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Remote-Control Percutaneous Coronary Interventions

Concept, Validation, and First-in-Humans Pilot Clinical Trial

Rafael Beyar, MD, DSc^_*,_*,1, Luis Gruberg, MD^_*, Dan Deleanu, MD, Ariel Roguin, MD, PhD^_*, Yaron Almagor, MD, Silviu Cohen, RN^_*, Ganesh Kumar, MD^_* and Tal Wenderow, BSc^,2

^_* Division of Invasive Cardiology, Rambam Medical Center and the Technion, Haifa, Israel
Cardiovascular Disease Institute "Prof. C. C. Iliescu," Fundeni Hospital, Bucharest, Romania
Department of Cardiology, Shaare’i Zedek Medical Center, Jerusalem, Israel
NaviCath Ltd., Haifa, Israel

View larger version (91K): [in a new window]   Figure 1 The setup of the Remote Navigation System (RNS) during the pilot clinical experiments. The operator control unit of the RNS was placed at the catheterization laboratory. The bedside unit was attached to the table side and adjusted to the groin position. The standard imaging screens were used for guiding the navigation process.

View larger version (88K): [in a new window]   Figure 2 (A) A prototype of the bedside unit attached to the patient table, loaded with a wire and device. A standard guiding catheter and Y-connector are hooked to a special holder on the base. (B) A schematic diagram of the bedside unit loaded with a wire and device. The guiding catheter hooks to a standard Y-connector, which is attached to the base through a sterile holder. Similarly, the wire and device navigators are attached to the sterile plastic sheet-covered base. The wire navigator controls both axial and rotational motions (arrows). The device navigator, composed of two pairs of rollers, controls the axial motion and discrete positioning of the device delivery system (arrows) and provides online position feedback of the device.

View larger version (84K): [in a new window]   Figure 3 The operator control unit, composed of a computer, a control console, and a joystick. The screen has various control features, including precise positioning and discrete wire rotation options. Safety "STOP" button is emphasized in red.