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

描述（由申请人提供）：在这个II期SBIR中，Actuated Medical, Inc.将完成“用于创伤较小的多用途骨病变通道的Actuated低力活检工具”的开发。公共卫生问题：经皮骨活检是为了获得组织，通过影像学或临床评估确定骨病变的具体诊断。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、厚的皮质骨来检查长骨髓内管内的硬化病变或病变样本是特别困难的。当前活组织检查设备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，限制了到达病变的路径选择。肿瘤细胞沿着活检针迹重新播种导致癌症复发是原发性肉瘤公认的风险。为了确保最佳预后并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，以确保针迹避开重要结构和组织间隔。需要一种设备，通过实现斜角度穿透，在规划病变路径时具有更大的灵活性，并且更容易在高曲率的骨表面上购买，同时通过减少穿透力来实现更好的控制。第一阶段成功实现了具体目标。第一阶段表明，振动尖锐可以减少60%的插入力，并大大改善动物和人体组织模型的骨活检程序。实践临床医生的评价非常积极，并指导了II期Beta原型设计要求。第二阶段假设：BIFOR系统将使核心针骨病变活检使用相对于皮质表面的低倾角（<30度），插入力降低60%。此外，与标准的商用针头系统相比，使用BIFOR系统进行的核心针骨活检将减少50%的病变活检过程时间，同时提高诊断样本的产出率。第二阶段具体目标：最终优化和验证-最终确定手机，电子设备和用户界面。2. 通过尸体试验验证设计-评估肋骨和股骨取样。3. 动物模型的安全性和有效性-评估活检部位愈合和安全性的性能数据。4. 试验人体临床评价。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.