Leadless Multi-Chamber Pacing Through Coronary Sinus Leadlets
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Solution Overview
Problem
Existing implantable medical devices face challenges in effectively pacing both the right atrium and left ventricle of the heart without the use of traditional leads, which can complicate implantation and reduce efficacy.
Innovation Solution
The development of leadless implantable medical devices (LIMDs) with deployable leadlets and electrodes that can be implanted in the right atrium and left ventricle through the coronary sinus ostium, allowing for direct electrical sensing and pacing therapy delivery using processing circuitry within the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional leads are used to pace both right atrium and left ventricle, then reliable cardiac therapy delivery is achieved, but device complexity and implantation difficulty increase
Solution Approach 1:
The device segments the lead system into a leadless right atrial pacing component and a separate leadlet for left ventricular pacing. The leadless RAA electrode is implanted independently in the right atrial appendage, while the leadlet with LV electrode is delivered through the coronary sinus. This segmentation eliminates the need for a single complex lead traversing multiple chambers, reducing overall device complexity while maintaining reliable therapy delivery to both chambers.
2Reliability
If traditional leads are used for multi-chamber pacing, then effective electrical sensing and pacing is achieved, but implantation procedure becomes more complex
Solution Approach 1:
The invention extracts the right atrial pacing function from the traditional transvenous lead system by implementing a leadless RAA electrode. This extracted component is implanted percutaneously in the right atrial appendage, separating it from the ventricular lead. The leadlet for left ventricular pacing is also delivered through a separate access route via the coronary sinus. This extraction simplifies the implantation procedure by allowing independent implantation of each chamber's pacing component without requiring a single complex lead.
3Ease of manufacture
If leadless implantation is used, then implantation is simplified, but the ability to pace both atrium and ventricle effectively is reduced
Solution Approach 1:
The invention introduces the coronary sinus as an intermediary access route to deliver the leadlet with left ventricular electrode. The leadlet traverses the coronary sinus ostium and extends into the coronary sinus or coronary vein to position the LV electrode proximate the left ventricle. This intermediary pathway enables effective left ventricular pacing while maintaining the leadless implantation approach for the right atrial component, thus achieving multi-chamber pacing efficacy through a simplified implantation procedure.
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 efficient and reliable cardiac therapy delivery to both atrial and ventricular chambers, simplifying implantation and enhancing therapeutic efficacy by eliminating the need for traditional leads.
Implementation Method 1
puncturing the right ventricular endocardium using the penetration element to form an opening
Implementation Method 2
advancing a distal portion of a guide element through the delivery catheter and the opening and into the interventricular septal wall to extend along the left ventricular endocardial wall
Implementation Method 3
delivering pacing therapy using the processing circuitry and at one or more of the plurality of electrodes
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3C
AI summary
Systems, devices, and methods may be used to deliver and provide cardiac pacing therapy to a patient. Leads or leadlets carrying one or more left ventricular electrodes may be positioned in or near the interventricular septum to sense and pace left ventricular signals of the patient's heart. In one example, a leadlet including one or more left ventricular electrodes may extend in the coronary sinus from a leadless implantable medical device located in the right atrium.