Intravascular Electrode Anchoring for Transvascular Stimulation
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Solution Overview
Problem
Current intravascular neurostimulation devices face challenges in accurately and permanently positioning electrodes within blood vessels to effectively stimulate nervous system targets, such as the vagus nerve, for controlling heart rate and blood pressure, due to limited anchoring mechanisms and adaptability during mapping and chronic retention processes.
Innovation Solution
The development of intravascular electrode arrays with temporary and chronic anchoring systems, utilizing shape-memory materials and expandable sleeves, allows for precise mapping and chronic retention within blood vessels, ensuring consistent electrode contact with the vessel wall for targeted nerve stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional anchoring mechanisms are used to position electrodes within blood vessels, then electrode placement is achieved, but the anchoring is insufficient for both mapping and chronic retention
Solution Approach 1:
The anchor system employs a shape-memory alloy structure that can dynamically change its configuration between a compressed delivery state and an expanded deployed state. During delivery, the anchor is compressed to fit within the catheter; upon deployment, it expands to engage the vessel wall, providing secure anchoring while allowing for repositioning during the mapping phase before final retention
Solution Approach 2:
The shape-memory material undergoes parameter changes in response to temperature or stress conditions, transitioning between different structural states. This allows the anchor to be delivered in a low-profile compressed state and then transform into an expanded anchoring configuration that provides reliable electrode retention while maintaining adaptability during the transition period
2Duration of action of stationary object
If electrodes are permanently positioned for chronic retention, then sustained stimulation is achieved, but adaptability for optimal site selection during mapping is reduced
Solution Approach 1:
The anchoring process is segmented into distinct phases: a temporary mapping phase where the anchor provides sufficient retention for electrode positioning and testing, and a permanent retention phase for long-term therapy. This segmentation allows the system to provide adaptability during mapping while ensuring chronic retention when optimal sites are identified
Solution Approach 2:
The anchor system transitions from a dynamic, adjustable state during mapping to a stable, fixed state for chronic retention. The shape-memory structure allows repositioning during the mapping phase by reversing the expansion, but can be locked into a final position for sustained therapeutic effect
3Manufacturing precision
If expandable anchors are used to engage vessel walls, then electrode contact is improved, but device complexity increases
Solution Approach 1:
The anchor utilizes shape-memory alloy material that combines structural strength with programmable deformation characteristics. This composite material approach allows the creation of complex three-dimensional anchor structures that can be precisely delivered and deployed, achieving accurate electrode contact without proportionally increasing overall device complexity
Solution Approach 2:
The anchor employs a thin-walled expandable structure that can be compressed for delivery and then expanded to engage the vessel wall. This flexible shell design allows precise electrode positioning through controlled expansion while maintaining a relatively simple overall device architecture that can be integrated into the catheter system
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 enables optimal electrode placement and retention, enhancing the efficacy of transvascular stimulation for heart rate and blood pressure control by allowing for empirical selection of stimulation sites and minimizing adaptation by the nervous system, thereby providing sustained therapeutic effects.
Implementation Method 1
a hand, sleeve, mesh or other framework formed of one or more shape memory (e.g. nickel titanium alloy, nitinol, thermally activated shape-memory material, or shape memory polymer) elements
Data Source
AI summary
An intravascular electrode device for use in neuromodulation includes an anchor expandable from a radially compressed position to a radially expanded position. A lead extends from the anchor and has at least one conductor extending through it. A flex circuit is coupled to the anchor and comprises a flexible insulative substrate, a plurality of electrodes carried by the substrate, and a plurality of conductive traces carried by the substrate, each trace electrically coupled to an electrode and a conductor. Expansion of the anchor within a blood vessel biases the electrodes into contact with the surrounding blood vessel wall. An exemplary anchor includes a first portion having expansion forces sufficient to bias the electrodes against the vessel wall for mapping and chronic stimulation, and a second portion having greater radial expansion forces sufficient to chronically engage the vessel wall once an optimal electrode location has been selected.