When cancer is suspected in a patient, the tissue in question must be removed and analyzed. This procedure is called a biopsy and is a crucial step in early detection of cancer. However, the procedure leaves a hole in the tissue which can continue to bleed, or in the case of lung tissue, leak air. In order to prevent any complications, we propose a new device to fill these tissue voids that addresses limitations of current technologies. The Biopsy Tract Sealing Device will be made of a shape memory foam and a gel that expand to fill the void made during biopsy. The device will seal the hole to prevent any leaks of air or blood, with an added benefit of being visible under MRI and X-ray imaging. This feature allows the physician to monitor any disease progression at the biopsy site in follow-up visits. The proposed work includes extensive pre-clinical testing and design verification that is required to translate this technology. Namely, we plan to: 1) finalize design of the device, 2) perform studies to confirm the devices are non-toxic and do not cause any undesirable tissue reaction after implantation, 3) conduct device design verification tests to ensure performance is successful, and 4) summarize all test results in reports that can later be used in an application to the Food and Drug Administration (FDA). This proposal has the potential to improve the safety and utility of a common procedure that can save lives through early detection of cancer. Approximately 140,000 lung biopsies and 110,000 liver biopsies are performed in the US each year. With high complication rates (~20-50%) of lung biopsy procedures and risk of severe bleeding complications with liver biopsies, the healthcare of thousands of patients will be improved by this device development.
This proposal aims to continue development of a composite shape memory polymer and hydrogel device for use in sealing biopsy tracts that would offer both superior therapeutic and diagnostic benefits over currently available technologies.