Design of surgical instrument for facilitating an easy process for anastomosis in vasculature of all sizes Anand Parikh ED10B053 Guide: Dr. Venkatesh Balasubramanian
Microvascular Surgery • Performed by plastic surgeons specialized in microsurgery • Anastomosis of blood vessels of diameter 3mm-5mm • Requires rigorous training & decades of experience 1 2 3 4 5 6 Anand Parikh – ED10B053 June 18, 2015 2 Department of Engineering Design, IIT-Madras
Surgeon Shortage • 1 in 10 plastic surgeons is a microsurgeon • Only 100 microsurgeons in India (1000 plastic surgeons) • Increasing demand, increasing physical & cognitive stress • High deficit of training facilities and institutions in India Anand Parikh – ED10B053 June 18, 2015 3 Department of Engineering Design, IIT-Madras
Operational Difficulty • Micro-anastomosis procedures have near zero margin for error • Requires tremendous skill • 15 years of experience • Consumes 10-15% of O.R. time Anand Parikh – ED10B053 June 18, 2015 4 Department of Engineering Design, IIT-Madras
Existing Solutions 1. Acland clamps and sutures (Gold standard) • Applies to all microvascular anastomosis procedures • Consumes more time • Requires high skill 2. Vascular Coupler • Applies to select microvascular anastomosis procedures • Consumes less time • Requires high skill Anand Parikh – ED10B053 June 18, 2015 5 Department of Engineering Design, IIT-Madras
Treatment gaps • A novel universal device that reduces the difficulty and operating time is needed. Vascular Acland ? Coupler Clamps Less skill required Used for all procedures Low time consumption Anand Parikh – ED10B053 June 18, 2015 6 Department of Engineering Design, IIT-Madras
The invention • A simpler way to perform microvascular anastomosis in order to provide quicker and error-free treatment 1. Enables all plastic surgeons, not only microsurgeons, to perform micro-anastomosis 2. Can be used in all types of micro-anastomosis procedures 3. Reduces O.R. time Anand Parikh – ED10B053 June 18, 2015 7 Department of Engineering Design, IIT-Madras
Clinical immersion • Mandibular composite resection & reconstruction from fibula, on 58 year old male. Anand Parikh – ED10B053 June 18, 2015 8 Department of Engineering Design, IIT-Madras
Market Size Global: • $7 bn global market for surgical devices, 6% CAGR • $2 bn for non-powered surgical devices US: • 6 million reconstructive microvascular procedures annually • 1% p.a. increase in reconstructive microsurgical procedures India: • 8% growth in surgical equipment market Anand Parikh – ED10B053 June 18, 2015 9 Department of Engineering Design, IIT-Madras
Constraints Design • Minimal deviation from current procedure to create maximal simplicity and training requirement • Scalable/modular design for all sizes of vessels • Manufacturability using conventional techniques Physical • Corrosion resistant metallurgy • Uniform gripping pressure • Light and compact design Regulatory • Class-A medical device according to Indian Law • 510k under FDA specification Anand Parikh – ED10B053 June 18, 2015 10 Department of Engineering Design, IIT-Madras
Concepts Primary challenge in microanastomosis: • Ends of vasculature collapses upon occlusion using clamps • Small vessels are difficult to manipulate under collapsed state Anand Parikh – ED10B053 June 18, 2015 11 Department of Engineering Design, IIT-Madras
Preliminary prototypes • Concepts were filtered based on expert opinion • Shortlisted concepts were prototyped using CAD and 3D printing Anand Parikh – ED10B053 June 18, 2015 12 Department of Engineering Design, IIT-Madras
Final design • One concept was chosen based on opinion of domain experts from surgical and manufacturing backgrounds • Prior art search report by ipMetrix concluded that the features of this invention have a high probability of patent grant. Anand Parikh – ED10B053 June 18, 2015 13 Department of Engineering Design, IIT-Madras
Validation • CAD model was validated through static FEA, for both operations, occlusion and eversion • Element name: C3D8R, Mesh Size: 0.3mm • Max Von Mises Stress = 118MPa, Yield Strength (min) = 170MPa Anand Parikh – ED10B053 June 18, 2015 14 Department of Engineering Design, IIT-Madras
Advanced prototyping Anand Parikh – ED10B053 June 18, 2015 15 Department of Engineering Design, IIT-Madras
Advanced prototyping Material • SS-316L was chosen over SS-304, SS-440, Titanium and Polycarbonate due to • Better corrosion resistance • Manufacturability (Excellent weldability and machinability due to low carbon content) • Commercial availability • Low cost (relative to Titanium) Manufacturing Laser Beam Cutting Assembly using spot-welding Forming using dies Anand Parikh – ED10B053 June 18, 2015 16 Department of Engineering Design, IIT-Madras
In-vitro trial • Chicken carotid artery was used due to its structural similarity to the human digital artery • Testing of advanced prototype yielded positive results • Proof of concept was considered valid • In-vivo trial suggested after improving the spring action Anand Parikh – ED10B053 June 18, 2015 17 Department of Engineering Design, IIT-Madras
Current work • Drafting of patent application • Design modifications based on feedback from the trial • Manufacturing of new prototype for testing SS-316L-SH Anand Parikh – ED10B053 June 18, 2015 18 Department of Engineering Design, IIT-Madras
Future work • Improved advanced prototype • In-vivo trial • Prototypes of the device for smaller and larger vessels • Pilot human trial • Registration of commercial entity Anand Parikh – ED10B053 June 18, 2015 19 Department of Engineering Design, IIT-Madras
Thank you Anand Parikh – ED10B053 June 18, 2015 20 Department of Engineering Design, IIT-Madras
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