Biopsy Reduction of Force Tool for Improved Sample Collection and Minimize Patien

活检减少力工具可改善样本采集并最大限度地减少患者时间

• 批准号: 7802367
• 负责人: Maureen L. Mulvihill
• 金额: $ 18.04万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-23 至 2010-10-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7802367
• 关键词: Adult; Anemia; Animal Model; Animal Testing; Anterior; Anxiety; Area; Be++ element; Beryllium; Biopsy; Biopsy Specimen; Bone Density; Bone Marrow; Bone marrow biopsy; Cadaver; Cannulas; Clinical; Core Biopsy; Databases; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diaphyses; Disadvantaged; Disease; Distal; Effectiveness; Electronics; Elements; Family suidae; Fatigue; Feasibility Studies; Feedback; Femur; Foot Ulcer; Frequencies; Goals; Grant; Hardness; Healed; Heating; Human; Intellectual Property; Kidney; Knowledge; Legal patent; Length; Licensing; Manuals; Marketing; Medical; Medical center; Metabolic Bone Diseases; Methodology; Modeling; Monitor; Motion; Needle biopsy procedure; Needles; Orthopedics; Osteogenesis; Osteoporosis; Paget' s Disease; Pathology; Patients; Penetration; Perception; Phase; Procedures; Production; Publications; Radiology Specialty; Safety; Sales; Sampling; Shapes; Signal Transduction; Site; Small Business Innovation Research Grant; Sterilization for infection control; System; Tactile; Technology; Temperature; Testing; Time; Tissues; Transducers; Ultrasonics; United States; United States National Institutes of Health; Weight; Work; base; bone; commercialization; healing; improved; innovation; interest; leukemia; next generation; programs; prototype; public health relevance; sample collection; soft tissue; success; technological innovation; tool; tumor; web site

DESCRIPTION (provided by applicant): In this Phase I NIH SBIR program, PRII will develop the Biopsy Force Reduction (BIFOR) Tool for adult patient Bone Marrow Biopsy. The BIFOR will reduce insertion force, improve biopsy sample quality and sampling rate success, and decrease patient discomfort and healing time. The Phase I feasibility study will determine if the BIFOR can reduce insertion force, improve biopsy sample quality, and is clinically desirable. Over 500,000 bone biopsies are performed every year in the United States. Inspection of the bone marrow is considered one of the most valuable diagnostic tools to evaluate hematologic disorders. Bone marrow biopsies are used to diagnose a variety of conditions including, leukemia, anemia, renal osteodystropy (ROD), tumors, osteoporosis, osteogenesis imperfect, Paget's disease, and other metabolic bone diseases The most commonly used site for the bone marrow biopsy is the anterior iliac crest. The major disadvantage is the force required to penetrate the cortical bone which is tiring to the clinician, often results in poor or crushed samples, and increases patient discomfort and healing time. Bone density and hardness can also vary significantly among patients, making it difficult for the clinician to obtain a suitable core. The Phase I Hypothesis is that an active motion technology device can be developed that reduces the force for penetrating cortical bone and improves bone marrow biopsy sample quality and reduces patient discomfort. The long-term objective of this work is to commercialize BIFOR in partnership with a major OEM. A tool that can reduce insertion force, decrease patient discomfort, and also improve biopsy core quality would generate significant commercial revenue. PUBLIC HEALTH RELEVANCE: This Phase I NIH SBIR will develop and test the Biopsy Force Reduction (BIFOR) Device for adult patient bone marrow biopsy. The BIFOR will reduce insertion force, reduce clinician fatigue, decrease patient discomfort and healing time, improve biopsy sample quality and sampling rate success.

描述（由申请人提供）：在该I期NIH SBIR项目中，PRII将开发用于成人患者骨髓活检的活检力降低（BIFOR）工具。BIFOR将减少插入力，提高活检样本质量和采样率成功率，并减少患者不适和愈合时间。I期可行性研究将确定BIFOR是否可以降低插入力，提高活检样本质量，以及是否符合临床需要。在美国，每年进行超过50万次骨活检。骨髓检查被认为是评估血液系统疾病的最有价值的诊断工具之一。骨髓活检用于诊断多种病症，包括白血病、贫血、肾性骨营养不良（ROD）、肿瘤、骨质疏松症、成骨不全、佩吉特病和其它代谢性骨疾病。骨髓活检最常用的部位是髂嵴前。主要缺点是穿透皮质骨所需的力，这对临床医生来说很累，通常导致样品质量差或压碎，并增加患者的不适感和愈合时间。骨密度和硬度也可能在患者之间存在显著差异，使得临床医生难以获得合适的核心。第一阶段假设是，可以开发一种主动运动技术器械，减少穿透皮质骨的力，提高骨髓活检样本质量，减少患者不适。这项工作的长期目标是与一个主要的原始设备制造商合作，使BIFOR商业化。能够减小插入力、减少患者不适并且还改善活检芯质量的工具将产生显著的商业收入。 公共卫生相关性：该I期NIH SBIR将开发和测试用于成人患者骨髓活检的活检力减小（BIFOR）器械。BIFOR将降低插入力，减少临床医生疲劳，减少患者不适和愈合时间，提高活检样本质量和采样率成功率。