Drug Diffusing Peritoneal Dialysis Catheter with Reservoir
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Solution Overview
Problem
Peritoneal dialysis catheters often experience inflammation and infection at the exit site and tunnel, leading to refractory infections that may require catheter removal and transition to hemodialysis or transplantation.
Innovation Solution
A drug diffusing peritoneal dialysis catheter with a catheter tube, cuffs, and a reservoir system that allows for the delivery of antimicrobial agents directly to the cuff and exit site, providing immediate and time-delayed release to prevent and treat infections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional PD catheter is used, then the catheter structure is simple, but inflammation and infection occur at the exit site and tunnel
Solution Approach 1:
The catheter is pre-loaded with antimicrobial agents in the delivery area before implantation. This preliminary action ensures that the antimicrobial protection is already in place when the catheter is inserted, preventing infections at the exit site and tunnel rather than treating them after they occur.
Solution Approach 2:
The patent introduces an intermediary substance (antimicrobial agent) that mediates between the catheter surface and the biological environment. This intermediary prevents direct interaction between potentially harmful microorganisms and the catheter-tissue interface, thereby reducing infection risk without requiring complex structural modifications.
2Reliability
If antimicrobial agents are applied topically at the exit site, then infection treatment is provided, but the treatment is cumbersome and may require catheter removal for refractory cases
Solution Approach 1:
The catheter is designed to self-administer antimicrobial agents through its built-in delivery area. The catheter structure itself provides the treatment by releasing antimicrobial agents directly at the exit site and tunnel, eliminating the need for external topical applications and making the system self-sufficient in preventing and treating infections.
Solution Approach 2:
The antimicrobial agents are pre-positioned in the delivery area of the catheter before implantation. This preliminary preparation ensures that the treatment is immediately available when needed, eliminating the need for subsequent topical applications and providing continuous protection without requiring additional patient or provider actions.
3Reliability
If the catheter is removed for refractory infections, then the infection can be treated, but the patient loses PD therapy and must transition to HD or transplantation
Solution Approach 1:
The catheter is pre-equipped with antimicrobial agents in the delivery area before implantation. This preliminary action provides ongoing infection prevention and treatment capabilities, allowing refractory infections to be managed without catheter removal and thus maintaining treatment continuity and avoiding transition to alternative therapies.
Solution Approach 2:
The catheter provides self-service infection control through its integrated antimicrobial delivery system. This self-capability allows the catheter to manage infections internally without requiring removal, thereby maintaining continuous PD therapy and preserving treatment productivity even when infections occur.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The catheter effectively reduces the incidence of inflammation and infection, allowing patients to continue peritoneal dialysis without the need for catheter removal, thereby maintaining treatment options and reducing the risk of transitioning to hemodialysis or transplantation.
Implementation Method 1
The reservoir is in one embodiment expandable to (i) hold additional antimicrobial agent and (ii) place the additional antimicrobial agent under a slight positive pressure, which helps to move the antimicrobial agent to a desired delivery area of the catheter tube
Implementation Method 2
In a further embodiment, the delivery area is made of a material that allows the antimicrobial agent to diffuse through the delivery area
Implementation Method 3
In another embodiment, the delivery area is made of a material that is hydrophilic to the antimicrobial agent, allowing passage of the antimicrobial agent through the delivery area
Data Source
AI summary
A peritoneal dialysis catheter includes: a catheter tube defining a lumen for carrying peritoneal dialysis fluid to at least one aperture located at or near a distal end of the lumen; at least one cuff located along the outside of the catheter tube; an access site proximally spaced from the at least one cuff, the access site allowing an antimicrobial agent to be introduced into the catheter tube; a reservoir operable with the catheter tube and in fluid communication with the access site, the reservoir storing an amount of the antimicrobial agent received from the access site after an antimicrobial agent introducer is removed from the access site; and a delivery area of the catheter tube in fluid communication with the reservoir, the delivery area positioned so as to target delivery of the antimicrobial agent to the at least one cuff or other desired location along the catheter tube.