Balloon Catheter Aspiration for Controlled Closure-Agent Delivery
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Solution Overview
Problem
Current treatments for superficial venous insufficiency, such as surgery or radiofrequency ablation, cause patient discomfort and risk nerve and skin injury, while catheter-based treatments can lead to unintended delivery of medication to healthy veins and ineffective substance distribution due to retained fluids in distorted vessels.
Innovation Solution
A method using a balloon therapy device to access and inflate a diseased vein, forming a closure zone, aspirating fluid, injecting a closure agent, and maintaining pressure until dwell time, followed by deflation, to effectively close the vein.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If catheter-based foam injection is used to treat diseased veins, then the treatment avoids surgery and anesthesia, but the foam can be delivered to unwanted areas causing injury to healthy veins
Solution Approach 1:
The treatment process is segmented into distinct phases: aspiration phase (emptying the vein), injection phase (delivering closure agent), and dwell phase (maintaining pressure). The balloon is segmented into different inflation states (partially inflated for engagement, fully inflated for occlusion). This segmentation allows precise control of the closure agent delivery location, preventing it from reaching healthy veins.
Solution Approach 2:
The aspiration step is performed as a preliminary action before injection. By aspirating blood and fluid from the treatment zone before injecting the closure agent, the system ensures that the closure agent remains contained in the intended treatment area and does not disperse to unwanted areas, thereby preventing injury to healthy veins.
2Ease of operation
If conventional preparatory steps (elevating or massaging the limb) are used to empty blood from the treatment zone, then the procedure is non-invasive, but the distorted vessel shape prevents sufficient emptying, diminishing treatment effectiveness
Solution Approach 1:
The patent replaces manual mechanical preparatory steps (elevation and massage) with a device-based mechanical system. The balloon therapy device, when partially inflated, mechanically engages with the vessel wall to stabilize the distorted vessel, and the aspiration system actively removes blood and fluid through suction, overcoming the limitations of gravity-dependent emptying methods.
Solution Approach 2:
The balloon acts as an intermediary element between the aspiration/injection system and the vessel wall. When partially inflated, it engages with the distorted vessel wall to create a stable treatment zone, enabling effective aspiration and subsequent closure agent delivery, thereby bridging the gap between the treatment system and the challenging vessel geometry.
3Manufacturing precision
If the balloon is inflated to high occlusion pressure to deliver closure agent, then precise delivery is achieved, but patient discomfort increases
Solution Approach 1:
The balloon inflation pressure is dynamically adjusted through distinct phases: initially inflated to a lower pressure to engage with the vessel wall and stabilize the treatment zone, then inflated to a higher occlusion pressure for precise closure agent delivery, and finally deflated. This dynamic pressure adjustment achieves precise delivery while minimizing patient discomfort during non-delivery phases.
Solution Approach 2:
The balloon inflation follows a periodic pattern with distinct stages: engagement phase (lower pressure), delivery phase (high pressure), and deflation phase. By applying high occlusion pressure only during the brief closure agent delivery window and maintaining lower pressure during aspiration and deflation, the system achieves precise delivery while limiting the duration of high-pressure exposure and associated patient discomfort.
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 method ensures precise delivery of the closure agent, reduces patient discomfort, and minimizes damage to healthy veins by effectively emptying blood and fluids from the treatment zone.
Implementation Method 1
inflating the balloon to an occlusion pressure, while maintaining the balloon at the occlusion pressure
Implementation Method 2
aspirating a portion of fluid from within the closure zone
Data Source
AI summary
Balloon based therapy devices for treatment of diseased vessels are described. The devices are adapted for active aspiration of a closure zone prior to delivery of a closure agent. The devices may be used for treatment of diseased veins in the lower limbs and pelvis.