Prosthetic Heart Valve Positional Markers for Radiographic Orientation
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Solution Overview
Problem
Current catheter-based methods for positioning prosthetic heart valves during minimally invasive procedures lack effective visualization techniques, making it difficult to ensure correct orientation and positioning relative to native heart valves, which can lead to patient complications due to the two-dimensional and radiographically non-distinguishable nature of existing imaging methods.
Innovation Solution
A prosthetic heart valve design featuring a valve assembly with a frame and control arms, where the control arms include positional markers that provide radiographic contrast and asymmetrical shapes or symbols to facilitate accurate alignment with native heart valves, allowing for rotational alignment verification through fluoroscopic imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiographic images are used for positioning the heart valve prosthesis, then the positioning can be achieved, but the images do not provide clear depth indication and device orientation information
Solution Approach 1:
The patent applies radiopaque markers with varying radiopacity (analogous to color changes in visual terms) to provide depth and orientation information. The markers include a first marker with higher radiopacity and a second marker with lower radiopacity, allowing physicians to distinguish between different components and determine spatial relationships in the two-dimensional radiographic image.
Solution Approach 2:
The patent employs asymmetric positioning of radiopaque markers relative to the heart valve prosthesis structure. The markers are positioned at specific locations that create an asymmetric pattern, enabling physicians to determine the orientation and rotational position of the prosthesis by comparing the asymmetric marker arrangement against known reference configurations.
2Ease of operation
If existing catheter-based delivery systems are used, then minimally invasive insertion is achieved, but visualization techniques cannot be effectively applied to verify correct positioning
Solution Approach 1:
The patent introduces radiopaque markers as intermediary elements that mediate between the heart valve prosthesis and the radiographic imaging system. These markers serve as visual intermediaries that translate the three-dimensional positioning information into two-dimensional radiographic images, allowing physicians to verify positioning without compromising the minimally invasive nature of the procedure.
3Loss of information
If radiopaque markers are added to the heart valve prosthesis, then device orientation can be distinguished, but the device complexity increases
Solution Approach 1:
The patent segments the radiopaque marking system into distinct, modular components including a first radiopaque marker and a second radiopaque marker with different radiopacity values. This segmentation allows each marker to serve a specific function (e.g., one for identifying the prosthesis location, another for indicating orientation), reducing the overall complexity compared to a single complex marking system.
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 use of positional markers on control arms enhances the ability to correctly position and orient prosthetic heart valves relative to native valves, reducing the risk of complications by providing clear visual cues for precise alignment and orientation during minimally invasive procedures.
Implementation Method 1
The positional marker may be made of a material with a different radiopacity than other portions of the prosthetic heart valve
Data Source
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AI summary
A prosthetic heart valve (100) includes a valve assembly (110), a frame (120), and a control arm (130). The prosthetic heart valve includes a commissural post (122) or multiple commissural posts. The prosthetic heart valve includes a positional marker (132) on a control arm. The prosthetic heart valve may include multiple positional markers on one or more control arms. The positional markers can be shapes, characters, or other symbols. The positional markers may themselves be asymmetric. The positional markers may be placed in an asymmetric location on a control arm. The control arm may be asymmetrically shaped.