Problem Statement

Pediatric hemodialysis patients lack vascular access options for hemodialysis on-par with the options available to adults. This is particularly apparent in the quality of hemodialysis catheters on the pediatric market. ABA Cath aims to bridge this gap in quality of care in the pediatric and adult markets and bring a hemodialysis catheter that minimizes recirculation no matter the flow orientation to the pediatric market.

The ABA Cath is used to treat kidney failure, which is commonly called end stage renal disease (ESRD) and is also known as the last stage of chronic kidney disease (CKD). Approximately 200,000 new cases of ESRD are recorded in the U.S. per year, 1400 of which are children [1, 2].

Kidney failure causes are linked to diabetes, high blood pressure, inflammation, and infection [3]. With the onset of kidney failure, many nonspecific symptoms may occur such as nausea, fatigue, itching, muscle cramps, sleep deprivation, and abnormal urination [1]. Progression of kidney failure is classified as ESRD when a patient loses more that 85% of their kidney function and these patients require hospitalization.

There is no cure to kidney failure. Patients of ESRD are given dialysis treatment until a kidney transplant is available [3].

There are two types of dialysis: hemodialysis and peritoneal dialysis [4].

In peritoneal dialysis, the abdomen is accessed with a narrow plastic tube that is called a catheter. The space within, which is known as the peritoneal cavity is then filled with dialysate through the catheter. The dialysate is used to draw out the waste from the blood in the surrounding veins and arteries. After a few hours, the dialysate is drained away from the catheter. This treatment is performed daily.

In hemodialysis, an artificial kidney (hemodialyzer) is used to filter your blood. One way for the hemodialyzer to access the blood in the body is a catheter that is inserted into a large vein called the internal jugular vein. The blood flows through the hemodialyzer, which filters it, and then returns back to the body. The catheter is typically temporary, but for long-term treatment more durable, tunneled central venous catheters (CVCs) are used. This sort of treatment is repeated for patients many times per week.

The quality of vascular access options in pediatric hemodialysis are worse than the equivalent options in adults. This disparity is particularly noticable in CVCs available for pediatric use. In pediatric CVCs, the lumens are designed to support flow in one direction. When flow rates decrease during treatment, however, clinicians reverse the flow lines and run hemodialysis in the opposite direction. This gives rise to an issue known as recirculation where the filtered blood returning to the body is once again sent to the hemodialyzer. This is a greater issue due in part to current catheter designs, which utilize a step-tip approach where the returning blood exits from a lumen that is extended further than the lumen used for blood intake. The flow reversal process that is typically used suffers from greater recirculation due to this design. Limited symmetrical designs for adult CVCs on the market exist and allow for hemodialysis in both flow directions, but don't offer the efficacy of step-tips. Additionally, there aren't symmetrical CVCs available in pediatric sizes.

ABA Cath provides the solution.

The ABA Cath and the in-development ABA Cath Slide provide innovative designs that tackle the problem of recirculation head-on for the pediatric market. The ABA Cath is made with this in mind by having an 8 Fr outer diameter while maximizing flow rate through its D-shaped lumen design. The symmetrical tips allow for the flow reversal of blood without compromising the recirculation of filtered blood. The ABA Cath Slide improves on the ABA Cath by utilizing a new approach for extendable and retractable tips allowing for a better response to flow reversal and recirculation.