Real-time bioimpedance based biopsy device

描述(由申请人提供)：在过去的三十年里，由于新的筛查和诊断工具的出现，被诊断为前列腺癌的男性人数增加了85%。然而，这些新诊断的男性中有相当一部分人患有临床上微不足道的疾病，这意味着他们不太可能死于前列腺癌。泌尿科医生每天面临的一个艰难决定是，决定是否需要治疗患有某种程度的前列腺癌的男性。目前，PSA水平升高或直肠指检异常的男性会接受活检，以确认是否存在前列腺癌。不幸的是，典型的活检方案对整个前列腺的样本不到1%。因此，活组织检查往往完全遗漏了癌症区域，而在其他病例中采样的少量癌症并不总是能够准确评估疾病的范围和侵袭性。我们建议开发一种配备传感器的活检针的商业原型，它能够感知较大的前列腺体积，同时仍能保持分辨能力 癌症和正常前列腺之间的区别，以改善对患者的护理。具体地说，我们已经开发了一种基于研究的活检针，它将能够测量前列腺电特性的传感器整合到标准的临床活检针中。我们之前已经证明，组织的电特性对组织的细胞排列很敏感，可以用来 区分癌症和良性前列腺。基于这些发现和基于研究的原型的开发，我们的目标是设计、建造和评估该设备的商业可行性原型。我们将根据探测到的组织体积来评估探头，并进行一项小型的临床前试验，以评估探头的实用性。这项研究的临床前阶段将包括从15名男性根治性前列腺切除术后获取新鲜前列腺。我们将使用设计的探头来收集组织样本，并记录每个切除的前列腺的电学性质，这是临床上通常使用的活检方案。这种新型探头的潜在临床应用包括在日常临床环境中使用，为泌尿科医生提供可用于治疗计划的额外信息。此外，由于这些电特性可以实时显示给泌尿科医生，因此他们可以根据记录的电特性签名从可疑癌症区域获得多次活组织检查。这种新型探头中使用的传感机制是基于注入微小的电流，这些电流是不可察觉的，远远低于FDA批准的电流水平。此外，该装置不会明显改变标准活检装置的结构和实施方式。因此，预计不会出现与临床使用该设备相关的可预见的额外风险。最后，由于我们正在增加一种临床标准工具(活检针)，我们预计在这一第一阶段计划结束时，我们将能够在体内临床试验中使用这种新设备，我们现实地设想在短短5年内看到这种产品进入临床医生手中，并使患者受益。

DESCRIPTION (provided by applicant): Over the last three decades the number of men diagnosed with prostate cancer has increased 85% as a result of new screening and diagnostic tools. However, a significant number of these newly diagnosed men are harboring clinically insignificant disease, which means that they are not likely to die from prostate cancer. A difficul decision facing urologists daily is determining whether a man with some degree of prostate cancer needs to be treated or not. Currently, men who have elevated PSA levels or abnormal digital rectal examinations are biopsied to confirm presence of prostate cancer. Unfortunately, typical biopsy protocols sample less than 1% of the entire prostate. As a result, regions of cancer are often entirely missed by biopsy and the small volumes of cancer sampled in other cases do not always provide an accurate assessment of the extent and aggressiveness of the disease. We propose to develop a commercial prototype of a sensor-equipped biopsy needle capable of sensing a larger volume of the prostate while still retaining the ability to distinguish between cancer and normal prostate to improve patient care. Specifically, we have developed a research-based biopsy needle that incorporates a sensor capable of measuring the electrical properties of prostate into a standard clinical biopsy needle. We have previously shown that the electrical properties of tissue are sensitive to a tissue's cellular arrangement and can be used to distinguish between cancer and benign prostate. Based on these findings and the development of a research-based prototype, we aim to design, construct and evaluate a commercially viable prototype of this device. We will evaluate the probe in terms of the tissue volume it senses and conduct a small pre-clinical trial to evaluate the probes utility. The pre- clinical phase of this investigation will consist of obtaining fresh prostates from 15 men following radical prostatectomy. We will use the designed probe to collect tissue samples and record electrical properties from each excised prostate following biopsy protocols typically used in the clinic. The potential clinical applications of this novel probe include use in an everyday clinical setting to provide urologists additional information they can use for treatment planning. Also, because these electrical properties can be displayed to the urologist in real-time it will be possible for them to obtain multiple biopsies from areas suspicious of cancer based on the electrical property signatures recorded. The sensing mechanism used in this novel probe is based on injecting small electrical currents that are imperceptible and well-below FDA-approved current levels. Further, the device does not change appreciably the construction and implementation of a standard biopsy device. As a result, no foreseeable additional risks associated with clinical use of this device are expected. Finally, since we are augmenting a clinical standard tool (a biopsy needle) we expect that by the end of this Phase I program we will be in a position to use this new device in an in vivo clinical trial and we realistically envision seeing this product in clinicians hands and benefiting patients in as little as 5 years.