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Related Experiment Videos

Shape-memory stapes prosthesis for otosclerosis surgery.

Glenn W Knox1, Harlan Reitan

  • 1Northeast Florida Ear Research Institute, University of Florida, 3663 Crown Point Court, Jacksonville, FL 32257, U.S.A.

The Laryngoscope
|August 12, 2005
PubMed
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Nitinol, a shape-memory alloy, simplifies stapes prosthesis surgery. This improved prosthesis offers secure incus contact and eliminates over-crimping, making it advantageous for otosclerosis treatment.

Area of Science:

  • Biomaterials Engineering
  • Otolaryngology
  • Medical Device Development

Background:

  • Stapes prostheses are crucial for hearing restoration in otosclerosis.
  • Current prostheses may require complex surgical manipulation.
  • A need exists for improved stapes prostheses offering enhanced ease of use and secure fit.

Purpose of the Study:

  • To evaluate the efficacy of Nitinol (shape-memory alloy) as a component for an improved stapes prosthesis.
  • To develop and test a novel Nitinol-based stapes prosthesis.

Main Methods:

  • Prospective laboratory and clinical study involving Nitinol wire analysis (diameter, temperature variants).
  • Measurement of 50 incus cadaver bones to determine prosthesis geometry.
  • Evaluation of heat sources (electrocautery, lasers, warm water) for shape memory activation.

Related Experiment Videos

  • Laboratory trials on human temporal bones and preliminary human subject trials.
  • Magnetic resonance imaging (MRI) safety testing at 1.5 Tesla.

    • Main Results:

    • Nitinol's shape-memory activated effectively with low heat, closing the prosthesis loop securely around the incus.
    • Laser settings were well below bone-removal thresholds.
    • MRI at 1.5 Tesla showed no prosthesis movement, indicating safety.
    • Preliminary human trials demonstrated excellent air-bone closure and uniform incus contact.

    Conclusions:

    • The Nitinol piston prosthesis simplifies the stapedectomy procedure by reducing the need for manual surgical instruments.
    • The inherent properties of Nitinol wire prevent over-crimping, ensuring a consistent fit.
    • This Nitinol prosthesis presents significant advantages for otosclerosis surgery.