Temporary Pacing Lead Navigation Using Directional Impedance Sensing

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Solution Overview

Problem

Medical professionals face challenges in navigating implantable medical leads without access to standard imaging devices, such as fluoroscopy, to deliver therapies like temporary cardiac pacing, requiring a method to determine the lead's position and orientation within the body.

Innovation Solution

A system using surface electrodes and an expandable member on the lead to transmit and sense electrical signals, allowing a computing system to determine the lead's position and orientation through impedance measurements and triangulation, without the need for traditional imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If standard imaging devices like fluoroscopy are used to navigate the implantable medical lead, then the position and orientation of the lead can be accurately determined, but the setup time, complexity, and costs increase

Engineering Contradiction:
Improveposition and orientation determinationVSAvoidimaging device requirement
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the navigation function from complex external imaging devices and implements it within the medical lead itself through integrated sensors (accelerometer, magnetometer, gyroscope) and processing circuitry. This allows the lead to autonomously determine its own position and orientation without requiring separate fluoroscopy or other imaging equipment.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The medical lead performs self-navigation by using its own integrated sensors and processing capabilities to autonomously determine its position and orientation within the body. The lead serves itself rather than requiring external imaging systems, thereby reducing overall system complexity and setup requirements.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If standard imaging devices like fluoroscopy are used to navigate the implantable medical lead, then the position and orientation of the lead can be accurately determined, but the setup time and costs increase

Engineering Contradiction:
Improveposition and orientation determinationVSAvoidsetup time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent removes the need for time-consuming external imaging setup by integrating navigation capabilities directly into the lead. The sensors and processing circuitry are built-in, eliminating the requirement for separate imaging equipment setup and reducing overall procedure time.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The navigation capabilities are pre-integrated into the lead structure during manufacturing, with sensors and processing circuitry already in place. This preliminary integration means no additional setup time is required during the medical procedure, as the lead is ready to autonomously navigate immediately upon insertion.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If an expandable member is added to the implantable medical lead for directional signal impedance, then the navigation precision is improved, but the device complexity increases

Engineering Contradiction:
Improvesignal sensing accuracyVSAvoidlead structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The expandable member can transition between expanded and collapsed states dynamically. When expanded, it provides directional signal impedance to improve sensing accuracy by blocking signals from certain directions. When collapsed, it minimizes its impact on lead flexibility and overall structure. This dynamic capability allows the system to optimize performance only when needed.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The expandable member changes the physical parameters of the lead structure (volume, shape, rigidity) only when required for navigation. By expanding to specific configurations, it alters the electrical signal characteristics in a controlled manner to improve directional sensing, then returns to its original state, effectively using parameter changes to enhance function without permanently increasing complexity.

Inventive Principle:
Principle #35Parameter changes

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 precise navigation of implantable medical leads, reducing setup time, complexity, and costs by eliminating the requirement for standard imaging devices, while providing accurate positioning and orientation information.

Implementation Method 1

the expandable member is configured, when expanded to directionally-impede the electrical signal

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Implementation Method 2

sensing circuitry coupled to a plurality of surface electrodes placed onto skin of the patient

Methodology Applied
Scientific EffectElectrical Conduction: Conduction (electrical)

Data Source

PatentEP4547318B1Temporary pacing lead navigation system
Publication Date: 2026.03.11 MEDTRONIC INC
  • EP4547318B1 patent drawingFigure 1
  • EP4547318B1 patent drawingFigure 2
  • EP4547318B1 patent drawingFigure 3

AI summary

This disclosure describes a method including outputting, by a computing system through a lead electrode on a distal portion of an implantable medical lead within vasculature of a patient, an electrical signal, wherein the implantable medical lead further includes an expandable member in an expanded state while the electrical signal is outputted, wherein the expanded expandable member is configured, to directionally-impede the electrical signal. The method may further include sensing, through each of a plurality of surface electrodes positioned on the patient, the electrical signal, determining, for each respective surface electrode of the plurality of surface electrodes, a value of the sensed electrical signal corresponding to an impedance between the respective surface electrode and the lead electrode, and determining a position and an orientation of the distal portion of the implantable medical lead within the vasculature of the patient based on the determined values of the sensed electrical signal.