Medical prosthetic devices having improved biocompatibility

A technology of prosthesis and biomolecules, applied in prosthesis, medical science, bone implants, etc., can solve the problems of increasing immune reactivity, inactivation of biomolecules, etc.

Inactive Publication Date: 2005-08-24
STRAUMANN HLDG AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Such conjugations are often performed using, for example, chemical reactants with two reactive functionalities, such as formalin or glutaraldehyde, bu

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] Example 1: Preparation and properties of titanium hydroxide layer

[0117] After careful cleaning, electropolished grade 2 titanium coins with a surface area of ​​0.35 cm2 were implanted in a liquid consisting of 0.5M NaCl and 1M NaOH for anodization. This operation is carried out at elevated temperature to achieve a suitable rate of reaction of titanium and hydroxide to form titanium hydroxide.

[0118] A temperature of 80°C was chosen as the reaction rate.

[0119] The presence of titanium hydroxide was confirmed by X-ray diffraction analysis. The thickness of the titanium hydroxide layer was determined by metallographic cross-sectional microscopy. The thickness is related to the time used for the treatment, 4 microns after 4 hours of electrolysis, increased to 5 microns after 8 hours, 8 microns after 16 hours, and 12 microns after 24 hours.

Embodiment 2

[0120] Example 2: Testing of titanium implants with enhanced biocompatibility by electrolytic incorporation of hydroxides on the surface

[0121] Eight coin-shaped implants with a diameter of 6.25 mm were attached to titanium electrodes and immersed in a sterile electrolyte containing 0.5 M NaCl, pH adjusted to 8.0 using 1.0 M NaOH. Add the electrodes to the positive outlet of the power supply, and apply a current of 100mA, 10V according to the device of Example 1. The electrolytic process, which produces a thin layer of titanium hydroxide on the implant surface, was carried out continuously at 70°C for eight hours. Eight additional implants co-existing in the electrolyte but not attached to the electrodes were included as controls.

[0122] After electrolysis, the implants were cleaned in sterile water and then placed in sterile glass containers, where they were air-dried.

[0123] Implants (n=8) with a titanium hydroxide surface and controls (n=8) were placed in labeled co...

Embodiment 3

[0127] Example 3: Preparation of titanium hydroxide implant surface layer comprising extracellular matrix protein

[0128] The surface area is 0.35cm 2 An electropolished titanium implant of , on which a titanium hydroxide layer containing the extracellular matrix molecule amelogenin was produced using the apparatus of Example 1, was immersed in electrolyte. The electrolyte in both chambers was 1 M NaCl in sterile aqueous solution, the pH was adjusted to pH 8.5 by using NaOH, and the initial concentration of amelogenin was 0.1 mg / ml. At a charge density of 1mA / cm 2 , Electrolysis was carried out under the condition of a voltage of 10 volts. T an Set to 70°C. Electrolysis was performed for 18 hours, after which the titanium implants were removed from the electrolysis cell, washed in sterile water and air dried in a desiccator.

[0129] The dried titanium sample was washed three times with 1 ml of brine (pH 6.5). After washing, boil the titanium sample in 0.1 ml 2xSDS samp...

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PUM

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Abstract

The invention relates to a medical prosthetic device comprising 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 comprises one or more biomolecule substances associated therewith. The invention also relates to an electrolytic process for the preparation of a medical prosthetic device.

Description

field of invention [0001] The present invention relates to medical prosthetic devices with improved biocompatibility. Background of the invention [0002] It has been proposed to improve the biocompatibility of metal prostheses, such as titanium prostheses, by modifying the metal surface of the metal prosthesis, eg by plasma bombardment, etching or electrolysis. [0003] Anodization has been described to form thick oxide layers (ie, thicker than naturally occurring oxide layers) on implant surfaces. For example, WO 00 / 72777 describes an electrolytic oxidation process in which an implant is immersed in an acidic electrolyte, the implant (anode) is in contact with an electrical source of electrical energy and a counter electrode (cathode) immersed in the same acidic electrolyte connect. It is also now proposed to increase the biocompatibility of prostheses and implants by joining or integrating different active biomolecules on the surface of the prosthesis, for example on th...

Claims

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Application Information

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IPC IPC(8): A61L27/00A61F2/18A61F2/24A61F2/28A61F2/30A61L27/04A61L27/30A61L31/08A61L31/14
CPCA61L27/306A61L31/148A61L31/088A61L27/04A61L27/06A61L27/30
Inventor J·E·埃林森S·P·林斯塔达斯
Owner STRAUMANN HLDG AG
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