This invention belongs to the field of medical devices, specifically relating to a positioning and marking device for
breast tumor surgery. The device includes a guide needle, a tissue marker clip, a delivery component, and a flexible outer sheath fitted over the needle. The flexible outer sheath is made of a biocompatible
shape memory polymer. At body temperature, it is in a first physical state,
puncturing the tissue along with the needle. Upon gentle
thermal stimulation, it transforms into a second physical state, significantly reducing friction with the needle, allowing the needle to be withdrawn independently, leaving the flexible outer sheath in place within the body, forming a stable guiding channel from the
body surface to the marked location. The device can also integrate an intelligent
temperature control unit, achieving closed-loop regulation through temperature sensor feedback to ensure safe and effective
thermal stimulation. This invention solves the intraoperative positioning problem caused by
lesion shrinkage after
chemotherapy, combining long-term placement safety, puncture rigidity, and placement flexibility, significantly improving the accuracy and reliability of surgical positioning.