Leadless Pacing Delivery Device with Flow Sensing

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Solution Overview

Problem

Current medical devices for delivering leadless cardiac pacing devices lack effective methods for ensuring proper positioning and deployment within the heart, leading to potential misplacement and inefficiencies in the delivery process.

Innovation Solution

A delivery device equipped with a catheter shaft, a distal holding section, flow-sensing devices, and a deployment mechanism, which uses fluid pressure and flow-rate sensing to determine the optimal positioning of the device against the heart chamber wall, ensuring acceptable wall apposition before deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional delivery devices are used without flow-sensing capabilities, then the device structure remains simple, but the positioning accuracy and reliability of leadless pacing device deployment deteriorates

Engineering Contradiction:
Improvepositioning accuracyVSAvoiddevice structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces traditional mechanical positioning verification methods with fluid dynamics-based sensing. Flow-sensing devices measure fluid flow characteristics to determine wall apposition, substituting mechanical assessment with hydrodynamic measurement for more precise positioning feedback

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

Solution Approach 2:

The patent introduces fluid injection systems and flow-sensing mechanisms that utilize hydraulic principles. By injecting fluid into the distal holding section and measuring flow characteristics, the system determines proper device positioning against the heart wall, adding functional complexity but enabling accurate deployment

Inventive Principle:
Principle #29Pneumatics and hydraulics

2Reliability

If traditional delivery devices without wall apposition sensing are used, then the deployment process is faster, but the reliability of proper positioning deteriorates

Engineering Contradiction:
Improvedeployment reliabilityVSAvoiddeployment time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent implements feedback control through flow-sensing devices that continuously monitor fluid flow characteristics during deployment. The system provides real-time feedback on wall apposition status, allowing operators to verify proper positioning before final deployment, thereby increasing reliability without excessive time loss

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent performs preliminary positioning verification using flow-sensing measurements before actual device deployment. By assessing wall apposition in advance through fluid dynamics measurements, the system ensures proper positioning is achieved prior to release, improving deployment reliability

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If no wall apposition verification is performed, then the delivery process is simpler and quicker, but the risk of misplacement increases

Engineering Contradiction:
Improvemisplacement riskVSAvoidsensing system
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent replaces direct mechanical verification of wall contact with indirect fluid dynamics measurement. By measuring fluid flow characteristics rather than directly sensing mechanical contact, the system reduces misplacement risk while avoiding complex mechanical sensing arrays

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 solution enables precise and accurate placement of leadless pacing devices, reducing the risk of misplacement and improving the efficiency of the delivery process by using fluid dynamics to verify proper positioning before deployment.

Implementation Method 1

a flow-sensing device having operational circuitry configured to determine a pressure or a flow-rate of a fluid within the cavity of the distal holding section

Methodology Applied
Scientific EffectFluid pressure sensing: Pressure Increase

Data Source

PatentUS10905465B2Delivery devices and wall apposition sensing
Publication Date: 2021.02.02 CARDIAC PACEMAKERS INC
  • US10905465B2 patent drawing
  • US10905465B2 patent drawing
  • US10905465B2 patent drawing

AI summary

A delivery device for delivering an implantable leadless pacing device may include a catheter shaft a distal holding section for receiving the implantable leadless pacing device. In some cases, the delivery device may include a flow-sensing device to determine a pressure or flow-rate of a fluid within the distal holding section. Also included may be a handle assembly and a deployment mechanism to deploy the implantable leadless pacing device.