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Microfluidic-Generated Injectable Bulking Agents with Biocompatible Surfaces and Their Mid-term Outcomes in a Rat

Joonbum Lee1, Jung-Woo Choi2, Sang-A Lee3

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Newly formulated bulking agents with uniform particle size show promising midterm stability for fecal incontinence treatment. Microfluidic fabrication ensures better injectability and minimal immune response, advancing minimally invasive therapies.

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Area of Science:

  • Biomaterials Science
  • Gastroenterology
  • Minimally Invasive Surgery

Background:

  • Bulking agents are emerging minimally invasive treatments for fecal incontinence.
  • Existing agents face challenges like nonuniform particle size, impacting injectability and in vivo performance.
  • Biocompatibility and long-term stability are key research areas for these agents.

Purpose of the Study:

  • To evaluate the midterm stability of newly developed bulking agents featuring uniformly sized particles.
  • To assess the performance of microfluidically fabricated particles in preclinical settings.

Main Methods:

  • Fabrication of uniform-sized particles using microfluidics, achieving <5% coefficient of variation in size dispersity.
  • In vivo testing including histological staining and microscopic observation up to 6 months.
  • Assessment of particle injectability and immune response.

Main Results:

  • Microfluidic fabrication yielded uniformly sized particles exceeding the 80 μm in vivo migratory limit.
  • Reduced maximum injection pressure was observed compared to conventional agents.
  • Histological analysis confirmed proper in vivo filler positioning and a negligible immune response over 6 months.

Conclusions:

  • The newly formulated bulking agents demonstrate successful midterm stability.
  • Uniform particle size achieved through microfluidics overcomes limitations of conventional agents.
  • These findings support the potential of uniform-sized bulking agents for improved fecal incontinence treatment.