HASI Project: DEBI

Mechanical device to reduce needle deflection in biopsies (DEBI)

Over 1 million core-needle breast biopsies are performed every year in the US alone [1]. Gastrointestinal and prostate biopsies are estimated in similar numbers. Research indicates that approximately 2.5% of breast biopsies fail. The cost of core-needle breast biopsies ranges between $500 for manual procedures to $6,000 for image-guided procedures [2].

Needle deflection has been identified as a major cause of error in biopsies and it is particularly likely to occur at the insertion stage [2]. The associated risks include: 1) biopsy of the wrong site; 2) puncture of sensitive areas in proximity of the insertion path; 3) repeated insertions, thus longer procedure duration and increased patient discomfort. Biopsy needles are also prone to buckling, which can damage the needle permanently.

We have developed a passive device that detects the needle deflection mechanically as soon as it occurs and that immediately reduces the insertion force. This helps to avoid deep insertions with deflected needles. Differently from existing solutions, our concept does not require actuators or sensors, thus it can be made MRI-safe, sterilizable/disposable, and it can be used with standard needles that have axial symmetric tip.

We have already shown that our proof-of-concept prototype reduces the insertion force in case of needle deflection. By the project end-date we aim to: 

1. develop a refined prototype that can be evaluated by clinicians;
2. conduct extensive pre-clinical in-vitro testing on surgical phantoms; 
3. complete a design review and risk analysis, and prepare a draft application for the NIHR i4i funding scheme.

Team

Leading applicant: Enrico Franco, PhD, CEng

Co-applicant: Prof Wladyslaw M. W. Gedroyc

Academic PI: Prof Ferdinando Rodriguez y Baena