Efficient and Effective Implantation of Multiple Intrafascicular Electrodes

Authors

Anil K. Thota, Florida International UniversityFollow

Document Type

Dissertation

Degree

Doctor of Philosophy (PhD)

Major/Program

Biomedical Engineering

First Advisor's Name

Ranu Jung

First Advisor's Committee Title

Committee Chair

Second Advisor's Name

James Abbas

Second Advisor's Committee Title

Committee Member

Third Advisor's Name

Lidia Kos

Third Advisor's Committee Title

Committee Member

Fourth Advisor's Name

Zachary Danziger

Fourth Advisor's Committee Title

Committee Member

Fifth Advisor's Name

Laura McPherson

Fifth Advisor's Committee Title

Committee Member

Sixth Advisor's Name

Markondeyaraj Pulugurtha

Sixth Advisor's Committee Title

Committee Member

Keywords

Medical Device Development Pathway, Medical Device Design Controls, Waterfall Process, Agile Process, Hybrid Waterfall-Agile, Peripheral Neural Interfaces, Medical Device Verification and Validation, Intraneural Electrodes, Longitudinal Intrafascicular Electrodes

Date of Defense

6-19-2023

Abstract

Bioelectronic medicine promises to improve and restore health without the debilitating side effects of the drugs by selectively stimulating specific nerve fibers to trigger the body's internal physiological responses for fighting diseases. Of the available peripheral neural interfaces, those with longitudinal intrafascicular electrodes (LIFEs) offer the ability to interface with a distinct group of nerve fibers within a fascicle that, when stimulated, elicit a distinct physiological response. Implanting highly flexible LIFEs in the compliant nerve presents challenges, such as the buckling of the nerve during the implantation of LIFEs. The difficulty and implantation time for implanting multiple LIFEs varies with the surgeon's skills and experience.

A system consisting of a longitudinal intrafascicular electrode implantation facilitator (LIFT), a fascicular mapper (MAP), and step-by-step instructions for the use of the LIFT and the MAP to implant LIFEs has been developed and validated to address the above challenge. The LIFT was designed to facilitate the implantation of LIFEs by stabilizing, securing, and reshaping the nerve. The design was developed iteratively using the Agile process, and prototypes were fabricated using a 3D printer. The MAP consists of three equally spaced microwires to map the functional outcomes of nerve fascicles. The surgeon uses the pre-mapped functional outcomes as a guide for an implantation approach to target specific LIFEs to enhance specificity.

In-vivo testing of the LIFT and the MAP was conducted in acute non-survival anesthetized rat sciatic nerve preparations. The results show that the LIFT could assist surgeons in implanting multiple LIFEs efficiently by significantly reducing implantation time. The impedance values and nerve excitability properties (rheobase and chronaxie) of LIFEs were not significantly affected when implanted with use of the LIFT. Further, the LIFEs implanted were functional. The overall mapping accuracy from all the LIFEs implanted was 94%. The LIFT and the MAP provide novel tools for implanting LIFEs, efficiently and effectively reducing implantation time and complexity and increasing selectivity and specificity. Their use and applicable surgical approach may lead to increased adoptability of LIFE electrodes as a neural interface in advanced bioelectronic medicine and implementation of neuromodulation therapies.

Identifier

FIDC011153

ORCID

http://orcid.org/0000-0003-0605-2269

Recommended Citation

Thota, Anil K., "Efficient and Effective Implantation of Multiple Intrafascicular Electrodes" (2023). FIU Electronic Theses and Dissertations. 5422.
https://digitalcommons.fiu.edu/etd/5422