A Hand-Held Robot to Cure BPH

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44EB024423-01A1
Agency Tracking Number: R44EB024423
Amount: $1,489,524.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIBIB
Solicitation Number: PAR14-088
Solicitation Year: 2014
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-04
Award End Date (Contract End Date): 2019-08-31
Small Business Information
5701 OLD HARDING PIKE, STE 200, Nashville, TN, 37205-3623
DUNS: 080295493
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (615) 322-0193
Business Contact
Phone: (615) 322-0193
Email: robert.webster@gmail.com
Research Institution
Project Summary AbstractThe 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 productThe system will feature needle sized arms deployed through the endoscope port and will enable independent tissue manipulationlaser aimingand visualizationmaking surgery more accurate and ef cientClinical signi cance comes fromthe large number of patients who could bene tinmen will need surgery for an enlarged prostateBPHthere aresurgeries per year in the USAprojected to double in the nextyearsandthe fact that onlyof these patients currently bene t from the holmium laserbased procedure we seek to facilitateThis is in spite of multiple randomized controlled trials demonstrating that it reduces reoperation rates fromto essentially zeroeliminates the need for blood transfusionsand reduces hospitalization time byand catheterization time byThe reason for the underdeployment of holmium laser surgery is clearthe procedure is challenging for surgeons to accomplishdue to the lack of dexterity in current endoscope deployed instrumentsCurrentlythe surgeon must use the tip of a rigid endoscope to do three things at onceaim a laserbervisualize the surgicaleldand maneuver tissue into position for cuttingWe 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 performand thereby facilitate wider adoption of a procedure that is already known to improve patient outcomesThe innovation in this work is that this is therst ever multi arm hand held surgical robotic systemFurthermorein contrast to current commercial surgical robotic systemswhich are largeexpensiveand complexour system will be smallcost effectiveand require no complex surgeon console or articulated manipulator system surrounding the patientThese bene ts come from the ability to deliver needle sized robotic arms through the port in a standard clinical endoscopeThe arms are made of telescopingcurvedelastic tubesBy axially rotating and telescopically extending the tubesour robot will provide the surgeon with two smalltentacle likemanipulators at the tip of the endoscopeOne carries the holmium laserber for cuttingand the other enables retractionOur approach in Aimis to design a robotic system that is suitable for regulatory approvaladdressing sterility and manufacturabilityIn Aimwe implement safety systems as well as software based reliability monitoring approachesIn Aimwe validate the system experimentallyquantitatively comparing surgeon performance with our robotic system to the current standard of careThe outcomes of this project arean operating roomready robotic systeman FDA pre submission with complete regulatory master planandquantitative 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 donecasesi eit eliminates the instrument dexterity barriers that currently prevent patients from bene ting from this procedure

* Information listed above is at the time of submission. *

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