SPATIAL SURGICAL LLC — Department of Health and Human Services SBIR Phase I: NIAMS

Description

Spatial Surgical is developing a novelfirst in class orthopedic laser system that rapidly and safely ablates soft tissue and bone through a single handpieceSpatial s technology couples a laser with a real time digital video system to offer computer guided surgery that stands to replace traditional orthopedic sawsdrillsand cauterization toolsSpatial s laser cuts soft and hard tissue via molecular absorption while sawsdrills and scalpels compressshear and tear the tissueThe laser s molecular absorption is referred to ascold couplingas no heat is transferred to the surrounding tissuewhich eliminates the necrosissmear layer and cauterization common with mechanical toolsThe elimination of dead tissuewhich the body must absorbleads to less painfaster healing and less post operative complicationsinfectionsimplant looseningetcIn vivo orthopedic surgery research has defined the steps to commercialization for an orthopedic laser surgical systemWhile successfully cutting bone necrosis free with rapid healinglimitations noted in the research were slow ablation speedtapered cutting and lack of depth controlAdditionallythere are practical medical device engineering developmental needsFor examplethe COablation laser is invisible so a visible aiming beam needs to be added colinear to the COlaser beamso surgeons can view where the laser will ablate the tissueThis SBIR project has three objectivesmodel a green aiming beam s optical requirementsmodel spinning wedges to rotate the COablation laser and define cutting speed by ablating porcine femur bone samplesTo define the final laser system s optical schemean OSLO software model for the COablation laser coupled with a green aiming beam is developedThe Fraunhofer Institute researched eliminating tapered laser cutting and found that laser beam rotational symmetry is integral to eliminating taperAn optical model is developed to add spinning optical wedges into the CObeam path to rotate and homogenize the COlaser modeFinallya bench top prototype with a COlaser and CNC controlled mirrors is built to define the fluence and repetition rate required to cut bone at clinically acceptable speedsSingle pass patterns will be cut in flat porcine femur bone samples to investigate the effect of fluencepattern spacing and repetition rate on the volumetric cutting speedThe volume removed will be measured with a confocal microscope to define the volumetric removal rateVRRFrom the VRR data an algorithm will be generated to define repetition ratesfluence levels and power levels that demonstrate necrosis free bone ablation at clinically viable speeds An orthopedic laser system is introduced that rapidly and safely cuts soft tissue and bone to replace surgical saws and drillsThe laser eliminates cauterizing soft tissue and bone necrosis leading to reduced patient painfaster healing and a lower infection rate