Innovation of a Neonatal Peritoneal Dialysis Catheter to Expand Dialysis Capabilities for Critically Ill Neonates in Low-Resource Settings

Abstract

Introduction: The lack of peritoneal dialysis (PD) catheters designed explicitly for neonates creates significant challenges in the provision of neonatal PD. High resource settings can circumvent this limitation by resorting to alternative extracorporeal dialysis methods. However, in low-resource settings, PD remains the preferred dialysis modality, and the use of off-label catheters for PD results in complications such as omental wrapping and occlusion. This study introduces a novel catheter design featuring a multi-diameter side port configuration and a helical geometry.

Methods: We employed numerical simulations to identify an optimal multi-diameter side port configuration, to address fluid dynamic issues that lead to catheter occlusion and omental wrapping. Following the simulations, we experimentally evaluated the catheter's performance in a series of benchtop tests designed to simulate physiological conditions encountered in neonatal PD.

Results: Our experimental evaluations demonstrated that the helical catheter outperforms commonly utilized pigtail catheters with same-sized diameter side ports by consistently achieving superior drainage efficiency during fibrin clot occlusion and omental wrapping tests.

Conclusion: The catheter is intended to be placed at the bedside to perform renal replacement therapy for neonates in low-resourced settings.

Introduction: The lack of peritoneal dialysis (PD) catheters designed explicitly for neonates creates significant challenges in the provision of neonatal PD. High resource settings can circumvent this limitation by resorting to alternative extracorporeal dialysis methods. However, in low-resource settings, PD remains the preferred dialysis modality, and the use of off-label catheters for PD results in complications such as omental wrapping and occlusion. This study introduces a novel catheter design featuring a multi-diameter side port configuration and a helical geometry.

Methods: We employed numerical simulations to identify an optimal multi-diameter side port configuration, to address fluid dynamic issues that lead to catheter occlusion and omental wrapping. Following the simulations, we experimentally evaluated the catheter's performance in a series of benchtop tests designed to simulate physiological conditions encountered in neonatal PD.

Results: Our experimental evaluations demonstrated that the helical catheter outperforms commonly utilized pigtail catheters with same-sized diameter side ports by consistently achieving superior drainage efficiency during fibrin clot occlusion and omental wrapping tests.

Conclusion: The catheter is intended to be placed at the bedside to perform renal replacement therapy for neonates in low-resourced settings.

Keywords: Low- and middle-income countries; Neonatal acute kidney injury; Peritoneal dialysis.

Fig. 1.

a Catheter shaping process. b Normal function of a drainage catheter for the use of PD. c Fibrin clot occlusion of catheter side ports during PD. d Simulated fibrin occlusion of side ports in a bench top setting. e Method for simulating a peritoneal cavity. f Simulated peritoneum with drainage catheter placement in a bench top setting.

Fig. 2.

a COMSOL simulation of control side port design drainage; inset: distribution of drainage along each side port number from left to right along the simulated control catheter. b COMSOL simulation of variable side port size design drainage; inset: distribution of drainage along each side port number from left to right along the simulated variable side port catheter. c Image of helical shaped multi-diameter side port drainage catheter. d Drainage volume of helical and control catheters with the presence or absence of a fibrin clot analog. e Drainage volume of helical and control catheters with the presence or absence of omental wrapping. f Difference in drainage in the presence of a different occlusion method.