Leadless Electrode Assembly Self-Expansion Anchoring
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional active implantable medical devices (IMDs) face challenges in delivering electrostimulation therapy to certain areas of the body, particularly in blood vessels with limited cross-sectional area or specific heart chambers, due to risks of thrombus formation and lead dislodgement.
Innovation Solution
A compact, intravascularly-deliverable electrode assembly that self-expands to securely anchor within the heart, allowing for electrostimulation and sensing without the need for tethered leads, using superelastic materials and independently controllable electrodes for precise therapy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tethered intravascular leads are used for electrostimulation, then electrostimulation therapy can be delivered to heart tissue, but the risk of thrombus formation and lead dislodgement increases in blood vessels with limited cross-sectional area
Solution Approach 1:
The patent removes the tethered lead component from the system, extracting the problematic connection between the pulse generator and electrodes. The leadless electrostimulator delivers electrodes directly to the target location without requiring intravascular leads, thereby eliminating the risks of thrombus formation and lead dislodgement associated with tethered leads while maintaining the ability to deliver electrostimulation therapy to difficult-to-reach anatomical locations
2Reliability
If a compact leadless electrode assembly is used to avoid lead-related complications, then the risk of thrombus formation and lead dislodgement is reduced, but the device must be small enough to navigate blood vessels with limited cross-sectional area
Solution Approach 1:
The patent employs a nested configuration where the electrodes and electrostimulation circuit are housed within a compact pulsed generator that can be delivered through catheters with limited cross-sectional area. The assembly is nested within the delivery catheter during insertion, then deployed at the target location, allowing the device to navigate narrow vasculature while maintaining sufficient size for effective electrostimulation delivery
3Adaptability or versatility
If multiple electrodes are included for versatile electrostimulation therapy, then the ability to treat different conditions (cardiac resynchronization, pain management) is improved, but the device complexity increases
Solution Approach 1:
The patent implements a multi-functional electrode assembly where multiple electrodes can be configured to provide various electrostimulation therapies including cardiac resynchronization, pain management, and other neuromodulation treatments. The same physical electrode structure serves multiple therapeutic purposes through programmable stimulation patterns and electrode combinations, thereby achieving versatility without proportionally increasing structural complexity
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
Enables effective electrostimulation and sensing in previously challenging anatomical locations, reducing the risk of complications and providing flexible therapeutic options, including cardiac resynchronization and pain management, while avoiding the limitations of traditional lead-based systems.
Implementation Method 1
using superelastic materials and independently controllable electrodes for precise therapy delivery
Data Source
AI summary
An intravascularly-deliverable electrode assembly can be used to provide electrostimulation. The electrode assembly can include an electrostimulation circuit located in a housing, two or more elongate members coupled to the housing and configured to anchor the housing to a heart, the two or more elongate members including two or more electrodes electrically coupled to the electrostimulation circuit and controllably addressable by the electrostimulation circuit for delivery of an electrostimulation to the heart. The two or more elongate members can be sized and shaped for intravascular delivery to the heart in a first configuration, and in response to a user actuation, the two or more elongate members can move to a second configuration that is expanded relative to the first configuration to securely anchor the intravascularly-deliverable electrode assembly to the heart. Circuitry within the electrode assembly can coordinate electrostimulation, such as for delivery to sites near each electrode.