Modular Catheter Systems in Minimally Invasive Interventional Medical Procedures: Case Study

Abstract

Medical device catheters that are used in minimally invasive interventional medical procedures all follow the same integrated design and use paradigm. The features and elements of any catheter device are combined in a single unitary construction. A modular approach to the design, construction, and use of these types of interventional catheters may provide significant advantages and benefits not available with an integrated design paradigm. This paper aimed to present the design of a modular catheter system and the findings from an initial veterinary use as a case study for the potential of modular catheter systems in general. A modular catheter system was designed using commercially available angioplasty balloon dilatation catheters as one module in the system and a custom designed scoring adapter as the other module. The scoring adapter incorporates wires to add scoring features to the angioplasty balloon catheter to improve the dilatation performance during a pulmonary valvuloplasty procedure. The scoring adapter also includes a novel attachment mechanism to couple the scoring adapter to any 0.035-inch guidewire–compatible angioplasty balloon catheter. The modular catheter system was successfully designed, manufactured, and used in an initial minimally invasive veterinary cardiovascular intervention to treat a case of canine subvalvular pulmonary stenosis. The scoring adapter and angioplasty balloon catheter were successfully combined tableside in the operating room at the time of the procedure and used to successfully dilate the subvalvular obstruction. The successful design and use of the presented modular catheter system demonstrates the feasibility and potential advantages of this type of paradigm to enable physicians to create interventional catheter devices at the time of a procedure guided by the procedural needs.