Bulkhead Anchor with Flexure Fingers for Lead Stability
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Solution Overview
Problem
Existing anchor structures for implantable medical device leads are prone to cause non-uniform force distribution, leading to potential damage and movement of the leads, especially when exposed to high-power RF radiation, and are not well-suited for RF-shielded configurations.
Innovation Solution
A bulkhead anchor configuration with flexure finger members and a radial bulkhead that impart a radial compressive force uniformly around the lead body, using a locking mechanism to maintain the anchor's position and minimize stress points.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional anchor structures are used to secure leads, then anchoring function is provided, but non-uniform force distribution occurs causing lead damage and movement
Solution Approach 1:
The anchor structure is divided into multiple discrete anchoring elements (e.g., tines, fingers, or prongs) that are distributed around the lead body. Each element independently engages with the tissue, distributing the anchoring force uniformly across multiple contact points rather than concentrating it at a single location, thereby preventing lead damage while maintaining secure fixation
Solution Approach 2:
The anchor incorporates features with locally optimized properties, such as varying the geometry, material composition, or surface characteristics of different anchoring elements based on their specific functional requirements. This allows each local region of the anchor to provide the appropriate level of engagement and force distribution for its designated area, ensuring uniform overall force distribution
2Stability of the object's composition
If anchors are secured to lead with high force, then anchoring stability is improved, but lead movement axially within anchor occurs
Solution Approach 1:
The anchor incorporates flexible or movable components that can dynamically adjust to the lead's position and movement. The anchoring elements are designed with inherent flexibility allowing them to conform to tissue contours and accommodate lead movement without transmitting excessive axial forces to the lead, thereby maintaining stability while preventing lead displacement
Solution Approach 2:
The anchor utilizes composite material structures combining materials with different mechanical properties (e.g., rigid structural components with flexible anchoring elements). This composite construction allows the anchor to provide stable fixation through rigid elements while the flexible components absorb stress and prevent force transmission that would cause axial lead movement
3Ease of manufacture
If conventional anchor designs are used, then manufacturing simplicity is maintained, but they are not suitable for RF-shielded configurations
Solution Approach 1:
The anchor is designed with universal features that enable it to function in both conventional and RF-shielded configurations. The structural design incorporates elements that can accommodate different lead types and shielding arrangements without requiring fundamental design changes, allowing the same anchor to be used across multiple application scenarios including RF-exposed environments
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
The bulkhead anchor provides robust anchoring performance by evenly distributing compressive forces, reducing lead damage and maintaining stability even in RF-exposed environments.
Implementation Method 1
A bulkhead anchor configuration with flexure finger members and a radial bulkhead that impart a radial compressive force uniformly around the lead body
Data Source
AI summary
Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.