SimQuest will design a prototype simulator for endovascular access and conduit upsizing that provides the most realistic training available. It will overcome the shortcomings of existing simulators, contain biofidelic haptics and novel metrics, and allow repeated practice so that proficiency is clearly defined and attainable. The goal is to provide trainees with a technologically advanced solution that allows development and practice of endovascular access/conduit upsizing with accurately simulated tools and realistic haptic feel. Unlike other trainers, the proposed simulator will start at needle puncture, move seamlessly into guidewire insertion through the just- inserted needle and then to the over-guidewire upsizing of the conduit catheter. The simulator will be built with an innovative combination of 3D printed physical trainer elements, augmented reality (AR), physics-based simulation, and haptics hardware interfaces. To facilitate expansion to other procedures, it will be developed using SimQuest's open-source platform, OpenSurgSim. During Phase II we will create a state-of-the-art prototype for our new endovascular surgery trainer based on an open-source software simulation. The trainer will generate realistic palpation cues and ultrasound localization without requiring a blood simulant, will automatically record metrics for both the needlestick and catheter guidance portions of the task, and will provide improved haptic feedback sensations compared with currently available endovascular training systems. Following Phase II, the prototype will be ready for validation, field-testing, and productization. This project will result in the first simulator to offer complete training in endovascular access and conduit upsizing, simulating actual tasks in real-life fashion. It will improve clinical practice by (1) teaching endo-vascular access, use of guidewires/catheters, and conduit upsizing as a seamless process; (2) providing accurate haptic feel through an innovative design; (3) using clinical metrics defined by SMEs; and (4) containing a tissue-phantom mannequin providing sense of touch and AR for visual enhancements. Specific pathologies will be able to be incorporated using a virtual reality (VR) anatomical component. In addition to the direct request for this simulator from Prytime Medical, many training facilities and device manufacturers also requested this innovation. Product launch will be both stand-alone and as part of a complete trainer for REBOA, integrating the current RATT with the products of this research and at the request of Prytime Medical. In addition to being in the public interest, and filling a real need in the market, reduction of endovascular surgical errors furthers NHLBI's mission to reduce the burden of heart disease, and the Cardiovascular Sciences Extramural Research Program Division's support of interventions.

Public Health Relevance

The enhanced endovascular training that will result from this R&D effort promises to reduce the disproportionate number of adverse events associated with vascular surgery and thus decrease patient risk. Increased safety and better outcomes resulting from better-trained surgeons and others who perform endovascular surgery will result in improved patient outcomes and reduced costs. To commercialize this research, SimQuest is working with Prytime Medical, the REBOA Company, and will insert this work into their existing RATT mannequin training system and will take advantage of their existing and very successful marketing and sales ? in just a few months, REBOA obtained a significant US and global footprint ? ensuring success of the SimQuest endovascular access project.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44HL132665-03
Application #
9766350
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Lee, Albert
Project Start
2016-09-01
Project End
2020-07-31
Budget Start
2019-08-01
Budget End
2020-07-31
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Simquest International, LLC
Department
Type
DUNS #
039514356
City
Annapolis
State
MD
Country
United States
Zip Code
21403