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An actuatable soft reservoir modulates host foreign body response.

E B Dolan1,2,3, C E Varela1,4, K Mendez1,4

  • 1Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA.

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Summary

This study introduces a dynamic soft reservoir (DSR) that reduces fibrous capsule thickness around medical implants by actively modulating the tissue interface. This technology improves implant performance and therapeutic delivery.

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Area of Science:

  • Biomaterials Science
  • Tissue Engineering
  • Medical Device Design

Background:

  • Indwelling medical devices face challenges from foreign body responses, including fibrosis, which impair function.
  • Fibrosis, characterized by fibrous capsule formation, negatively impacts devices like breast implants and biosensors.
  • Current strategies struggle to mitigate the complex biological host responses at the biotic-abiotic interface.

Purpose of the Study:

  • To develop and evaluate a milliscale dynamic soft reservoir (DSR) that actively modulates the biomechanics of the tissue-device interface.
  • To investigate the DSR's effect on reducing fibrous capsule formation and altering cellular activity in peri-implant tissues.
  • To assess the DSR's potential for enhancing therapeutic delivery and pharmacokinetic profiles.

Main Methods:

  • Cyclical actuation of the DSR in a preclinical rodent model.
  • Histological analysis to quantify fibrous capsule thickness, collagen density, and myofibroblast presence.
  • Computational modeling to analyze strain and fluid flow dynamics.
  • In vitro assessment of drug analog transport and pharmacokinetic enhancement.

Main Results:

  • Actuated DSR significantly reduced fibrous capsule thickness compared to controls (P = 0.0005).
  • No significant changes in collagen density or orientation were observed.
  • A significant reduction in myofibroblasts was noted in the actuated group (P = 0.0036).
  • Enhanced transport of a therapy analog and improved pharmacokinetics of an inotropic agent were demonstrated.

Conclusions:

  • Actuation-mediated strain in DSRs effectively reduces myofibroblast differentiation and proliferation, thereby mitigating fibrosis.
  • The DSR technology offers a promising approach to ameliorate host responses to implantable biomaterials.
  • Dynamic reservoirs represent a versatile tool for understanding and managing the foreign body response, potentially improving implantable device performance and therapeutic efficacy.