Leadless Pacemaker Conducted Communication

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Solution Overview

Problem

Conventional cardiac pacing systems with subcutaneously implanted pulse generators face issues such as unsightly bulges, erosion, extrusion, infection, and mechanical stress leading to lead conductor breakage or insulation damage, along with complex connections that increase the risk of malfunction.

Innovation Solution

The development of a leadless cardiac pacemaker that incorporates a housing with integrated electrodes and a hermetically contained pulse delivery system, powered by a primary battery, allowing for electrical pacing and sensing without the need for external leads.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a subcutaneous pulse generator with external leads is used, then electrical pacing and sensing can be achieved, but mechanical stress and infection risk increase

Engineering Contradiction:

Improvepacing functionVSAvoidmechanical stress and infection

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the external pulse generator and lead system from the conventional pacing configuration. The generator is eliminated as a separate subcutaneous device, and leads are removed as external conductors. Instead, a leadless generator capsule is implanted directly into the cardiac chamber, integrating all pacing functions within the heart itself, thereby eliminating mechanical stress points and infection risks associated with external components

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent merges the pulse generator, electrodes, and housing into a single integrated leadless generator capsule. This consolidation eliminates the need for separate generator and lead components, removing mechanical connection points that are susceptible to stress, disconnection, and infection. The combined device is implanted directly in the cardiac chamber, achieving pacing function without external hardware

Inventive Principle:

Principle #5Merging (Combining)

2Reliability

If subcutaneous pulse generator placement is used, then pacing function is achieved, but erosion and extrusion occur

Engineering Contradiction:

Improvepacing functionVSAvoiderosion and extrusion

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent inverts the conventional placement approach by moving the generator from a subcutaneous position (outside the heart) to an intracardiac position (inside the heart chamber). This reversal places the device in a location that is naturally protected by the heart wall, eliminating the problem of erosion through skin and extrusion that plagues subcutaneous implants. The generator is secured to the endocardial surface, ensuring stable positioning without risk of external migration

Inventive Principle:

Principle #13The other way round (Inversion)

3Reliability

If complex connector interfaces are used for lead connection, then electrical connection is achieved, but malfunction risk increases

Engineering Contradiction:

Improveelectrical connectionVSAvoidconnector interface

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the electrical connection between generator and electrodes into a single integrated unit. The generator housing directly incorporates the electrode contacts, eliminating separate connector interfaces, terminal blocks, and wiring harnesses. This integration removes multiple potential failure points including loose connections, insulation damage, and contact corrosion that arise from complex multi-component electrical interfaces

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent extracts and removes all external lead and connector components from the pacing system. By eliminating the lead cable and its associated connectors, terminal blocks, and insulation layers, the system achieves electrical connection through direct integrated contacts within the leadless generator capsule, vastly simplifying the electrical interface and removing sources of malfunction

Inventive Principle:

Principle #2Taking out (Extraction)

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

This solution reduces the risk of mechanical stress and infection, simplifies the connection process, and enhances the reliability and longevity of the pacemaker system by eliminating the need for subcutaneous implantation and reducing power consumption.

Implementation Method 1

Cardiac pacing electrically stimulates the heart when the heart's natural pacemaker and/or conduction system fails to provide synchronized atrial and ventricular contractions

Methodology Applied

Scientific EffectElectrical stimulation:

Implementation Method 2

a hermetic housing (110), multiple electrodes (108) coupled to the housing (110), and a pulse generator (116) hermetically contained within the housing (110)

Methodology Applied

Scientific EffectHermetic containment:

Data Source

PatentEP4230251B1Leadless cardiac pacemaker with conducted communication

Publication Date: 2025.02.12 PACESETTER INC

Figure 1A
Figure 1B
Figure 2~3

AI summary

A leadless pacemaker (102) for pacing a heart (104) of a human includes a hermetic housing (110) and at least two electrodes (108) on or near the hermetic housing (110). The leadless pacemaker (102) also comprises a first pulse generator (116) configured to pace through the at least two electrodes (108) and a second pulse generator (776) configured to deliver communication pulses through the at least two electrodes (108) to an external device (106, 1104, 1204). The second pulse generator (776) is configured to generate different pulses at different amplitudes from the first pulse generator (112).