Flexible Cavity-Filling Device with Fiducial Markers for Patients Undergoing Lumpectomy

Background & Unmet Need

• Patients with breast cancer often undergo a lumpectomy procedure to remove cancerous tissue prior to additional radiotherapy or chemotherapy
• Resection of tumor and a margin of healthy tissue can create a cavity in the breast tissue
• Implants are often used to demark the cavity for future radiation therapy, and to help maintain the shape of the breast
• However, current implant designs (such as Biozorb) may lead to patient discomfort due to the stiff, rigid design
• In addition, current implants sometimes break apart into sharp fragments prior to being fully absorbed, requiring surgical intervention
• Unmet Need: Flexible implants to fill space and provide markers following lumpectomy

Technology Overview

• The Technology: A flexible ribbon-like implant comprising a hydrogel material imbedded with a radiopaque marker
• The hydrogel material may be either bioresorbable or non-bioresorbable, and is intended to match the density and elasticity of human subcutaneous breast tissue
• The radiopaque marker may be configured as a wire that runs the length of the ribbon, and may be used to demark the cavity for future radiotherapy
• Unlike rigid implant designs, the flexibility of the implant is expected to reduce patient anxiety and increase patient comfort
• Furthermore, the flexibility of the implant reduces the possibility of fragmentation into sharp pieces that require removal
• The small thickness of the ribbon may accelerate reabsorption compared to current implant designs

Technology Applications

• Demarcation of resected cancerous tissue following lumpectomy to guide radiotherapy
• Flexible implant to fill cavity following resection for the maintenance of normal breast appearance and feel

Technology Advantages

• Flexible design improves patient comfort
• Hydrogel composition emulates the density and elasticity of normal breast tissue
• Small thickness of the ribbon enables rapid reabsorption
• Includes radiopaque markers to guide subsequent radiotherapy