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

描述（由申请人提供）：在这个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成功率，减少患者不适和愈合时间。I期可行性研究将确定BIFOR是否可以减少插入力，提高活检样本质量，并在临床上是可取的。在美国，每年有超过50万例骨活组织检查。骨髓检查被认为是评估血液疾病最有价值的诊断工具之一。骨髓活检可用于诊断多种疾病，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、Paget病和其他代谢性骨病。骨髓活检最常用的部位是髂前嵴。主要的缺点是穿透皮质骨所需的力，这对临床医生来说是很累的，经常导致不良或破碎的样品，并增加患者的不适和愈合时间。患者的骨密度和硬度也会有很大差异，这使得临床医生很难获得合适的骨芯。第一阶段假设是，可以开发一种主动运动技术设备，减少穿透皮质骨的力量，提高骨髓活检样本的质量，减少患者的不适。这项工作的长期目标是与一家主要OEM合作，使BIFOR商业化。一种可以减少插入力，减少患者不适，并提高活检核心质量的工具将产生可观的商业收入。

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.