Cardiac Electrode Lead Positioning With Deployable Tissue Fixation

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Solution Overview

Problem

Conventional electrode systems for temporary bradycardia support have drawbacks in positioning electrodes within body tissue, necessitating improved methods and devices for safe and reliable electrode placement.

Innovation Solution

The development of an electrical sensing/stimulation apparatus with an elongate lead body, deployable/retractable displacement member, and tissue attachment mechanism, allowing for precise positioning of electrodes within body tissue through a deployable/retractable displacement member that biases the electrode towards a prescribed direction and affixes to the target tissue using a tissue attachment mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional transvenous electrode pacing leads are inserted directly into the right ventricle, then temporary bradycardia support is provided, but safe and reliable positioning of the electrode is difficult to achieve

Engineering Contradiction:
Improveelectrode positioning reliabilityVSAvoidelectrode insertion difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

A guide catheter is introduced as an intermediary device to facilitate electrode positioning. The catheter provides a controlled pathway to the target tissue, enabling more reliable and safer electrode placement compared to direct insertion methods. The catheter acts as a mediator between the operator and the target tissue, improving positioning accuracy while maintaining operational feasibility.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If a deployable/retractable displacement member is used to bias the electrode towards prescribed direction, then electrode positioning precision is improved, but device complexity increases

Engineering Contradiction:
Improveelectrode positioning precisionVSAvoiddevice structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The displacement member is designed with deployable and retractable capabilities, allowing it to dynamically change its configuration. When deployed, it provides directional biasing force to position the electrode precisely; when retracted, it minimizes interference with the lead body. This dynamic design enables precise positioning control while managing structural complexity through controlled deployment rather than permanent complex structures.

Inventive Principle:
Principle #15Dynamics

3Stability of the object's composition

If tissue attachment mechanism is deployed to affix the lead body to body tissue, then electrode positioning stability is improved, but device complexity increases

Engineering Contradiction:
Improveelectrode positioning stabilityVSAvoiddevice structure complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The tissue attachment function is segmented as a separate deployable mechanism distinct from the lead body and electrode components. The attachment mechanism can be deployed independently to secure the lead to tissue, providing stability without requiring the entire device to be complex. This segmentation allows the attachment function to be added only when needed, maintaining simplicity in the core lead structure while achieving stable positioning through the specialized attachment component.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP4431146B1Device for positioning an electrode in a body cavity
Publication Date: 2026.03.04 MERIT MEDICAL SYSTEMS INC
  • EP4431146B1 patent drawingFigure 1a~2a
  • EP4431146B1 patent drawingFigure 2b~3a
  • EP4431146B1 patent drawingFigure 3a'~3c

AI summary

Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.