11.3 Senior Design Plan

Introduction

Every year, an estimated 15 million Americans have some kind of surgery. Despite surgeons being professionally trained and following strict procedures, there is always a chance for some type of complication to occur during surgery. A study in 2022 found that postoperative complications were observed in 31.50%; minor complications in 19.75% and major complications in 8.0% of patients. While risk factors can vary, a prominent one that's done after every surgery is applying sutures to an open wound. Fortunately, as technology improves, it continues to be integrated in many areas that were once never thought to happen. Our team believes applying sutures is a procedure that can be heavily assisted by a robotic surgical system.

Project Overview

The senior design project aims to develop an innovative robotic surgical system capable of performing precise and efficient suturing in tight spaces. This system will leverage hybrid technology, combining manual dexterity with robotic precision to address the challenges faced by surgeons in intricate surgeries.

Problem Statement

Surgeons encounter difficulties suturing in confined areas, leading to longer surgery times and potential complications. Our goal is to design a compact, automated suturing system that enhances surgical precision and efficiency.

Objectives

1. Develop a robotic system that can suture with high precision in small and hard-to-reach spaces.

2. Minimize the time required for suturing procedures while maintaining or improving accuracy.

3. Ensure the system is user-friendly and integrates seamlessly into existing surgical workflows.

4. Meet medical regulations and safety standards for surgical equipment.

Design Concept

Our approach involves designing a hybrid robotic system that enhances the capabilities of surgeons rather than replacing them entirely. This system will feature:

• Manual Interface: Surgeons will control the robotic arm's movements and suturing process.

• Robotic Precision: The system will provide enhanced accuracy and stability, crucial for delicate suturing tasks.

• Compact Design: Emphasis will be placed on minimizing the size of the system to facilitate maneuverability in tight spaces.

• Integration with Vision Technology: Utilizing a vision system for real-time imaging to aid in precise placement of sutures.

Development Phases

1. Research and Analysis:

   • Study existing suturing techniques and technologies.

   • Analyze constraints including medical regulations and technological limitations.

2. Conceptualization:

   • Develop design concepts based on identified needs and constraints.

   • Conduct feasibility studies and initial prototyping.

3. Detailed Design:

   • Refine the selected design concept through iterative development.

   • Integrate user feedback and expert input to optimize the system.

4. Prototype Development:

   • Construct a functional prototype of the robotic suturing system.

   • Conduct rigorous testing in simulated surgical environments.

5. Validation and Optimization:

   • Validate system performance through trials with medical professionals.

   • Optimize the design based on feedback and performance metrics.

6. Documentation and Presentation:

   • Prepare comprehensive documentation detailing the design process, specifications, and test results.

   • Create a formal presentation outlining the project's objectives, methodology, and outcomes.

Risk Mitigation and Safety Measures

• Surgeon Training: Implement a comprehensive training program to ensure safe and effective use of the robotic system.

• Safety Protocols: Integrate safety features to mitigate risks associated with robotic surgery.

• Regulatory Compliance: Adhere to medical regulations and standards to ensure patient safety and device efficacy.

Deliverables

1. Functional robotic suturing system prototype.

2. Detailed design documentation, including CAD models and technical specifications.

3. Test reports and performance evaluation data.

4. Final presentation summarizing project goals, achievements, and future recommendations.

Conclusion

The proposed robotic suturing system aims to revolutionize surgical procedures by addressing the challenges of suturing in confined spaces. Through innovative design and technological integration, this project will contribute to advancing the field of robotic surgery and improving patient outcomes.