The Novel Biopsy Needle Design and Delivery System to Minimize Needle Deflection and Optimize Needle Positioning to Improve Lesion Sampling Accuracy Using a Co-registered MRI/US Fusion Biopsy Platform

项目摘要 前列腺癌的准确诊断对于个体化治疗决策至关重要。使用更新的 多参数磁共振成像(MpMRI)的进展，可以识别可疑的癌症病变。 联合注册的MRI-超声融合靶向活检(MRF-TB)允许对特定的病变进行采样 对于患有前列腺癌的男性来说，前列腺内的问题已经成为首选的诊断程序。 对前列腺癌的担忧。随着靶向前列腺活检技术的使用范围扩大，一种能够 可以沿着预期的活检路径从目标位置准确且可重复地获得组织样本 是高诊断准确率的关键。现有的活检针不能满足这一需求。目标明确 前列腺活检程序有两个阶段：(I)针定位和(Ii)针发射。当务之急 分娩过程和针头设计导致术中I期和 针头在第二阶段严重偏斜，使得所需的活检核心轨迹难以实现。这条线索 以改变所获得的组织核心的目标位置和实际位置。这样的抽样误差导致 在病变部位取样不足、假阴性结果和误诊。这项研究的目的是建立 我们专为优化病变取样而设计的新型前列腺针活检装置的有效性 联合登记的MRF-TB的准确性。为了减少第二阶段的采样误差，我们开发了双斜面针尖。 在使用前列腺样组织体模的初步活检研究中，这种针尖通过以下方式减少了针的偏转 与当前的针头设计相比提高了77%，并展示了按顺序等值的芯长 使用商业活组织检查驱动装置。为了解释第一阶段的前列腺运动，我们开发了一种 以蚊子鼻子为灵感的(MPI)针，具有渐进式针头运动和微缺口针头。这个 在前列腺样组织体模中，mpi针可以减少目标器官运动高达34%(p&lt；0.001)。 与目前的针头输送过程相比。上述创新展示了更大的 与目前的行业标准针相比，针的取样精度更高。这项研究建议 将这些创新结合到一种新型的前列腺针刺活检设备中来演示最佳采样 准确性，并获得充分的临床前验证。这项研究将对患者产生重大影响 提出了对前列腺癌的担忧。我们的创新将减少假阴性活检结果，并 通过一种更方便、创伤更小的活检程序来提高活检诊断的准确性。这个 拟议的技术可能进一步有益于其他器官活检程序(例如肝脏活检)以及其他 临床实践需要精确的针头部署。

Project Abstract Accurate diagnosis of prostate cancer is essential for individualized treatment decisions. With more recent advances in multiparametric magnetic resonance imaging (mpMRI), suspicious cancer lesions can be identified. Co-registered MRI-ultrasound fusion targeted biopsy (MRF-TB) allows 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 cancer. As the use of targeted prostate biopsy techniques expands, a biopsy needle that can accurately and reproducibly obtain tissue samples from the targeted sites along the anticipated biopsy path is crucial for high diagnostic accuracy. The biopsy needles currently available do not meet this need. Targeted prostate biopsy procedure has two phases: (I) needle positioning and (II) needle firing. The current needle delivery process and needle design cause the undesired intraoperative prostate movement in Phase I and significant needle deflection in Phase II, making the desired biopsy core trajectory difficult to achieve. This leads to variance in the targeted and actual locations of the obtained acquired tissue core. Such sampling errors result in a lesion undersampling, false negative results and misdiagnosis. This research aims to establish the effectiveness of our novel prostate needle biopsy device designed specifically to optimize lesion sampling accuracy in co-registered MRF-TB. To reduce sampling errors in Phase II, we developed a dual-bevel stylet tip. In a preliminary biopsy study using the prostate-like tissue phantom, this stylet tip reduced needle deflection by 77% when compared to the current needle design and demonstrated the sequentially equivalent core length using a commercial biopsy actuation device. To account for the prostate movement in Phase I, we developed a mosquito proboscis-inspired (MPI) needle with incremental needle-stylet motion and micro-notched stylet. The MPI needle can reduce the targeted organ movement by up to 34% (p < 0.001) in a prostate-like tissue phantom when compared to the current needle delivery process. The aforementioned innovations demonstrate greater needle sampling accuracy when compared to the current industry standard needles. This research proposes to combine these innovations in a novel prostate needle biopsy device to demonstrate the optimal sampling accuracy and acquire adequate preclinical validation. This research will have significant impact on patients presenting with a concern for prostate cancer. Our innovations will reduce false negative biopsy results and increase the biopsy diagnostic accuracy with a more expedient and less traumatic biopsy procedure. The proposed technique may further benefit other organ biopsy procedures (e.g. the liver biopsy) as well as other clinical practices requiring precise needle deployment.