Intravascular Imaging Catheter for Precise Heart Valve Placement
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Solution Overview
Problem
Conventional heart valve replacement surgeries are invasive and lack precise guidance for implant placement, leading to risks of injuring heart or surrounding tissue due to improper deployment of valve stents, and require multiple catheters, which can further complicate the procedure.
Innovation Solution
A single catheter device equipped with intravascular imaging and functional flow sensing capabilities for guiding and verifying the placement of replacement heart valves, minimizing tissue injury and reducing the number of catheters needed by providing real-time imaging and flow assessment during and after implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If fluoroscopic guidance is used for valve delivery, then the procedure is less invasive, but precise placement of the implant cannot be achieved
Solution Approach 1:
The patent combines fluoroscopic imaging guidance with intravascular imaging capabilities within a single catheter system. The catheter includes both fluoroscopic markers for external guidance and intravascular imaging elements (such as ultrasound or optical sensors) that provide internal visualization of the valve annulus and surrounding structures, enabling precise placement while maintaining less-invasive percutaneous access.
Solution Approach 2:
The patent introduces an intermediary imaging system that bridges the gap between external fluoroscopic guidance and the actual implantation site. Intravascular imaging sensors act as intermediaries, providing real-time visual feedback about the catheter's position relative to the native valve and annulus, allowing operators to achieve precise placement without requiring open-heart surgery.
2Reliability
If multiple catheters are used for valve replacement, then comprehensive assessment can be performed, but the risk of injuring weakened vasculature increases
Solution Approach 1:
The patent designs a multi-functional catheter that performs multiple assessment tasks through a single device. The catheter integrates pressure sensors for hemodynamic assessment, intravascular imaging sensors for anatomical evaluation, and flow sensors for blood flow characterization. This universal catheter eliminates the need to exchange multiple specialized catheters, reducing mechanical trauma to the vasculature while providing comprehensive pre- and post-implantation assessment.
Solution Approach 2:
The patent performs preliminary assessment of the valve annulus, surrounding vasculature, and hemodynamic conditions using the integrated catheter before implantation. This preliminary action includes imaging the implantation site, measuring pressure gradients, and evaluating blood flow characteristics, allowing operators to plan the procedure and select appropriate implants without requiring multiple catheter insertions during the procedure.
3Object-affected harmful factors
If a single catheter is used for delivery, then vasculature risk is reduced, but precise placement guidance becomes more difficult
Solution Approach 1:
The patent merges multiple guidance systems into a single catheter, combining fluoroscopic markers visible under external imaging with intravascular imaging sensors that provide internal visualization. The catheter also integrates position sensors and potentially magnetic or electromagnetic tracking capabilities, allowing precise localization of the catheter tip relative to the native valve annulus while maintaining a single-catheter configuration that minimizes vasculature risk.
4Manufacturing precision
If intravascular imaging is added to the catheter, then placement precision is improved, but device complexity increases
Solution Approach 1:
The patent employs a nested catheter design where intravascular imaging sensors, pressure sensors, and other assessment devices are housed within a collapsible or telescoping structure. The imaging elements and sensors can be collapsed into a compact configuration for delivery through the vasculature and then expanded or deployed at the implantation site to provide high-resolution imaging and precise placement guidance, reducing the complexity of navigating a complex device through tortuous vessels.
Data Source
AI summary
The invention generally relates to devices and methods that provide for guided delivery of a heart replacement valve or other implant into the vasculature. In certain embodiments, a delivery device of the invention includes an outer sheath and an inner sheath moveably disposed within the outer sheath. The outer sheath includes a first imaging element and defining a center lumen that leads to an opening. The outer sheath is further configured to releasably hold an implant within the center lumen. The first imaging element is configured to at least partially surround the center lumen such that the implant is deployable through the first imaging element. The inner sheath is configured to engage with and deploy the implant out of the opening of the elongate body and into a body lumen.


