Polymeric Lead Tip with Radiopaque Drug Coating
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Solution Overview
Problem
Existing cardiac rhythm management (CRM) system leads face challenges in securing the lead to heart tissue effectively and maintaining a stable therapeutic agent coating without contraction due to solvent evaporation, which affects the consistency and duration of drug delivery.
Innovation Solution
The implementation of a solventless method for forming a therapeutic agent eluting layer using a polymeric material with dispersed radiopaque agents and elutable drug components, combined with a rotatable terminal pin and helical electrode assembly for enhanced fixation and drug delivery, facilitates secure anchoring and controlled drug release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a solvent-based method is used to form a therapeutic agent coating on the lead, then the coating process is simpler and faster, but the coating contracts due to solvent evaporation during curing, affecting thickness control and delivery consistency
Solution Approach 1:
The patent changes the fundamental parameter of the coating formation process by eliminating the solvent component entirely. Instead of using a solvent-based slurry that requires evaporation, the invention employs a solventless slurry composition where therapeutic agents are suspended in a liquid carrier that does not require evaporation for curing. This parameter change resolves the contradiction by maintaining coating thickness control without sacrificing productivity, as the coating can be applied and cured without the dimensional instability caused by solvent evaporation.
Solution Approach 2:
The patent creates a composite material system by combining therapeutic agents, radiopaque agents, and the liquid carrier into a homogeneous solventless slurry. This composite approach allows multiple functional components to be integrated into a single coating layer, achieving both precise thickness control and consistent drug delivery. The composite material structure ensures that radiopaque agents remain uniformly distributed while therapeutic agents are delivered at controlled rates, resolving the contradiction between manufacturing precision and productivity.
2Adaptability or versatility
If multiple separate components (drug collar, fluoro ring) are used to provide radiopacity and drug delivery, then each component can be optimized independently, but the device complexity increases and requires multiple assembly steps
Solution Approach 1:
The patent merges the functions of radiopaque agents and therapeutic agents into a single integrated coating layer applied directly to the lead. By combining these previously separate components (drug collar and fluoro ring) into one homogeneous solventless slurry coating, the invention reduces device complexity while maintaining the ability to optimize each agent's performance. The merging is achieved through careful formulation of the slurry composition, where radiopaque and therapeutic agents coexist in a stable suspension that can be applied in a single coating process.
Solution Approach 2:
The patent creates a multi-functional coating layer that simultaneously provides radiopacity for imaging, drug delivery for therapy, and structural integrity for lead protection. This universal coating eliminates the need for separate specialized components, reducing overall device complexity while maintaining adaptability. The single coating layer performs multiple functions that previously required distinct components, resolving the contradiction between versatility and complexity through functional integration.
3Quantity of substance
If a thick coating is applied to ensure sufficient drug delivery, then the drug dosage is adequate, but the coating contracts during curing, resulting in inconsistent thickness and unreliable delivery
Solution Approach 1:
The patent changes the curing mechanism parameter from solvent evaporation-based drying to a solventless curing process. By eliminating the evaporation step that causes coating contraction, the invention maintains consistent coating thickness even when applying sufficient drug dosages. The liquid carrier in the solventless slurry allows the coating to cure without dimensional changes, ensuring that the thickness applied is the thickness delivered, thus resolving the contradiction between adequate drug dosage and thickness consistency.
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 solution ensures a stable and controlled drug delivery system that maintains the lead's position within the heart while providing a time-released dosage of anti-inflammatory agents, enhancing the CRM system's efficacy and reducing the need for separate drug collars or fluoro rings.
Implementation Method 1
A radiopaque agent is dispersed within the polymeric material
Implementation Method 2
An elutable drug component is dispersed within the polymeric material
Data Source
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AI summary
An assembly for an implantable device can be made from PEEK and can incorporate one or more radiopaque agents and one or more elutable drug components into a polymeric lead tip. The assembly can be machined or injection molded and can be configured, for example, as a housing for an active fixation lead or as an electrode base supporting a foil electrode.