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Ossicular replacement prostheses from banked bone with ergonomic and functional geometry.

Mario Milazzo1, Serena Danti1,2, Francesco Inglese1

  • 1The BioRobotics Institute, Scuola Superiore Sant'Anna, 56025, Pontedera (PI), Italy.

Journal of Biomedical Materials Research. Part B, Applied Biomaterials
|September 24, 2016
PubMed
Summary
This summary is machine-generated.

Researchers developed new ossicular replacement prostheses (ORPs) from banked bone, significantly reducing weight and improving acoustic performance. These innovative prostheses offer enhanced biocompatibility and surgical handling for otosurgery.

Keywords:
computer-assisted manufacturing (CAM)cortical bonehomograftmiddle earossiculoplasty

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Area of Science:

  • Biomaterials Engineering
  • Otolaryngology
  • Medical Device Manufacturing

Background:

  • Current ossicular replacement prostheses (ORPs) have limitations in weight, biocompatibility, and surgical handling.
  • Second-generation ORPs require further improvements for optimal middle ear reconstruction.

Purpose of the Study:

  • To fabricate innovative, off-the-shelf ossicular replacement prostheses (ORPs) from banked cortical bone.
  • To combine the biocompatibility of bone with the desirable features of synthetic ORPs, such as lightness and accuracy.
  • To improve surgical manageability and acoustic performance in middle ear prostheses.

Main Methods:

  • Utilized computer numerically controlled (CNC) ultraprecision micromilling for fabrication.
  • Designed prostheses with surface motifs and holed head plates to prevent migration and facilitate surgical positioning.
  • Performed finite element modeling analysis to assess anti-migration properties.
  • Conducted comparative acoustic response measurements against synthetic partial ORPs.

Main Results:

  • Achieved an 81% weight reduction in the new total ORP prototype (13.1 ± 0.1 mg).
  • Demonstrated superior acoustic behavior of bone ORPs compared to synthetic partial ORPs across a wide frequency range (250-8000 Hz).
  • Confirmed that banked compact bone can be manufactured into light, standardized, and high-performance ORPs.

Conclusions:

  • Banked cortical bone is a suitable material for manufacturing advanced ORPs.
  • The new bone ORPs offer an ideal combination of biocompatibility and technological features for otosurgery.
  • These prostheses address unmet needs in otosurgical reconstruction by providing enhanced performance and manageability.