A Novel Ultrasound Guided Cerebral Biopsy Device

The objective of this study was the development and validation of a simple, low cost, disposable cerebral biopsy device visible with intraoperative ultrasound (IOUS).  The designed biopsy device was first tested on non-animal tissue, then on a cadaver. Clinical trials were conducted on eight patients with intracranial lesions to obtain biopsy specimens for microscopic examination.  The biopsy obtained from a non-animal specimen was used to evaluate size of the sample.  Cadaver samples were evaluated by microscopic examination.  In the final phase of the project, samples were obtained and examined from eight clinical patients after a standard craniectomy / craniotomy using IOUS guidance.   Biopsy samples were successfully obtained from the cadaver and the clinical patients using the device.  Microscopic examination of the eight clinical samples by pathologists resulted in a histopathologic diagnosis representative of the intracranial lesions seen on advanced imaging and intraoperatively. Quality of the biopsy was measured by visual and ultrasound imaging evidence and the ability of pathologists to evaluate the sample and render a diagnosis based on the samples.   Microscopic evaluation of formalin-fixed samples revealed representative tissues and were of diagnostic quality in all patients.   The novel biopsy device provided high-quality, diagnostic samples with no observed negative effect on the patients either clinically or as determined by IOUS of the site post-biopsy.   The device is disposable and offers a good alternative to other cerebral biopsy techniques.  The novel cerebral biopsy device coupled with intraoperative ultrasound offers a simple, reliable method of obtaining quality biopsy in patients with intracranial masses