Wireless Electrode Assemblies for Cardiac Stimulation

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Solution Overview

Problem

Current cardiac pacing systems using wired leads are limited in their ability to deliver electrical stimulation to multiple sites within the heart, particularly the left chambers, due to the risk of thrombus formation and embolic injury, and they often require complex venous pathways, which can be traumatic and inefficient.

Innovation Solution

The development of wireless electrode assemblies that use inductive coupling for energy reception and can be advanced over a guide wire instrument to be implanted directly into the heart chamber walls, allowing for controlled and precise placement of electrodes for electrical stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If wired leads are used to deliver electrical stimulation to the heart, then electrical energy can be delivered to heart tissue, but the risk of thrombus formation and embolic injury increases

Engineering Contradiction:
Improvesafety of electrical stimulation deliveryVSAvoidthrombus formation and embolic injury
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the wired lead component from the system entirely, extracting the harmful element that causes thrombus formation. The wireless electrode assembly delivers electrical stimulation without requiring a physical wired connection through the venous system, thereby eliminating the source of thrombus risk while maintaining the therapeutic function of cardiac pacing and defibrillation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical wired lead system with a wireless electromagnetic energy transmission system. Instead of using physical wires that traverse the venous system and risk thrombus formation, the system uses electromagnetic fields to transmit energy from an external source to the implanted electrode assembly, substituting a mechanical delivery mechanism with a field-based mechanism that avoids the harmful thrombus formation pathway.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Adaptability or versatility

If wired leads are directed through the cardiac venous system to pace the left side of the heart, then pacing of left heart chambers is achieved, but the complexity and trauma of the implantation procedure increases

Engineering Contradiction:
Improveability to pace left heart chambersVSAvoidcomplexity of venous pathway navigation
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent extracts the complex venous pathway navigation requirement from the implantation process. By using a wireless electrode assembly that can be positioned percutaneously without requiring traversal of the entire venous system, the system eliminates the need for complex catheter manipulation through multiple heart chambers and veins, significantly simplifying the implantation procedure while maintaining the ability to pace left heart chambers.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a percutaneous access point as an intermediary approach. Instead of navigating wired leads through the complex venous system from central veins to target chambers, the system uses a simple percutaneous puncture as an intermediary access method, allowing direct placement of the wireless electrode assembly into the heart wall with minimal navigation complexity.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If multiple wired leads are implanted for biventricular pacing, then synchronized contraction of both ventricles is achieved, but the number of venous punctures and potential complications increases

Engineering Contradiction:
Improvebiventricular pacing capabilityVSAvoidcomplications from multiple venous punctures
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent merges multiple separate lead implantation procedures into a single wireless electrode assembly implantation. By combining the functions of multiple wired leads (atrial pacing, ventricular pacing, defibrillation) into a single percutaneously delivered wireless device, the system achieves biventricular pacing capability while reducing the number of venous punctures from multiple separate access points to a single access site.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The wireless electrode assembly is designed with multi-functionality, serving as a universal device that can perform atrial pacing, ventricular pacing, and defibrillation functions that previously required multiple separate wired leads. This universal device approach eliminates the need for multiple specialized leads and their associated venous punctures, reducing complications while maintaining comprehensive cardiac rhythm management capability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 approach enables safer and more efficient delivery of electrical stimulation therapy to multiple heart chambers, reducing the risk of complications and allowing for more precise control over electrode placement, thereby improving cardiac pacing and defibrillation therapies.

Implementation Method 1

The wireless electrode assemblies may receive energy via an inductive coupling with another device outside the heart

Methodology Applied
Scientific EffectInductive coupling: Electromagnetic Induction

Data Source

PatentUS12102822B2Delivery of cardiac stimulation devices
Publication Date: 2024.10.01 BOSTON SCIENTIFIC SCIMED INC
  • US12102822B2 patent drawing
  • US12102822B2 patent drawing
  • US12102822B2 patent drawing

AI summary

Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.