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

描述（由申请人提供）：在本II期SBIR中，Actuated Medical，Inc.将完成“用于多功能骨病变入路且创伤较小的驱动式低作用力活检工具”的开发。“公共卫生问题：进行经皮骨活检以获得组织，用于通过成像或临床评价确定的骨病变的特异性诊断。活检过程的一个主要缺点是穿透皮质骨所需的力。穿透致密、厚的皮质骨以询问包含在长骨的髓内管内的骨质病变或样本病变是特别困难的。当前活检装置的另一个主要限制是使用相对于皮质表面的低倾角（< 30度）穿透皮质骨的挑战，限制了可用于到达病变的路径选择。肿瘤细胞沿着活检针道重新接种导致癌症复发是原发性肉瘤的公认风险。为了确保最佳预后并保留肢体保留切除的选择，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隔室。需要一种装置，其通过实现斜角穿透并更容易地在具有高曲率的骨表面上抓握而允许在规划到病变的路径时具有更大的灵活性，同时通过减小穿透力而允许更大的控制。第一阶段成功实现了具体目标。第一阶段证明，振动尖可以减少60%的插入力，并大大改善动物和人体组织模型中的骨活检程序。执业临床医生的评论非常积极，并指导了第二阶段Beta原型设计要求。第二阶段假设：BIFOR系统将能够使用相对于皮质表面的低倾角（<30度）进行空心针骨病变活检，插入力降低60%。此外，使用BIFOR系统进行的空心针骨活检将减少病变活检手术时间50%，同时与标准市售活检针系统相比提高诊断样本产量。第二阶段具体目标：1.最终优化和验证-最终确定手持设备、电子设备和用户界面。2.通过尸体测试进行设计确认-评价肋骨和股骨取样。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.初步人体临床评价-图像引导病变活检的临床评价。

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.