Removable Catheter EMR Conduction System for Infection Control
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Solution Overview
Problem
Current methods for reducing or eliminating infectious agents on catheters are of low efficacy, leading to high morbidity and mortality rates, and existing solutions, such as sterile handling and antibiotics, are not effective in preventing catheter-related infections, especially in smaller diameter catheters where sterilization delivery systems are inadequate.
Innovation Solution
A medical device assembly that uses non-ultraviolet electromagnetic radiation (EMR) with specific wavelengths and intensities to inactivate infectious agents and promote healing, comprising an EMR source, a removable conduction system with an optical element, and a coupling mechanism for insertion into a catheter lumen, allowing radial emission of therapeutic EMR to treat infectious agents and stimulate healthy cell growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If smaller diameter catheters are used for prolonged insertion, then patient comfort and suitability for prolonged use is improved, but the catheter wall thickness becomes inadequate to carry a sterilization delivery system
Solution Approach 1:
The optical fiber is inserted through the catheter lumen and positioned within the catheter body, nesting the sterilization delivery system inside the existing catheter structure without requiring additional wall thickness. The optical element is contained within the catheter lumen space rather than requiring structural integration into the catheter wall.
Solution Approach 2:
The optical fiber acts as an intermediary delivery mechanism that transmits therapeutic EMR through the catheter lumen to reach the catheter wall and surrounding tissues. This mediator approach allows sterilization without requiring the catheter material itself to conduct or generate the therapeutic energy.
2Reliability
If UV light is used for antimicrobial purposes, then infectious agents are inactivated, but the light source must be mounted within the catheter which increases device complexity
Solution Approach 1:
The light source is extracted from the catheter structure itself and placed externally. The optical fiber serves as a conduit to deliver light energy from an external source through the catheter lumen, eliminating the need to mount complex light generating components within the constrained catheter space.
Solution Approach 2:
The patent replaces the need for complex mechanical mounting of UV LEDs or other light sources within the catheter with a simpler optical fiber delivery system. This substitution transforms a mechanically complex integration problem into a simpler optical transmission problem.
3Reliability
If catheters are removed when infections are suspected, then infectious agent growth is stopped, but patient discomfort and treatment cost increase
Solution Approach 1:
The therapeutic EMR system is applied continuously or periodically to the catheter while it remains in place, performing preliminary sterilization action before infections can establish themselves. This preventive approach eliminates the need for reactive catheter removal when infections are detected.
Solution Approach 2:
The patent converts the potential harm of catheter-related infections into a benefit by using the catheter itself as a delivery vehicle for therapeutic EMR. The same structure that could harbor infections becomes the conduit for delivering anti-infective therapy, turning a vulnerability into a solution.
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 EMR device effectively inactivates infectious agents and promotes healing by delivering therapeutic radiation with sufficient intensity and wavelength, reducing the risk of catheter-related infections and enhancing tissue repair, thereby improving patient outcomes and reducing medical costs.
Implementation Method 1
The EMR source can be from a single or group of EMR sources including, but not limited to, a light emitting diode
Implementation Method 2
The EMR source can be from a single or group of EMR sources including, but not limited to, a semiconductor laser, a diode laser
Implementation Method 3
The optical element is comprised of at least one optical fiber
Data Source
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AI summary
A medical device assembly is provided for removable insertion into a catheter with a lumen. The medical device assembly comprises an electromagnetic radiation (EMR) source for providing non-ultraviolet, therapeutic EMR having an intensity sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect, and a removable EMR conduction system at least partially insertable into and removable from the lumen of the catheter. The EMR conduction system has at least one optical element providing axial propagation of the therapeutic EMR through an insertable elongate body. The elongate body may have an exterior surface between a coupling end and a distal end tip that has at least one modified portion permitting the radial emission of therapeutic EMR from the elongate body proximate the modified portion. Such modified portion may be gradient along the exterior surface.