Integrated Catheter with Intravascular Imaging and Flow Sensing
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Solution Overview
Problem
Conventional heart valve replacement surgeries, especially percutaneous procedures, lack precise guidance for implant placement and intraluminal assessment, leading to potential tissue injury and inefficiencies due to the need for multiple catheters, which increases the risk of complications.
Innovation Solution
A single catheter device equipped with intravascular imaging and functional flow sensing capabilities for guiding valve replacement surgery, allowing for real-time imaging and flow measurement to verify valve location, assess condition, visualize implantation, and evaluate blood flow restoration, thereby minimizing tissue injury and reducing the number of catheters needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If fluoroscopic guidance is used for percutaneous heart valve replacement, then the procedure is less invasive, but precise placement of the implant cannot be achieved and intraluminal assessment is not provided
Solution Approach 1:
The patent combines fluoroscopic imaging with intravascular imaging (IVUS/OCT) and functional flow sensing capabilities into a single integrated catheter system. This merging allows the system to provide both less-invasive percutaneous access and precise intraluminal placement guidance simultaneously, resolving the contradiction between invasiveness and measurement precision.
Solution Approach 2:
The catheter system is designed with multi-functionality, serving as both a delivery catheter for the valve implant and an imaging/sensing platform. The single catheter provides fluoroscopic guidance, intravascular imaging, flow measurement, and pressure sensing capabilities, eliminating the need for multiple separate catheters while achieving both low invasiveness and high placement precision.
2Reliability
If multiple catheters are introduced into the vasculature for valve replacement, then comprehensive assessment can be performed, but the risk of complications increases
Solution Approach 1:
The patent merges multiple catheter functions into a single integrated catheter system that combines delivery, intravascular imaging (IVUS/OCT), fluoroscopic guidance, flow sensing, and pressure measurement capabilities. This consolidation maintains comprehensive assessment reliability while reducing the number of catheter introductions and manipulations, thereby lowering complication risks.
Solution Approach 2:
The single catheter system is designed with universal multi-functionality, performing both structural imaging (IVUS/OCT) and functional assessment (flow and pressure sensing) simultaneously. This eliminates the need for multiple specialized catheters while maintaining complete pre- and post-implantation assessment capabilities.
3Ease of operation
If conventional separate catheters are used for imaging and delivery, then implant delivery can be performed, but real-time intraluminal assessment during implantation is not possible
Solution Approach 1:
The patent merges the implant delivery function with real-time intravascular imaging and functional sensing capabilities within the same catheter system. This allows the operator to perform valve delivery while simultaneously obtaining real-time intraluminal images and flow/pressure data, eliminating information loss and enabling immediate assessment of implant placement accuracy.
Solution Approach 2:
The integrated system provides real-time feedback through intravascular imaging and functional flow sensing during the implantation process. The catheter delivers the valve while continuously monitoring intraluminal conditions, allowing immediate verification of proper placement and function, thus preventing information loss and enabling corrective actions if needed.
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 precision and safety of heart valve replacement surgeries by providing comprehensive guidance for implant placement and post-implantation assessment, reducing the risk of complications and tissue injury through a single catheter system that integrates imaging and flow sensing.
Implementation Method 1
an imaging element configured to at least partially surround the center lumen such that the implant is deployable through the imaging element
Implementation Method 2
a flow sensor adapted to measure the velocity of flow through the vasculature
Implementation Method 3
a pressure sensor adapted to measure pressure within the vasculature
Data Source
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Figure 5
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.