby
US5308704A (en) * 1991-08-20 1994-05-03 Sony Corporation Cell adhesive material and method for producing same
WO1995019796A1 (fr) * 1994-01-21 1995-07-27 Brown University Research Foundation Implants biocompatibles

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
RONGZHI L ET AL: "Application of plasma technologies in fibre-reinforced polymer composites: a review of recent developments" COMPOSITES PART A: APPLIED SCIENCE AND MANUFACTURING, Bd. 28, Nr. 1, 1. Januar 1997, Seite 73-86 XP004014648 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001045595A2 (fr) * 1999-12-17 2001-06-28 Cartificial A/S Dispositif prothetique
WO2001045595A3 (fr) * 1999-12-17 2002-03-07 Cartificial As Dispositif prothetique
US7993566B2 (en) 1999-12-17 2011-08-09 Dsm Ip Assets B.V. Method for the production of medical implants
US7229545B2 (en) 2000-06-21 2007-06-12 Biomet Deutschland Gmbh Process for the coating for metallic implant materials
WO2016048155A1 (fr) 2014-09-26 2016-03-31 Dsm Ip Assets B.V. Composition médicale

Also Published As

Publication number Publication date
EP1039939A2 (fr) 2000-10-04
WO1999030672A3 (fr) 1999-09-02
DE19755334A1 (de) 1999-06-24
WO1999030672A8 (fr) 1999-07-29

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