Pediatric interventional cardiology lacks appropriately sized instruments

Current strategies for pediatric interventional cardiology involve modifying adult-sized devices such as continuum robots to maneuver through the smaller vascular structures of pediatric patients ranging in size from 600 grams to adult size (100 kilograms and higher). This sub-optimal approach for pediatric procedures lacks steerability and stability and can lead to tissue, vascular, and valvular damage—resulting in increased morbidity and mortality.

The need for a pediatric-sized device is a critical unmet need during the placement of a transcatheter pulmonary valve (TPV), which has a high risk of tricuspid valve damage that can result in severe regurgitation. Other risks when using adult-size devices in pediatric patients include tissue perforation due to the difficulty of manipulating the delivery sheath. 

Versatile guidewire design minimizes trauma for pediatric or adult interventions

This patient-specific, coaxially aligned balloon guidewire can be manually or robotically steered to control the curvature and the length of bending segments (e.g., in a continuum robot) simultaneously and independently. The device can be used in any number of pediatric or adult procedures but was originally designed to be placed in the distal branch of the pulmonary artery with the goal of minimizing damage to the tricuspid valve during right ventricular outflow tract (RVOT) interventions. It can also aid in minimizing or eliminating trauma to structures within the body by preventing entanglement during procedures.

The versatility of this design enables many variations in usage and control that can be beneficial for different interventional medical applications—both in pediatrics and in adults. 

Solution Advantages
  • Increased control: Stiffness, curvature, and bending length can be precisely manipulated by varying the sequence of tubes, the relative motion among them, and the number and geometry of notches. 
  • Reduced trauma: The soft balloon tip of the guidewire is designed to minimize patient trauma and injury during procedures. 
  • Improved patient outcomes: This patient-specific device has the potential to reduce tissue, vascular, and valvular damage for better patient outcomes than current systems that are not designed for patients that weigh less than <20 kg.
  • Reduced cost: Certain variations of the design can use the inflatable balloon and a single wire to serve as both the wedge and guidewire  requiring no exchanges and saving cost of multiple materials used. 
  • Versatility: This technology is not limited to pediatric cardiac applications. It can be used for other pediatric and adult interventions with commercially available systems, and can also be applied to steerable, non-steerable, and non-robotic guidewires.
Potential Commercial Applications

This technology has applications in interventional medical procedures that require the use of guidewires, and procedures where it is necessary to minimize or eliminate damage to the environment in which the guidewire is maneuvered.

Outer sheath with inner hollow tube, notched middle tube, and a notched outer tube. Cutaway shows the tendon and inflatable balloon are inside the inner hollow tube.

Robotically steerable balloon guidewire system components.

Four drawings showing the progression of the guidewire to deploy a stent in the pulmonary valve.

The sequence of maneuvers of the guidewire passing through the inferior vena cava (IVC), right atrium (RA), tricuspid valve, right ventricle (RV), pulmonary valve (PV), and finally deploying it in the distal section of the pulmonary artery before stent delivery to PV.