Leadless Pacemaker with Embedded Piezoelectric Generator
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Solution Overview
Problem
Conventional pacemaker systems face challenges such as lead dislodgement, vascular access limitations, and inadequate anchoring mechanisms, particularly in treating symptomatic bradycardia and heart failure, with existing leadless pacemakers lacking contiguous atrial and ventricular pacing and adjustable diameter capabilities.
Innovation Solution
An implantable system with expandable and collapsible ring electrodes embedded within a flexible conductive shaft, allowing for radial displacement and conforming to cardiac structures for secure contact, and an embedded electrical generator for wireless energy production and sensing, enabling simultaneous pacing of both cardiac chambers without external energy sources.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional transvenous leads are used for cardiac pacing, then pacing function is provided, but lead dislodgement and vascular access limitations occur
Solution Approach 1:
The patent removes the external generator and traditional transvenous lead configuration by embedding the generator directly within the leadless pacemaker device that contacts cardiac tissue. This extraction of the generator from the traditional external-subcutaneous location eliminates the need for vascular access and prevents lead dislodgement while maintaining pacing function.
Solution Approach 2:
The generator is nested within the leadless pacemaker device structure, which itself is implanted within the cardiac chamber. This nested configuration integrates the generator and electrode functions into a single stable unit that contacts the heart tissue directly, eliminating the need for separate leads and vascular access procedures.
2Ease of operation
If leadless pacemakers are used, then vascular access is improved, but contiguous atrial and ventricular pacing capability is lost
Solution Approach 1:
The leadless pacemaker device is segmented into multiple independent electrode contacts distributed across different cardiac chambers (atria and ventricles). Each contact can independently sense and pace its respective chamber, enabling contiguous multi-chamber pacing while maintaining a leadless configuration that avoids vascular access.
Solution Approach 2:
The single leadless pacemaker device performs multiple functions across different cardiac chambers simultaneously - sensing, pacing, and defibrillation in both atrial and ventricular chambers. This multi-functional design provides contiguous coverage for all cardiac chambers without requiring separate devices or vascular access.
3Ease of manufacture
If fixed diameter pacemaker leads are used, then manufacturing is simplified, but adaptability to different cardiac structures is reduced
Solution Approach 1:
The pacemaker device incorporates expandable electrodes that can dynamically change their configuration from a compressed delivery state to an expanded contact state. This dynamic expansion allows the device to adapt to different cardiac chamber geometries and contact surfaces, providing versatility across various cardiac structures while maintaining manufacturability through a standardized expansion mechanism.
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 system provides secure, efficient, and adaptable pacing with reduced risk of dislodgement and improved cardiac synchronization, suitable for a broader range of patients, including those requiring left-ventricular resynchronization, while minimizing interference with ultrasonic and electrical signals.
Implementation Method 1
The subject system is in the area of sensing myocardial electrical impulses, as well as providing low/high voltage pacing and defibrillation. The subject system is further directed to the field of permitting pacing using electric, ultrasound, or magnetic stimulation permitting wireless stimulation of the tissue.
Data Source
AI summary
A system to generate and sense electrical energy to and from tissue within a mammalian body. The system includes a flexible shaft and an electrical generator disposed on or embedded within the flexible shaft. Radially displaceable arcuate arm members forming electrodes are displaceable responsive to actuation of the electrical generator.