Ideation Process Project Initiation Project name: Design of an Infrared Nerve Stimulator Project timeline: October 2010 - May 2011 Project team: Melanie Gault, Greg Wigger, Chris Tedder Primary Objectives 1. Develop three infrared nerve stimulator prototypes containing optical fibers running parallel to the nerve for eventual implantation in a nerve cuff stimulator 2. Compare the efficacy and infrared light output of each of the three designs Importance of the Situation Design of the side-firing prototypes will provide the means for an implantable nerve stimulator. This implantable device will have the capabilities to be included in the next generation of prosthetic devices and for treatment of those suffering from paralysis. Innovation Situation Questionnaire Brief description of the situation Researchers have determined that infrared light can stimulate nerve fascicles with greater precision, specificity, and less damage than electrical nerve stimulation. For future use and implantation of infrared nerve stimulators, a design must be created that can direct an infrared beam at a 90° angle, or “side-fire” the signal. Using mirrors and/or optical properties of an optical fiber, the side-firing of the beam is possible. Detailed description of the situation In order for a nerve stimulator to be feasible for implantation, it must lay in parallel with the nerve fascicle of the patient. To lie in parallel and still stimulate the nerve, the infrared light must be directed at a 90° angle. By polishing an optical fiber at a 45° angle, the infrared light experiences total internal reflection so that it goes in the 90° direction. The other two strategies involve using a flat mirror or a concave mirror laid at a 45° angle so that the infrared light is reflected in a 90° direction. Supersystem - System - Subsystems System name Infrared Nerve Stimulator System structure The infrared nerve stimulator must always contain an optical fiber that transmits the infrared light from the laser source. Ideally, this optical fiber has maximum flexibility and minimum size. All nerve stimulators must also include a casing, made of glass, nylon, or some other transparent material, to protect the air-fiber interface of the polished fiber or to contain the mirrors for the mirrored stimulators. The mirrored stimulators must contain either a concave or flat first-surface mirror with a minimum size. Supersystems and environment The infrared nerve stimulator must be attached to an infrared light source. This light source must emit an infrared laser with a high energy output and will therefore be connected to an external power source. In order for the nerve stimulator to be as precise and efficient as possible, the stimulator must lie, in parallel, on top of the nerve fascicle and aligned with pre-determined, particular axons. This conditions requires that the patient be alive, healthy, and with a viable nerve system. Systems with similar problems No other system experiences a similar problem since electric stimulation does not rely on “sidefiring” methods. Electric stimulation simply attaches to the nerve fascicle for direct delivery of stimulation while infrared light must be delivered in less direct fashion. However in optical research, mirrors have been precisely fabricated and are used throughout to reflect light in any desired direction. Using this previous mirror usage, along with the known optical properties of an optical fiber, the three side-firing methods can utilize the solutions. Input - Process - Output Functioning of the system Infrared light will be passed through the different side-firing prototypes and the various properties of infrared beam directed in the 90° angle will be measured. System inputs The input of our system is the infrared light and its energy. System outputs The output of our system is an infrared beam that has been directed in a 90°angle or “side-fired.” The output of this beam includes its beam size, radiant exposure, and energy loss in each stage of the infrared light’s movement. Cause - Problem - Effect Problem to be resolved Infrared light must be directed at a 90° angle while maintaining a minimum beam size, a high energy throughput, and a sufficient radiant exposure for nerve stimulation. Mechanism causing the problem The human body anatomy requires that the infrared nerve stimulator lie in parallel with nerve fascicles in order for a patient to maintain functionality and a high quality of life. Undesirable consequences if the problem is not resolved Patient using an infrared nerve stimulator without side-firing abilities will lose original mobility and functionality of affected body areas. Other problems to be solved Reflection and transmission of the infrared light changes the beam’s characteristics and its energy output. Past - Present - Future History of the problem