Flexible Controlled Release Device for Medical Leads
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Solution Overview
Problem
Existing implantable medical leads face challenges in chronically releasing anti-inflammatory agents near stimulation electrodes to prevent tissue inflammation, with existing devices often requiring smaller diameters to maintain effective tip pressure.
Innovation Solution
A flexible controlled release device (CRD) with a distal end having an increased outer diameter, allowing for enhanced agent elution and reduced tip pressure, is integrated into the medical lead, featuring a cylindrical body with a larger distal end diameter and a flexible component that expands after introduction, reducing tip pressure by up to 50%.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the outer diameter of the distal end of the CRD is increased, then agent elution is increased and effective tip area is increased, but tip pressure may increase
Solution Approach 1:
The CRD is designed with a flexible component that can dynamically change its configuration. The flexible component allows the CRD to adapt its shape and diameter during insertion and upon deployment, enabling it to achieve a larger effective tip area for enhanced agent elution while maintaining compatibility with introducers and preventing tissue puncture through controlled expansion.
Solution Approach 2:
The patent employs a flexible component that changes physical parameters such as diameter and shape in response to mechanical stress or deployment conditions. This allows the CRD to transition from a compact configuration during insertion to an expanded configuration at the target site, increasing agent elution surface area while managing tip pressure through controlled parameter changes.
2Area of stationary object
If the outer diameter of the distal end of the CRD is increased, then effective tip area is increased, but compatibility with introducers may be compromised
Solution Approach 1:
The flexible component enables the CRD to dynamically adjust its diameter. During insertion through the introducer, the CRD maintains a smaller diameter for compatibility, then expands to a larger effective tip area at the target site, achieving both small profile for insertion and large surface area for agent elution.
Solution Approach 2:
The flexible component is nested within the CRD structure, allowing the CRD to be compact during insertion and then expand at the target site. The nested flexible component acts as a deployable element that increases the effective tip area only when needed, maintaining introducer compatibility during the insertion phase.
3Quantity of substance
If the outer diameter of the distal end of the CRD is increased, then agent elution is increased, but tissue puncture risk may increase
Solution Approach 1:
The flexible component provides dynamic control over the CRD's contact with tissue. The flexibility allows the CRD to conform to tissue surfaces rather than imposing rigid stress, reducing the risk of tissue puncture while still providing sufficient surface area for chronic agent elution.
Solution Approach 2:
The flexible component acts as a compliant shell that covers the CRD distal end. This flexible shell distributes mechanical stress over a larger area, preventing localized stress concentrations that could cause tissue puncture, while still allowing the underlying CRD structure to provide adequate surface area for agent elution.
Data Source
AI summary
A medical device lead is presented. One embodiment of the claimed invention includes a lead body, a conductor, and a flexible component. The lead body includes a proximal end and a distal end. The conductor is coupled to the lead body. A sleeve is coupled to the distal end of the lead body. The flexible component is coupled to the distal end of the sleeve. The distal end of the flexible component includes an outer diameter that is greater than the outer diameter of the proximal end.