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

工程摘要 前列腺癌的准确诊断对于个体化治疗决策至关重要。随着最近 多参数磁共振成像（mpMRI）的进步，可以识别可疑的癌症病变。 共配准MRI-超声融合靶向活检（MRF-TB）允许对特定病变进行采样， 前列腺内的关注已经成为男性表现为前列腺增生的首选诊断程序。 前列腺癌的症状随着靶向前列腺活检技术的使用扩展， 可以精确地和可重复地从目标部位沿着预期的活检路径获得组织样本 对于高诊断准确性至关重要。目前可用的活检针不能满足这种需求。针对性 前列腺活检过程具有两个阶段：（I）针定位和（II）针发射。当前指针 输送过程和针设计导致第I阶段中不期望的术中前列腺移动， 在第II阶段中，针发生显著偏转，使得难以实现期望的活检芯轨迹。这导致 所获得的采集组织核心的目标位置和实际位置的变化。这种抽样误差导致 在病变采样不足，假阴性结果和误诊。本研究旨在建立 我们专门设计的新型前列腺穿刺活检装置用于优化病变取样的有效性 共同登记的MRF-TB的准确性。为了减少第二阶段的采样误差，我们开发了双斜面探针头端。 在一项使用前列腺样组织体模的初步活检研究中，该探针头端减少了针头偏转， 与当前缝针设计相比为77%，并证明了芯线长度的顺序等同性 使用商业活检致动装置。为了解释第一阶段的前列腺运动，我们开发了一个 具有增量针-管心针运动和微切口管心针的蚊子长鼻激发（MPI）针。的 在前列腺样组织体模中，MPI针可减少靶器官运动高达34%（p < 0.001） 与当前的针头输送过程相比。上述创新表明， 与当前行业标准针头相比，针头采样精度更高。这项研究提出， 联合收割机将这些创新结合在一种新型前列腺穿刺活检装置中，以证明最佳采样 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 患有前列腺癌我们的创新将减少假阴性活检结果， 通过更方便和创伤更小的活检程序提高活检诊断准确性。的 所提出的技术可以进一步有益于其他器官活检程序（例如，肝活检）以及其他器官活检程序。 需要精确针部署的临床实践。

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.