Leadless Pacemaker Remote Programming via Conductive Gateway

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Solution Overview

Problem

Current leadless pacemakers (LPs) require frequent in-person visits to medical facilities for programming and interrogation, which is time-consuming, costly, and inconvenient, especially during the COVID-19 pandemic.

Innovation Solution

A system comprising a remote non-implantable device (RNID), a local non-implantable device (LNID), and a second implantable device (SID) that acts as a communication gateway, enabling remote programming and communication with the LP through conductive and RF communication signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conductive communication is used between external programmer and leadless pacemaker, then communication capability is achieved, but patient must be in physical contact with skin electrodes which reduces convenience and increases time loss

Engineering Contradiction:
Improvecommunication capabilityVSAvoidpatient convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent introduces an intermediary device (smartphone or tablet with external communication module) that mediates between the leadless pacemaker and the programmer. The intermediary device communicates with the pacemaker through conductive coupling via skin electrodes, then transmits data wirelessly to the programmer, eliminating the need for direct physical contact between patient and programmer while maintaining communication reliability

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical system of direct physical contact between patient and programmer with a wireless communication system. The intermediary device captures data through conductive coupling and transmits it wirelessly via Bluetooth or Wi-Fi, substituting the mechanical interaction with electromagnetic communication

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

2Reliability

If in-person visits to medical facilities are required for programming and interrogation, then effective communication with leadless pacemaker is achieved, but time loss and cost increase significantly

Engineering Contradiction:
Improvecommunication effectivenessVSAvoidpatient and medical personnel time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The intermediary device enables remote communication by acting as a mobile bridge between the pacemaker and the programmer. Patients can be monitored and programmed remotely through the intermediary device's wireless connection to the programmer, eliminating the need for in-person visits while maintaining communication effectiveness

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The intermediary device serves multiple functions: it acts as a communication interface, a data transmitter, and a remote monitoring station. This multi-functional device enables various programming and interrogation tasks to be performed remotely, reducing time loss for both patients and medical personnel

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Loss of information

If frequent in-person visits are required for leadless pacemaker follow-up, then diagnostic information can be obtained, but medical costs increase for patients

Engineering Contradiction:
Improvediagnostic information acquisitionVSAvoidmedical bill cost
Core Design Contradiction:
Loss of informationVSLoss of time

Solution Approach 1:

The patent replaces the mechanical system of in-person clinic visits with a wireless remote monitoring system. The intermediary device continuously or periodically collects diagnostic information from the pacemaker and transmits it wirelessly to the programmer, eliminating the need for frequent patient trips to the doctor's office while ensuring diagnostic information is obtained

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

Enables LPs to be programmed and interrogated remotely without the need for an external programmer, reducing patient and medical personnel time, costs, and the risk of infection, while maintaining effective communication and diagnostic capabilities.

Implementation Method 1

Communication between an LP and an external programmer may be facilitated by conductive communication via patient tissue

Methodology Applied
Scientific EffectConduction (electrical): Conduction (electrical)

Implementation Method 2

The LNID is configured to send the one or more commands to the SID by transmitting one or more radio frequency (RF) communication signals

Methodology Applied
Scientific EffectElectromagnetic radiation: Electromagnetic Induction

Data Source

PatentEP4070853B1Systems and methods for remote programming of, and other follow-up capabilities with, leadless pacemakers
Publication Date: 2025.01.29 PACESETTER INC
  • EP4070853B1 patent drawingFigure 1
  • EP4070853B1 patent drawingFigure 2
  • EP4070853B1 patent drawingFigure 3

AI summary

Described herein are methods, and systems that enable a remote non-implantable device (RNID) to send commands to a leadless pacemaker (LP) implanted within a patient. The RNID provide commands to a local non-implantable device (LNID) over one or more communication networks, and the LNID sends the commands to a second implantable device (SID) by transmitting radio frequency (RF) communication signals, which include the commands, using an antenna of the LNID. After receiving the commands from the LNID, by receiving RF communication signals that include the commands using an antenna of the SID, the SID transmits conductive communication signals, which include the commands, using electrodes of the SID. The LP receives the commands from the SID by receiving the conductive communication signals, which include the commands, using electrodes of the LP, and the LP performs command responses based on the commands that originated from the RNID.