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.
Bone biopsies are used to analyze suspected tumors in bones throughout the body. A major disadvantage is the force required to insert the needle through the cortical bone to reach the target tissue, which often results in poor, crushed, or otherwise inadequate samples, clinician fatigue, and increased patient discomfort, anxiety, and healing time. Penetrating dense, thick cortical bone to interrogate sclerotic lesions in long or thn bones is particularly difficult. Sampling bone in locations with delicate tissue nearby, such as th spine or ribs, is risky. A device that reduces insertion force would lower risk for sampling near delicate tissue structures, allow more flexibility in sampling approach for the clinician, and provide the ability to sample in some locations without having to resort to an open surgery.