Endoscopic Device for Diagnosis and Tissue Sampling of Neoplasia in Urinary Bladder

Background

Appropriate staging forms the basis for “life and death” decisions in patients with urothelial carcinoma of the bladder (UCB). Current staging methods are woefully inadequate. Today, to stage UCB, the procedure known as transurethral resection of bladder tumor (TURBT) is employed. Analysis of tissue sampled dictates whether patients undergo a life-saving but life-changing radical operation requiring bladder removal and urinary diversion. Staging shortfalls plague UCB management due to limitations of space within instruments and inadequate tissue collection. Greater than 25% of patients with UCB are understaged with TURBT, resulting in mortality rates as high as 30% in patients who have an otherwise curable disease. In 2011, as for over 50 years, TURBT is performed without radiologic guidance, using rigid instrumentation and employing electrocautery for tissue procurement. The result is poorly-targeted, often inadequate tissue that is marred by cautery artifact. The proposed innovation bypasses multiple limitations of TURBT. As such, the device will be used by urologists worldwide all of whom currently routinely perform TURBT.

Summary of the Invention

We propose a novel device that will change the paradigm for diagnosis and staging of UCB. Although modern cystoscopes afford excellent visualization of lesions, tissue manipulation and sampling through these scopes is limited. The proposed flexible transurethral endoscope affords maximization of available space and significantly enhances tissue sampling. It will overcome limitations of today’s flexible and rigid instruments:

1. Innovative strategy for maximization of an endoscope’s space/real-estate is achieved through a novel concept of removing high resolution optics equipment –which currently dominates modern scopes  – from the main channel, while a side channel still has optics capabilities that are of lower quality, allowing the user to have a scout image during tissue manipulation once the target area is localized. This strategy frees up space within the medical instrument system for other tools such as such as ultrasound, optical coherence tomography, ramen scattering, confocal microscopy, and biopsy devices. Removal of high resolution optics to free up endoscope space is a truly novel approach.
2. Novel tissue anchor methodology proposed here obviates the need for electrocautery and affords precise image-guided tissue targeting. The system eliminates the cautery artifact that so often limits TURBT staging and minimizes sampling error. The novel concept centers on deploying an anchor using image guidance into the bladder wall at a defined depth and then uniting this anchor with a biopsy sheath. Such a device that allows for core-biopsy within the bladder lumen previously has never been described.

This invention also can be applied to diagnosis and treatment of neoplasms in other hollow viscera (e.g. colon, esophagus, etc.).

Patent Status: Patent pending ( Published Application No.US20110105841A1)

For Licensing/Partnering information, please contact:
Inna Khartchenko, MS, MBA
Director, Technology Transfer
Fox Chase Cancer Center
E-mail: inna.khartchenko@fccc.edu