Polymer-Based Biocompatible Packaging for Implantable Devices: Packaging Method, Materials, and Reliability Simulation

Abstract

Polymer materials attract more and more interests for a biocompatible package of novel implantable medical devices. Medical implants need to be packaged in a biocompatible way to minimize FBR (Foreign Body Reaction) of the implant. One of the most advanced implantable devices is neural prosthesis device, which consists of polymeric neural electrode and silicon neural signal processing integrated circuit (IC). The overall neural interface system should be packaged in a biocompatible way to be implanted in a patient. The biocompatible packaging is being mainly achieved in two approaches; (1) polymer encapsulation of conventional package based on die attach, wire bond, solder bump, etc. (2) chip-level integrated interconnect, which integrates Si chip with metal thin film deposition through sacrificial release technique. The polymer encapsulation must cover different materials, creating a multitude of interface, which is of much importance in long-term reliability of the implanted biocompatible package. Another failure mode is bio-fluid penetration through the polymer encapsulation layer. To prevent bio-fluid leakage, a diffusion barrier is frequently added to the polymer packaging layer. Such a diffusion barrier is also used in polymer-based neural electrodes. This review paper presents the summary of biocompatible packaging techniques, packaging materials focusing on encapsulation polymer materials and diffusion barrier, and a FEM-based modeling and simulation to study the biocompatible package reliability.

Research on the Factors Damaging Hydrogen Peroxide Low-Temperature Plasma Sterile Packaging Bags and the Control of Link Quality

“…In addition, packaging redesign and opening technology are also related to the pollution of medical device packaging bags [ 19 , 20 ]. The factors that affect the selection and design of packaging materials for medical devices include specific characteristics of medical devices; expected sterilization methods; expected uses; expiration dates; and transportation and storage conditions [ 21 , 22 ]. The results of this study showed that improper transport was the most damaging factor of Tyvek packaging bags among the four links of device packaging, sterilization, transport, and storage, accounting for 41.31% of the damage factors.…”

“…In addition, packaging redesign and opening technology are also related to the pollution of medical device packaging bags [19,20]. e factors that affect the selection and design of packaging materials for medical devices include specific characteristics of medical devices; expected sterilization methods; expected uses; expiration dates; and transportation and storage conditions [21,22].…”

Development of nano- and microdevices for the next generation of biotechnology, wearables and miniaturized instrumentation

“…12). 122 All these strategies and approaches could be considered as tools for the design of new proofs of concept in the next generation of wearables. In this context, other developments such as lab-on-particles 123 for optical biodetection, lab-on-a-disc assays for protein detection by optomagnetic readouts and optical imaging using nano-and microsized magnetic beads, 124 and microelectromagnetic traps for DNA detection; 125 could lead to new designs of portable and implantable device designs.…”

Heat‐sealing integrity assessment through nondestructive evaluation techniques

“…In addition to the wide traditional applications of the polymers in packaging industry, their application is expanding rapidly in variety of new and advanced technologies such as novel implantable T A B L E 1 Thermoplastic polymers used for heat sealing medical devices. 13 Biocompatible packaging of medical implants reduces the foreign body reaction (FBR) of the implants and thus increases the chance of successful applications. Consequently, longterm reliability of the implanted biocompatible package is of high importance.…”