Biopsy Clip Metal Detector to Aid Breast Surgery

Description:

This metal detector localizes biopsy clips (e.g. titanium) placed at the site of breast tissue biopsies. The device is a handheld metal detector that can be inserted into a surgical incision to help locate small markers without an invasive procedure to insert a localizing wire, radioactive seed, or other localization technologies. The device is able to directly locate a biopsy clip without increasing the incision site and with no additional procedures pre-op. The probing wand guides the surgeon’s path to the marker through continuous feedback. The system relates proximity information to clinicians both through auditory feedback mechanisms and a digital display on the base.

 

Overview: This handheld metal detector aids surgeons with localizing breast cancers, eliminating the need for invasive procedures. With the increased use of mammographic screening, breast cancer is more frequently detected as a radiographic lesion only rather than a palpable mass. This has made image-directed localization a necessity for surgical excision in a significant proportion of cases. When a patient has an abnormal mammogram, a radiologic breast biopsy is performed and a titanium clip is placed at the biopsy site to mark the site of the cancer. When a patient has a surgical localization procedure, a wire, radioactive seed, or reflective devise are all placed adjacent to the site of the titanium clip to guide the removal of the cancer with the clip. MUSC Health and Clemson University researchers have developed a method to directly detect a clip without an invasive procedure to localize the lesion. This approach eliminates the need for invasive procedures and will save time for the patient, reduce pain, eliminate fees associated with the localization procedure, and improve operating room utilization.

 

Development Status:

•       No added patient safety risk via specific absorption ratio

•       Can detect a nitinol clip in open-air and ballistic gel models at ≥3.0cm

•       Can detect a 1cm diameter titanium chip in open-air and ballistic gel models at ≥3.0cm

•       Can detect a 1cm diameter titanium chip through breast tissue

•       FEA modeling data showing efficacy of shielding to direct magnetic field to prevent errant detection of metal objects (e.g. surgical retractors)

•       User interface with visual readout of signal vs. distance

 

Next Development Milestones:

•       Design and engineering optimization to increase amplitude and signal strength to detect titanium clip at 5cm

•       Conversion of signal amplitude to sound and distance readout for user interface

•       Refine signal processing method to address drifts in baseline

•       Shielding to prevent interference of metal artifacts in field (surgical retractors, etc.), and better direct field to ensure minimal angle of divergence (feasibility shown via modeling data)

 

Applications: Breast cancer localization

Advantages:  Eliminates invasive procedures to localize clip, increasing patient comfort. Facilitates operating room scheduling and workflow, reducing wait time and fees for patients

Key Words: Cancer, breast cancer, localization, biopsy

 

Inventors: Nancy DeMore, MD, Delphine Dean, PhD, Cody Jordan, Melissa McCullough, Scott Slaney, Joseph Wilson

Patent Status: PCT/US2017/048909 with national stage applications filed in:

              U.S. App. Ser. No. 16/328,430

              EPO App. Ser. No. 17844562.3

              CA App. Ser. No. 3034561

 

MUSC-FRD Technology ID: P1672

 

For more information regarding this technology please contact Chelsea Ex-Lubeskie, Business Development Manager, at exlubesk@musc.edu.

Patent Information:
Category(s):
Device
For Information, Contact:
Chelsea Ex-Lubeskie
Licensing Manager, Devices
MUSC Foundation for Research Development
843-876-1900
exlubesk@musc.edu
Inventors:
Nancy DeMore
Delphine Dean
Scott Slaney
Joseph Wilson III
Cody Jordan
Melissa McCullough
Keywords:
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