A Hand-Held Robot to Cure BPH

点击翻译按钮获取中文摘要

Project Summary/Abstract: The objective of this proposal is to transform a hand-held surgical robotic system for transurethral laser prostate surgery from a lab prototype into a commercial product. The system will feature needle-sized arms deployed through the endoscope port and will enable independent tissue manipulation, laser aiming, and visual- ization, making surgery more accurate and efficient. Clinical significance comes from (1) the large number of patients who could benefit (1 in 3 men will need surgery for an enlarged prostate (BPH); there are 300,000 surgeries per year in the USA – projected to double in the next 10 years), and (2) the fact that only 1.7% of these patients currently benefit from the holmium laser- based procedure we seek to facilitate. This is in spite of multiple randomized controlled trials demonstrating that it reduces reoperation rates from 9-18% to essentially zero, eliminates the need for blood transfusions, and reduces hospitalization time by 43% and catheterization time by 63%. The reason for the underdeployment of holmium laser surgery is clear: the procedure is challenging for surgeons to accomplish, due to the lack of dexterity in current endoscope-deployed instruments. Currently, the surgeon must use the tip of a rigid endoscope to do three things at once: aim a laser fiber, visualize the surgical field, and maneuver tissue into position for cutting. We hypothesize that the availability of dexterous needle-sized arms to aim the laser and retract tissue at the endoscope tip will make the procedure easier to perform, and thereby facilitate wider adoption of a procedure that is already known to improve patient outcomes. The innovation in this work is that this is the first-ever multi-arm hand-held surgical robotic system. Further- more, in contrast to current commercial surgical robotic systems, which are large, expensive, and complex, our system will be small, cost effective, and require no complex surgeon console or articulated manipulator system surrounding the patient. These benefits come from the ability to deliver needle-sized robotic arms through the port in a standard clinical endoscope. The arms are made of telescoping, curved, elastic tubes. By axially rotating and telescopically extending the tubes, our robot will provide the surgeon with two small “tentacle-like” manipulators at the tip of the endoscope. One carries the holmium laser fiber for cutting, and the other enables retraction. Our approach in Aim 1 is to design a robotic system that is suitable for regulatory approval, addressing sterility and manufacturability. In Aim 2 we implement safety systems as well as software-based reliability monitoring approaches. In Aim 3 we validate the system experimentally, quantitatively comparing surgeon performance with our robotic system to the current standard of care. The outcomes of this project are (1) an operating-room- ready robotic system, (2) an FDA pre-submission with complete regulatory master plan, and (3) quantitative data showing that our system makes surgeons who have not previously tried holmium laser surgery operate with speed and quality comparable to surgeons without the robot who have done 50+ cases (i.e. it eliminates the instrument dexterity barriers that currently prevent patients from benefiting from this procedure).