Actuated Low-Force Biopsy Tool for Versatile Bone Lesion Access with Less Trauma

描述(由申请人提供)：在这一第二阶段的SBIR中，Actuated Medical，Inc.将完成“Actuated Low-Force活检工具的开发，以便以更少的创伤获得多功能骨病变。”公共卫生问题：经皮骨活检是为了获得用于通过成像或临床评估确定的骨损伤的特定诊断的组织。活组织检查过程的一个主要缺点是需要穿透皮质骨的力量。穿透致密、厚实的皮质骨以询问包含在长骨髓内管内的硬化性病变或样本病变尤其困难。目前活组织检查设备的另一个主要局限性是使用相对于皮质面的低倾角(30度)穿透皮质骨，限制了到达病变的可用路径选择。肿瘤细胞沿着活检针轨迹重新种植导致癌症复发是公认的原发肉瘤风险。为了确保最好的预后和保留保留肢体切除的选择，临床团队必须仔细规划病变的入路，以确保针道避开重要结构和组织分区。需要一种设备，通过允许斜角穿透并更容易地购买到高曲率的骨表面，从而在规划到病变的路径时具有更大的灵活性，同时通过减少穿透力来允许更好的控制。第一阶段成功地实现了具体目标。第一阶段证明，在动物和人类组织模型中，振动锐器可以将插入力减少60%，并显著改进骨活检程序。执业临床医生的评价非常积极，并指导了第二阶段Beta原型设计要求。第二阶段假设：BIFOR系统将使用相对于皮质表面的低倾角(&lt；30度)实现核心针骨病变活检，插入力减少60%。此外，使用BIFOR系统进行的核心针骨活检将使病变活检程序的时间减少50%，同时比标准的商用针系统提高了诊断样本产量。第二阶段的具体目标：1.最终优化和验证--最终确定手机、电子产品和用户界面。2.通过身体测试进行设计验证--评估肋骨和股骨样本。3.动物模型中的安全性和有效性--评估活检部位愈合和安全性的性能数据。4.试行人类临床评估--影像引导下病变活检的临床评估。

DESCRIPTION (provided by applicant): In this Phase II SBIR, Actuated Medical, Inc. will complete the development of the "Actuated Low-Force Biopsy Tool for Versatile Bone Lesion Access with Less Trauma." Public Health Problem: Percutaneous bone biopsy is performed to obtain tissue for specific diagnosis of bone lesions identified through imaging or clinical evaluation. A major disadvantage of the biopsy process is the force required to penetrate the cortical bone. Penetrating dense, thick cortical bone to interrogate sclerotic lesions or sample lesions contained within the intramedullary canal of long bones is particularly difficult. Another major limitation of current biopsy devices is the challenge of penetrating through cortical bone using low inclination angles (< 30 degrees) relative to the cortical surface, limiting the path choices available to reach the lesion. Re-seeding of tumor cells along the biopsy needle track leading to cancer recurrence is a recognized risk with primary sarcomas. In order to ensure the best prognosis and preserve the option of limb-sparing resection, the clinical team must carefully plan out the approach to the lesion to ensure the needle track avoids vital structures and tissue compartments. A device is needed that allows greater flexibility in planning the path to the lesion by enabling oblique angle penetration and easier purchase onto bone surfaces with high curvature, while simultaneously allowing greater control by reducing penetration force. Phase I successfully met the Specific Aims. Phase I demonstrated that a vibrated sharp can reduce insertion force by 60% and substantially improve bone biopsy procedures in animal and human tissue models. Reviews by practicing clinicians were extremely positive and have guided the Phase II Beta prototype design requirements. Phase II Hypothesis: The BIFOR system will enable core needle bone lesion biopsy using low inclination angles (<30 degrees) relative to the cortical surface with 60% reduced insertion force. In addition, core needle bone biopsy performed with the BIFOR system will reduce lesion biopsy procedure time by 50% while increasing diagnostic sample yield over the standard commercial needle system. Phase II Specific Aims: 1. Final Optimization and Verification - Finalize handset, electronics, and user interface. 2. Design Validation through Cadaver Testing - Evaluate rib and femur sampling. 3. Safety and Efficacy in Animal Model - Performance data with assessment of biopsy sites for healing, and safety. 4. Pilot Human Clinical Evaluation - Clinical evaluation in image-guided lesion biopsy.