ProDevice Medical Supplies and Equipment LLC — Department of Health and Human Services STTR Phase I: 101

Description

Project Abstract Accurate diagnosis of prostate cancer is essential for individualized treatment decisionsWith more recent advances in multiparametric magnetic resonance imagingmpMRIsuspicious cancer lesions can be identifiedCo registered MRI ultrasound fusion targeted biopsyMRF TBallows the sampling of specific lesions of concern within the prostate has emerged as the preferred diagnostic procedure for men presenting with a concern for prostate cancerAs the use of targeted prostate biopsy techniques expandsa biopsy needle that can accurately and reproducibly obtain tissue samples from the targeted sites along the anticipated biopsy path is crucial for high diagnostic accuracyThe biopsy needles currently available do not meet this needTargeted prostate biopsy procedure has two phasesIneedle positioning andIIneedle firingThe current needle delivery process and needle design cause the undesired intraoperative prostate movement in Phase I and significant needle deflection in Phase IImaking the desired biopsy core trajectory difficult to achieveThis leads to variance in the targeted and actual locations of the obtained acquired tissue coreSuch sampling errors result in a lesion undersamplingfalse negative results and misdiagnosisThis research aims to establish the effectiveness of our novel prostate needle biopsy device designed specifically to optimize lesion sampling accuracy in co registered MRF TBTo reduce sampling errors in Phase IIwe developed a dual bevel stylet tipIn a preliminary biopsy study using the prostate like tissue phantomthis stylet tip reduced needle deflection bywhen compared to the current needle design and demonstrated the sequentially equivalent core length using a commercial biopsy actuation deviceTo account for the prostate movement in Phase Iwe developed a mosquito proboscis inspiredMPIneedle with incremental needle stylet motion and micro notched styletThe MPI needle can reduce the targeted organ movement by up top andltin a prostate like tissue phantom when compared to the current needle delivery processThe aforementioned innovations demonstrate greater needle sampling accuracy when compared to the current industry standard needlesThis research proposes to combine these innovations in a novel prostate needle biopsy device to demonstrate the optimal sampling accuracy and acquire adequate preclinical validationThis research will have significant impact on patients presenting with a concern for prostate cancerOur innovations will reduce false negative biopsy results and increase the biopsy diagnostic accuracy with a more expedient and less traumatic biopsy procedureThe proposed technique may further benefit other organ biopsy procedurese gthe liver biopsyas well as other clinical practices requiring precise needle deployment Project Narrative This research aims to achieve the precision needle positioning to optimize the lesion sampling accuracy for accurate prostate cancer diagnosis in co registered magnetic resonant imaging and ultrasound fusion prostate targeted biopsy