Stent Delivery Catheter with Direct Visualization Imaging Hood
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Solution Overview
Problem
Conventional stent delivery systems face challenges in accurately positioning stents at ostial lesions due to limited visualization, angulations of the aorto-coronary segment, and difficulties with guiding catheter placement, leading to potential complications and high re-stenosis rates.
Innovation Solution
A tissue imaging and manipulation apparatus with an expandable imaging hood and deployment catheter that allows for direct visualization and precise positioning of stents by displacing blood with a transparent fluid, enabling accurate measurement and deployment of stents within the vessel lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If conventional imaging balloons are inflated to visualize tissue, then imaging capability is improved, but tissue displacement and interference with fine positioning occurs
Solution Approach 1:
The imaging system is nested within a delivery catheter that can be advanced to the target site first, then the imaging balloon is deployed from within the catheter. This nesting allows the imaging system to be compact during delivery and only expand when needed, minimizing tissue displacement while enabling visualization when required.
Solution Approach 2:
The delivery catheter is advanced to the target lesion site and positioned accurately before the imaging balloon is inflated. This preliminary positioning action allows the operator to establish the correct location first, then activate imaging only when the catheter is properly positioned, avoiding tissue displacement that would occur if imaging were used for positioning.
2Reliability
If imaging balloons are inflated to create working area, then tissue contact is improved, but working area becomes cramped and limited
Solution Approach 1:
The system separates the imaging function from the stent delivery function by using distinct components - an imaging balloon for visualization and a separate stent delivery catheter. This segmentation allows the imaging balloon to be inflated to provide stable tissue contact for imaging, while the stent delivery system operates independently with adequate working space, avoiding the cramped conditions that would result from combining both functions in a single inflated structure.
3Device complexity
If conventional stent delivery systems are used without direct visualization, then device complexity is reduced, but stent positioning precision deteriorates
Solution Approach 1:
The system merges the imaging system and stent delivery system into a single integrated delivery catheter assembly. The imaging balloon and stent delivery catheter can be advanced together through the vasculature and deployed at the same location, providing real-time visualization during stent placement. This merging enables precise positioning while maintaining relative system simplicity through integrated design.
4Device complexity
If imaging is performed without displacing blood, then device complexity is reduced, but image quality deteriorates due to intervening blood
Solution Approach 1:
The patent introduces a clear fluid as an intermediary substance between the imaging system and the tissue. This clear fluid displaces the blood within the imaging field, providing optical clarity for imaging while the imaging system itself remains relatively simple. The clear fluid acts as a mediator that eliminates the obscuring effect of blood without requiring complex imaging technology.
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
Enables real-time, accurate visualization and precise placement of stents at ostial lesions, reducing complications and re-stenosis rates by providing clear images and facilitating optimal stent sizing and positioning.
Implementation Method 1
introducing a clear fluid between the imaging system and the tissue to displace blood from within the imaging field
Implementation Method 2
provides an optical pathway through which to view the tissue surface
Data Source
AI summary
A system includes a deployment catheter having a lumen, a delivery sheath configured for positioning within the lumen of the deployment catheter, and a first measurement instrument configured for positioning within the delivery sheath. The first measurement instrument includes a plurality of expandable members each having a known diameter in an expanded state. The first measurement instrument is configured to determine a diameter of an anatomical lumen based on the known diameter of a most proximal expandable member that fits within the anatomical lumen.