SBIR-STTR Award

This project represents Phase I of a combined Phase I/Phase II STTR proposal to develop a telerobotic surgical system with an integrated robot-assisted laparoscopic ultrasound (LUS) capability, based upon Intuitive Surgical's da Vinci(r) robot and upon ongoing research at Intuitive Surgical and Johns Hopkins University (JHU). The project uses laparoscopic liver cancer surgery as a focusing application in both phases, although the broader aim is development of a versatile system that is useful for many procedures. The proposed work will develop robot-assisted laparoscopic ultrasound integrated into the da Vinci surgical robot system, for application to cancer staging, biopsy, ablative therapy, and resection, in order to make these procedures significantly more accurate, more effective, and less expensive. Phase I specific aims include: 1) integration of an ultrasound probe with da Vinci, 3D image generation from scanned 2D images, ultrasound probe tracking, calibration, and image presentation; 2) development of robot probe manipulation behaviors to be carried out under the surgeon's supervisory control; and 3) evaluation of the Phase I system capabilities to determine quantitative performance and assess user acceptability. At the end of Phase I, the surgeon will be able to manually control the ultrasound probe being held by da Vinci to acquire 2D ultrasound slices calibrated and registered in the endoscopic camera frame. A client workstation (the "Intelligent Controller") communicating with da Vinci will assemble these 2D slices into a 3D ultrasound image that da Vinci will display in the 3D display in its surgeon console, side-by-side with the video endoscope image. The Phase I system will have a limited ability to actively assist the surgeon in making 3D scans, primarily a "rocking" behavior in which the LUS probe is rotated on its axis and possibly a "lawn mowing" behavior in which the LUS probe is swept along a surgeon defined path. Performance and clinical usefulness will have been assessed using phantom and animal cadaver experiments.

Thesaurus Terms:
biomedical equipment development, laparoscopy, liver neoplasm, neoplasm /cancer surgery, robotics, ultrasound imaging /scanning biopsy, computer program /software, image processing, neoplasm /cancer classification /staging, phantom model, three dimensional imaging /topography animal tissue, bioengineering /biomedical engineering, bioimaging /biomedical imaging

This proposal represents the second phase of an STTR partnership involving Intuitive Surgical Systems and Johns Hopkins University. Phase I demonstrated the feasibility and promise of integrating laparoscopic ultrasound (LUS) capability into daVinci. Phase II will develop a complete, integrated application environment and testbed surgical applications for LUS-guided liver surgery. Our general goal is to provide the image quality and access of "open" ultrasonography in a minimally-invasive environment, while also improving the surgeon's ability to do ultrasound-guided procedures. The Phase II system will provide a realistic evaluation of the potential of an LUS-capable daVinci system for hepatic surgery as well as evaluation of the design choices and trade-offs in the functions developed. Phase II has three specific aims: Specific Aim 1: Develop functional capabilities required for LUS-assisted robotic surgery. We will extend the Phase I architecture to improve robustness, flexibility, and suitability for evaluation. Other functional enhancements include an articulated robotic LUS probe, prototype biopsy and ablation tools, "virtual fixtures" and improved semi- automated behaviors for ultrasound imaging and targeting of lesions, LUS visualization capabilities integrated into the daVinci user interface, as well as other significant enhancements to the interface permitting the surgeon to interact with LUS system, images, and other functions of the system. Specific Aim 2: Produce an Integrated Robotic System for LUS-Assisted Hepatic Surgery. We will combine these capabilities to produce a system suitable for in-vivo testing of three hepatic procedures: 1) assessment (staging) to locate and measure tumors; 2) Needle placement for biopsy/ablation; and 3) resection of small tumors. In each case, the goal is to combine the fundamental capabilities developed in Aim 1 with sufficient application-specific tooling and software to provide necessary clinically relevant context for development and to support the evaluations proposed in Aim 3. Specific Aim 3: Evaluate the effectiveness of the overall system and specific functions for hepatic surgery through in-vivo evaluations and ex vivo phantoms. A successful Phase II will provide the foundation of a product that will enable surgeons to perform US-guided hepatic procedures in a minimally invasive manner with the image quality and dexterity currently available with open laparotomies. This has the potential to reduce morbidity, and improve efficacy and efficiency for liver cancer treatment