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

具有磁共振和 X 射线图像对比的活检道封闭装置

• 批准号: 10343733
• 负责人: DUNCAN J MAITLAND
• 金额: $ 59.53万
• 依托单位: TEXAS ENGINEERING EXPERIMENT STATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10343733
• 关键词: Address; Aging; Air; American; Animals; Biopsy; Blood; Breast biopsy; Cancer Center; Cancer Patient; Cannulas; Chelating Agents; Chemical Structure; Chest; Chronic; Clinical; Complication; Development; Device Designs; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Disease Progression; Ensure; Equipment; Extravasation; Family suidae; Freezing; Frequencies; Gadolinium; Gel; Healthcare; Hemorrhage; Hemothorax; Hour; Hydrogels; Image; Image Enhancement; Implant; Intervention; Intubation; Iodine; Kidney; Liver; Location; Lung; Magnetic Resonance; Magnetic Resonance Imaging; Malignant Neoplasms; Measures; Medical; Memory; Modeling; Monitor; Names; Needles; Particulate; Patients; Performance; Physicians; Pneumothorax; Polymers; Polyurethanes; Positioning Attribute; Preclinical Testing; Principal Investigator; Procedures; Property; Radial; Reaction; Recovery; Reporting; Research Contracts; Risk; Roentgen Rays; Safety; Screening for cancer; Services; Shapes; Site; Sterilization; Structure of parenchyma of lung; System; Techniques; Technology; Test Result; Testing; Texas; Therapeutic; Time; Tissues; Toxic effect; Translating; United States; United States Food and Drug Administration; Universities; Visit; Visualization; Work; X-Ray Medical Imaging; aged; biomaterial compatibility; bone; cancer type; contrast imaging; cytotoxicity; design verification; follow-up; genotoxicity; healing; hemocompatibility; image guided; imaging modality; implantable device; implantation; improved; interest; irritation; liver biopsy; mechanical properties; member; new technology; pediatric patients; pre-clinical; prevent; programs; radiologist; seal; sealant; secondary endpoint; soft tissue; tool; tumor

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.

项目摘要 当怀疑患者患有癌症时，必须切除有问题的组织并进行分析。本程序是 这被称为活组织检查，是早期发现癌症的关键一步。然而，该过程在 可能继续出血的组织，或者在肺组织的情况下，漏气。为了防止并发症， 我们提出了一种新的设备来填充这些组织空隙，以解决当前技术的局限性。活检 通道密封装置将由形状记忆泡沫和凝胶制成，可膨胀以填充在手术过程中形成的空隙。 活检该设备将密封孔，以防止任何空气或血液泄漏，另外还有一个好处是可见 核磁共振和X光成像。该功能允许医生在活检时监测任何疾病进展 网站在后续访问。 拟议的工作包括广泛的临床前测试和设计验证，需要将其转化为 技术.也就是说，我们计划：1）完成器械的设计，2）进行研究以确认器械 无毒，植入后不会引起任何不良组织反应，3）进行器械设计 验证测试，以确保性能是成功的，和4）总结所有测试结果的报告，可以以后 用于向美国食品药品监督管理局（FDA）提交申请。 这一提议有可能提高一种可以挽救生命的通用程序的安全性和实用性 通过癌症的早期发现。进行大约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（约20-50%）， 出血并发症与肝活检，医疗保健的数千名患者将得到改善， 发展