TAVI Stent Apposition With Integrated OCT Imaging
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Solution Overview
Problem
Current methods for assessing stent apposition in transcatheter aortic valve implantation (TAVI) procedures are inadequate, leading to potential paravalvular leakage and annular rupture due to insufficient visualization and control of prosthetic heart valve placement.
Innovation Solution
The integration of an optical coherence tomography (OCT) catheter with a transparent sheath and a first imaging probe into the TAVI delivery system allows for real-time imaging and assessment of stent apposition, using a single mode optical fiber and graded index lens to provide high-resolution images of the valve placement, enabling precise adjustment and reduction of paravalvular leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional echocardiography or angiography is used to assess stent apposition, then the procedure can be performed with standard equipment, but the measurement precision and real-time visualization capability are insufficient
Solution Approach 1:
The OCT imaging system is nested within the TAVI delivery catheter structure. The imaging probe is positioned inside the delivery system, allowing the catheter to serve dual purposes: delivering the prosthetic heart valve and providing real-time imaging for stent apposition assessment. This nesting eliminates the need for separate imaging equipment while achieving high measurement precision.
Solution Approach 2:
The patent replaces traditional mechanical imaging methods (echocardiography, angiography) with optical coherence tomography. OCT uses light waves instead of sound waves or contrast agents, providing superior resolution for visualizing stent apposition to the native annulus tissue. This substitution enables real-time, high-precision imaging without the limitations of traditional methods.
2Reliability
If aggressive stent apposition is applied to prevent paravalvular leakage, then sealing performance improves, but the risk of annular rupture increases
Solution Approach 1:
The OCT imaging system provides real-time feedback during stent deployment by visualizing the contact between the stent and native annulus tissue. This feedback allows operators to assess apposition quality immediately and make adjustments before completing deployment, ensuring adequate sealing while avoiding excessive force that could cause annular rupture.
Solution Approach 2:
The patent enables controlled partial expansion or staged deployment of the stent, allowing operators to achieve sufficient apposition for preventing paravalvular leakage without applying excessive force. The real-time OCT imaging allows stopping the expansion process at the optimal point where adequate sealing is achieved but before dangerous pressure levels are reached.
3Manufacturing precision
If real-time OCT imaging is integrated into the delivery system, then stent apposition precision improves, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The delivery catheter is designed with multi-functionality, serving both as a delivery mechanism for the prosthetic heart valve and as a platform for OCT imaging. By combining these functions into a single integrated device, the patent reduces the need for multiple separate components and procedures, ultimately simplifying the overall manufacturing process despite the advanced capabilities.
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 OCT-enabled delivery system enhances the precision of prosthetic heart valve placement, reducing the risk of paravalvular leakage and annular rupture by providing real-time feedback for optimal stent apposition and allowing for automated or semi-automated adjustments to achieve proper valve alignment and expansion.
Implementation Method 1
an optical coherence tomography (OCT) catheter with a transparent sheath and a first imaging probe
Implementation Method 2
configured for cardiovascular imaging having a first imaging probe comprising a first end, a second end, and a first lens assembly disposed at the second end of the first imaging probe, the first imaging probe being configured to transmit light between the first and second ends
Data Source
AI summary
In some examples, a system includes a transparent sheath defining a lumen, a first optical coherence tomography catheter configured for cardiovascular imaging having a first imaging probe comprising a first end, a second end, and a first lens assembly disposed at the second end of the first imaging probe, the first imaging probe being configured to transmit light between the first and second ends thereof, and a prosthetic heart valve disposed about the transparent sheath.