Sonomotion Inc. — Department of Health and Human Services SBIR Phase I: 400

Description

DESCRIPTION provided by applicant Kidney stones affect in Americans at an annual cost of $ B with both numbers steadily climbing Watchful waiting is the preferred approach to stone management but there are no means to predict when the stone will pass or if the stone will pass Intervention is typically recommended once a stone is over mm and usually involves breaking the stone into smaller fragments which are then expected to pass on their own Multiple studies have shown that these residual fragments often do not pass on their own and lead to symptomatic stone events in up to and secondary surgery in of the procedures performed yearly A non invasive tool that could facilitate stone fragment passage would significantly improve the management of kidney stones Technology Ultrasonic propulsion is a non invasive tool to move stones within the collecting space using acoustic radiation force The technology uses an existing commercial diagnostic probe so the stone movement can be monitored in real time with imaging The technology has the potential to aid in the passage of small stones and fragments in an office setting improve stone free rates immediately following lithotripsy procedures and relieve pain by moving a stone blocking the ureter Preliminary Data Investigational results from a feasibility trial has shown the technology to be safe and effective in humans with stone repositioning in of subjects and an aggregate stone fragments passed by of post lithotripsy subjects Specific Aims This is a Fast Track proposal that will use Phase to test technical advances from which final design specifications will be formed for commercial prototype development in Phase Phase Aim expands the capabilities of our technology augmenting the Push pulse designed to move one stone at a time in order to collectively move a cluster of small stone fragments A custom phantom model will be used to quantify improvement in the Push efficiency of a broadened beam relative to that of the existing narrow beam system The outcome will improve an operatorandapos s ability to clear the many small residual fragments found in post lithotripsy subjects in a short timeframe Phase includes integrating imaging that tracks an acoustic signature unique to stones and assembling a focus group all to improve the usability of the system porting the technology onto an FDA approved OEM complete urological ultrasound system and performing the safety and effectiveness tests necessary for application for an investigational device exemption The outcome of this proposal will be a clinical trial ready commercially viable ultrasonic propulsion and imaging system that can effectively treat post lithotripsy stone fragments PUBLIC HEALTH RELEVANCE Kidney stones are one of the most common and painful urological disorders around the world one in Americans will suffer from kidney stones at an annual economic burden of $ billion in part from recurrence and repetitive treatment and monitoring In data from the year average annual medical cost for stone sufferers $ was more than twice the average annual medical cost for non stone formers $ The proposed research aims to solve remaining technical hurdles to development of a completely new way to treat kidney stones which involves applying ultrasound through the skin to move stones out of the kidney in order to avoid surgery emergency room visits and radiation exposure of watchful monitoring