Ultrasound-Guided Transcatheter Valve Delivery System
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Solution Overview
Problem
Current transcatheter aortic valve replacement (TAVR) procedures face challenges in accurately positioning the transcatheter heart valve due to limitations in imaging modalities, leading to issues like paravalvular leakage and coronary ostia obstruction, primarily because existing technologies rely on 2D fluoroscopy and transesophageal echocardiography, which are inadequate for precise real-time visualization of the native valve and annulus.
Innovation Solution
An integrated ultrasound-guided delivery system that combines intravascular ultrasound (IVUS) with a transcatheter heart valve delivery system, allowing for real-time imaging and precise positioning of the valve within the native valve annulus, enabling accurate deployment and repositioning without additional imaging modalities like CT, MRI, or X-ray.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If 2D fluoroscopy and transesophageal echocardiography are used for imaging, then the procedure can be performed with existing technologies, but the positioning accuracy of the transcatheter heart valve is insufficient
Solution Approach 1:
The patent combines intravascular ultrasound (IVUS) imaging with the delivery catheter system, integrating the imaging modality directly into the delivery device. This merging allows real-time 3D visualization of the native valve and annulus during the procedure, significantly improving positioning accuracy without requiring separate complex imaging systems.
Solution Approach 2:
The patent replaces the mechanical 2D fluoroscopy and transesophageal echocardiography systems with an intravascular ultrasound system that provides real-time 3D imaging. This substitution eliminates the limitations of 2D imaging and external echocardiography, enabling precise visualization of the implantation site from within the vasculature.
2Reliability
If accurate positioning is achieved through advanced imaging, then procedural success improves, but the device complexity and procedure time increase
Solution Approach 1:
The patent performs preliminary imaging and measurement of the native valve annulus using IVUS before valve deployment. This allows the operator to plan the optimal deployment position in advance, ensuring accurate positioning on the first attempt and reducing the need for bailout procedures, thereby improving procedural success without significantly extending overall procedure time.
Solution Approach 2:
The patent provides real-time feedback during the positioning process through intravascular ultrasound imaging. The operator can continuously monitor the delivery catheter's position relative to the native valve annulus and make immediate adjustments, ensuring accurate placement and reducing the need for corrective bailout procedures.
3Manufacturing precision
If real-time 3D imaging is implemented, then positioning precision improves, but the device complexity increases
Solution Approach 1:
The patent nests the intravascular ultrasound catheter within the delivery catheter system. The IVUS catheter is positioned concentrically within the delivery device, allowing the imaging modality to be housed within the existing delivery structure. This nesting approach provides real-time 3D imaging capability without significantly increasing the overall device complexity or profile.
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
This approach enhances the accuracy of transcatheter heart valve placement, reducing the risk of paravalvular leakage and coronary ostia obstruction by providing high-resolution, real-time 3D imaging, thus improving procedural success and reducing the need for bailout procedures like valve-in-valve implantation.
Implementation Method 1
an intravascular ultrasound (IVUS) catheter operably coupled to the delivery catheter, wherein the IVUS catheter includes an ultrasound transducer tip that is aligned with a base of leaflets of the transcatheter heart valve
Data Source
AI summary
Some embodiments relate to Some embodiments relate to an integrated ultrasound guided delivery system for positioning or repositioning of a transcatheter heart valve including: a delivery catheter coupled to the transcatheter heart valve, and an intravascular ultrasound (IVUS) catheter operably coupled to the delivery catheter, wherein the IVUS catheter includes an ultrasound transducer tip that is aligned with a base of leaflets of the transcatheter heart valve. Also disclosed is a method for positioning or repositioning a transcatheter heart valve at a target site in a subject including: providing an integrated ultrasound guided delivery system as disclosed herein; advancing the transcatheter heart valve in the vicinity of a native valve, viewing the native valve and the target site in real-time with the IVUS catheter, and deploying the transcatheter heart valve at the target site aiming to maintain a conformal placement within the native valve annulus, thereby avoiding or minimizing paravalvular leak.