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Medical prosthetic devices and implants having improved biocompatibility

a technology of biocompatibility and medical prosthetics, applied in the direction of electrolysis coating, electrophoretic coating, electrolytic inorganic material coating, etc., can solve the problems of bioactive biomolecules on metals, considered difficult to bind and stabilize unmodified,

Inactive Publication Date: 2006-07-13
NUMERICAL TECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] The invention, therefore, concerns a medical prosthetic device or implant containing a metal material (A) selected from the group consisting of titanium or an alloy thereof, zirconium or an alloy thereof, tantalum or an alloy thereof, hafnium or an alloy thereof, niobium or an alloy thereof and a chromium-vanadium alloy, wherein surface parts of the metal material (A) are coated with a layer of a corresponding hydride material (B) selected from titanium hydride, zirconium hydride, tantalum hydride, hafnium hydride, niobium hydride and chrom

Problems solved by technology

Prior to this observation, it was considered very difficult to bind and stabilize unmodified, bioactive biomolecules on metals, especially for use as bioactive surfaces on metals for use as implants in the vertebrate body in vivo.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0055] Preparation of a titanium hydride implant surface layer containing an extracellular matrix protein.

[0056] A two-chamber electrolysis cell was used to prepare a layer of titanium hydride containing the extracellular matrix molecule amelogenin onto five coin-shaped electropolished titanium implants each with a surface area of 0.6 cm2 exposed to the electrolyte. Five similar items were used as controls by being present in the electrolyte chamber, but not connected to the electrolysis current. The electrolyte in both chambers was 1 M NaCl in sterile water, pH adjusted to pH 4 by the use of HCl, and the initial concentration of amelogenin was 0.1 mg / ml. For electrolysis a voltage of 10 volts at a charge density of 1 mA / cm2 was used. The temperature of the cathode chamber was set to 70° C. Electrolysis was allowed to progress for 18 hours, after which the titanium implants were removed from the electrolysis cell, washed in sterile water and allowed to air-dry in a desiccator.

[005...

example 2

[0059] Production of an amelogenin-containing titanium hydride implant surface layer.

[0060] The set-up from example one was used to produce a layer of titanium hydride containing the extracellular matrix molecule amelogenin onto electropolished titanium implants with a surface area of 0.35 cm2 exposed to the electrolyte. The electrolyte in both chambers was 1 M NaCl in sterile water, pH adjusted to pH 4 by the use of HCl, and the initial concentration of amelogenin was 0.1 mg / ml. For electrolysis a voltage of 10 volts at a charge density of 1 mA / cm2 was used. Tcat was set to 70° C. Electrolysis was allowed to progress for 18 hours after which the titanium implants were removed from the electrolysis cell, washed in sterile water and allowed to air-dry in a desiccator.

[0061] After drying, the titanium specimens were washed three times in 1 ml saline at pH 6.5. Following the washes the proteins remaining on the titanium surfaces were dissolved by boiling the titanium specimen in 0.1 ...

example 3

[0063] Production of a nucleic acid-containing titanium hydride implant surface layer.

[0064] The set-up from example one was used to produce a layer of titanium hydride containing nucleic acids in the form of radio labeled total human placenta DNA onto electropolished titanium implants with a total surface area of 0.35 cm2 exposed to the electrolyte. The electrolyte in both chambers was 1 M NaCl in sterile water. The pH was adjusted to pH 2 by the use of HCL. The initial concentration of DNA in the electrolyte was 10 μg / ml. For electrolysis a voltage of 10 volts at a charge density of 1 mA / cm2 and a Tcat of 75° C. were used. Electrolysis was allowed to progress for 16 or 24 hours after which the titanium specimens were removed from the electrolysis cell, rinsed three times in ample amounts of Tris-EDTA buffer (TE-buffer; 10 mM Tris-Cl and 1 mM EDTA in sterile water, pH 7.6) and then allowed to air dry over night in a desiccator.

[0065] The DNA was radiolabeled using a Stratagene Pr...

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Abstract

A medical prosthetic device or medical implant containing a metal material (A) selected from the group consisting of titanium or an alloy thereof, zirconium or an alloy thereof, tantalum or an alloy thereof, hafnium or an alloy thereof, niobium or an alloy thereof and a chromium-vanadium alloy, wherein surface parts of the metal material (A) are coated with a layer of a corresponding hydride material (B) selected from titanium hydride, zirconium hydride, tantalum hydride, hafnium hydride, niobium hydride and chromium and / or vanadium hydride, respectively, said device or implant being characterised in that the layer of hydride material (B) comprises one or more biomolecule substances (C) associated therewith. The device or implant exhibits improved biocompatibility. The metal material (A) is preferably titanium. The biomolecule substance (C) may be selected from the following types of substances: Natural or recombinant bio-adhesives; natural or recombinant cell attachment factors; natural, recombinant or synthetic biopolymers; natural or recombinant blood proteins; natural or recombinant enzymes; natural or recombinant extracellular matrix proteins; natural or synthetic extracellular matrix biomolecules; natural or recombinant growth factors and hormones; natural, recombinant or synthetic peptide hormones; natural, recombinant or synthetic deoxyribonucleic acids; natural, recombinant or synthetic ribonucleic acids; natural or recombinant receptors; enzyme inhibitors; drugs; biologically active anions and cations; vitamins; adenosine monophosphate (AMP), adenosine diphosphate (ADP) or adenosine triphosphate (A TP); marker biomolecules; amino acids; fatty acids; nucleotides (RNA and DNA bases); and sugars.

Description

RELATED APPLICATIONS [0001] This application is a 37 C.F.R. § 1.53(b) continuation of U.S. application Ser. No. 10 / 010,140 filed Dec. 6, 2001, which claims priority on U.S. Provisional Application 60 / 254,987 filed on Dec. 12, 2000, and Denmark Patent Application No. PA 2000 01829 filed on Dec. 6, 2000. The entire contents of each of these applications is incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention concerns medical prosthetic devices and implants having improved biocompatibility. BACKGROUND OF THE INVENTION [0003] It has been proposed to improve the biocompatibility of e.g., a titanium prosthesis by coating metal surfaces thereof with a layer of titanium hydride. Such a hydride layer may be applied by plasma bombardment, or in may be applied by electrolysis; see, for example. U.S. patent application Ser. No. 09 / 868,965 which is hereby incorporated by reference. [0004] It has also been proposed to improve the biocompatibility of prostheses or i...

Claims

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Application Information

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IPC IPC(8): A61F2/28A61F2/02A61F2/00A61F2/30A61L27/04A61L27/06A61L27/30A61L27/54A61L31/08A61L31/16
CPCA61F2/30767A61F2310/00023A61F2310/00059A61F2310/00089A61F2310/00095A61F2310/00125A61F2310/00131A61F2310/0079A61F2310/00808A61F2310/00814A61F2310/0082A61F2310/00826A61F2310/00832A61F2310/00838A61F2310/00844A61F2310/0097A61F2310/00976A61L27/047A61L27/06A61L27/306A61L27/54A61L31/088A61L31/16A61L2300/606C25D9/08C25D13/04
Inventor ELLINGSEN, JAN EIRIKLYNGSTADAAS, STAALE PETTER
Owner NUMERICAL TECH INC
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