VIRTUOSO SURGICAL, INC. — Department of Health and Human Services SBIR Phase II: NIBIB

Description

Project Summary AbstractThe objective of this proposal is to transform a hand held surgical robotic system for transurethral laser prostate surgery from a lab prototype into a commercial productThe system will feature needle sized arms deployed through the endoscope port and will enable independent tissue manipulationlaser aimingand visualizationmaking surgery more accurate and ef cientClinical signi cance comes fromthe large number of patients who could bene tinmen will need surgery for an enlarged prostateBPHthere aresurgeries per year in the USAprojected to double in the nextyearsandthe fact that onlyof these patients currently bene t from the holmium laserbased procedure we seek to facilitateThis is in spite of multiple randomized controlled trials demonstrating that it reduces reoperation rates fromto essentially zeroeliminates the need for blood transfusionsand reduces hospitalization time byand catheterization time byThe reason for the underdeployment of holmium laser surgery is clearthe procedure is challenging for surgeons to accomplishdue to the lack of dexterity in current endoscope deployed instrumentsCurrentlythe surgeon must use the tip of a rigid endoscope to do three things at onceaim a laserbervisualize the surgicaleldand maneuver tissue into position for cuttingWe hypothesize that the availability of dexterous needle sized arms to aim the laser and retract tissue at the endoscope tip will make the procedure easier to performand thereby facilitate wider adoption of a procedure that is already known to improve patient outcomesThe innovation in this work is that this is therst ever multi arm hand held surgical robotic systemFurthermorein contrast to current commercial surgical robotic systemswhich are largeexpensiveand complexour system will be smallcost effectiveand require no complex surgeon console or articulated manipulator system surrounding the patientThese bene ts come from the ability to deliver needle sized robotic arms through the port in a standard clinical endoscopeThe arms are made of telescopingcurvedelastic tubesBy axially rotating and telescopically extending the tubesour robot will provide the surgeon with two smalltentacle likemanipulators at the tip of the endoscopeOne carries the holmium laserber for cuttingand the other enables retractionOur approach in Aimis to design a robotic system that is suitable for regulatory approvaladdressing sterility and manufacturabilityIn Aimwe implement safety systems as well as software based reliability monitoring approachesIn Aimwe validate the system experimentallyquantitatively comparing surgeon performance with our robotic system to the current standard of careThe outcomes of this project arean operating roomready robotic systeman FDA pre submission with complete regulatory master planandquantitative data showing that our system makes surgeons who have not previously tried holmium laser surgery operate with speed and quality comparable to surgeons without the robot who have donecasesi eit eliminates the instrument dexterity barriers that currently prevent patients from bene ting from this procedureNarrativePublic Health Relevance Enlarged prostate affects more men than any other symptomatic diseasebut is treated with the best available surgical approach onlyof the timeThis holmium laser based approach has been shown in multiple randomized controlled trials to yield better patient outcomese glower reoperation ratesno blood transfusionsand shorter hospitalization and catheterization timesyet is so challenging to perform with current tools that most surgeons cannot offer it to their patientsTo make the procedure more ef cient and accurate to performwe propose a hand held system that can pass needle diametertentacle like robotic instruments through a transurethral endoscope to facilitate laser resection of prostate tissue