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Method for improving the wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopaedic joint prostheses

Inactive Publication Date: 2019-10-10
SINTX TECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent is about improving the wear performance of a material called silicon oxynitride. This material is made by oxidizing silicon nitride. The technical effect of this patent is the creation of a better performing silicon oxynitride material.

Problems solved by technology

While the longevity of these prostheses are reasonable (i.e., 10-15 years), their failure is generally associated with excessive polyethylene wear, ceramic wear, or component damage which results in aseptic loosening, osteolysis, and / or osteomyelitis.
Revision surgery (an unwanted and expensive secondary procedure for both the surgeon and hospital) is then required to replace the worn components, often resulting in poorer ambulatory function with added comorbidities for the patient.

Method used

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  • Method for improving the wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopaedic joint prostheses
  • Method for improving the wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopaedic joint prostheses
  • Method for improving the wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopaedic joint prostheses

Examples

Experimental program
Comparison scheme
Effect test

example 1

on of Biocompatible Silicon Nitride Ceramic Components

[0073]α-Si3N4 (90 wt. %), yttrium oxide (Y2O3, 6 wt. %), and aluminum oxide (Al2O3, 4 wt. %) raw powders were admixed in water, milled, and spray dried. The spray dried powders were then consolidated using uniaxial or isostatic compacting equipment (up to 310 MPa) to form appropriate shapes, i.e., femoral heads and mechanical test-bars. These components were subsequently machined to pre-fired dimensions using conventional computer-numerically-controlled (CNC) turning or milling machinery. They were then subjected to a series of heat-treatment operations including bisque firing, sintering, and hot-isostatic pressing at temperatures up to 1700° C. The firing steps eliminated carbonaceous compounds and water, reacted the constituent raw materials, and densified the ceramic to near-final size. Diamond grinding and polishing were then performed to achieve final size and surface finish for the components.

example 2

of Biocompatible Silicon Nitride Ceramic Components

[0074]The final components from Example 1 were subjected to hydrothermal oxidation using a steam autoclave at a pressure of 2 atm and a temperature of 121° C. for 24, 48, or 72 hours.

[0075]To determine the extent of the oxidation reaction, x-ray photoelectron spectroscopy was conducted on the oxidized components following 0 (FIG. 2A and FIG. 2E), 24 (FIG. 2B and FIG. 2F), 48 (FIG. 2C and FIG. 2G), and 72 (FIG. 2D and FIG. 2H) hours of exposure to the hydrothermal oxidation process. Further, the x-ray photoelectron spectroscopy analyzed the deconvolution of the O1s and Si2P bands. The results of the deconvolution of the O1s band (FIG. 2E, FIG. 2F, FIG. 2G, and FIG. 2H) demonstrated a reduction of near-surface N—Si—O—Si bonds in favor of O—Si—O—Si bonds. The results of the deconvolution of the Si2P band (FIG. 2E, FIG. 2F, FIG. 2G, and FIG. 2H) demonstrated a reduction of surface N—Si—N bonds in favor of N—Si—O and O—Si—O bonds. Both t...

example 3

ing

[0077]Femoral heads prepared as described in Examples 1 and 2 and femoral heads prepared with BIOLOX delta (zirconia-toughened alumina) were subjected to wear testing using a hip joint simulator. Specifically, the acetabular cups were subjected to hydrothermal oxidation treatment for 72 hours at 121° C. Briefly, the acetabular cups were weighted and pre-soaked in a bath comprising bovine serum to achieve a steady level of fluid sorption (as recommended in ISO 14242 / 2). After 50 hours of soaking, all acetabular cups were cleaned and re-weighted. This procedure was repeated until the incremental change of the acetabular cups over 24 hours was less than 10% of the previous cumulative mass change (as part ISO 14242—Part 2).

[0078]The acetabular cups were coupled to femoral heads and tested on a 12-station hip joint simulator using a lubricant (25% sterile calf serum (Sigma Aldrich, St. Louis, Mo.) balanced with deionized water, 0.2% sodium azide, and 20 mmol / dm3 ethylenediaminetetraac...

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Abstract

Methods for improving the wear performance of silicon nitride and / or other ceramic materials, particularly to make them more suitable for use in manufacturing biomedical implants.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims priority to U.S. Provisional Application No. 62 / 655,457, filed Apr. 10, 2018, the contents of which are entirely incorporated by reference herein.FIELD[0002]The present disclosure generally relates to methods for producing silicon oxynitride materials that have improved polyethylene wear performance.BACKGROUND[0003]Orthopaedic reconstructive surgeries, including total hip (THA), total knee (TKA), or total shoulder (TSA) arthroplasty, are proven procedures for treatment of various end-stage degenerative osteoarthropathy conditions. These therapies involve the replacement of native biological articulation tissues with abiotic biomaterials. Typical THA prosthetic devices include mobile metallic or ceramic heads articulating against stationary polyethylene counterfaces (MoP or CoP, respectively). Other variations include ceramic-on-ceramic (CoC) devices. While the longevity of these prostheses are reasonable (i.e., 10-1...

Claims

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Application Information

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IPC IPC(8): A61F2/30A61L27/10A61F2/34
CPCA61L31/026A61L27/10A61F2310/00317A61F2/3094A61F2/34A61L2420/02A61F2/30767A61L2400/10A61L2430/24A61F2/36A61L27/306A61F2/3609C04B35/597C04B35/62625C04B35/6261C04B35/62655C04B35/584C04B2235/663C04B2235/96C04B2235/80C04B2235/6588C04B2111/00836C04B41/86C04B41/009C04B41/4556C04B2235/3878C04B2235/3225C04B2235/3217C04B2235/94C04B35/6455C04B41/0072C04B41/4519C04B41/4521C04B41/5022A61F2002/30026
Inventor MCENTIRE, BRYAN J.BOCK, RYAN M.
Owner SINTX TECH INC
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