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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要当怀疑患者患有癌症时，必须切除相关组织并进行分析。这个程序是称为活检，是早期发现癌症的关键步骤。然而，该程序留下了一个漏洞可能会继续流血的组织，或者对于肺组织来说，会漏气。为了防止出现任何并发症，我们提出了一种新设备来填补这些组织空隙，解决了当前技术的局限性。活检导管密封装置将由形状记忆泡沫和凝胶制成，凝胶会膨胀以填充手术过程中产生的空隙。活检。该装置将密封孔以防止空气或血液泄漏，还有一个额外的好处是可见在 MRI 和 X 射线成像下。此功能允许医生在活检时监测任何疾病进展后续访问中的站点。拟议的工作包括翻译此内容所需的广泛的临床前测试和设计验证技术。也就是说，我们计划：1）完成设备的设计，2）进行研究以确认设备是无毒且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，并且 4) 在报告中总结所有测试结果，以便以后使用用于向食品和药物管理局 (FDA) 提出申请。该提案有可能提高可以挽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 份肺活检和 110,000 份肝活检每年在美国。肺活检手术的并发症发生率较高（约 20-50%），且存在严重并发症的风险肝活检出血并发症，数千名患者的医疗保健将通过该设备得到改善发展。