Shape-Memory Vein Clips for Low-Trauma Percutaneous Closure
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Solution Overview
Problem
Existing treatments for venous insufficiency, such as endovenous ablation, cause significant pain and bruising due to tissue destruction along the full length of the vein, and have high recurrence rates, while minimally invasive methods like vein stripping and high-ligation are not effective in the long term.
Innovation Solution
A percutaneous method using ultrasound-guided delivery of shape memory metal clips to segmentally close veins, minimizing tissue destruction and recurrence by deploying clips at multiple locations with minimal anesthesia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If endovenous ablation is used to treat venous insufficiency, then the vein is closed along the full length of the treatment segment, but significant pain and bruising occur due to tissue destruction
Solution Approach 1:
The invention divides the vein closure process into discrete segments by deploying multiple individual clips at different locations along the vein rather than applying continuous energy along the full length. Each clip creates a localized closure point, segmenting the treatment into manageable sections that minimize cumulative tissue damage while maintaining overall vein occlusion effectiveness.
Solution Approach 2:
The invention extracts the harmful thermal energy destruction mechanism from the treatment and replaces it with a mechanical clipping approach. By removing the tissue destruction element entirely and using shape memory alloy clips to physically constrict the vein, the treatment achieves vein closure without the painful side effects of thermal ablation.
2Ease of operation
If vein stripping or high-ligation is performed to treat varicose veins, then the procedure is minimally invasive, but the recurrence rate is high
Solution Approach 1:
The invention applies segmentation by placing multiple clips at different locations along the vein rather than a single ligation point. This creates multiple occlusion zones that prevent blood flow through the incompetent vein segments, reducing the likelihood of recurrence compared to single-point ligation while maintaining the minimally invasive percutaneous approach.
Solution Approach 2:
The invention replaces the traditional mechanical ligation (surgical tying off of the vein) with a shape memory alloy-based mechanical system. The clips use superelastic and shape memory properties to automatically constrict and secure the vein upon deployment, providing a more reliable and consistent occlusion mechanism than manual surgical ligation while remaining minimally invasive.
3Reliability
If endovenous ablation is performed, then the vein is destroyed from the inside out, but post-procedural pain lasts more than a week and requires prescription medications
Solution Approach 1:
The invention extracts the thermal destruction mechanism from the treatment process entirely. By using mechanical clips instead of radiofrequency or laser energy, there is no tissue burning or boiling, which eliminates the source of prolonged post-procedural pain while maintaining effective vein occlusion through physical constriction.
Solution Approach 2:
The invention converts the potential harm of incomplete vein closure into a benefit by using multiple clips. The segmented approach ensures thorough occlusion while the localized nature of each clip deployment minimizes tissue trauma, transforming what could be a harmful extensive destruction into a beneficial localized mechanical constriction.
4Ease of operation
If foam sclerotherapy is used to treat venous insufficiency, then the procedure is minimally invasive, but visual disturbance and neurologic deficits occur in less than two percent of cases
Solution Approach 1:
The invention replaces the chemical mechanism of foam sclerotherapy (which involves injecting sclerosing agents that cause inflammation and vein closure) with a purely mechanical system using shape memory alloy clips. This eliminates the risk of chemical-induced complications such as visual disturbances and neurologic deficits while maintaining the minimally invasive percutaneous approach.
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 reduces pain, bruising, and recurrence rates, offering a faster, less expensive procedure with lower risks of systemic embolization and post-procedural inflammation compared to existing methods.
Implementation Method 1
a clip including shape memory metal and proximal and distal tines or extensions, which may be deployed to compress against the outer wall of the vein, closing it off
Data Source
AI summary
Apparatus and methods are provided for closing a tubular structure within a patient's body. The apparatus includes a needle including a proximal end including a hub, a distal end including a sharpened distal tip, a lumen having an oblong cross-section extending proximally from the distal end, and defining a longitudinal axis between the proximal and distal ends, and a clip deliverable from the lumen. The clip is compressible between a relaxed state in which a plurality of tines of the clip are shaped to engage and close a tubular structure within a patient's body, and a stressed state in which the tines are compressed to allow the clip to be loaded into the. The apparatus may also include a pusher member for deploying the clip from the distal tip of the needle such that the tines engage and close a tubular structure through which the tubular member is directed.