SBIR-STTR Award

The long-term objective of this project is the development and marketing of easily-swallowed electrodes for temporary transesophageal cardiac pacing. This pill electrode can replace cardiac catheterization in a variety of diagnostic and therapeutic applications, including initiation and/or termination of tachycardias, short-term maintenance of adequate rate in sinus bradycardia, and acceleration of rate to produce stress during echocardiographic or radionuclide studies of ventricular function. With transesophageal instead of catheter pacing, these applications become outpatient procedures with a greatly reduced complexity and cost.The specific objectives for Phase I are to (1) determine an optimal design for the bipolar transesophageal pacing electrode, (2) implement the design in an electrode that can be enclosed in an ordinary pharmaceutical capsule like the present pill electrode for esophageal electrocardiography, (3) develop new electronic circuits for the special nonpolarizing stimulator to be used in this high-current, switched pacing/recording application, (4) fabricate a flexible, ultrathin silicone rubber sheath to use with the pill electrode to improve fixation and provide for delivery of air and local anesthetic, and (5) design a continuation study in Phase 11 that will evaluate the electrode/stimulator system under clinical conditions, conceive new clinical applications, and develop a manufacturing and marketing plan for wide use of the technique.National Heart, Lung, And Blood Institute

The long term objective of this project is the development and marketing of easily swallowed electrodes for temporary transesophageal cardiac pacing. This "Pill Electrode" can replace cardiac catheterization in a variety of diagnostic and therapeutic applications, including initiation and/or termination of tachycardias, short term maintenance of adequate rate in sinus bradycardia, acceleration of rate to produce stress during echocardiographic or radionuclide studies of ventricular function. With transesophageal instead of catheter pacing, these become out-patient procedures with greatly reduced complexity and cost. The aim of Phase II is to conduct extensive animal and clinical studies to demonstrate safety and efficacy of the electrodes and stimulator which were designed, constructed and bench-tested in Phase I. The following hypotheses will be tested: 1) Short-term transesophageal pacing at currents and pulse-widths within the limits of the Arzco stimulator does not produce significant burning of the esophageal muscoa in dogs. 2) Transesphageal pacing with the extendible Pill Electrode results in successful left atrial capture in 95% of patients and can be used in many clinical procedures. 3) The procedure is tolerable without sedation due to the optimal electrode configuration and to the local anesthetic effect of lidocaine of similar agent delivered directly to the site of stimulation.

Thesaurus Terms:
Biomedical engineering, instrumentation clinically oriented, electrodes, gastrointestinal system, esophagus, heart disorders diagnosis, electrocardiography monitor, heart pacemakers electronic biomaterials, biomaterials evaluation, heart disorders diagnosis (incl exams), heart disorders, arrhythmia, bradycardia, heart disorders, arrhythmia, tachycardia, plastics, silicone rubber, sensory depression, anesthesia conduction, local, heart visualization human subjects, volunteers, mammals, carnivores, dogs