Phase II year
2017
(last award dollars: 2018)
Phase II Amount
$1,489,524
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 ef?cient. Clinical signi?cance comes from (1) the large number of patients who could bene?t (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 bene?t 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 ?ber, visualize the surgical ?eld, 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 ?rst-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 bene?ts 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 ?ber 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 bene?ting from this procedure).
Public Health Relevance Statement: Narrative: Public Health Relevance Enlarged prostate affects more men than any other symptomatic disease, but is treated with the best available surgical approach only 1.7% of the time. This holmium laser-based approach has been shown in multiple ran- domized controlled trials to yield better patient outcomes (e.g. lower reoperation rates, no blood transfusions, and shorter hospitalization and catheterization times), yet is so challenging to perform with current tools that most surgeons cannot offer it to their patients. To make the procedure more ef?cient and accurate to perform, we pro- pose a hand-held system that can pass needle-diameter, tentacle-like robotic instruments through a transurethral endoscope to facilitate laser resection of prostate tissue.
Project Terms: Address; Adoption; Affect; arm; base; Benign Prostatic Hypertrophy; biomaterial compatibility; Blood Transfusion; Cadaver; Caliber; Catheterization; Clinical; clinically significant; Complex; Computer Simulation; Computer software; Consultations; cost effective; Couples; Data; design; design and construction; Devices; dexterity; Disease; Endoscopes; Excision; experience; experimental study; Fiber; Fiber Optics; Goals; grasp; Hand; Holmium; Homing; Hospitalization; Imagery; improved; in vivo; innovation; instrument; instrumentation; Laser Surgery; Lasers; Magnetism; men; Monitor; Nature; Needles; Neuroendoscopy; Operating Rooms; Operative Surgical Procedures; Optics; Outcome; Patient-Focused Outcomes; Patients; Performance; Phase; Positioning Attribute; prevent; Procedures; Prostate; prostate surgery; Protocols documentation; prototype; public health relevance; Randomized Controlled Trials; Repeat Surgery; Research; Robot; robot assistance; Robotics; Safety; Small Business Innovation Research Grant; Software Design; Software Validation; Speed; standard of care; Sterility; success; Surgeon; System; Testing; Time; Tissues; tool; Torque; Training; Tube; Validation; Work; X-Ray Computed Tomography
