SBIR-STTR Award

The proposed project here aims to facilitate the use of laparoscopically mounted ultrasound transducers during minimally invasive surgical (MIS) procedures. During a standard laparoscopic procedure, the surgeon operates through small incisions in the abdomen while viewing the internal anatomy on a remote video monitor; this creates a significant spatial coordination problem involving the surgeon's vision, his hands and the laparoscopic instruments. Because of this, many injuries occur during MIS procedures. Intra-operative ultrasound could provide a more thorough understanding of the surgery area (and thereby decrease the risk of injury), but the surgeon must then view an additional video stream on a second monitor. This exacerbates the spatial coordination problem of conventional MIS; with laparoscopic ultrasound, the surgeon is imaging two different areas of tissue within the body, and anatomical features in one image do not correspond to the same features in the other. We offer a solution to this problem with the Registered Ultrasound-Endoscope (RUE). In this system, the ultrasound video is spatially registered to the laparoscopic video, and is superimposed over it in the correct location. In this way, the echographic image of the tissue will be aligned to its image in the laparoscope's view. By fusing the video imagery and the ultrasound imagery into a single, unified display, the RUE addresses the serious problems associated with laparoscopic ultrasound (a complex dual-monitor interface and a difficult spatial coordination problem). We expect this device to significantly increase the use of laparoscopic ultrasound, by making it easier and faster to use. In this Phase I project, we propose to develop a RUE prototype and test it both quantitatively and qualitatively. Building the prototype will require both hardware and software efforts. We will test the performance accuracy of the system, followed by two rounds of testing with our surgeon collaborator. The first round will allow us to optimize technological and ergonomic aspects of the device, while the second round will quantitatively assess the system's utility. If funded, we will propose a Phase II project that would include wider-scale testing in animal models and human subjects. We are focusing initially on laparoscopic cholecystectomy for deployment of the technology, but we are by no means limited to it; this system could be adapted to any procedure that would benefit from laparoscopic ultrasound.

Public Health Relevance:
We propose an advanced visualization system for minimally-invasive surgery (MIS) that facilitates the use of laparoscopic ultrasound, for targeted use during laparoscopic cholecystectomy in order to reduce the rate of injury to the bile duct. When realized, the proposed system will provide visual information to exceed even that which is currently available via either the laparoscopic or even traditional ""open"" (i.e. laparotomic) approach. It can be adapted to different procedures, and holds to potential to enable procedures that currently cannot be carried out via MIS to become MIS-amenable. Compared to the conventional laparotomic (or ""open"") approach, MIS procedures have been shown to reduce trauma, recovery time, length of hospital stay, hospital cost, blood loss, post-operative fever, and time until the patient is able to return to work.

Thesaurus Terms:
Abdomen; Abdominal; Abscission; Address; Anatomic; Anatomical Sciences; Anatomy; Animal Model; Animal Models And Related Studies; Appearance; Area; Articulation; Au Element; Bile Ducts; Bile Tract; Bile Duct Structure; Biliary System; Biliary Tract; Biliary Tree; Biliary Tract Structure; Biopsy; Bleeding; Body Tissues; Cancers; Celioscopes; Cholangiography; Cholecystectomy; Cholecystectomy, Celioscopic; Cholecystectomy, Laparoscopic; Clinical; Cognitive; Comparative Study; Complex; Complication; Computer Programs; Computer Software; Consult; Data; Development; Devices; Diagnosis, Ultrasound; Echography; Echotomography; Effectiveness; Endoscopes; Excision; Extirpation; Feedback; Fever; Figs; Figs - Dietary; Funding; Gold; Hosp; Hand; Hemorrhage; Hepatic; Hepatobiliary; Hospital Costs; Hospitals; Hybrids; Hyperthermia; Image; Imagery; Injury; Insurance, Liability; Joints; Laboratories; Laparoscopes; Laparoscopic Cholecystectomy; Length Of Stay; Liability Insurance; Life; Liver; Load-Bearing; Loadbearing; Location; Magnetism; Malignant Neoplasms; Malignant Tumor; Measurement; Medical; Medical Imaging, Ultrasound; Medical Center; Methods; Minimal Access Surgical Procedures; Minimal Surgical Procedures; Minimally Invasive Surgical Procedures; Monitor; Number Of Days In Hospital; Operating Rooms; Operation; Operative Procedures; Operative Surgical Procedures; Organ; Otomy; Patients; Performance; Peritoneoscopes; Phase; Pilot Projects; Position; Positioning Attribute; Post-Operative; Postoperative; Postoperative Period; Principal Investigator; Procedures; Programs (Pt); Programs [publication Type]; Pyrexia; Qualitative Evaluations; Rf Ablation; Radio Frequency Ablation; Radiofrequency Ablation; Radiofrequency Interstitial Ablation; Removal; Research; Risk; Rue; Ruta; Scanning; Science Of Anatomy; Shapes; Sight; Software; Solutions; Source; Stream; Surface; Surgeon; Surgical; Surgical Interventions; Surgical Procedure; Surgical Procedures, Minimally Invasive; Surgical Removal; Surgical Incisions; System; System, Loinc Axis 4; Technology; Testing; Time; Tissues; Transducers; Trauma Recovery; Ultrasonic Imaging; Ultrasonic Transducer; Ultrasonogram; Ultrasonography; Ultrasound Test; Ultrasound Transducer; Ultrasound, Medical; Validation; Vision; Visual; Visualization; Weight-Bearing; Weight-Bearing State; Weightbearing; Work; Anatomy; Base; Bile Duct; Bile Ductule; Biliary Tract; Blood Loss; Body System, Hepatic; Computer Monitor; Computer Program/Software; Cost; Design; Designing; Diagnostic Ultrasound; Ergonomics; Febrile; Febris; Flexibility; Gallbladder Removal; Hospital Days; Hospital Length Of Stay; Hospital Stay; Human Subject; Imaging; Imaging Modality; Incision; Innovate; Innovation; Innovative; Instrument; Magnetic; Malignancy; Minimally Invasive; Model Organism; Neoplasm/Cancer; Organ System, Hepatic; Performance Tests; Pilot Study; Programs; Prototype; Public Health Relevance; Repair; Repaired; Resection; Skills Training; Sonogram; Sonography; Sound Measurement; Spatial Relationship; Success; Surgery; Tool; Ultrasound; Ultrasound Imaging; Ultrasound Scanning; Visual Information

