One of every 16 Americans will be diagnosed with lung cancer in their lifetime. Each year in the United Statesthere are nearly 250,000 new diagnoses and 150,000 deaths with an estimated productivity loss in excess of$20 billion. Thanks to recent advancements in CT imaging, detection of smaller suspicious pulmonary noduleswithin distal regions of the lung is now possible. As a result, mortality rates have decreased by nearly 20% dueto earlier initiation of treatment protocols. The ability to safely obtain a viable biopsy sample is critical.However, despite the availability of better CT imaging, little progress has been made in expanding affordabletools which can safely access distal regions of the lung to diagnose and stage suspicious nodules.Percutaneous needle biopsy remains the standard of care used to obtain nodule tissue samples, although theprocedure is associated with pneumothorax complication rates greater than 20%. In contrast, bronchoscopesare 10X safer when used to acquire biopsies. However, bronchoscopes possess two main limitations whichresult in many lung cancers not being successfully diagnosed. First, the relatively large size prevents themfrom being able to access most of the lung. Second, because the bronchoscope's tip is manipulated fromnearly a meter away using complex pull-wire based mechanisms, limited control of the tip is provided whichlargely restricts biopsy to nodules within the airway. To improve upon manual bronchoscopes, robotic solutionshave been developed; however, these technologies are difficult to learn, do not greatly improve distal accessor tip control, and are prohibitively expensive (~$500k) for most hospitals. As a result, adoption of robotics forbronchoscopy has been slow. UNandUP has invented a novel robotic bronchoscopy platform that providesprecise control of the bronchoscope's tip using a smaller scope diameter than previously possible that enablessafe access into otherwise inaccessible lung regions and the ability to better biopsy nodules not directly in theairway. By overcoming the complexities of traditional robotic approaches, the proposed technology can bepriced at a fraction of the cost of competing robotic solutions. This will allow advanced lung biopsy capabilitiesto be offered to nearly all hospital versus only being available at select institutions. Importantly, the technologyalso promises to serve as an exploratory platform for emerging cancer therapies which include gene,photodynamic, and ablation therapies. The project's aims include 1) building the robotic workstation, 2) buildinga steerable bronchoscope, and 3) assessing performance in CT-based bronchial phantoms.
Public Health Relevance Statement: Lung cancer is the most common cancer worldwide and the leading cause of cancer death in the US,
accounting for 2.1 million new cases each year (229,000 in the US) with 1.8 million deaths (150,000 in the US).
Earlier screening and detection drive an increasing rate of interventions to smaller lesions in more remote
regions of the lung, and although bronchoscopy is safer than percutaneous intervention, accessing distal lung
regions and controlling the bronchoscope's tip to obtain a viable biopsy are difficult. In this Phase I proposal,
UNandUP, LLC (short for "Unmet Needs and Underserved Populations") will demonstrate proof of concept that
its novel and cost-effective robotic platform can extend access into otherwise inaccessible lung territories and
improve bronchoscope control, thereby allowing for more efficient and safer biopsies.
Project Terms: Accounting ; Acrylates ; Adoption ; Angiography ; Angiogram ; angiographic imaging ; Animals ; Biopsy ; Needle biopsy procedure ; needle biopsy ; Bronchoscopy ; Malignant Neoplasms ; Cancers ; Malignant Tumor ; malignancy ; neoplasm/cancer ; Cause of Death ; Complication ; Cessation of life ; Death ; Diagnosis ; Fatigue ; Lack of Energy ; Forcep ; Genes ; Goals ; Hospitals ; Human ; Modern Man ; In Vitro ; Learning ; Lung ; Lung Respiratory System ; pulmonary ; Manuals ; Metals ; mortality ; Needles ; Nodule ; Optics ; optical ; Pneumothorax ; pneumothorax disorder ; Lung nodule ; pulmonary nodule ; Research Personnel ; Investigators ; Researchers ; Robotics ; Safety ; Technology ; Time ; X-Ray Computed Tomography ; CAT scan ; CT X Ray ; CT Xray ; CT imaging ; CT scan ; Computed Tomography ; Tomodensitometry ; X-Ray CAT Scan ; X-Ray Computerized Tomography ; Xray CAT scan ; Xray Computed Tomography ; Xray computerized tomography ; catscan ; computed axial tomography ; computer tomography ; computerized axial tomography ; computerized tomography ; Treatment Protocols ; Treatment Regimen ; Treatment Schedule ; United States ; Roentgen Rays ; X-Radiation ; X-Ray Radiation ; X-ray ; Xray ; Measures ; Price ; pricing ; Device Designs ; Data Set ; Dataset ; base ; Bronchoscopes ; sensor ; improved ; Procedures ; Distal ; Surface ; Clinical ; Phase ; Lesion ; Malignant neoplasm of lung ; Malignant Tumor of the Lung ; Pulmonary Cancer ; Pulmonary malignant Neoplasm ; lung cancer ; Measurement ; Staging ; Shapes ; tool ; mechanical ; Mechanics ; Complex ; System ; 3-D ; 3D ; three dimensional ; 3-Dimensional ; meter ; Width ; Ablation ; meetings ; magnetic ; Magnetism ; magnetic field ; American ; early detection ; Early Diagnosis ; Performance ; success ; Biopsy Sample ; Biopsy Specimen ; Structure ; novel ; Modality ; Devices ; Position ; Positioning Attribute ; Statistical Methods ; Sampling ; performance tests ; Property ; Intervention Strategies ; interventional strategy ; Intervention ; Cancer Treatment ; Malignant Neoplasm Therapy ; Malignant Neoplasm Treatment ; anti-cancer therapy ; anticancer therapy ; cancer-directed therapy ; cancer therapy ; Institution ; Tissue Sample ; preventing ; prevent ; Diameter ; Caliber ; Length ; Data ; Detection ; Resolution ; Cancer Etiology ; Cancer Cause ; Pathway interactions ; pathway ; Joystick ; pre-clinical ; preclinical ; productivity loss ; cost ; Underserved Population ; under served group ; under served people ; under served population ; underserved group ; underserved people ; Outcome ; cost effective ; usability ; prototype ; standard of care ; flexibility ; flexible ; arm ; 3D Print ; 3-D print ; 3-D printer ; 3D printer ; 3D printing ; three dimensional printing ; imaging detection ; imaging-based detection ; imaging-based disease detection ; early screening ; robotic system ; safety assessment ; Visualization ;
