This novel stenting device provides effective temporary protection from post-operative leaks in the gastrointestinal tract without the problems associated with conventional stents.
Stenting devices are utilized to provide coverage from leaks which may occur in the gastrointestinal tract from gastrointestinal surgical procedures or perforations from ulcers, tumors or fistulas. These leaks may delay healing and result in peritonitis, serious morbidity, prolonged hospitalization, interventional procedures, and even death.
Conventional stents, although commonly used, may create additional risks of leakage, because of their relatively rigid design and structure. As one example, patients undergoing total gastrectomy currently have a post-operative leak rate of 10% from esophagojejunal anastomosis, despite many technical efforts to prevent or manage this complication. The need exists for a better technology to minimize morbidity and mortality relating to gastrointestinal tract leaks.
Summary of Invention
Flexible in its design, this stent prevents further damage to a compromised site by excluding the area of pathology, whether a leak or perforation. In contrast, conventional stents provide a more rigid coverage in areas of stenosis or leak, with the use of metal or plastic devices that exert pressure directly at the already weakened site of abnormality, which may produce additional problems.
This device may be utilized to provide coverage and prophylactic protection of any site of potential leak. The device is temporary and may be placed or removed endoscopically.
The clinical utility and feasibility of this device will be tested in a porcine model of esophagojejunal automatic leak.
This device might be utilized in a variety of cases, including: total or partial gastrectomies, which are the treatment of choice for many of the 1-in-113 men and women diagnosed with stomach cancer in their lifetimes; bariatric surgery, an increasingly common weight-loss procedure; and surgery for some cases of colon, rectal, and anal cancer, which are diagnosed yearly in 106,000, 41,000, and 5,000 people, respectively, in the U.S. alone. Another likely use of this device is with patients who experience perforations from ulcers, an overall condition that affects 1 of every 10 people during their lives.
This device is unique in that it excludes the area of pathology (leak or perforation) without any direct manipulation of the weakened area, which reduces the risk of complications.
Areas of Application
Procedures or perforations in the gastrointestinal tract
Stage of Development
Stephen Solomon, MD
Yashodhara Dash, MBBS, PhD, MBA
Tel. 212-639-6181; Fax 212-717-3439