Clog-Resistant Catheter Design for Implantable Fluid Management

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Solution Overview

Problem

Existing treatments for intracorporeal fluid accumulations, such as ascites, pleural effusion, and pericardial effusion, face challenges with catheter clogging due to viscous fluids and tissue ingrowth, leading to increased morbidity, mortality, and patient non-compliance due to manual operation requirements.

Innovation Solution

A fluid management system with clog-resistant mechanisms, including catheters with anti-clogging designs and programmed routines for autonomous fluid cycling, utilizing a microcontroller to actuate pumps and valves to prevent clogging, and sensors to monitor physiological conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional catheters are used for fluid drainage, then fluid can be drained from body cavities, but the catheters become clogged due to viscous fluids and tissue ingrowth

Engineering Contradiction:

Improvecatheter patencyVSAvoidcatheter clogging

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The catheter is divided into multiple lumens (inflow lumen and outflow lumen) that can operate independently. The inflow catheter has multiple holes for fluid entry while the outflow catheter has a single lumen, creating segmented flow paths that reduce clogging risk by distributing fluid intake across multiple entry points

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system implements periodic reverse pumping cycles where the pump operates in reverse direction for predetermined time intervals. This periodic reverse action flushes the inflow catheter to prevent and remove clogs, transforming a static clogging problem into a dynamically managed system

Inventive Principle:

Principle #19Periodic action

Solution Approach 3:

Pressure sensors monitor fluid pressure within the catheter system and provide feedback to the control circuit. When pressure differential exceeds predetermined thresholds indicating potential clogging, the system automatically activates reverse pumping or alerts the patient, creating a closed-loop feedback system that prevents complete catheter occlusion

Inventive Principle:

Principle #23Feedback

2Productivity

If manual pumping mechanisms are used, then fluid can be transferred between cavities, but patient compliance decreases due to difficulty of operation

Engineering Contradiction:

Improvefluid drainage efficiencyVSAvoidpatient compliance

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The implantable pump system operates autonomously without requiring patient manipulation. The pump, controlled by an integrated control circuit and pressure sensors, automatically transfers fluid between body cavities based on sensed pressure differentials, eliminating the need for patient to locate and manually actuate pumping mechanisms

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The manual mechanical pumping system is replaced with an implantable electromechanical pump system. The pump is actuated by a battery-powered motor controlled by electronic circuits that respond to pressure sensor feedback, substituting patient manual operation with an automated implantable device

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Duration of action of stationary object

If implantable pumps are used for chronic fluid management, then continuous drainage is achieved, but infection risk increases

Engineering Contradiction:

Improvecontinuous drainage capabilityVSAvoidinfection risk

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The system separates the pump and control electronics into an implantable unit while keeping the fluid reservoir and external connection components outside the body. This extraction minimizes the implanted volume that could harbor infection while maintaining continuous drainage capability through the implantable pump

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The catheters are constructed with flexible biocompatible materials that minimize tissue irritation and infection risk. The soft flexible construction allows the catheters to conform to body cavities without causing trauma, reducing infection risk while enabling continuous long-term operation

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS10716922B2Implantable fluid management system having clog resistant catheters, and methods of using same

Publication Date: 2020.07.21 SEQUANA MEDICAL NV

AI summary

A fluid management system for moving bodily fluid accumulated due to ascites, pleural effusion or pericardial effusion is provided including an implantable pump coupled to an inflow catheter, an outflow catheter, and optionally an anti-clog catheter. The fluid management system facilitates removal of fluid from a body region, such as the peritoneum, pleural cavity or pericardial sac, where drainage is desired to another body region, such as the urinary bladder or the peritoneal cavity. The system includes clog resistant mechanisms such as clog resistant catheters and/or programmed routines for cycling fluid through inlet catheters in predetermined time intervals and/or responsive to sensed conditions to minimize the risk that inlet catheters become clogged due to, for example, tissue ingrowth and/or solid objects within accumulated fluid.