Methods and compositions for decontaminating PD catheters

Inventors

Maenle, Garrick Lawrence • RADFORD, Robert • Menzel Bueno, Cristian Adolfo • Pasmore, Mark Edward • Oppegard, Shawn Collin

Assignees

Vantive Health GmbH • Vantive US Healthcare LLC

Abstract

A method of performing peritoneal dialysis (PD), the method comprising: delivering a PD fluid to the peritoneal cavity of a patient through a PD catheter; dwelling the PD fluid within the peritoneal cavity; and while dwelling the PD fluid, removing a biofilm from the PD catheter wall using a biofilm removing solution. The biofilm removing solution comprises: sodium citrate dihydrate; citric acid anhydrous; sodium lauryl sulfate; and water. In another aspect, a method for decontaminating a peritoneal dialysis (PD) catheter and removing a biofilm from the PD catheter and a transfer set, the method comprising: providing a biofilm removing solution; transferring the biofilm removing solution into a syringe; connecting the syringe to a transfer set of the PD catheter; and filling the transfer set and the PD catheter with the biofilm removing solution.

Core Innovation

The disclosed invention relates to performing peritoneal dialysis in a manner that removes biofilm from a wall of a PD catheter while PD fluid is dwelling within a peritoneal cavity of a patient. The method delivers and dwells PD fluid through the PD catheter, and while the PD fluid dwells it removes a biofilm from the catheter wall using a biofilm removing solution defined by sodium citrate dihydrate, citric acid anhydrous, sodium lauryl sulfate, and water in stated concentration ranges.

Further variants define the biofilm removing solution to include alkyl sulfonates in a concentration range of about 0.61 g/L to about 1.10 g/L. Other variants define an antimicrobial ingredient within the biofilm removing solution, wherein the antimicrobial ingredient is selected from the group consisting of an antibiotic, a bleach and silver sulfadiazine.

Additional aspects address pumping or delivering a PD fluid including a biofilm removing solution into the peritoneal cavity through the PD catheter and dwelling the PD fluid including the biofilm removing solution. Another approach removes at least a portion of a biofilm present in a lumen of an indwelling peritoneal catheter by injecting the biofilm removing solution into the lumen to occupy at least a portion of the lumen, dwelling the dialysis fluid within the peritoneal cavity, and removing at least a portion of the biofilm removing solution by withdrawing at least a portion of the dialysis fluid from the peritoneal cavity into the catheter.

Claims Coverage

The independent claims cover five inventive frameworks for PD-associated biofilm removal: removing biofilm from a PD catheter wall during PD dwelling using a defined citrate/citric acid/surfactant solution; adding alkyl sulfonates; adding an antimicrobial ingredient; delivering PD fluid that includes the biofilm removing solution; and removing biofilm from a lumen of an indwelling peritoneal catheter by injecting the solution into the lumen and then withdrawing dialysis fluid to remove the solution. Each framework is grounded in the stated, concentration-ranged composition of the biofilm removing solution.

Across the independent claims, the coverage centers on PD-associated biofilm removal using a citrate/citric acid/sodium lauryl sulfate aqueous biofilm removing solution defined by concentration ranges. Claim coverage extends to alkyl sulfonates, an antimicrobial ingredient selected from antibiotic, bleach, or silver sulfadiazine, pumping or delivering PD fluid that includes the biofilm removing solution, and lumen-resident biofilm in an indwelling peritoneal catheter via injection of the biofilm removing solution followed by withdrawal of dialysis fluid to remove the solution.

Stated Advantages

Documented Applications