The proposed project aims to facilitate the use of flexible laparoscopic ultrasound transducers during minimally invasive surgery (MIS) in order to reduce injury rates. During a standard laparoscopic procedure, the surgeon operates through small incisions in the abdomen while viewing the internal anatomy on a remote video monitor, creating an eye-hand-instrument spatial coordination problem. Because of this, many injuries occur during MIS procedures. Laparoscopic ultrasound provides a more thorough understanding of the anatomy, offering complementary anatomical information to the laparoscopic camera image and thereby decreasing the risk of injury. However, its use aggravates the inherent spatial coordination problem of conventional MIS, since the same anatomical features appear very differently between the two imaging modalities. Precisely placing interventional instruments such as needles becomes particularly difficult without extensive experience.This problem is addressed with the guidance system of this project, which shows the surgeon how his instruments are positioned with respect to features in the ultrasound scan. The dynamic stereoscopic imagery of the Phase I system shows the current position and orientation of the needle as well as its future trajectory, integrated with the live ultrasound image. Both needle and ultrasound scan are presented to the user in their actual spatial orientations. In Phase I, a prototype system was developed and its efficacy tested. The results were stunning: two expert users increased their placement accuracy from 60% without our guidance to 100% with it; while two novice users (who had never before held an ultrasound probe) improved from 5% accuracy without our guidance to 100% with it. In other words, the novice users were not able to place the needle into a feature in the LUT video without our system, and with it they could not miss. In this Phase II project, we propose to (1) investigate new capabilities that will increase the usefulness of the system; and (2) to continue refinement of the prototype so that, at the project's conclusion, it will be ready for clinical trials with human subjects. It will be tested both quantitatively and qualitatively in multiple animal studies. We will also test its usability in a clinical setting, as well as experimentally evaluate the usefulness of the novel features developed throughout Phase II.

Public Health Relevance:
We propose to develop an advanced stereoscopic visualization system for minimally-invasive surgery that facilitates the use of laparoscopic ultrasound during MIS interventions, in order to reduce patient injury rates. The system offers three-dimensional guidance for accurate placement of needles or other interventional instruments into structures seen in the laparoscopic ultrasound image, so that the surgeon can conduct the procedure more easily and more safely.

Thesaurus Terms:
"abdomen; Abdominal; Ablation; Address; Anatomic; Anatomical Sciences; Anatomy; Anesthesia; Anesthesia Procedures; Animals; Body Tissues; Caliber; Clinical; Clinical Trials; Clinical Trials, Unspecified; Clinical Effectiveness; Cognitive; Communities; Data; Development And Research; Devices; Diagnosis, Ultrasound; Diameter; Doctor Of Philosophy; Echography; Echotomography; Effectiveness; Endoscopes; Equipment; Ethics Committees, Research; Evaluation; Eye; Eyeball; Family Suidae; Feedback; Figs; Figs - Dietary; Fluoroscopy; Future; Goals; Grant; Hand; Hepatobiliary; Human; Human, General; Irbs; Image; Imagery; Injury; Institutional Review Boards; Intervention; Intervention Strategies; Life; Liver; Load-Bearing; Loadbearing; Magnetism; Man (Taxonomy); Man, Modern; Medical Imaging, Ultrasound; Medical Center; Mind; Monitor; Movement; Nature; Needles; Operating Rooms; Operation; Operative Procedures; Operative Surgical Procedures; Otomy; Outcome; Participant; Patients; Performance; Ph.D.; Phd; Phase; Physicians; Pigs; Position; Positioning Attribute; Procedures; Quantitative Evaluations; R & D; R&D; Relative; Relative (Related Person); Research; Research Ethics Committees; Risk; Safety; Science Of Anatomy; Slice; Space Perception; Spatial Discrimination; Structure; Suidae; Surgeon; Surgical; Surgical Interventions; Surgical Procedure; Surgical Incisions; Swine; System; System, Loinc Axis 4; Technology; Testing; Time; Tissues; Training; Ultrasonic Imaging; Ultrasonic Transducer; Ultrasonogram; Ultrasonography; Ultrasound Test; Ultrasound Transducer; Ultrasound, Medical; Visualization; Weight-Bearing; Weight-Bearing State; Weightbearing; Anatomy; Body Movement; Body System, Hepatic; Clinical Investigation; Diagnostic Ultrasound; Efficacy Testing; Ergonomics; Expectation; Experience; Flexibility; Human Subject; Imaging; Imaging Modality; Improved; Incision; Instrument; Interventional Strategy; Magnetic; Meetings; Minimally Invasive; Novel; Organ System, Hepatic; Perceptual Spatial Orientation; Phase 1 Study; Porcine; Prototype; Public Health Relevance; Research And Development; Skills Training; Sonogram; Sonography; Sound Measurement; Spatial Orientation; Spatial Orientation (Perception); Spatial Perception; Spatial Relationship; Stereoscopic; Success; Suid; Surgery; Ultrasound; Ultrasound Imaging; Ultrasound Scanning; Usability"