SBIR-STTR Award

Microflex Technology for Early Detection of Lung Disease
Award last edited on: 4/29/19

Sponsored Program
STTR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,491,476
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Dale N Lawrence

Company Information

Quest Product Development Corporation (AKA: Quest Technologies Group)

6833 Joyce Street
Arvada, CO 80007
   (303) 670-5088
   N/A
   www.quest-corp.com

Research Institution

University of Colorado

Phase I

Contract Number: 1R41HL083331-01A1
Start Date: 9/19/05    Completed: 8/30/07
Phase I year
2005
Phase I Amount
$145,155
Lung cancer is the leading cause of cancer deaths in the United States, causing more deaths than breast, prostate and colorectal cancer combined. Some progress has been made in reducing lung cancer mortality, however, progress has been slow and hampered by the lack of effective early detection strategies. New, cost-effective techniques are needed to screen, localize, sample, and treat suspicious lesions. Bronchoscopy is a proven method of visualizing the airways of the lung and performing biopsies of suspicious tissue. While the bronchoscope has proven to be a very valuable tool, it has not yet lived up to its full potential since its size precludes access to more than half of the lung. In response to the current limitations of bronchoscopy, Rose Biomedical Development Corporation and its partner the University of Colorado, propose developing and testing the MicroFlex Scope, an innovative 1 mm diameter, highly dexterous extension of current bronchoscopes to support early detection of lung cancer in a greater area of the lung. The team proposes developing and testing the technology during the Phase I proof of concept. In Phase II, the prototype scope will be built and in vivo testing conducted.

Thesaurus Terms:
Biomedical Equipment Development, Bronchoscopy, Lung Neoplasm, Neoplasm /Cancer Diagnosis Diagnosis Design /Evaluation, Early Diagnosis, Miniature Biomedical Equipment

Phase II

Contract Number: 2R42HL083331-03A2
Start Date: 9/19/05    Completed: 6/30/13
Phase II year
2011
(last award dollars: 2013)
Phase II Amount
$1,346,321

MicroFlex Technology for Early Detection of Lung Cancer Project Summary MicroFlex technology will provide unprecedented flexibility and controllability for bronchoscopes, enabling minimally invasive bronchoscopy to reach previously inaccessible peripheral bronchi and provide direct visualization and tool manipulation capabilities for diagnostic and therapeutic procedures. MicroFlex technology combines innovations in actuation, sensing, control and assembly to produce an ultra-slim digitally controlled bronchoscope more flexible and controllable than currently possible. This technology promises to improve detection, for example of early-stage lesions, and provide more accurate diagnoses to improve cure rates for lung cancer and other lung diseases. This project will refine technology proven in the Phase I study to design, fabricate and functionally test novel 1mm diameter actively-guided MicroFlex Tool prototypes for bronchoscopy procedures. A lung-specific MicroFlex device will be developed, built and tested in the laboratory for force and motion capabilities, a control manipulative and associated control electronics and software will be developed, and pulmonologists will test the integrated system in-vivo in animals for function and usability. Since MicroFlex tools are controlled by temperature change in internal actuators, thermal effects of contacting bronchial epithelial tissue will be studied for thermal tissue damage and validation of thermal control models. Effectiveness of a prototype MicroFlex device including a Guide Catheter and MicroFlex Tool will be evaluated in accessing peripheral sites down to a 1mm bronchiole diameter, visualizing tissue, placing markers and performing tissue sampling. MicroFlex technology, fabrication processes and prototypes will be refined by integrating input from experienced bronchoscopists, engineers with expertise in medical product design, and prospective Phase III manufacturing partners and suppliers of complementary technology. Potential Phase III manufacturing partners will be identified and utilized for Phase II prototype components, where possible, to accelerate the commercialization process.

Public Health Relevance:
MicroFlex Technology for Early Detection of Lung Cancer Project Narrative Lung cancer is the leading cause of cancer-related deaths in the United States, and despite advances in treatment the prognosis remains poor with a less than 15% five year survival rate, due to the difficulty of early stage detection and diagnosis. Bronchoscopy is used to diagnose various lung diseases, but current bronchoscopes are too large and too limited in flexibility and control to reach most of the peripheral lung. MicroFlex technology enables a 1mm diameter, ultra-flexible, actively-guided, digitally-controlled bronchoscope that can access nearly all locations in the lung to about the 15th bronchial branch. This bronchoscope is compatible with state of the art electromagnetic navigation, and provides direct visualization and dexterous MicroFlex tools for accurate tissue sampling and therapeutic agent delivery in the airways and pleural space.

Thesaurus Terms:
Affect;Alloys;Animal Testing;Animals;Articular Range Of Motion;Biopsy;Body Tissues;Bronchi;Bronchioles;Bronchiolus;Bronchoscopes;Bronchoscopist;Bronchoscopy;Coad;Copd;Caliber;Catheters;Chronic Obstructive Airway Disease;Chronic Obstructive Lung Disease;Chronic Obstructive Pulmonary Disease;Colorado;Computer Software;Computers;Detection;Devices;Diagnosis;Diagnostic Method;Diagnostic Procedure;Diagnostic Technique;Diameter;Distal;Early Diagnosis;Effectiveness;Electronics;Elements;Endoscopes;Endoscopy;Engineering;Epithelial;Fiber;Fingers;Illumination;Image;Imagery;Industry;Joint Range Of Motion;Loinc Axis 4 System;Laboratories;Laboratory Animal Models;Laboratory Animals;Lead;Lesion;Lesion By Stage;Licensing;Lighting;Location;Lung;Lung Cancer Screening;Lung Respiratory System;Lung Diseases;Malignant Tumor Of The Lung;Malignant Neoplasm Of Lung;Measurement;Mechanics;Medical;Memory;Modeling;Motion;Outcome;Patients;Pb Element;Peripheral;Phase;Phase I Study;Position;Positioning Attribute;Procedures;Process;Pulmonary Cancer;Pulmonary Diseases;Pulmonary Disorder;Pulmonary Malignant Neoplasm;Relative;Relative (Related Person);Research;Respiratory Disease;Respiratory System Disease;Respiratory System Disorder;Safety;Sampling;Screening For Lung Cancer;Shapes;Side;Site;Software;Speed;Speed (Motion);Structure;System;Technology;Temperature;Testing;Therapeutic Procedure;Tissue Sample;Tissues;Universities;Validation;Visual Fields;Visualization;Base;Commercialization;Computer Program/Software;Cost;Design;Designing;Early Detection;Experience;Eye Field;Flexibility;Flexible;Heavy Metal Pb;Heavy Metal Lead;Imaging;Improved;In Vivo;Innovate;Innovation;Innovative;Innovative Technologies;Instrument;Interest;Lung Cancer;Lung Cancer Early Detection;Lung Disorder;Mechanical;Minimally Invasive;New Technology;Next Generation;Novel;Novel Technologies;Phase 1 Study;Product Development;Programs;Prospective;Prototype;Pulmonary;Range Of Motion;Tool;Usability