Medical prosthetic devices having improved biocompatibility

Abstract

The invention relates to a medical prosthetic device having a metal material, such as titanium or an alloy thereof, where the surface parts of the metal material are coated with a layer of a corresponding hydroxide material, such as titanium hydroxide. Preferably, the hydroxide layer includes one or more biomolecule substances associated therewith. The invention also relates to an electrolytic process for the preparation of a medical prosthetic device.

1 . A medical prosthetic device comprising a metal material having a surface, wherein the metal material is selected from the group consisting of titanium, titanium alloy, zirconium, zirconium alloy, tantalum, tantalum alloy, hafnium, hafnium alloy, niobium, niobium alloy and a chromium-vanadium alloy,
 wherein surface parts of the metal material comprises a layer of a corresponding hydroxide material selected from the group consisting of titanium hydroxide, zirconium hydroxide, tantalum hydroxide, hafnium hydroxide, niobium hydroxide, chromium hydroxide, vanadium hydroxide and chromium-vanadium hydroxide,   wherein said surface layer of hydroxide material comprises predominantly hydroxide in comparison to corresponding oxides, and   wherein the hydroxide layer controllably releases one or more biomolecule substances associated therewith.   
     
     
         2 . The device according to  claim 1 , wherein the metal material is titanium or titanium alloy. 
     
     
         3 . The device as claimed in  claim 1 , wherein the layer of hydroxide material has a thickness within the range of 1 nm to 50 μm. 
     
     
         4 . The device as claimed in  claim 3 , wherein the layer of hydroxide material has a thickness equal to or above 0.5 μm. 
     
     
         5 . The device as claimed in  claim 3 , wherein the layer of hydroxide material has a thickness within the range of 1 to 20 μm. 
     
     
         6 . The device according to  claim 1 , wherein said surface parts of the metal material comprising the layer of the hydroxide material is adapted to be in contact with bone or other tissue when the device is deployed in the body of a mammal. 
     
     
         7 . The device according to  claim 1 , wherein the device is selected from the group consisting of a prosthetic femoral hip joint, a prosthetic femoral head, a prosthetic acetabular cup, a prosthetic elbow, a prosthetic knee, a prosthetic shoulder, a prosthetic wrist, a prosthetic ankle, a prosthetic hand, a prosthetic finger, a prosthetic toe, a prosthetic vertebra, a prosthetic spinal disc, a prosthetic cochlea, a prosthetic heart valve, and a prosthetic vessel. 
     
     
         8 . The device according to  claim 1 , wherein the device is selected from the group consisting of an artificial joint, a dental implant, an ossiculoplastic implant, a middle ear implant, a cochlear implant, an orthopaedic fixation device, a pacemaker, a catheter, a space filling implant, an implant for retention of a hearing aid, an implants for external fixation, an intrauterine device (IUD), and a bioelectronic device. 
     
     
         9 . The device according to  claim 7 , wherein said prosthetic elbow implant is adapted to replace a stem, a wedge or an articular insert. 
     
     
         10 . The device according to  claim 7 , wherein said prosthetic knee implant is adapted to-replace a femoral component, a tibial component, a stem, a wedge, an articular insert or a patellar component. 
     
     
         11 . The device according to  claim 7 , wherein said prosthetic shoulder implant is adapted to replace a stem or a head. 
     
     
         12 . The device according to  claim 8 , wherein said prosthetic middle-ear implant is adapted to replace an incus, a malleus, a stapes, an incus-stapes, a malleus-incus, or a malleus-incus stape. 
     
     
         13 . The device according to  claim 8 , wherein said orthopaedic fixation device is a nail, a screw, a staple or a plate. 
     
     
         14 . The device according to  claim 8 , wherein said bioelectronic device is an intracochlear or intracranial electronic device. 
     
     
         15 . A device according to  claim 1 , wherein said device is sterile. 
     
     
         16 . A method for preparing a medical prosthetic device as defined in  claim 1 , said method comprising subjecting surface parts of the metal material to an electrolysis treatment at a pH above 7.0 to form the layer of hydroxide material, optionally followed by a sterilization treatment. 
     
     
         17 . The method according to  claim 16 , said electrolysis treatment is carried out at a pH above 7.0 in the presence of one or more biomolecule substances. 
     
     
         18 . The method according to  claim 17 , wherein the one or more biomolecule substances is selected from the group of substances consisting of natural bioadhesives, recombinant bioadhesives, natural cell attachment factors, recombinant cell attachment factors, natural biopolymers, recombinant biopolymers, synthetic biopolymers, natural blood proteins, recombinant blood proteins, natural enzymes, recombinant enzymes, natural extracellular matrix proteins, recombinant extracellular matrix proteins, natural extracellular matrix biomolecules, synthetic extracellular matrix biomolecules, natural growth factors, recombinant growth factors, natural hormones, recombinant hormones, natural peptide hormones, recombinant peptide hormones, synthetic peptide hormones, natural deoxyribonucleic acids, recombinant deoxyribonucleic acids, synthetic deoxyribonucleic acids, natural ribonucleic acids, recombinant ribonucleic acids, synthetic ribonucleic acids, natural receptors, recombinant receptors, enzyme inhibitors, drugs, biologically active anions, biologically active cations, vitamins, adenosine monophosphate (AMP), adenosine diphosphate (ADP), adenosine triphosphate (ATP), marker biomolecules, amino acids, fatty acids, nucleotides (RNA and DNA bases), and sugars. 
     
     
         19 . The method according to  claim 17 , where the one or more biomolecule substances is interlocked, bound trapped and/or integrated on or with the hydroxide material. 
     
     
         20 . The method according to  claim 18 , where the one or more biomolecule substance is interlocked, bound trapped and/or integrated on or with the hydroxide material. 
     
     
         21 . The method according to  claim 17 , wherein the layer of hydroxide material comprises one or more biomolecule substances in an amount of from 1 picogram per mm 2  to 1 mg per mm 2 . 
     
     
         22 . The method according to  claim 18 , wherein the layer of hydroxide material comprises one or more biomolecule substances in an amount of from 1 picogram per mm 2  to 1 mg per mm 2 . 
     
     
         23 . The method according to  claim 19 , wherein the layer of hydroxide material comprises one or more biomolecule substances in an amount of from 1 picogram per mm 2  to 1 mg per mm 2 .