Optical breast lesion localization fiber: preclinical testing of a new device.

Abstract

Preclinical testing was performed of an optical breast lesion localization fiber to guide surgical excision. The prototype device comprised dual 0.010- inch (0.254-mm)-diameter hooks attached to the tip of a 1,000-microns (0.03937-inch)-diameter optical fiber, which allowed retention in soft tissue after passage through a 17-gauge extra-thin-wall needle. The proximal end of the optical fiber was attached to a 15-mW, 635-nm diode laser, with a thumbscrew connector. The tip of the optical fiber was visible through several centimeters of breast tissue in two human mastectomy specimens, which facilitated determination of the location of the hooks. The optical localization fiber may allow lesions to be approached at surgery by many different paths. Clinical tests are indicated to further evaluate this device.