Bleeding complications occurred in approximately 45% of surgical procedures. In trauma, 30% to 40% of deaths are related to uncontrolled bleeding. Blood transfusions and reoperations are used to mitigate bleeding and avert death, however, these procedures can be costly and are associated with complications. Blood transfusion can lead to nosocomial infection, immunosuppression, transfusion-related acute lung injury, and even death. Reoperations lead to increased costs and longer hospitalization. Many needless bleeding complications occur resulting in increased hospitalization, hospital costs, and patient deaths. Hemostats and sutures, in the hands of a skilled surgeon, are very effective. However, they are laborious and costly due to the surgical time required. Radio Frequency and Ultrasonic Vibrating Scalpel systems have the limitation that they can't focus their energy source often creating ablated regions that are too wide. In addition, they perform poorly when blood vessels exist in the vicinity of the heat source and inherently adhere to tissue as their heat source is in direct contact with the tissue. There is an unmet clinical need for a technology that allows for fast and robust control of bleeding, thereby allowing surgical procedures without hemorrhaging as well as rapidly controlling bleeding in trauma. High Intensity Focused Ultrasound (HIFU) provides a novel approach for pre-cauterizing tissue to prevent bleeding complication and mitigate hemorrhage due to trauma. HIFU has been demonstrated qualitatively to effectively induce hemostasis. Our overarching objectives are to reduce surgical time, mitigate surgical bleeding complications, and quickly stop trauma hemorrhage. The objective of this proposal is to transition our UltraStat technology from our proven prototype into a clinical device that can be used in pre-clinical studies for surgical pre-cauterization and traumatic injuries. To accomplish this objective, we will: (i) develop complimentary configurations for the UltraStat (SPECIFIC AIM 1), (ii) develop an automated control system to operate the UltraStats (SPECIFIC AIM 2), (iii) implement a user interface for the automated control system (SPECIFIC AIM 3), and (iv) conduct in vivo studies to evaluate the safety and efficacy of the UltraStat technology (SPECIFIC AIM 4). This research brings together acoustics and instrumentation expertise at Novuson and product development expertise at Product Development Studio to develop a device for mitigating bleeding. This Direct to Phase II application proposed to conduct the necessary safety and efficacy studies to develop an indication specific device. Phase III of this project will be to conduct validation and verification studies and clinical studies.
Bleeding complicates approximately 45% of surgical procedures, increases hospitalization by about 125% (7 days on average), and increases hospital costs by ~$7,500 per patient (per procedure). Bleeding also significantly contributes to the majority of the approximately 120,000 trauma deaths per year. There is no effective way to quickly and permanently stop bleeding during surgical procedures or in trauma. Bleeding leads to longer procedural times, worsens patient outcomes due to blood product use, and increases anesthesia time. This leads to increased hospitalization time and therefore increased healthcare costs. This project is to develop an active hemostatic clamp that can be used to pre-cauterize tissue prior to surgery (thus preventing bleeding complications) or to mitigate hemorrhage of trauma injuries.