A Smart Entry Needle System for Peritoneal Access and Insufflation during Laparoscopic Surgery

AbstractIn themillion laparoscopic surgeries performed annually worldwideachieving peritoneal access for insufflation accounts for one third of the associated complicationsPeritoneal access is typically achieved using the Veress needleHoweverthe use of the Veress needle has been identified as the source ofof the complications associated with laparoscopic proceduresIt has been shown that complications associated with peritoneal entry and Veress needle positioning result in significant increases in morbidity and mortalityCurrentlytechniques to assess proper placement of the Veress needle do not reduce the incidence of damage to the underlying visceraand may lead to conversion from laparoscopy to open laparotomyThe use of other open proceduressuch as the Hasson techniqueor direct trocar access or optical trocar systemshave not been shown to reduce the complications associated with bowel perforation and have additional complications of their ownThereforethe Veress needle remains the most common entry techniquedespite the complicationsleading to significant physician concern with achieving error free entryThusthere is a need for a reliablesafe alternative to the Veress needle that offers peritoneal access for insufflationTheraNova has developed the TheraNova SENSSmart Entry Needle Systema smartblunt needle access system for achieving peritoneal access and insufflation during laparoscopic surgical proceduresThis instrumentedblunt needle system allows real time guidance and controlled access to the peritoneal cavity and requires less motive force from the physicianthereby decreasing the risk of complicationsThe objective of this Phase I proposal is to optimize the TheraNova SENS for safecontrolled access to the peritoneal spaceThree Specific Aims will be conducted to meet this objectiveA calibration and accuracy assessment and optimizationA benchtop evaluation of tissue mechanics compared to the Veress NeedleAn in vivo investigation into the sensing thresholds for the tissue layers of the abdominal wall and the peritoneal spaceThe data obtained through this proposal will be used to demonstrate proof of concept for this novel smart entry device for laparoscopic proceduresThese data will also be used to support a Phase II submission which will include a comparative study between expert and novice surgeons as well as a pilot clinical evaluation to determine the safety and efficacy of the TheraNova SENS system during laparoscopy Narrative Peritoneal access and insufflationadministration of gas into the peritoneal cavityis an integral first step in overmillion laparoscopic surgeries performed annually worldwideHowevercurrent peritoneal access techniques are associated with complications due to unguided and uncontrolled placement of the needleoften leading to significant morbidity and mortalityIn this Phase I proposalwe propose to further develop a smartblunt needle access system for safe and controlled access to the peritoneal cavity