Radiopaque Heart Valve Frames for Lower-Radiation Annuloplasty Guidance
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Solution Overview
Problem
Existing medical procedures for implanting cardiac devices under fluoroscopy expose patients to excessive radiation due to inadequate imaging guidance.
Innovation Solution
The use of radiopaque devices, such as annulus-marking devices and implants with radiopaque materials, to provide enhanced imaging guidance during cardiac device implantation, minimizing patient exposure to fluoroscopy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used continuously for imaging guidance during cardiac device implantation, then procedural accuracy is improved, but patient radiation exposure increases
Solution Approach 1:
The patent applies preliminary action by pre-marking the heart valve annulus with radiopaque markers before device implantation. These markers are placed in advance to define the anatomical landmarks, allowing the implantation procedure to proceed with minimal fluoroscopic guidance. The markers remain in place during the procedure to provide continuous visual reference without requiring ongoing radiation exposure.
Solution Approach 2:
The patent replaces the continuous fluoroscopic imaging system with a static radiopaque marking system. Instead of relying on ongoing mechanical/electromagnetic imaging processes that expose patients to radiation, the solution substitutes permanent visual markers that can be seen under fluoroscopy only when needed for initial positioning, then allow procedure continuation without active imaging.
2Object-affected harmful factors
If radiopaque marking devices are used to reduce fluoroscopy exposure, then patient radiation exposure is reduced, but device complexity increases
Solution Approach 1:
The marking device is segmented into multiple independent radiopaque markers that can be placed at different locations around the heart valve annulus. Each marker is a simple, discrete element that can be positioned independently to define specific anatomical landmarks such as commissures and annular boundaries. This segmentation allows the complex task of anatomical mapping to be divided into simple, manageable marker placements.
Solution Approach 2:
The radiopaque markers serve as intermediaries between the anatomical structure and the imaging system. Rather than requiring complex imaging equipment or processing, the markers act as simple visual mediators that translate three-dimensional anatomical features into two-dimensional fluoroscopic images, enabling accurate positioning without complex device structures.
3Manufacturing precision
If radiopaque markers are placed to define annulus geometry, then implantation accuracy is improved, but procedure time increases
Solution Approach 1:
The radiopaque markers are placed in advance during the imaging-guided portion of the procedure, establishing the anatomical reference framework before the actual device implantation begins. This preliminary marking phase allows subsequent implantation steps to proceed rapidly using the pre-established visual guides, reducing the need for repeated imaging and measurements during the time-sensitive implantation phase.
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 imaging guidance during cardiac device implantation, reducing patient exposure to fluoroscopy and improving procedural accuracy.
Implementation Method 1
an annulus-marking device including a radiopaque material
Data Source
AI summary
A radiopaque frame is transluminally advanced to an atrium of a heart of a subject. The frame is expanded within a valve adjacent the atrium such that part of the frame remains disposed in the atrium. While the frame remains expanded within the valve, progressive portions of an annuloplasty structure are progressively positioned and anchored around the annulus using multiple anchors by, for each of the anchors sequentially (i) while fluoroscopically imaging the frame and a distal end of a delivery tool, and facilitated by mechanical guidance from the frame, positioning the distal end of the delivery tool between the frame and a wall of the atrium; and (ii) driving the anchor into the annulus laterally from the frame. Subsequently, the frame is contracted and withdrawn from the subject while leaving the annuloplasty structure anchored around the annulus. Other embodiments are also described.