Prosthetic Heart Valve Radiographic Identifiers for Rotational Alignment
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Solution Overview
Problem
The challenge in minimally invasive prosthetic heart valve implantation procedures is the lack of line-of-sight visualization, leading to difficulties in accurately positioning the prosthesis due to two-dimensional radiographic imaging, which can result in device migration or improper functioning.
Innovation Solution
Incorporation of commissural posts with radiographic identifiers, such as reflection-asymmetric shapes or materials with different radiopacity, to facilitate rotational alignment with native commissures using fluoroscopic imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If minimally invasive implantation procedures are used, then patient trauma and recovery time are reduced, but line-of-sight visualization is lost making accurate positioning difficult
Solution Approach 1:
The patent applies radiographic identifiers with different radiopacity (analogous to color changes in visual systems) to commissural posts. These identifiers appear as distinct radiopaque patterns on fluoroscopic images, enabling physicians to distinguish correct rotational alignment from incorrect alignment despite the two-dimensional nature of the imaging. This resolves the contradiction by providing visual differentiation without requiring open surgical exposure.
2Ease of operation
If two-dimensional radiographic imaging is used for positioning, then the procedure can be performed minimally invasively, but rotational alignment cannot be accurately determined
Solution Approach 1:
The patent employs reflection-asymmetric radiographic identifiers on commissural posts. These asymmetric patterns create unique radiographic signatures that allow physicians to determine the rotational orientation of the prosthesis in two-dimensional fluoroscopic images. The asymmetry provides directional information that would otherwise be lost in the collapsed delivery state, enabling accurate rotational alignment while maintaining minimal invasiveness.
3Difficulty of detecting and measuring
If commissural posts are made radiopaque for visibility, then they can be seen on imaging, but they blend together making individual identification difficult
Solution Approach 1:
The patent applies different radiographic identifiers to different commissural posts (local differentiation). Each post receives a unique radiopaque pattern or marking, allowing individual identification and precise rotational alignment. This local quality approach distinguishes between otherwise identical radiopaque structures, resolving the contradiction between visibility and individual identification.
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
Enhances the accuracy of prosthetic heart valve positioning by allowing physicians to distinguish between correct and incorrect rotational alignments, reducing the risk of device misplacement and ensuring proper implantation.
Implementation Method 1
materials with different radiopacity, to facilitate rotational alignment with native commissures using fluoroscopic imaging
Data Source
AI summary
A method for rotationally aligning a valve prosthesis using imaging identifiers includes delivering the valve prosthesis in a collapsed configuration in a catheter to a vicinity of a functioning native heart valve of a heart of the subject using a retrograde approach, generating an image of the functioning native heart valve and the valve prosthesis, rotationally aligning engagement arms of the valve prosthesis with sinuses of the functioning native heart valve using at least one of the imaging identifiers of the heart valve prosthesis visible in the image.