Precision Resection Device for Skin and Soft Tissue Lesions

Allows for Resection of Malignant Skin and Soft Tissue Lesions in a Precise and Reproducible Fashion, with the Ability to Perform Patient-Specific Customized Resections

This resection system allows for the excision of skin and soft tissue lesions with a precise and reproducible margin of tissue around the lesion. Malignant soft-tissue lesions, while less common, often require complex and challenging surgical resections associated with high morbidity. Skin cancer is the most common cancer in the United States, with approximately 9,500 people diagnosed daily. The annual cost of skin cancer treatment is about $8.1 billion.

With current methods, when a skin lesion’s size and shape are known, manual surgical removal involves taking out a resection specimen with a predetermined shape and size, including both the tumor and a specific tissue area beyond the lesion called the margin. Manual dissection typically involves using a scalpel and electrocautery to carry out this dissection freehand. However, excision of the lesion and its margin is challenging, time-consuming, and introduces several layers of human error, leading to increased recurrence and surgery-associated risks, as well as an increase in surgical procedure costs.

Researchers at the University of Florida have developed a resection system that allows for rapid, reproducible resection of soft tissue lesions with minimal time and less human error. This system also takes advantage of image analysis, three-dimensional modeling, and additive manufacturing techniques to customize the resection volume for each individual patient’s disease, allowing for expedited and safe resection of the lesion while preserving the patient’s native anatomy. This strategy circumvents many of the shortcomings of traditional methods of tumor excision.

Application

Expeditiously resects skin and soft tissue lesions with predetermined shape and volume and a precise and reproducible margin of tissue around the lesion, which may be customized for individual patients

Advantages

• Excises skin tumors with a precise and reproducible tissue margin around the lesion, decreasing the risk of residual tumor and local recurrence
• The system makes the resection process significantly more efficient, lowering the patient risks and costs associated with time-consuming and morbid surgeries
• The ability to customize resection devices for every patient’s individual tumor is an unprecedented development in this field, with no current devices on the market
• The systems and procedures for 3-dimensional analysis of the tumor, adding a margin, and subtracting vital structures is a broadly protected idea with many associated applications
• Works with standard electrosurgical units worldwide, making it immediately marketable and available to hospitals without additional capital expenditures

Technology

This resection system is enhanced with image analysis and three-dimensional modeling, offering customizability for specific patients’ lesions. It uses cross-sectional images of a tumor within a patient, identifies the types of tissue around it, and determines the size and shape of the resection volume, encompassing the tumor and margin while avoiding vital structures. It ultimately generates a three-dimensional model for a resection tool specific for the excision of the mass and the information necessary to manufacture it. This tool uses one or more anatomical landmarks, or the lesion itself, as guidance for tissue removal during the resection procedure.

The device design makes it intuitive for any surgeon, offering visual feedback for the placement and use of the device. It uses a tool that can be used with any standard electrosurgical unit to resect a volume of tissue around a skin-based or soft tissue lesion quickly and reproducibly. The compatibility with standard electrocautery machines makes this product viable for immediate availability “on the shelf” at any hospital with pre-determined sizes and depths.