Strain Relief Loop Tissue Growth Inhibition
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Solution Overview
Problem
Strain relief loops in implantable medical leads are restricted by tissue growth, which limits their ability to maintain the position of the distal end of the lead during patient movements, as the loops become encapsulated by tissue before the distal end is adequately secured.
Innovation Solution
Inhibiting tissue growth by obstructing the interior of the strain relief loop with objects or coatings, or applying a mechanical bias to maintain a steady state size, ensuring the loop can provide slack and adjust to patient movements without being compromised by tissue encapsulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a strain relief loop is created to allow patient movement, then the distal end of the lead can maintain position during movement, but tissue growth encapsulates the loop and restricts its function
Solution Approach 1:
The patent applies preliminary anti-action by pre-coating the strain relief loop with tissue growth inhibitor material before implantation. This prevents tissue encapsulation from restricting the loop's movement function, allowing the loop to maintain its strain relief capability while accommodating patient movement without being encased by growing tissue.
2Object-affected harmful factors
If tissue growth inhibitor is applied to the lead, then tissue encapsulation is reduced, but the inhibitor may affect lead body performance
Solution Approach 1:
The patent applies local quality by selectively coating only the strain relief loop portion of the lead with tissue growth inhibitor material, while leaving the rest of the lead body unchanged. This localized application prevents tissue encapsulation of the loop without affecting the electrical or mechanical performance of the lead conductors and electrodes.
Solution Approach 2:
The patent uses a thin film coating of tissue growth inhibitor material applied to the strain relief loop. This thin film provides tissue rejection functionality while maintaining the flexibility and electrical properties of the underlying lead structure, ensuring that lead body performance is not compromised.
3Ease of operation
If the loop is allowed to change size freely, then it provides strain relief during movement, but tissue growth restricts the loop size change
Solution Approach 1:
The patent applies preliminary anti-action by pre-coating the strain relief loop with tissue growth inhibitor material before implantation. This prevents tissue encapsulation from restricting the loop's movement function, allowing the loop to maintain its strain relief capability while accommodating patient movement without being encased by growing tissue.
Data Source
AI summary
The function of a strain relief loop of an implantable medical lead is preserved by inhibiting restriction of the strain relief loop from tissue growth onto the strain relief loop. The restriction may be inhibited by either obstructing tissue growth and/or by utilizing a mechanical advantage to overcome the restriction. The tissue growth may be obstructed be isolating the interior of the strain relief loop such as by enclosing the strain relief loop or including an object within the loop. The mechanical advantage to overcome restriction from tissue growth may be provided in various ways such as utilizing a spring loaded mechanism or a structure such as an elastic mesh, tube, or mold having an inherent bias toward a steady state position.