Inflatable Anchor Catheter for Epidural Fixation
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Solution Overview
Problem
Epidural and peripheral nerve block anesthesia catheters experience high rates of inadvertent dislodgement, leading to complications such as increased pain, prolonged hospital stays, and risks of epidural hematoma, particularly in thoracic surgery patients and those with chronic pain, due to inadequate fixation techniques.
Innovation Solution
A catheter system with an inflatable anchor at the distal end, which expands to secure the catheter within the internal body region, reducing dislodgement and migration by moving radially outward upon inflation, thereby providing internal fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external fixation techniques (subcutaneous tunneling, suturing, external fixation devices) are used to prevent catheter dislodgement, then catheter stability is improved, but patient comfort deteriorates and infectious risk increases
Solution Approach 1:
The invention extracts the fixation function from external techniques and relocates it to an internal inflatable anchor mechanism. The anchor is positioned within the epidural space and inflated to secure the catheter internally, eliminating the need for external fixation devices that cause discomfort and infection risk while maintaining catheter stability.
Solution Approach 2:
The inflatable anchor serves as an intermediary mechanism between the catheter and the epidural space tissue. Instead of directly suturing or tunneling external structures, the inflated anchor mediates the fixation by expanding within the epidural space to create secure attachment, reducing direct trauma and infection pathways.
2Object-affected harmful factors
If conventional catheters without internal fixation are used, then patient comfort is maintained, but catheter dislodgement rate increases to 3-53%
Solution Approach 1:
The invention introduces a dynamic fixation mechanism where the anchor can transition from a deflated state (during insertion) to an inflated state (for fixation). This dynamic capability allows the catheter to be easily inserted without resistance, then securely fixed once in position, achieving both patient comfort during insertion and high retention during use.
Solution Approach 2:
The invention changes the physical parameter of the anchor from a small, flexible, deflated state during insertion to a larger, rigid, inflated state for fixation. This parameter change enables the anchor to navigate through tissue easily when deflated, then expand to lock the catheter in place when inflated, resolving the contradiction between comfort and retention.
3Duration of action of stationary object
If long-term epidural catheters are used for chronic pain patients, then pain relief duration is extended, but dislodgement rate increases and treatment costs increase
Solution Approach 1:
The invention applies preliminary action by inflating the anchor immediately after catheter insertion to secure the catheter in place before any dislodgement can occur. This preliminary fixation prevents the high dislodgement rates that typically plague long-term catheters, ensuring reliable pain relief throughout the extended treatment period.
4Ease of manufacture
If catheter dislodgement occurs, then catheter replacement is required, but this increases healthcare costs, extends hospital stay, and exposes patients to additional risks
Solution Approach 1:
The invention applies beforehand cushioning by implementing the inflatable anchor mechanism that prevents dislodgement before it can occur. This preventive approach cushions against the harmful effects of dislodgement, eliminating the need for costly and time-consuming replacements and associated complications.
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 inflatable anchor significantly reduces catheter dislodgement and associated complications, ensuring prolonged pain relief and minimizing the risk of epidural hematoma, while maintaining patient comfort and reducing healthcare costs.
Implementation Method 1
A balloon is in fluid communication with the inflation lumen, and the balloon is configured to move between a collapsed position and an expanded position as fluid enters the balloon through the inflation lumen
Implementation Method 2
Upon inflation of the balloon, the movable section of the anchor moves radially outward from the first contracted position to the second deployed position to secure the catheter in the internal body region
Data Source
AI summary
Embodiments of the invention provide a system and method for accessing an internal body region using a catheter. The catheter includes a catheter body and a medication lumen positioned within the catheter body for delivering medication to the internal body region. An inflation lumen is positioned within the catheter body. A balloon is in fluid communication with the inflation lumen, and the balloon is configured to move between a collapsed position and an expanded position as fluid enters the balloon through the inflation lumen. An anchor covers at least a portion of the balloon on an outer surface of the catheter body and includes a movable section with a first retracted position and a second deployed position. Upon inflation of the balloon, the movable section of the anchor moves radially outward from the first contracted position to the second deployed position to secure the catheter in the internal body region.