Balloon Medical Lead Pressure Sensing for Leak and Inflation Status

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Solution Overview

Problem

Current implantable medical leads face challenges in determining the inflation status and leak detection of distal balloons, which can lead to physical interference with anatomical structures during navigation through vasculature.

Innovation Solution

A medical lead system with a pressure sensor connected to a distal balloon that senses pressure within its interior volume and communicates a signal to the clinician, along with an inflation mechanism to manipulate the balloon between configurations, ensuring proper inflation and minimizing interference.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a distal balloon is used in the medical lead system, then the ability to secure positioning and reduce physical interference with anatomical structures is improved, but the complexity of determining inflation status and detecting leaks worsens

Engineering Contradiction:
Improveballoon inflation status determinationVSAvoidinflation monitoring system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies feedback by implementing a pressure sensor that continuously monitors the pressure within the distal balloon and communicates this information to the clinician. This closed-loop feedback system allows real-time determination of balloon inflation status and detection of leaks without requiring complex external monitoring equipment, thereby improving reliability while managing system complexity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces complex mechanical monitoring systems with a pressure sensor-based detection system. Instead of using mechanical indicators or complex visualization systems to determine balloon inflation status, the invention uses pressure sensing to directly measure and communicate the inflation state, simplifying the overall system while improving reliability.

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

2Object-affected harmful factors

If the distal balloon is inflated to prevent physical interference with anatomical structures, then the protection of anatomical structures is improved, but the risk of interference during navigation worsens if inflation status is not properly monitored

Engineering Contradiction:
Improvephysical interference with anatomical structuresVSAvoidballoon inflation status
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The pressure sensor provides continuous feedback on balloon inflation status, allowing the clinician to verify that the balloon is properly inflated before and during navigation. This ensures the balloon maintains its protective function while preventing situations where improper inflation could lead to anatomical interference.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system enables preliminary verification of balloon inflation status before navigation begins. By using the pressure sensor to confirm proper inflation in advance, the system ensures the balloon is ready to prevent physical interference with anatomical structures, thereby improving reliability of the protective function.

Inventive Principle:
Principle #10Preliminary action

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 system provides real-time feedback on balloon inflation and leak detection, reducing physical interference and enhancing navigation through vasculature by ensuring the balloon is fully inflated and securely positioned.

Implementation Method 1

a pressure sensor fluidly connected to the inlet of the lumen and configured to sense a pressure within an interior volume of the distal balloon

Methodology Applied
Scientific EffectPressure sensing:

Data Source

PatentUS20250345599A1Medical lead system
Publication Date: 2025.11.13 MEDTRONIC INC
  • US20250345599A1 patent drawing
  • US20250345599A1 patent drawing
  • US20250345599A1 patent drawing

AI summary

Various embodiments of a medical lead system are disclosed. The lead system includes a lead body that includes a lumen that extends along the lead body between an inlet adjacent to a proximal end of the lead body and an outlet adjacent to a distal end of the lead body; a fixation member; and a distal balloon connected to an exterior surface of the distal end of the lead body and fluidly connected to the outlet of the lumen. The medical lead system further includes a pressure sensor fluidly connected to the inlet of the lumen of the lead body and configured to sense a pressure within an interior volume of the distal balloon and communicate a signal indicative of the pressure to a clinician. The fixation member is further configured to extend distal to the distal balloon when the distal balloon is in an inflated configuration.