SBIR-STTR Award

Endoscopy is an important tool in the diagnosis and treatment of many gastrointestinal, urological, and kidney diseases. Endoscopes have typically been reusable and are cleaned with high level disinfection (HLD) between patients. Publications and reports in recent years have shown that endoscopes are not sufficiently cleaned between patients, resulting in unacceptable levels of infection transmission among patients and even patient deaths. This has become a particular concern among complex endoscopes such as duodenoscopes, however the risk of infection transmission is not unique and extends across all flexible endoscopes including duodenoscopes, bronchoscopes, gastroscopes, ureteroscopes, and colonoscopes. Disposable endoscopes have been developed to address sterility but these usually offer inferior performance (including manipulability as well as image quality) compared to existing reusable endoscopes which has impeded clinician adoption. Elements Endoscopy is taking a novel approach to solve this problem by developing a modular flexible endoscopy system that lightly roboticizes the endoscope to remove infection risk, improve performance and reduce per procedure cost. The breakthrough is separating the handle from the flexible portion of the endoscope, allowing the flexible portion to become single use and be discarded after every use, eliminating patient to patient contamination risk. The reusable handle houses actuators that connect to pull wires in the separable flexible portion of the endoscope. Software will be used to enhance device handling performance and closely match the behavior of existing reusable endoscopes that are preferred by clinicians. Our design addresses the issue of contamination while offering enhanced performance at a lower per procedure cost. In this proposal, we will refine our knowledge of existing endoscope performance, iterate our design for both a duodenoscope and a colonoscope body, and confirm that we can match the mechanical handling performance of the preferred reusable devices now in use. Mechanical performance will be tested in benchtop experiments and with advanced device prototypes tested in relevant phantom models by experienced physicians to assess usability. Successful completion of this work will result in working duodenoscope and colonoscope prototypes, demonstrating the abilities of our novel endoscope platform. In the future these prototypes will be refined and the platform expanded to provide a solution to the issue of contaminated endoscopes without sacrificing performance or increasing cost to the customer.

Public Health Relevance Statement:
Project Narrative Endoscopy is an important tool in the diagnosis and treatment of many gastrointestinal, urological, and kidney diseases, but publications and reports in recent years have shown that reusable endoscopes are not being sufficiently cleaned between patients, resulting in unacceptable levels of infection transmission among patients and even patient deaths. Elements Endoscopy is developing a novel, modular flexible endoscopy platform with a reusable operator body (handle) and disposable endoscope bodies specifically designed for different applications. With initial duodenoscope and colonoscope designs, our device will offer better usability and cost then other single-use endoscopes while removing the risk of infection present with current reusable options.

Project Terms:
Behavior; Cecum; Cholangiography; Colon; Colonoscopy; Cessation of life; Death; Diagnosis; Disinfection; Elements; Endoscopes; Endoscopy; endoscopic imaging; Future; Gastrointestinal Diseases; gastrointestinal disorder; Infection; Intubation; Kidney Diseases; Nephropathy; Renal Disease; kidney disorder; renal disorder; Marketing; Medical Device; Patients; Physicians; Publications; Scientific Publication; Risk; Robotics; Computer software; Software; Testing; Time; Urologic Diseases; Urinary Tract Diseases; Urologic Disorder; Urological Diseases; Urological Disorders; urinary tract disorder; Work; Bronchoscopes; Colonoscopes; Duodenoscopes; Gastroscopes; Ureteroscopes; improved; Procedures; Distal; Phase; tool; Knowledge; Mechanics; mechanic; mechanical; Complex; System; Test Result; Inferior; experience; Performance; phantom model; success; Sterility; sterile; novel; Devices; Reporting; Modeling; response; Cannulations; Manufacturer; Address; Motor; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; transmission process; Transmission; Characteristics; Process; Development; developmental; Image; imaging; cost; designing; design; new approaches; novel approaches; novel strategy; novel strategies; innovate; innovative; innovation; usability; iterative design; prototype; flexible; flexibility; imaging system; experiment; experimental research; experiments; experimental study; procedural costs; procedure cost; infection risk; adoption by clinician; adoption by healthcare providers; adoption by physician; adoption by provider; clinician adoption; physician adoption; provider-level adoption; provider adoption