Radiopaque Annulus-Marking Mesh for Low-Radiation Valve Implantation
Find Innovative SolutionsGenerate Solutions
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, that guide the implantation process by marking cardiac valve annuli, allowing for reduced exposure to fluoroscopy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used extensively to guide cardiac device implantation, then implantation precision 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 implantation. These markers are positioned in advance to define the implantation geometry, allowing the implant to be placed with high precision using minimal fluoroscopy guidance. The markers serve as permanent reference points that eliminate the need for continuous fluoroscopic monitoring during the implantation process.
Solution Approach 2:
The patent introduces radiopaque markers as an intermediary element between the fluoroscopy system and the implantation process. These markers act as mediators that provide visible reference points on the heart valve annulus, enabling precise implant placement without requiring direct fluoroscopic visualization of the entire procedure. The markers translate the need for high-precision imaging into a low-radiation solution.
2Object-affected harmful factors
If fluoroscopy exposure is minimized during implantation, then patient radiation exposure is reduced, but implantation precision deteriorates
Solution Approach 1:
The system performs preliminary marking of the heart valve annulus with radiopaque markers before the low-radiation implantation phase. This pre-positioning of reference points ensures that high-precision positioning is achieved upfront, allowing subsequent implantation steps to proceed with minimal fluoroscopy exposure while maintaining accuracy.
Solution Approach 2:
The patent creates a radiopaque copy or representation of the heart valve annulus geometry using markers that replicate the annular structure's key features. This radiopaque copy serves as a permanent template that guides implant placement without requiring continuous fluoroscopic imaging, thus maintaining precision while minimizing radiation exposure.
3Object-affected harmful factors
If radiopaque marking devices are used to guide implantation, 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 positioned separately around the heart valve annulus. This segmentation allows the complex task of annular marking to be broken down into simple, discrete marker placements, each of which can be performed with basic catheter techniques, thereby reducing the overall operational complexity despite the multiple components involved.
Solution Approach 2:
The radiopaque markers serve as simple intermediary elements that bridge the gap between complex implantation requirements and simple low-radiation procedures. By introducing these passive, radiopaque reference points, the system transforms a complex fluoroscopy-dependent procedure into a simpler, marker-guided process that requires minimal imaging.
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 during cardiac device implantation, minimizing patient radiation exposure while ensuring precise placement of implants.
Implementation Method 1
radiopaque devices which act as guides in order to facilitate enhanced imaging of the cardiac space during implantation
Data Source
AI summary
A system includes an annulus-marking device that comprises a two or more pull wires coupled to an expandable braided mesh. Pulling the pull wires can transition the braided mesh into a shape in which the mesh assumes (1) a sloped upper portion configured for positioning within an atrium of a heart of the subject, (2) a bulging ledge portion configured for positioning above the heart valve, and (3) a narrow portion for positioning within the heart valve. The system can also include an implant configured for placement along a native heart valve annulus of a subject. The implant can include a body portion comprising flexible material, the body portion having a longitudinal axis that runs along a length of the body portion. Other embodiments are also described.