Real-time bioimpedance based biopsy device

描述（由申请人提供）：在过去的三十年中，由于新的筛查和诊断工具，被诊断患有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患有临床无关紧要的疾病，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困难决定是确定患有某种程度前列腺癌的男性是否需要治疗。目前，PSA水平升高或直肠指检异常的男性都要接受活检以确认前列腺癌的存在。不幸的是，典型的活检方案取样不到整个前列腺的1%。因此，活组织检查常常完全遗漏了癌症区域，而在其他病例中取样的少量癌症并不总是提供对疾病范围和侵袭性的准确评估。我们建议开发一种配备传感器的活检针的商业原型，能够在保留区分能力的同时感知更大体积的前列腺

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.