This invention, the WiPOX, is a compact handheld device for real-time monitoring of oxygen saturation during surgery to check viability of biological tissues. It incorporates a contact pressure-sensing head which allows for consistent, high quality, tissue-oxygenation waveform readouts, even in the presence of body fluids and blood, and wireless technology for data transmission to intraoperative monitors.
The WiPOX utilizes materials that meet FDA regulations for intraoperative use and re-use. This prototype has demonstrated highly accurate and reproducible real-time assessment of tissue oxygenation in human volunteers, as well as intraoperatively in animals during gastrointestinal surgery (relative accuracy within 3% when compared to commercially available pulse oximeters). It reliably detects tissue hypoxia after bowel resection in rats and swine before overt clinical signs of ischemia.
Leakage following bowel anastomoses occurs at a rate of 15% to 50%, with a high associated mortality. Evidence suggests that vascular perfusion and tissue oxygenation (SpO₂) at the anastomotic site are fundamental determinates of anastomotic viability and healing.
Routine use of the WiPOX may help surgeons to reduce anastomotic complications after gastrointestinal surgery, thereby decreasing mortality, required hospitalization, and associated costs. With more than 270,000 (nonesophageal) GI tract anastomotic surgeries performed each year, there is a significant market for the device.
Additionally, the WiPOX is easily applicable for use in other indications such as intraoperative and perioperative monitoring of tissue oxygenation in microsurgery flaps.
The WiPOX’s advantages include:
- Its specifications meet the standards set forth by the FDA for device implantation in humans.
- It can be used through endoscopic ports.
- It can be utilized in many types of surgeries.
- Gastrointestinal surgery
- Obesity surgery
- Plastic/Reconstructive surgery
- Vascular surgery – limb perfusion monitoring (intra- and post-operative)
The WiPOX device has been successfully tested in 10 patients undergoing esophageal resection and anastomosis at Memorial Sloan Kettering Cancer Center. Results confirmed that the device is capable of detecting tissue ischemia and compromised blood supply that are not obvious to a surgeon’s eye.
Prasad Adusumilli, MD, FACS, Deputy Chief, Thoracic Service, Memorial Sloan Kettering
The prototype was produced in collaboration with the City College of New York, CUNY.
- PCT application published: WO2010/011763.
National stage filing published in the U.S.; national stage filings pending in Canada and Europe
Servais EL, et al. Surg. Endosc. 2011 May: 25(5)1383-9 EPub 2010 Oct.23.