Biopsy Tract Sealing Device with Magnetic Resonance and X-Ray Image Contrast

项目总结 当患者被怀疑患有癌症时，必须将相关组织取出并进行分析。此过程是 被称为活组织检查，是早期发现癌症的关键一步。但是，该过程会在 可以继续出血的组织，或者在肺组织的情况下，泄漏空气。为了防止任何并发症， 我们提出了一种新的装置来填补这些组织空白，解决了当前技术的局限性。活组织检查 肠道封闭器将由形状记忆泡沫和凝胶制成，这些泡沫和凝胶可以膨胀以填补在 活组织检查。该装置将密封孔洞，以防止任何空气或血液泄漏，另外一个好处是可以看到 在核磁共振和X射线成像下。此功能允许医生在活检时监视任何疾病进展 网站在后续访问中。 拟议的工作包括广泛的临床前测试和设计验证，这是将这一点 技术也就是说，我们计划：1)最终确定设备的设计，2)进行研究，以确认设备是 无毒，植入后不会引起任何不良组织反应，3)进行装置设计 验证测试以确保性能成功，以及4)将所有测试结果汇总到报告中，以便以后 在提交给食品和药物管理局(FDA)的申请中使用。 这项提议有可能提高可以拯救生命的常见程序的安全性和实用性 通过早期发现癌症。进行了大约140,000次肺活检和110,000次肝活检 每年在美国。肺活检手术的并发症发生率高(~20%-50%)，并有严重 肝脏活检的出血并发症，数千名患者的医疗保健将通过这种设备得到改善 发展。

PROJECT SUMMARY 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.