Electric stimulation of nerve fascicles have existed for over 150 years. Infrared stimulation of nerve fascicles has existed for less than 50 years however. Until now, infrared stimulation has only occurred by directing infrared light on the nerve fascicle in a perpendicular manner. With the future of implantation ensuing, side-firing techniques must be developed. Pre-process time Research into previous methods of nerve stimulation. Determining top prototype candidates through proof-of-concept modeling. Post-process time Research into afferent stimulation and a portable, infrared laser source are future directions. Resources, constraints and limitations Available resources The substance resources that we have are optical fibers from Ocean Optics, transparent nylon tubing, glass tubing, and first-surface flat and concave mirrors from Edmund Optics. Our primary resources for space are Vanderbilt Optics lab facilities. We have two semesters to complete the project which is our time resource. Dr. Duco Jansen, Dr. Kurt Schoener, and Dr. Paul King are our information resources. Allowable changes to the system Small changes are allowed regarding the tubing/encasement of the side-firing prototypes. The fiber optic system must be encased in a material that is biocompatible and transparent to infrared light with maximum throughput. Constraints and limitations The system is constrained to emit an infrared beam with a minimum radiant exposure of 0.4 J/cm^2 to result in nerve stimulation. The air-fiber interface must remain on the 45° polished fiber prototype so that is optical properties retain its ability for side-firing. Criteria for selecting solution concepts Primary characteristics include radiant exposure and energy throughput. The ideal model will have the highest values in both of these categories. Other considerations include durability, cost, and design complexity. Problem Formulation and Brainstorming Infrared Nerve Stimulator Infrared Nerve Stimulator produces Side-Firing Capabilities, Spatially selective 1. stimulation and Need for nerve cuff produces Narrow energy window for effective stimulation. Side-Firing Capabilities produces Ability to lie fiber in parallel with nerve and Ability to fire infrared beam at 90 degree angle produces Difficulty in producing desired 2. beam profile, Energy lost in reflection and Polished fiber requires air-fiber interface is produced by Infrared Nerve Stimulator. Ability to lie fiber in parallel with nerve produces Ideal for implantation produces 3. More contact with nerve that could induce damage to nerve is produced by SideFiring Capabilities. 4. Ideal for implantation is produced by Ability to lie fiber in parallel with nerve and Ability to fire infrared beam at 90 degree angle. 5. Difficulty in producing desired beam profile produces Energy lost in reflection is produced by Side-Firing Capabilities. 6. Energy lost in reflection is produced by Side-Firing Capabilities and Difficulty in producing desired beam profile. 7. Spatially selective stimulation produces Ability to stimulate individual fascicle is produced by Infrared Nerve Stimulator and Need for nerve cuff. 8. More contact with nerve that could induce damage to nerve is produced by Ability to lie fiber in parallel with nerve. 9. Ability to stimulate individual fascicle is produced by Spatially selective stimulation. 10. Polished fiber requires air-fiber interface produces Need for material is produced by Side-Firing Capabilities. 11. Need for material produces Larger risk for immune response is produced by Polished fiber requires air-fiber interface. 12. Larger risk for immune response is produced by Need for material. Narrow energy window for effective stimulation produces Below stimulation 13. threshold results in no effect and Above safety range can cause tissue ablation is produced by Infrared Nerve Stimulator. 14. Below stimulation threshold results in no effect is produced by Narrow energy window for effective stimulation. 15. Above safety range can cause tissue ablation is produced by Narrow energy window for effective stimulation. 16. Ability to fire infrared beam at 90 degree angle produces Ideal for implantation is produced by Side-Firing Capabilities. Need for nerve cuff produces Spatially selective stimulation, Stimulate multiple 17. fascicles at once and Need for biocompatibility produces Must anchor cuff to nerve is produced by Infrared Nerve Stimulator. 18. Stimulate multiple fascicles at once is produced by Need for nerve cuff. 19. Must anchor cuff to nerve produces Potential damage to nerve is produced by Need for nerve cuff. 20. Potential damage to nerve is produced by Must anchor cuff to nerve. 21. Need for biocompatibility produces Limits use of materials is produced by Need for nerve cuff. 22. Limits use of materials is produced by Need for biocompatibility.