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

用于 MRI 引导经会阴前列腺活检的智能导针模板

基本信息

批准号：
8832138
负责人：
JOHN C MAGILL
金额：
$ 16.77万
依托单位：
PHYSICAL SCIENCES, INC
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-26 至 2015-09-25
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8832138
关键词：
Address Anogenital region Area Biopsy Businesses Cancer Detection Cancerous Cessation of life Characteristics Cicatrix Clinical Clinical Research Collaborations Development Devices Diagnosis Diagnostic Engineering Ensure Evaluation Feedback Gel Goals Government Health Hospital Design Hospitals Imagery Laboratories Laboratory Scientists Lead Lesion Location Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of prostate Manuals Modeling Needle biopsy procedure Needles Operative Surgical Procedures Patients Persons Phase Positioning Attribute Problem Solving Procedures Prostate Public Health Research Research Personnel Robot Robotics Safety Scientist Screening for Prostate Cancer Seed Implantation Skin Small Business Technology Transfer Research Tactile Technology Testing Tissues Translating Translations Ultrasonography United States National Institutes of Health Woman Work base commercialization cost design experience image guided intervention image guided therapy improved meetings novel physical science prevent programs prototype pubis bone structure public health relevance research clinical testing success tissue phantom usability

项目摘要

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.

描述（由申请人提供）：物理科学公司 (PSI) 和布莱根妇女医院 (BWH) 的手术导航和机器人实验室 (SNR) 提议开发和测试智能模板，以指导经会阴靶向前列腺活检和后续治疗磁共振成像（MRI）。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症在最初的诊断性活检中被遗漏，导致重复活检、过度采样和延迟治疗。所提出的装置根据诊断和术中（MRI）提供对进针位置的精确控制，从而精确定位可疑组织。 SNR 多年来一直致力于开发和测试该设备的原型。在此 STTR 计划中，该技术将转移至 PSI 进行高级工程开发和商业化。由于SNR已经测试了该设备的原型，因此我们已经确定了该设备向前发展需要解决的问题，并量化了验证可行性的要求。 SNR 团队和其他研究人员已经对用于进行靶向前列腺活检的机器人进行了测试。与其他设备相比，使用智能模板时，针头由临床医生插入。因此，有关机器人的监管安全问题被最小化，设备成本大大降低，临床医生使用它会感觉更舒服，因为他们保留了更大程度的控制和触觉反馈。在第一阶段计划中，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 MRI 扫描仪中组织模型的瞄准精度演示结束。