Leadless Pacemaker Septal Electrode Positioning
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Solution Overview
Problem
Existing implantable medical devices face challenges in effectively sensing and pacing both ventricles of the heart, particularly due to difficulties in accessing and stabilizing electrodes within the ventricular septum, which can lead to tissue ingrowth, clotting, and debris formation, posing risks to the patient.
Innovation Solution
The development of a dual chamber leadless cardiac pacemaker (LCP) with adjustable electrodes and fixation mechanisms that allow for precise positioning and secure anchoring within the septum, enabling sensing and pacing across both ventricles while minimizing foreign body response.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If electrodes are positioned within the ventricular septum to enable dual chamber pacing, then sensing and pacing capability is improved, but tissue ingrowth and clotting risks increase
Solution Approach 1:
The electrode support assembly incorporates a movable outer shaft that can be extended or retracted relative to the housing. This dynamic positioning allows the electrode to be adjusted to optimal locations on the ventricular septum surface, enabling effective dual chamber pacing while minimizing penetration depth to reduce tissue ingrowth and clotting risks.
Solution Approach 2:
The patent introduces an intermediate adjustment mechanism (outer shaft with coupling) between the fixed housing and the electrode. This intermediary structure allows precise control of electrode positioning on the ventricular septum surface, achieving stable electrical contact for dual chamber pacing without direct deep tissue penetration that would cause harmful ingrowth and clotting.
2Measurement precision
If the LV electrode is positioned deeper into the ventricular septum to improve sensing, then sensing precision is improved, but stability and security of anchoring deteriorate
Solution Approach 1:
The adjustable outer shaft mechanism allows the electrode to be dynamically positioned at optimal depths on the ventricular septum surface. This enables sufficient sensing precision through controlled extension while preventing excessive depth penetration that would compromise anchoring stability and increase tissue ingrowth risks.
Solution Approach 2:
The patent changes the positional parameter of the electrode by allowing extension and retraction of the outer shaft. By adjusting this parameter, the electrode achieves optimal sensing precision at controlled distances from the housing without compromising the stability provided by the fixation helix and coupling mechanism.
3Device complexity
If the device structure is simplified to reduce complexity, then ease of implantation is improved, but adjustability of electrode position deteriorates
Solution Approach 1:
The patent incorporates a dynamic adjustment mechanism consisting of an outer shaft and coupling that can be rotated to extend or retract the electrode. This adds minimal structural complexity while providing essential position adjustability, allowing the electrode to be optimized for each patient's anatomy without requiring a completely complex device architecture.
Solution Approach 2:
The adjustment mechanism is designed to be self-contained within the device housing, with the outer shaft and coupling forming an integrated system. The surgeon can adjust the electrode position using the provided coupling without requiring external tools or complex assistance, achieving adaptability through a self-service adjustment system that maintains overall device simplicity.
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 solution enables efficient dual chamber pacing with reduced risk of tissue ingrowth and clotting, improving the stability and effectiveness of the device while minimizing debris formation and foreign body response.
Implementation Method 1
The fixation helix may include a proximal shaft portion extending through a lumen of the housing and terminating in the coupling such that rotating the coupling rotates the fixation helix relative to the housing and causes the fixation helix to thread itself into the ventricular septum.
Data Source
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AI summary
An implantable medical device (IMD) includes a housing that is configured to be positioned at least in part in a chamber of a heart, and in some cases, in a right ventricle (RV) proximate an RV facing side of the ventricular septum of the heart. When so provided, an RV electrode may be fixed relative to the housing to be proximate the RV facing side of the ventricular septum. An LV electrode may be spaced a distance from the RV electrode and the housing such that the LV electrode is positioned at least partially within the ventricular septum. An LV electrode position adjustment assembly may be used to adjust the depth at which the LV electrode is positioned within the ventricular septum.