Andre Spiguel

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.

Provides Real-Life Tactile Feedback for Dissection, Electrocautery, and Resection

This hand-worn dissection device allows for precise and direct manual dissection of tissues via electrocautery. The accurate dissection of soft tissue is critical to surgical outcomes during an open procedure, especially for the removal of benign and malignant lesions which is associated with a slim margin for error. In many types of surgery, tactile feedback is crucial for determining the exact dissection location, with distinct types of tissues being more readily distinguishable with touch rather than visually.

However, conventional dissection methods employ electrocautery and surgical instruments, limiting direct tactile feedback. In many places within the body, the ability to get electrocautery devices directly to the necessary locations results in significant difficulty, or the need to employ techniques like robotic surgery which can be costly and time-consuming. The imprecise dissection with traditional techniques can lead to greater blood loss, more damage to nearby structures, and all of the complications associated with longer surgeries.

Researchers at the University of Florida have developed a hand-worn dissection device for the precise dissection of soft tissue. Worn directly on a surgeon’s finger(s), it provides real-life tactile feedback. This can be employed in a monopolar or bipolar fashion, and interface with standard electrosurgical units already employed at hospitals worldwide. This apparatus circumvents many of the shortcomings traditional tissue dissection strategies present.

Application

Hand-worn dissection device provides tactile feedback for the precise dissection of soft tissues during surgery

Advantages

• Tactile feedback distinguishes distinct types of tissues, reducing the need for visual inspection
• Allows for palpation of the entire area of tissue before and during dissection, increasing precision during surgery
• Increases the range of anatomic locations which can be accessed safely during surgery
• The devices naturally brings the electrode in direct contact with tissues and pushes away fluids, allowing the device to function “underwater” where traditional electrocautery devices would not work
• Allows for rapid dissection of tissue, minimizing risks associated with long surgical procedures
• Reduces the size of incisions, downsizing morbidities related to larger exposures
• Allows for monopolar and bipolar electrocautery, increasing surgical options available to the surgeon
• Works with standard electrosurgical units worldwide, making it immediately marketable and available to hospitals without additional capital expenditures

Technology

This hand-worn dissection device consists of a thin, flexible, and insulating cap a surgeon can wear over their gloved index finger and thumb. It enables the precise dissection of the soft tissue by providing tactile feedback during surgical procedures. An exposed conductive member serves as an incisive surface, while an insulated wire delivers radiofrequency energy in a monopolar fashion to the exposed part via traditional electrosurgical unit interfaces.

In monopolar mode, a single finger divides the tissue, while a different finger or footswitch can control the on/off and cut/coagulate behavior of the instrument. The insulating cap serves as a heat insulator to protect the surgeon’s fingers during this process. For bipolar operation, the surgeon can wear two insulating caps on two fingers of the same or opposing hands. In this mode of operation, the bipolar device can work with pre-existing technologies for current modulation, allowing it to seal blood vessels within the tissues.

The addition of computerized controls would also allow for the devices to switch instantaneously from monopolar to bipolar to instrument-coupled modes depending upon how much resistance is sensed through the system, allowing the system to intelligently deliver the type of current needed by the surgeon in real-time without changing instruments or relying on hand/foot switches.