Leadless Pacemaker Dual-Chamber Pacing via Septal Mounting
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Solution Overview
Problem
Current leadless pacemakers (LLPM) offer limited functional capability, primarily providing single-chamber pacing and sensing, and face challenges with power consumption and reliability of wireless communications, which are essential for dual-chamber functionality and widespread clinical acceptance.
Innovation Solution
A leadless intra-cardiac medical device (LIMD) is designed to provide dual-chamber functionality without external leads, featuring electrodes that stimulate and sense both the right atrium and right ventricle from a single chamber, using a housing secured to the heart's septum with electrodes positioned to engage activation sites in both chambers, allowing synchronous stimulus pulse delivery in DDD or DDDR modes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a leadless pacemaker is designed to provide dual-chamber functionality, then the functional capability is improved, but the device complexity increases
Solution Approach 1:
The patent applies multi-functionality by enabling a single leadless pacemaker device to perform dual-chamber pacing and sensing functions. The device includes multiple electrodes (first electrode for first chamber, second electrode for second chamber) that allow it to pace and sense in both atrial and ventricular chambers, eliminating the need for separate single-chamber devices and reducing overall system complexity despite increased functional capability.
Solution Approach 2:
The patent segments the device into distinct functional components including a housing, multiple electrodes positioned at different locations, and a controller that independently manages pacing and sensing for each chamber. This segmentation allows the complex dual-chamber functionality to be organized into manageable modules, making the device easier to manufacture and maintain while providing versatile functionality.
2Adaptability or versatility
If electrodes are positioned to engage activation sites in both chambers, then dual-chamber pacing functionality is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The patent employs dynamic positioning mechanisms where the electrodes are designed to self-align or adapt to the cardiac tissue during implantation. The electrodes may include flexible segments or positioning features that conform to the anatomical structures, allowing accurate engagement with activation sites in both chambers without requiring extremely tight manufacturing tolerances. The device can accommodate variations in implantation geometry while maintaining functional precision.
3Object-affected harmful factors
If the device is entirely within the heart, then the risk of infections is reduced, but the ease of operation for implantation increases
Solution Approach 1:
The patent introduces an introducer assembly as an intermediary device that facilitates the implantation of the leadless pacemaker. The introducer assembly includes a delivery catheter and positioning mechanisms that guide the device through the vasculature to the target chamber, simplifying the implantation process despite the device being entirely intracardiac. The introducer acts as a mediator that makes the complex implantation procedure more manageable while ensuring sterile placement and reducing infection risk.
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 LIMD enables dual-chamber pacing and sensing without the need for external leads, reducing the risk of infections and complications associated with traditional devices, while maintaining reliable operation and efficient power use, thus improving patient outcomes and device longevity.
Implementation Method 1
The braid is configured to resist rotational torque and longitudinal compression to facilitate delivery of rotational forces and longitudinal pressure to the housing of the device
Implementation Method 2
The braid is configured to resist rotational torque and longitudinal compression to facilitate delivery of rotational forces and longitudinal pressure to the housing of the device
Implementation Method 3
a shaped intra-cardiac (IC) device extension configured to passively secure the device within the heart
Data Source
AI summary
A leadless intra-cardiac medical device (LIMD) is configured to be implanted entirely within a heart of a patient. The LIMD comprises a housing configured to be securely attached to an interior wall portion of a chamber of the heart, and a stabilizing intra-cardiac (IC) device extension connected to the housing. The stabilizing IC device extension may include a stabilizer arm, and/or an appendage arm, or an elongated body or a loop member configured to be passively secured within the heart.