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 当怀疑在患者中怀疑癌症时，必须去除并分析所讨论的组织。此过程是 被称为活检，是早期检测癌症的关键步骤。但是，该过程在 可以继续流血的组织，或者在肺组织中泄漏空气。为了防止任何并发症， 我们提出了一种填充这些组织空隙的新设备，以解决当前技术的局限性。活检 道密封装置将由形状的记忆泡沫和凝胶膨胀，以填充在 活检。该设备将密封孔以防止空气或血液泄漏，并有可见的额外好处 在MRI和X射线成像下。此功能使医生可以监测活检时的任何疾病进展 站点进行后续访问。 拟议的工作包括大量的临床前测试和设计验证，这些验证需要翻译这一点 技术。即，我们计划：1）完成设备的设计，2）执行研究以确认设备是 无毒，不会在植入后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，4）总结所有测试结果，以稍后的报告 用于食品和药物管理局（FDA）的应用。 该提案有可能提高可以挽救生命的共同程序的安全性和实用性 通过癌症的早期检测。进行了大约140,000个肺活活检和110,000个肝活检 每年在美国。肺活检程序的高并发症发生率（约20-50％）和严重的风险 与肝活检的出血并发症，该设备将改善数千名患者的医疗保健 发展。