Leadless Cardiac Electrode Assemblies for Wireless Pacing
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Solution Overview
Problem
Conventional pacemakers with leads extending into the heart face challenges such as lead entanglement, difficulty in repositioning or removal, risk of thrombosis, and limited sites for electrical energy delivery, which restricts effective pacing, especially for conditions like congestive heart failure and arrhythmias.
Innovation Solution
The development of leadless electrode assemblies that use wireless transmission to deliver pacing control information and energy from an implantable pulse generator to electrodes positioned within the heart, allowing for multiple-site pacing without physical leads, thereby reducing the risk of thrombosis and improving energy efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional leads are used to extend from the pulse generator into the heart, then electrical stimulation can be delivered to cardiac tissue, but the leads cause thrombosis risk, entanglement, and difficulty in repositioning or removal
Solution Approach 1:
The patent extracts the electrode assembly from the lead structure, creating a leadless electrode that can be delivered independently to the heart. The electrode is separated from the pulse generator connection, eliminating the physical lead that causes thrombosis while maintaining electrical stimulation capability through wireless or inductive coupling
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary tool that temporarily carries the electrode to the heart and then withdraws. This intermediary enables precise electrode placement without requiring permanent leads, allowing the electrode to be positioned accurately and then delivered independently
2Adaptability or versatility
If multiple leads are positioned in cardiac veins to pace multiple sites, then more comprehensive cardiac coverage is achieved, but significant occlusion of the vena cava and branching veins occurs
Solution Approach 1:
The patent segments the pacing system into multiple independent leadless electrodes that can be positioned at different cardiac sites simultaneously. Each electrode operates independently without requiring shared venous access, allowing multiple pacing sites to be achieved without the venous occlusion problems of multiple leads
Solution Approach 2:
The patent transitions from the conventional approach of accessing the heart through venous pathways to direct cardiac placement. By changing the delivery dimension from venous access to direct cardiac chamber or wall placement, multiple electrodes can be positioned without competing for venous space
3Stability of the object's composition
If leads are secured to tissue using tines or hooks, then the lead remains in place over time, but the lead becomes difficult to remove or reposition when needed
Solution Approach 1:
The patent employs dynamic fixation mechanisms where the electrode is initially delivered in a constrained state within the catheter, then transitions to a deployed state with fixation elements (such as expandable arms or tines) that can be actively controlled. This allows the electrode to be easily removable during the acute phase while providing stable fixation long-term if needed
Solution Approach 2:
The patent performs preliminary positioning and testing during the catheter delivery phase, allowing the physician to optimize electrode placement before final deployment. The electrode can be repositioned or removed easily during this preliminary phase before commitment to permanent fixation
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 enables efficient pacing at multiple sites within the heart, reduces the risk of stroke, and improves left ventricle response by allowing optimal stimulator positioning, while minimizing the need for implanted defibrillators and reducing energy requirements.
Implementation Method 1
a transmitter assembly located near the distal end of the lead body and electrically connected to the pulse generator assembly via the lead conductor to wirelessly transmit pacing control information and pacing energy from the transmitter assembly to an implanted leadless electrode assembly
Data Source
AI summary
A seed assembly for delivery to an interior of a heart includes an electrical stimulation circuit for delivering an electrical stimulus to cardiac tissue. A first electrode assembly is mechanically and electrically coupled to the seed assembly via a micro lead, the first electrode assembly configured to deliver the electrical stimulus generated by the electrical stimulation circuit to the cardiac tissue. The seed assembly and the first electrode assembly are sized and shaped to fit entirely within the heart.