Abstract

Medical devices, such as silicone-based prostheses designed for soft tissue implantation, often induce a suboptimal foreign-body response which results in a hardened avascular fibrotic capsule around the device, often leading to patient discomfort or implant failure. Here, it is proposed that additive manufacturing techniques can be used to deposit durable coatings with multiscale porosity on soft tissue implant surfaces to promote optimal tissue integration. Specifically, the "liquid rope coil effect", is exploited via direct ink writing, to create a controlled macro open-pore architecture, including over highly curved surfaces, while adapting atomizing spray deposition of a silicone ink to create a microporous texture. The potential to tailor the degree of tissue integration and vascularization using these fabrication techniques is demonstrated through subdermal and submuscular implantation studies in rodent and porcine models respectively, illustrating the implant coating's potential applications in both traditional soft tissue prosthetics and active drug-eluting devices.

Highlights

  • Medical implants typically evoke a Foreign Body Response (FBR), which can be exacerbated around implants with a smooth surface.[1,2] FBR modulation is crucial for implanted devices requiring tissue integration and vascularization – for example, in cosmetic reconstruction,[3] drug-delivery,[4] biosensors,[5] and cellular-encapsulation.[6]

  • Building upon pre-existing principles,[24,25] we show that a substrate can be coated by first ascertaining the surface topology using laser measurements, and calculating a toolpath over that surface – resulting in an evenly distributed coating

  • To generate a micro-porous coating, we describe a formulation for a sprayable silicone ink, whereby a silicone elastomer is emulsified with a saturated saline solution using suitable surfactants

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Summary

Introduction

Medical implants typically evoke a Foreign Body Response (FBR), which can be exacerbated around implants with a smooth surface.[1,2] FBR modulation is crucial for implanted devices requiring tissue integration and vascularization – for example, in cosmetic reconstruction,[3] drug-delivery,[4] biosensors,[5] and cellular-encapsulation.[6].

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