Self-Expanding Stent for Below-Ankle CLI Treatment
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Solution Overview
Problem
Current stent technologies are inadequate for treating critical limb ischemia (CLI) below the ankle due to high stress, torsion, and anatomical challenges, leading to limited access and effectiveness in the ankle area, where traditional stents fail to provide sufficient support and expansion.
Innovation Solution
A low-profile stent system and method for antegrade and retrograde advancement, utilizing a 3 mm by 60 mm self-expanding stent that can be inserted into the Left Popliteal artery and deployed in the distal posterior tibial artery, capable of sustaining high filling pressure for better wound healing and conforming to arterial diameters from 1.5 mm to 4 mm, allowing for treatment of CLI in an office-based outpatient setting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If traditional stents are used in the ankle area, then the stent structure is simple and easy to manufacture, but the stent fails to provide sufficient support and expansion due to high stress, torsion, and anatomical challenges
Solution Approach 1:
The stent is divided into multiple segments or cells arranged in a pattern that allows both structural integrity and flexibility. This segmentation enables the stent to distribute mechanical stresses across multiple load-bearing elements while maintaining overall structural strength in the high-stress ankle environment.
Solution Approach 2:
The stent employs composite material construction combining different metals or metal alloys with varying mechanical properties. This allows the stent to achieve superior strength-to-weight ratio, corrosion resistance, and mechanical performance necessary for withstanding ankle stresses while maintaining reasonable structural complexity.
2Ease of operation
If a low-profile stent system is used for below-the-ankle treatment, then the ease of operation and access is improved, but the stent must conform to varying arterial diameters from 1.5 mm to 4 mm
Solution Approach 1:
The stent incorporates dynamic elements such as shape memory alloy components or phase-changing materials that allow the stent to transition from a compressed delivery state to an expanded functional state. This dynamic behavior enables the stent to adapt to different arterial diameters while maintaining a low-profile delivery configuration for easy access below the ankle.
Solution Approach 2:
The stent design utilizes parameter changes in material properties or structural configuration to achieve diameter adaptation. By changing physical parameters such as temperature, stress state, or structural phase, the stent can conform to arterial diameters ranging from 1.5 mm to 4 mm while maintaining ease of delivery through a low-profile system.
3Ease of operation
If self-expanding stent technology is used, then the ease of operation is improved, but the stent requires sustained high filling pressure for effective wound healing
Solution Approach 1:
The stent employs self-service mechanisms where the stent structure itself generates or maintains the necessary filling pressure through its expansion force or integrated pressure-generation features. This eliminates the need for external pressure application devices while ensuring sustained high filling pressure for effective wound healing, maintaining ease of operation.
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 system enables effective treatment of CLI and PAD by providing sustained blood flow and wound healing, reducing the need for amputation and allowing for minimally invasive procedures in an outpatient setting, addressing the limitations of existing stent technologies in the ankle region.
Implementation Method 1
The stent will sustain high filling pressure to the microcirculation for better and faster wound healing
Implementation Method 2
conforming to arterial diameters from 1.5 mm to 4 mm
Data Source
AI summary
Systems, methods and accompanying apparatuses to treat critical limb ischemia through the superficial femoral arteries utilizing a specifically designed delivery package for entry proximal to area above the ankle with the capability to antegrade access via PT or AT into ankle and foot and retrograde access via pedal or plantar arch into the dorsalis pedis artery (DP).