Research Project
9680755
Abstract In the 7.5 million laparoscopic surgeries performed annually worldwide, achieving peritoneal access for insufflation accounts for one-third of the associated complications. Peritoneal access is typically achieved using the Veress needle. However, the use of the Veress needle has been identified as the source of 39.8% of the complications associated with laparoscopic procedures. It has been shown that complications associated with peritoneal entry and Veress needle positioning result in significant increases in morbidity and mortality. Currently, techniques to assess proper placement of the Veress needle do not reduce the incidence of damage to the underlying viscera, and may lead to conversion from laparoscopy to open laparotomy. The use of other open procedures, such as the Hasson technique, or direct trocar access or optical trocar systems, have not been shown to reduce the complications associated with bowel perforation and have additional complications of their own. Therefore, the Veress needle remains the most common entry technique, despite the complications, leading to significant physician concern with achieving error-free entry. Thus, there is a need for a reliable, safe alternative to the Veress needle that offers peritoneal access for insufflation. TheraNova has developed the TheraNova SENS (Smart Entry Needle System), a smart, blunt needle access system for achieving peritoneal access and insufflation during laparoscopic surgical procedures. This instrumented, blunt needle system allows real-time guidance and controlled access to the peritoneal cavity and requires less motive force from the physician, thereby decreasing the risk of complications. The objective of this Phase I proposal is to optimize the TheraNova SENS for safe, controlled access to the peritoneal space. Three Specific Aims will be conducted to meet this objective: (1) A calibration and accuracy assessment and optimization; (2) A benchtop evaluation of tissue mechanics compared to the Veress Needle; (3) An in vivo investigation into the sensing thresholds for the tissue layers of the abdominal wall and the peritoneal space. The data obtained through this proposal will be used to demonstrate proof-of-concept for this novel smart entry device for laparoscopic procedures. These 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.
