Deflection Analysis of Different Needle Designs for Prostate Biopsy and Focal Therapy

The biopsy needles currently used were designed for a transrectal biopsy and are known to experience significant deflection from the point of entry into the gland to the needle tip.

Five designs were selected for testing: 18-gauge Bard, 15-gauge lancet tip needle with 12° vet-point cannula, and trocar tip needle with 12°, 15°, and 20° vet-point cannulas. The 15-gauge needle was designed to take a variable specimen sample between 20 and 60 mm, whereas the Bard needle specimen bed was fixed at 20 mm. The needles were bench tested on a spring-loaded platform and fired into gelatin matrix with modulus of elasticity similar to human prostate.

The Bard device with lancet tip needle deflected an average of 0.9 mm (range 0.3-1.3 mm) and 1.9° (range 0.6°-2.8°). Increasing needle diameter from 18-gauge Bard to 15-gauge variable with the same lancet tip needle design resulted in an average deflection across the 3 test lengths of 0.9 mm (range 0-2.0 mm) and 0.9° (range 0°-2.0°) with no significant difference. On the contrary, the use of the 3-point trocar tip needles with 12°, 15°, and 20° vet-point cannulas demonstrated significant reduction in the extent of deflection in both millimeters and degrees. There was no deflection at the 2- and 4-cm shots for both spring loads and preloads for the 3 vet tip angles tested. At 6 cm, the 20° vet tip performed the best.

We proposed a mechanism that provides more accurate prostate sampling by combining a 3-point trocar tip on the needle with a 20° vet tip on the cutting cannula. Using the phantom, mimicking prostate gland tissue density, no deflection was revealed between 20- and 60-mm biopsy lengths, which should permit a straight sample in the majority of prostate glands and improve cancer localization for focal therapy planning.