Leadless Pacemaker Guide Wire Delivery Lumen

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Solution Overview

Problem

Existing implantable medical devices, such as traditional pacemakers, face challenges in reaching and securely positioning electrodes within the heart, particularly in the left ventricle, due to anatomical difficulties and the risk of debris formation, which can lead to complications like tissue ingrowth and clotting.

Innovation Solution

The development of leadless cardiac pacemakers (LCPs) configured for delivery over a guide wire, featuring a housing with internal circuitry and electrodes, a wire lumen for sliding over the guide wire, and a fixation element like helical screws or tines to secure the device to the heart chamber wall, allowing for pacing of both ventricles without the need for leads.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional pacemakers with leads are used, then pacing function is achieved, but risk of debris formation and tissue ingrowth increases

Engineering Contradiction:
Improvepacing functionVSAvoiddebris formation and tissue ingrowth
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The traditional pacemaker system is segmented into two separate components: a leadless pacemaker device implanted in the right ventricle and a separate fixation element (helical screw or tines) that is delivered and deployed independently to secure the device. This segmentation eliminates the need for traditional leads connecting to the heart wall, thereby reducing debris formation and tissue ingrowth risks while maintaining pacing functionality.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If leadless pacemaker is delivered over guide wire, then precise placement is achieved, but device complexity increases

Engineering Contradiction:
Improveplacement precisionVSAvoiddelivery system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

A guide wire serves as an intermediary tool to facilitate the delivery of the leadless pacemaker device to the precise implantation site within the heart chamber. The guide wire provides a tracked pathway that enables accurate positioning of the device without requiring complex delivery catheters or surgical exposure, thereby achieving precise placement while keeping the delivery system relatively simple.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Stability of the object's composition

If fixation element is used to secure LCP, then device stability is improved, but risk of chamber wall penetration increases

Engineering Contradiction:
Improvedevice stabilityVSAvoidchamber wall penetration
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The fixation element (helical screw or tines) is delivered to the implantation site beforehand on the guide wire, positioned adjacent to the leadless pacemaker device but not yet engaged with the chamber wall. This preliminary positioning allows the operator to verify correct placement and orientation before deploying the fixation element into the chamber wall, thereby ensuring device stability while minimizing the risk of unintended penetration or malpositioning.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10668294B2Leadless cardiac pacemaker configured for over the wire delivery
Publication Date: 2020.06.02 CARDIAC PACEMAKERS INC
  • US10668294B2 patent drawing
  • US10668294B2 patent drawing
  • US10668294B2 patent drawing

AI summary

Implantable medical devices such as leadless cardiac pacemakers (LCP) may be configured to be delivered to a target location within the heart over a guide wire. In some cases, using a guide wire for delivery facilitates placement of devices in regions not otherwise easily reached. An LCP may include a housing and a wire lumen disposed relative to the housing. The wire lumen may be configured to allow the LCP to slide over a guide wire. In some cases, the guide wire may include a guide wire electrode that may be used to test potential implantation sites.