Collapsible Extravascular Lead for Dynamic Therapy Vector Adjustment
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Solution Overview
Problem
Current subcutaneous and substernal electrical stimulation leads provide limited therapy vectors for defibrillation and pacing due to their linear design, which restricts the delivery of electrical energy to a narrow area of the heart, making it challenging to effectively manage variable heart positions and sizes.
Innovation Solution
An implantable medical electrical lead with a plurality of defibrillation electrodes that can transition from an expanded configuration to a collapsed configuration, allowing for a wider array of therapy vectors by changing their orientation relative to the lead body, and a joint mechanism that facilitates this transition to accommodate different anatomical positions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If linear arrays of electrodes are used on the lead body, then the lead structure is simple and easy to manufacture, but the therapy vectors are limited and the treatment area is narrow
Solution Approach 1:
The lead incorporates a collapsible section that can transition between expanded and collapsed configurations, allowing the electrodes to dynamically adjust their spatial arrangement. This dynamic structure enables the lead to provide multiple therapy vectors when expanded and to be easily implanted when collapsed, resolving the contradiction between versatility and complexity.
Solution Approach 2:
The collapsible lead design transitions from a one-dimensional linear array to a three-dimensional expanded configuration with electrodes positioned in multiple planes. This dimensional change allows the electrodes to deliver electrical energy across a broader area of the heart, providing diverse therapy vectors without requiring multiple separate leads.
2Adaptability or versatility
If the lead body is designed with fixed electrode positions, then the manufacturing process is simplified, but the lead cannot adapt to variable heart positions and sizes
Solution Approach 1:
The collapsible section allows the lead to adapt its configuration after implantation based on the specific anatomical conditions. The lead can be implanted in a collapsed state through a minimally invasive approach, then expanded to achieve optimal electrode positioning relative to the heart, providing adaptability without complicating the implantation procedure.
3Area of stationary object
If electrodes are extended radially outward from the lead body, then the therapy coverage area is increased, but the lead profile is enlarged and implantation difficulty increases
Solution Approach 1:
The lead maintains a low-profile collapsed configuration during implantation, making it easy to insert through minimally invasive access. Once positioned, the collapsible section is expanded to extend the electrodes radially outward, maximizing the therapy coverage area. This dynamic transformation resolves the contradiction between compact implantation and expanded treatment area.
Solution Approach 2:
The collapsible design allows the electrodes to be nested within the lead body during implantation, presenting a compact profile. After implantation, the electrodes are deployed outward from the lead body, similar to a nested doll being expanded, achieving both easy implantation and broad therapy coverage.
Data Source
AI summary
An implantable medical electrical lead having an elongate lead body having a proximal end and a distal portion. A plurality of defibrillation electrodes coupled to the distal portion is included, the plurality of electrodes being transitionable from a first configuration in which the defibrillation electrodes are biased in an expanded configuration to a second configuration in which the defibrillation electrodes are in a collapsed configuration. A joint slideably disposed around a portion of the lead body is included, at least a portion of the plurality of defibrillation electrodes being coupled to the joint.