Leadless Cardiac Resynchronization Therapy System
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Solution Overview
Problem
Current implantable medical devices for cardiac resynchronization therapy (CRT) face challenges such as lengthy implantation procedures, skilled personnel requirements, post-implant complications like LV lead dislodgement and phrenic nerve stimulation, and variability in patient response due to incorrect delivery of electrical stimulation.
Innovation Solution
The use of a subcutaneous device (SD) and a leadless pacing device (LPD) system that eliminates the need for a conventional left ventricular lead, allowing for wireless communication and precise delivery of CRT through electrodes on the SD and LPD, with the SD determining the timing of pacing pulses and the LPD delivering therapy based on sensed cardiac signals.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional left ventricular lead is used for CRT, then CRT therapy can be delivered to the heart, but implantation procedure becomes lengthy and requires skilled electrophysiologists
Solution Approach 1:
The patent extracts the leadless pacemaker from the traditional lead-based system. The leadless pacemaker is a self-contained device that performs both sensing and pacing functions within a single implantable unit, eliminating the need for separate leads and generators. This extraction of the core pacing function into a standalone device simplifies the implantation procedure and reduces the time required while maintaining CRT therapy delivery capability
Solution Approach 2:
The patent segments the CRT system into multiple independent components: a leadless pacemaker for sensing and pacing, and a separate CRT device for delivering resynchronization therapy. This segmentation allows each component to be optimized independently and simplifies the overall implantation process by eliminating the need for complex lead wiring between components
2Reliability
If conventional left ventricular lead is used for CRT, then CRT therapy can be delivered, but post-implant complications such as lead dislodgement and phrenic nerve stimulation occur
Solution Approach 1:
The patent removes the vulnerable lead component from the system by using a leadless pacemaker design. The pacing electrodes are integrated directly into the pacemaker body, eliminating the risk of lead dislodgement, fracture, or insulation failure that plagues traditional lead-based systems. This extraction of the lead eliminates the primary source of post-implant complications
Solution Approach 2:
The patent introduces wireless communication as an intermediary between the leadless pacemaker and the external world. Data and control signals are transmitted wirelessly, eliminating the need for physical wire connections that can cause phrenic nerve stimulation. The wireless interface acts as a mediator that maintains communication while avoiding the harmful effects of direct electrical connections to sensitive nerves
3Reliability
If conventional left ventricular lead is used for CRT, then electrical stimulation can be delivered to the heart, but some patients are non-responsive due to incorrect stimulation delivery location
Solution Approach 1:
The patent applies local quality by using a leadless pacemaker that can be precisely positioned at specific locations within the heart chambers. The device incorporates local sensing and pacing capabilities that allow for targeted delivery of electrical stimulation to specific myocardial regions. This localized approach ensures that the stimulation is delivered precisely where needed, improving patient response to CRT therapy
Solution Approach 2:
The patent implements feedback mechanisms where the leadless pacemaker continuously monitors cardiac electrical activity and provides real-time information about the effectiveness of pacing. This feedback allows for adjustment of pacing parameters and verification that stimulation is being delivered to the correct location, ensuring optimal CRT therapy delivery and patient responsiveness
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 approach reduces implantation time and expertise, minimizes post-implant complications, and enhances CRT effectiveness by allowing for precise synchronization of cardiac contractions without the need for invasive leads.
Implementation Method 1
a first electrical signal (also referred to as the baseline rhythm) is sensed from a heart of a patient through the SD
Implementation Method 2
The LPD delivers pacing pulses to cardiac tissue after receiving a command signal from the IID
Data Source
AI summary
Techniques and systems for monitoring cardiac arrhythmias and delivering electrical stimulation therapy using a subcutaneous device (e.g. subcutaneous implantable (SD)) is described. In one or more other embodiments, SD is implanted into a patient's heart. Electrical signals are then sensed which includes moderately lengthened QRS duration data from the patient's heart. A determination is made as to whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate based upon the moderately lengthened QRS duration in the sensed electrical signals. The CRT pacing pulses are delivered to the heart using electrodes. In one or more embodiments, the SD can switch between fusion pacing and biventricular pacing based upon data (e.g. moderately lengthened QRS, etc.) sensed from the heart.