A smart needle guide template for MRI-guided transperineal prostate biopsy

描述（由申请人提供）：物理科学公司（PSI）和布里格姆妇女医院（BWH）的外科导航和机器人实验室（SNR）提议开发和测试一个智能模板，以指导经会阴靶向前列腺活检和随后的磁共振成像（MRI）治疗。该项目旨在解决前列腺活检诊断率低的问题。多达一半的前列腺癌在最初的诊断活检中被遗漏，导致重复活检，过采样和延迟治疗。该装置提供基于诊断和术中（MRI）的针入位置精确控制，导致可疑组织的精确靶向。SNR多年来一直在开发和测试该设备的原型。在这个STTR项目中，该技术将转移给PSI进行先进的工程开发和商业化。由于SNR已经测试了设备的原型，我们已经确定了在推动设备向前发展时需要解决的问题，并量化了验证可行性的要求。SNR团队和其他研究人员已经测试了用于进行针对性前列腺活检的机器人。与其他设备相比，当使用智能模板时，针由临床医生插入。因此，对机器人的监管安全担忧被最小化，设备的成本大大降低，临床医生使用它会感到更舒服，因为它们保留了更大程度的控制和触觉反馈。在第一阶段项目中，PSI工程师将与SNR的科学家合作，进行必要的设计升级，以满足可行性目标。这些设计升级将基于SNR在43名患者中测试原型智能模板的经验。升级将在智能模板的现有原型上进行测试。第一阶段将以在MRI扫描仪中对组织幻影的靶向准确性进行演示来结束。

DESCRIPTION (provided by applicant): Physical Sciences Inc. (PSI) and the Surgical Navigation and Robotics Laboratory (SNR) at Brigham and Women's Hospital (BWH) propose to develop and test a Smart Template to guide transperineal targeted prostate biopsies and subsequent therapy under magnetic resonance imaging (MRI). The project aims to solve the problem of poor diagnostic yield in prostate biopsies. As many as half of cancers in the prostate are missed in an initial diagnostic biopsy, resulting in repeated biopsy, oversampling, and delayed treatment. The proposed device provides precise control of needle entry location based on diagnostic and intra-operative (MRI), leading to precise targeting of suspicious tissue. SNR has been developing and testing prototypes of the device for several years. In this STTR program, the technology will be transferred to PSI for advanced engineering development and commercialization. Because SNR has tested prototypes of the device, we have identified the issues to be addressed in moving the device forward and quantified the requirements for verifying feasibility. Robots for performing targeted prostate biopsies have been tested by the SNR team and other researchers. In contrast to other devices, when using the Smart Template the needle is inserted by the clinician. Regulatory safety concerns about robots are thus minimized, cost of the device is much reduced, and clinicians will feel more comfortable using it because they retain a greater degree of control and tactile feedback. In the Phase I program, PSI engineers will work with scientists at SNR to make design upgrades necessary to meet the feasibility goals. These design upgrades will be based on SNR's experience of testing a prototype smart template in 43 patients. The upgrades will be tested on an existing prototype of the Smart Template. Phase I will conclude with a demonstration of targeting accuracy on a tissue phantom in an MRI scanner.