Challenge: Develop a remote catheter manipulation device for cardiac procedures which allows a cardiologist to complete the catheterization procedure outside of the fluoroscopy field.
Concept: A gantry positioned robot, controlled mechanically, with strict design requirements where the controller had to mimic controllers currently used in the surgical suite. This would ease training requirements and speed adaptation of the device.
Solution: The design provides 3 degrees of catheter control, insertion and withdrawal, rotation, and tip deflection, for cardiac mapping and ablation catheters. The robot is compatible with conventional, commercially available mapping catheters and sheaths. Its remote controller replicates the form and function of a catheter handle. The device was developed such that any electrophysiology catheter model from any of several manufacturers may be mounted in the manipulation head. Proven Process engineers designed and developed the linear track and gimbaled mechanism, the molded plastic enclosure, the remote-control ergonomics, and the control system. The control system was developed without imbedded microprocessors and without software in order to minimize the compliance overhead by eliminating software verification and validation. Proven Process also designed and developed several low-cost injection-molded and vacuum-formed sterile disposables necessary to operate this device in the sterile surgical field. The device is now commercially available.