Radiopaque Ring Configuration for Implantable Lead MRI Safety
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Solution Overview
Problem
Implantable medical devices (IMDs) face compatibility issues with nuclear magnetic resonance (MRI) scans due to induced torques, forces, and heating, which can disrupt their operation and safety, especially since existing radiopaque markers are difficult to manufacture uniformly and provide limited information.
Innovation Solution
The use of a specified configuration of radiopaque rings with varying inner diameters and arrangements about the implantable lead, injection molded into the rear seal, to provide information on MRI compatibility, including indications of MR Conditional status for different magnetic field strengths, allowing for automatic recognition and enhanced visibility during X-Ray or fluoroscopy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional radiopaque markers are used, then visibility during X-Ray or fluoroscopy is provided, but manufacturing uniformity is difficult and information provision is limited
Solution Approach 1:
The radiopaque marker is segmented into multiple discrete rings with different inner diameters rather than using a single uniform marker. This segmentation allows each ring to be manufactured separately with consistent dimensions, improving overall manufacturing uniformity while the collective arrangement provides rich information encoding capability
Solution Approach 2:
Different portions of the marker structure (individual rings) have different local qualities, specifically different inner diameters. This local variation in dimensions allows the marker to encode multiple pieces of information about the lead and device while maintaining manufacturing consistency through standardized ring production
2Loss of information
If multiple radiopaque rings with different configurations are used, then information provision about MRI compatibility is enhanced, but device complexity increases
Solution Approach 1:
The radiopaque marker serves multiple functions simultaneously: it provides visibility during imaging procedures, encodes information about the lead type and construction, and communicates MRI compatibility status. By making the marker multi-functional, the patent reduces information loss without proportionally increasing complexity, as the same structural elements serve multiple purposes
Solution Approach 2:
The marker uses variations in physical parameters (number of rings, inner diameters, spacing) to encode different information states. This parameter-based encoding system allows rich information provision about MRI compatibility and lead characteristics while maintaining a relatively simple physical structure that can be manufactured consistently
3Manufacturing precision
If radiopaque rings are injection molded into the rear seal, then manufacturing precision is improved, but ease of manufacture may be affected
Solution Approach 1:
The radiopaque rings are merged with the rear seal through injection molding, creating an integrated component. This combining of elements improves positioning precision and structural integrity while the injection molding process itself is aĉç, well-established manufacturing technique that can be implemented with standard equipment, balancing precision requirements with manufacturing ease
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 configuration effectively communicates MRI compatibility and device information, enhancing safety and visibility, thereby mitigating the risks associated with MRI exposure for IMDs and facilitating proper placement and monitoring.
Implementation Method 1
a specified configuration of a plurality of radiopaque rings about at least a portion of an implantable lead
Data Source
AI summary
Specified information can be provided to a user, to a machine, or to an automated process using a specified configuration of a plurality of radiopaque rings about at least a portion of an implantable lead.