Project Grant R44EB035063

A ROBOTIC SYSTEM TO REMOVE BLADDER TUMORS INTACT: THE KEY TO MAKING LIFESAVING TREATMENT DECISIONS - PROJECT SUMMARY/ABSTRACT: THE OBJECTIVE OF THIS PROPOSAL IS TO CREATE A NEW ROBOTIC SYSTEM THAT ENABLES BLADDER TUMORS TO BE REMOVED COMPLETELY AND INTACT. CURRENTLY THEY ARE REMOVED PIECEMEAL, WHICH SPREADS CANCER CELLS, AND RESULTS IN INCON- CLUSIVE DIAGNOSIS AND STAGING, WHICH DRAMATICALLY INCREASES MORBIDITY AND MORTALITY FOR PATIENTS. OUR SYSTEM WILL DELIVER TWO NEEDLE-SIZED, TENTACLE-LIKE ARMS THROUGH THE PORT OF A STANDARD TRANSURETHRAL ENDOSCOPE, ENABLING DEXTEROUS AND INDEPENDENT TISSUE MANIPULATION, ELECTROSURGICAL DISSECTION, AND VISUALIZATION. CLINICAL SIGNIFICANCE COMES FROM THE LARGE NUMBER OF PATIENTS WHO EXPERIENCE BLADDER CANCER - 81,180 NEW DIAGNOSES PER YEAR IN THE USA ALONE [12] - AS WELL AS THE HIGH MORBIDITY AND MORTALITY THESE PATIENTS FACE. 17,000 PEOPLE DIE EACH YEAR FROM THE DISEASE AND TUMORS RECUR 78% OF THE TIME [47]. THIS IS BELIEVED TO BE DUE TO THE CURRENT NEED TO REMOVE THE TUMOR PIECEMEAL, RATHER THAN INTACT, WHICH RESULTS IN POSITIVE MARGINS, SPREADS CANCER CELLS, AND MAKES PATHOLOGICAL ASSESSMENT HIGHLY UNCERTAIN. OUR SYSTEM AIMS TO ENABLE TUMORS TO BE REMOVED INTACT, WITH NO POSITIVE MARGINS, AND WITH MUSCLE TISSUE ATTACHED, WHICH WILL ENABLE ACCURATE, TIMELY DIAGNOSIS, WITH CRITICAL, URGENTLY NEEDED STAGING INFORMATION. THE INNOVATION THAT ENABLES OUR SYSTEM TO BE SO SMALL IS THAT WE HARNESS ELASTIC INTERACTIONS OF CURVED TUBES TO CREATE MINIATURE, DEXTEROUS SURGICAL INSTRUMENTS THAT CAN BEND AND ELONGATE. THESE INSTRUMENTS PASS THROUGH THE PORT IN AN EXISTING CLINICAL TRANSURETHRAL ENDOSCOPE TO PROVIDE TENTACLE-LIKE DEXTERITY AT ITS TIP. OUR SYSTEM IS INNOVATIVE BECAUSE IT PROVIDES DEXTERITY AND VISUALIZATION AT THE 8.6MM DIAMETER NEEDED TO PASS THROUGH THE URETHRA, I.E. 1/4 THE DIAMETER OF THE SMALLEST SINGLE PORT ROBOTS USED CLINICALLY TODAY. WE HYPOTHESIZE THAT PROVIDING THE SURGEON WITH TWO HANDS THAT CAN MOVE INDEPENDENTLY OF THE ENDOSCOPE WE WILL MAKE INTACT REMOVAL OF BLADDER TUMORS MORE ACCURATE. THIS WILL REDUCE POSITIVE MARGIN RATES AND PROVIDE SAMPLES WITH MUSCLE ATTACHED, WHICH IS KNOWN TO FACILITATE ACCURATE STAGING. ALSO, BECAUSE OUR SYSTEM HAS DRAMATICALLY FEWER MECHANICAL AND ELECTRONIC COMPONENTS THAN CURRENT COMMERCIAL SURGICAL ROBOTS, IT CAN BE MADE APPROXIMATELY 10 TIMES LESS EXPENSIVE, WHILE STILL PROVIDING A HEALTHY REVENUE STREAM AND PROFIT MARGIN FOR OUR COMPANY. APPROACH IN OUR PHASE I EQUIVALENT PRELIMINARY STUDIES, WE DEMONSTRATED THAT CONCENTRIC TUBES CAN BE DELIVERED THROUGH AN ENDOSCOPE AND CONTROLLED ROBOTICALLY BY A SURGEON. LEVERAGING THESE EXCITING PRELIMINARY STUDIES, IN THIS DIRECT TO PHASE II PROJECT, WE CONVERT OUR SYSTEM INTO A CLINICAL PRODUCT AND EXPERIMENTALLY DEMONSTRATE THAT IT IMPROVES RESECTION ACCURACY AND FACILITATES OBTAINING INTACT SPECIMENS WITH NEGATIVE MARGINS AND MUSCLE ATTACHED, IN REALISTIC PHANTOM AND CADAVER STUDIES. TO DO THIS, IN AIM 1, WE DESIGN AN OR-READY SUPPORT SYSTEM AND PERFORM BENCHTOP VERIFICATION OF SYSTEM ACCURACY. IN AIM 2 WE PERFORM BOTH FORMATIVE AND SUMMATIVE HUMAN FACTORS STUDIES TO ENSURE THE USABILITY AND SAFETY OF THE SYSTEM. IN AIM 3 WE VALIDATE THE SYSTEM EXPERIMENTALLY IN ANTHROPOMORPHIC PHANTOMS AND CADAVERS. THE ENDPOINT OF THIS PHASE II PROJECT WILL BE A SYSTEM THAT IS READY TO UNDERGO FINAL FDA TESTING (E.G. BIOCOMPATIBILITY, STERILITY, ELECTROMAGNETIC INTERFERENCE, ETC.), IN PREPARATION FOR INITIAL HUMAN CLINICAL USE.