Forward Looking Intracardiac Imaging Catheters for Electrophysiology

Minimally invasive electrophysiology interventions to treat cardiac arrhythmias are increasing worldwide due to advances in technologies that enable more effective clinical procedures. A forward imaging ultrasound catheter design has been developed and tested to advance the methods of integration of intracardiac imaging and electrophysiology sensing. The first catheters built have been constructed with a 9F (3mm) shaft and a large (15F) tip to support experimental wire ports adjacent to a 24 element phased array operating at 14MHz. The final tip design construction size will be 9F and possess an integrated metal electrode at the catheter distal end. Two forward looking array designs have been developed in parallel to produce two contrasting fine pitch (65 microns) 24 element phased array construction approaches. The first array has been assembled with a standard 2-2 composite PZT technology with the flex circuit mounted on the front facing side, and the second design is a cMUT version with a flip-chip bonded silicon die bonded to a backside flex circuit. The cMUT design requires a special interface to assure a safe element biasing scheme while enhancing the array's linearity and sensitivity. The first PZT array prototypes, built without explicit matching layers, have been characterized and agree with FEA and KLM analyses in operation at 14MHz. Matching layer variations have been used on the front layer flex circuit to optimize the sensitivity and bandwidth of the PZT arrays while minimizing the thermal boundary layer. Specially designed assembly approaches addressed the challenging forward looking array configurations that utilize interconnection flex circuits with bend radii at 250 microns. Animal studies have been performed utilizing beam forming adaptations for the forward looking imaging catheter operation on a Vingmed Vivid-7 system. The first piezoceramic array devices were used successfully to image the myocardium of the right atrium of a pig while simultaneous tissue ablation was performed.