Product development cycle of a surgical device for mitral valve repair and surgical training simulator development plan for the same.
2011-02
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Product development cycle of a surgical device for mitral valve repair and surgical training simulator development plan for the same.
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2011-02
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Mitral Valve Regurgitation (MR) is a disease in which the valve leaflets fail to fully coapt (close together) allowing blood to flow in the reverse direction. If left untreated, MR progression can lead to serious heart problems including atrial fibrillation and congestive heart failure.
A study of the Society of Thoracic Surgeons Adult Cardiac Surgery Database for the eight year period spanning 2000-2007 found that 47,126 operations were performed for isolated MR alone [2] with an increase of the surgical valve repair rate (versus total valve replacement) from 51% to 69% in the same time interval [2][3].
The NeoChord DS1000 is a novel surgical instrument that facilitates mitral valve repair for MR on a beating heart. As the demand for further instrumentation for beating heart mitral valve surgery grows, so too will the demand for mitral valve surgical training simulators. There exists an unmet need for such a simulator that incorporates the beating heart, anatomically correct heart anatomy and leaflet motion, physiologically correct flow rates, and the ability to interface with surgical devices. The objective of this thesis is to 1) describe the product development cycle for the DS1000, a surgical instrument for Mitral Valve repair. A chapter is then provided for 2) adapting the device development cycle to a development cycle for a simulator. This is followed by 3) a chapter of cardiac related simulators currently on the market as well as examples of how these simulators were validated. This thesis concludes by 5) combining the knowledge of the first four chapters to describe a development plan for a surgical training simulator for the beating mitral heart valve.
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University of Minnesota M.S. thesis. February 2011. Major: Mechanical engineering. Advisor: Arthur G. Erdman, Ph.D. 1 computer file (PDF); viii, 91 pages.
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