His Bundle Pacing Device with Dual Flange Anchoring

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Solution Overview

Problem

Conventional pacemakers face challenges in securely anchoring electrodes to the myocardium without puncturing the heart's conduction system, leading to potential defects and inefficient pacing, particularly in thin septum membranes, and often require invasive procedures with long recovery times.

Innovation Solution

A cardiac pacing device with a collapsible and self-expandable design, featuring a dual flange structure with electrodes on both flange portions, allowing for secure anchoring and stimulation of the His bundle without septum perforation, and enabling minimally invasive implantation techniques.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional pacemakers use leads to deliver pacing pulses to the myocardium, then cardiac pacing function is achieved, but the conduction system may be punctured causing defects

Engineering Contradiction:
Improvepacing function reliabilityVSAvoidconduction system damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a delivery sheath as an intermediary device that guides the pacing lead through the myocardium without direct puncture. The sheath acts as a protective mediator, allowing the lead to be positioned adjacent to the myocardium while avoiding damage to the conduction system. The sheath is advanced through the septum and positioned such that the pacing electrode can deliver pulses without the lead itself penetrating the conduction system.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Stability of the object's composition

If pacemaker leads are anchored in thin septum membranes, then secure positioning is achieved, but the thin septum is more susceptible to perforation

Engineering Contradiction:
Improvelead anchoring stabilityVSAvoidseptum perforation risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The delivery sheath serves as a mediator that enables secure lead anchoring without direct lead penetration of the thin septum. The sheath is advanced through the septum and provides a protective pathway, allowing the pacing electrode to be positioned securely adjacent to the myocardium while the sheath itself bears the mechanical stress of anchoring, thereby protecting the fragile septal tissue from perforation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The delivery sheath utilizes a flexible, thin-walled structure that can navigate through the thin septal membrane without causing perforation. The sheath's flexible construction allows it to conform to the anatomical structures while providing sufficient mechanical strength to anchor the lead securely. The thin film structure of the sheath enables it to pass through delicate tissues without damage.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If invasive procedures are used for pacemaker implantation, then reliable electrode placement is achieved, but patient recovery time increases

Engineering Contradiction:
Improveelectrode placement accuracyVSAvoidpatient recovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces traditional open-chest surgical mechanics with a minimally invasive catheter-based delivery system. The pacing lead is delivered through a transvenous approach using a delivery sheath that can be inserted through peripheral veins and advanced to the heart under fluoroscopic guidance. This substitution of mechanical access methods reduces surgical trauma, eliminates the need for sternotomy or thoracotomy, and significantly decreases patient recovery time while maintaining reliable electrode placement accuracy.

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

Data Source

PatentUS11219772B2Devices and Methods for cardiac pacing and resynchrontzation
Publication Date: 2022.01.11 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH
  • US11219772B2 patent drawing
  • US11219772B2 patent drawing
  • US11219772B2 patent drawing

AI summary

This document relates to methods and materials for improving artificial cardiac pacing and/or resynchronization. For example, this document relates to methods and devices for artificial cardiac pacing and/or resynchronization by stimulating the His bundle.