Multi-area Pacing Lead for Coronary Vein Stimulation

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Solution Overview

Problem

Current cardiac pacing leads for the left heart cavity face challenges in achieving small diameter for deep vein access and maintaining effective electrical contact, leading to difficulties in reaching deep collateral veins and stabilizing electrodes for optimal cardiac resynchronization therapy (CRT).

Innovation Solution

A microcable pacing lead with a diameter of at most 2 French (0.66 mm) and exposed electrodes along its length, allowing stimulation of multiple areas via separate veins through anastomosis, enabling simultaneous stimulation of remote areas in the coronary venous system with improved flexibility and reduced mechanical complexity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If a conventional pacing lead is used to access deep collateral veins, then the lead structure provides stable electrode contact, but the lead diameter is too large to reach deep veins in the coronary network

Engineering Contradiction:
Improvelead diameterVSAvoidelectrode contact stability
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The lead body is segmented into multiple modular sections that can be selectively deployed. The lead includes a proximal portion and a distal portion that can be independently positioned, allowing the thin distal section to access deep veins while the proximal section provides stable anchoring and electrical connections.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lead employs an ultra-thin flexible insulating coating that can conform to the delicate venous walls in deep collateral veins. This thin-film structure reduces the overall lead diameter to at most 2 French while maintaining electrical insulation and providing flexibility to navigate tortuous venous pathways.

Inventive Principle:
Principle #30Flexible shells and thin films

2Adaptability or versatility

If multiple electrodes are added to the lead body to stimulate multiple areas, then the stimulation coverage is improved, but the lead complexity and number of components increase

Engineering Contradiction:
Improvestimulation area coverageVSAvoidlead structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The lead body is designed as a universal platform with multiple electrode contact points that can be selectively activated. The same lead structure can stimulate different cardiac areas by repositioning or selecting different electrodes, eliminating the need for multiple specialized leads while maintaining versatility.

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

Solution Approach 2:

The lead incorporates dynamic repositioning capabilities where electrodes can be selectively deployed or repositioned along the lead body. This dynamic configuration allows the same lead structure to adapt to different stimulation requirements without increasing structural complexity, as electrodes can be activated or deactivated based on clinical needs.

Inventive Principle:
Principle #15Dynamics

3Length of moving object

If the lead diameter is reduced to access deep veins, then the flexibility and access capability are improved, but the mechanical strength and stability decrease

Engineering Contradiction:
Improvelead diameterVSAvoidmechanical strength
Core Design Contradiction:
Length of moving objectVSStrength

Solution Approach 1:

The lead employs composite construction combining ultra-thin flexible insulating material with embedded high-strength conductive elements. The insulating coating is thin enough to reduce overall diameter to at most 2 French while the embedded structural elements provide the necessary mechanical strength to withstand implantation forces and long-term physiological stresses.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The lead structure uses a nested configuration where the thin insulating coating envelops the conductive core and structural elements. This nested arrangement maximizes the strength-to-diameter ratio by concentrating mechanical strength in the inner layers while maintaining an ultra-thin outer profile for venous access.

Inventive Principle:
Principle #7Nested doll (Nesting)

4Reliability

If electrodes are positioned to contact the epicardium through the coronary vein wall, then the electrical contact efficiency is improved, but the risk of mechanical failure and tissue damage increases

Engineering Contradiction:
Improveelectrical contact efficiencyVSAvoidtissue damage risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The lead uses the coronary vein lumen as an intermediary pathway to deliver electrical stimulation to the epicardium. Instead of penetrating the vein wall, the electrodes contact the blood-filled lumen which acts as a conductive medium to transmit electrical energy to the adjacent epicardial tissue, reducing mechanical trauma while maintaining electrical efficiency.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention replaces mechanical penetration of the vein wall with an electrical field-based approach. The electrodes are positioned within the vein lumen and use electrical fields to stimulate the epicardium through the vein wall without mechanical contact, substituting a mechanical insertion process with a non-invasive electrical stimulation method.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical 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

The microcable lead effectively accesses small diameter veins, provides stable and efficient electrical contact, and enhances CRT by allowing stimulation of multiple areas, improving heart function resynchronization while minimizing surgical risks and mechanical failures.

Implementation Method 1

A microcable pacing lead with a diameter of at most 2 French (0.66 mm) and exposed electrodes along its length, allowing stimulation of multiple areas via separate veins

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentUS9216283B2Multi-area pacing lead for a left cavity of the heart, implantable in the coronary network
Publication Date: 2015.12.22 SORIN CRM
  • US9216283B2 patent drawing
  • US9216283B2 patent drawing
  • US9216283B2 patent drawing

AI summary

A multi-area pacing lead implantable in a target vein of the coronary network for stimulating a left cavity of the heart, comprising an electrically conductive microcable (12), an electrically insulating outer coating, and carrying at its distal end a free active portion containing a plurality of separate denuded areas forming a network of active stimulation electrodes (14, 16), intended to contact the wall of target veins. The active free portion has a proximal corrugated portion carrying a first set of electrodes (14), a distal corrugated portion carrying a second series of electrodes (16) and an intermediate portion (20) that traverses an anastomosis (22) connecting the ends of two veins (VA, VPL). Both sets of electrodes (14, 16) can thus be placed in two different veins, defining two remote stimulation areas.