Subcutaneous Lead Movable Sleeve for Signal Detection

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Solution Overview

Problem

Existing subcutaneous leads for implantable cardiac devices face challenges in detecting electrical surface activity due to artefacts like muscle noise and environmental interference, and their fixed geometry fails to adapt to varying patient morphologies, affecting both detection and defibrillation functions.

Innovation Solution

A subcutaneous lead with a movable insulating sleeve that allows adjustable positioning and exposure of sensing electrodes, enabling variable geometry to better fit patient morphology and minimize noise interference, while maintaining optimal positioning and orientation for improved signal detection and cardiac stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fixed geometry subcutaneous leads are used, then the lead structure is simple and easy to manufacture, but the detection quality is impaired due to inability to adapt to different patient morphologies

Engineering Contradiction:
Improvedetection qualityVSAvoidlead structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The insulating sleeve is made movable relative to the lead body, allowing the sensing electrode configuration to be dynamically adjusted during implantation. This enables optimization of detection quality for different patient morphologies while maintaining a relatively simple fixed structure in the manufactured lead.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The lead is divided into separable components: the lead body with sensing electrodes and the movable insulating sleeve. This segmentation allows independent optimization of each component and enables adjustment of their relative positioning to achieve optimal detection geometry for each patient.

Inventive Principle:
Principle #1Segmentation

2Object-affected harmful factors

If fixed positioning of sensing electrodes is used, then the manufacturing process is simple, but the lead cannot minimize surface muscle noise for different patients

Engineering Contradiction:
Improvesurface muscle noiseVSAvoidimplantation procedure
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The insulating sleeve can be moved to different positions along the lead body during implantation, allowing the practitioner to adjust the sensing electrode positioning to minimize surface muscle noise specific to each patient's anatomy, rather than being constrained by a fixed electrode configuration.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If annular sensing electrodes with fixed inter-electrode distance are used, then the lead design is simplified, but the pacing function is insufficient due to inability to create effective distant electric field

Engineering Contradiction:
Improvepacing functionVSAvoidelectrode configuration
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The movable insulating sleeve enables dynamic adjustment of the exposed sensing electrode surfaces and their effective spacing, allowing optimization of the electric field configuration for pacing functions while maintaining a relatively simple annular electrode design in the manufactured lead.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS11484703B2Subcutaneous lead for an implantable cardiac device
Publication Date: 2022.11.01 SORIN CRM
  • US11484703B2 patent drawing
  • US11484703B2 patent drawing
  • US11484703B2 patent drawing

AI summary

A subcutaneous lead for an implantable cardiac device, in particular for a defibrillator or/and a pacemaker comprising a lead body, itself comprising at least one sensing electrode and an insulating sleeve into which the lead body is threaded so that the insulating sleeve and the lead body are movable relative to each other so as to at least partially cover the at least one sensing electrode with the insulating sleeve.