Research Project
7746190
DESCRIPTION (provided by applicant): Thoracotomies are common approaches for thoracic surgery. In 2005, approximately 200,000 were performed in the US. Thoracotomy causes significant trauma of the thoracic tissues due to mechanical separation of the ribs to create surgical access. Immediately post-surgery, respiratory function is compromised, and pain is severe, requiring significant analgesia and other medical attention. These can frequently limit release from the surgical ICU and hospital, and, most importantly, can lead to further complications. Chronic post-thoracotomy pain is also common, sometimes lasting for months or years, and is a significant contributor to morbidity. There have been extensive efforts to replace thoracotomies with minimally invasive procedures. Acceptance of most of these procedures has been low in thoracic surgery. For example, despite more than 15 years of development, thoracoscopic procedures have seen wide use only in exploration and biopsy of the lungs. For all other procedures, thoracotomies are used. In fact, the number of thoracotomies has risen by 20% over the past decade and is expected to grow dramatically as baby boomers age. Most trauma from thoracotomy occurs during spreading of the ribs by an instrument known as a "thoracic retractor". Today's thoracic retractors have had little technological innovation for nearly 70 years. Physcient, Inc. is advancing new technology, first developed at NC State University, to develop a thoracic retractor that will reduce tissue trauma in thoracotomies. Preliminary results have been positive, demonstrating that these retractors can decrease rib fractures and retraction force, greatly smooth the force of retraction, and detect imminent fractures in time to prevent them. Physcient is currently building a new prototype that combines these technologies to automate retraction. The work proposed in Phase 1 of this SBIR is to test this automated retractor against current retractors in a porcine model of thoracotomy. Primary endpoints will be reduced frequency of rib fracture, faster recovery of respiratory function (tidal volume), and faster recovery from pain (behavioral measures). Phase II of this project will begin with additional preclinical studies to ensure appropriately powered studies and then proceed to clinical trials to demonstrate efficacy of Physcient's retractor in thoracotomies in humans. PUBLIC HEALTH RELEVANCE: There are approximately 200,000 thoracotomies in the US each year. These procedures frequently are followed by significant post-operative respiratory dysfunction and pain. The goal of this project is to develop a new surgical instrument that greatly decreases respiratory dysfunction and pain after thoracotomy.
