Self-Expanding Endovascular Pacemaker Anchoring
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Solution Overview
Problem
Conventional cardiac pacemakers and defibrillators face limitations such as anchoring issues, limited endothelial contact, and inability to provide atrioventricular synchrony, especially in patients requiring biventricular pacing or those with compromised venous access, leading to complications like dislodgement and ineffective ventricular contraction.
Innovation Solution
A self-expanding endovascular pacemaker system with flexible, curvilinear electrodes that radially expand for secure anchoring and pacing, embedded within a conductive shaft with an integrated electrical generator, allowing for wireless stimulation and sensing of cardiac tissue without the need for external batteries or transvenous leads, capable of detecting electrical and mechanical signals for synchronized pacing and defibrillation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional anchoring systems (screws or tines) are used to fix the lead to cardiac tissue, then the lead is secured in place, but the device complexity increases and the risk of dislodgement or tissue damage remains
Solution Approach 1:
The patent removes the separate anchoring system (screws or tines) from the lead structure entirely. Instead, the lead itself is designed with an expandable distal end that directly engages the vessel wall through radial expansion, eliminating the need for additional anchoring components and simplifying the overall device structure while maintaining secure fixation.
Solution Approach 2:
The anchoring function is merged with the lead structure itself. The distal end of the lead is designed to perform both the electrical conduction function and the anchoring function simultaneously through its expandable geometry, rather than requiring a separate anchoring mechanism. This integration reduces device complexity while ensuring reliable fixation.
2Adaptability or versatility
If a single-chamber pacemaker is used, then the device simplicity is maintained, but the ability to provide atrioventricular synchrony and improve cardiac function is limited
Solution Approach 1:
The patent designs a single lead system that can be configured to pace multiple chambers (atria and ventricles) through different electrode placements and configurations. The expandable distal end can provide both atrial and ventricular pacing capabilities, allowing the system to function as a single-chamber, dual-chamber, or biventricular pacemaker depending on the specific electrode activation sequence, thereby providing universal pacing capability without requiring multiple separate leads.
3Reliability
If transvenous leads are used for pacemaker implantation, then the electrodes can be positioned in the heart chambers, but the risk of vascular damage, infection, and lead dislodgement increases
Solution Approach 1:
The patent replaces the mechanical threading and securing mechanisms (screws, tines) with a radial expansion mechanism. The expandable distal end of the lead is deployed within the vessel lumen and secures itself through controlled radial expansion against the vessel wall, eliminating the need for penetrating mechanical anchors that could cause tissue damage or serve as infection pathways.
4Ease of manufacture
If adhesive bonding is used to connect the lead sleeve and tip electrode, then the assembly is simplified, but the bond strength decreases over time and separation may occur
Solution Approach 1:
The patent eliminates the adhesive bonding step from the lead manufacturing process. Instead of using adhesives to connect the sleeve and tip electrode, the design uses a mechanical interference fit or friction lock mechanism where the expandable distal end structure inherently secures the electrical contacts through its geometry, removing the reliance on time-dependent adhesive bonds.
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 anchoring and effective pacing of multiple heart chambers without dislodgement, enabling physiologic cardiac contraction and defibrillation, reducing complications associated with traditional systems, and allowing for wireless operation with reduced risk of infection and vascular damage.
Implementation Method 1
The electrodes and the shaft are removable from the delivery catheter, and the electrodes elastically self-expand to the expanded position when removed from the delivery catheter
Data Source
AI summary
A system applies and senses electrical energy to and from tissue within a patient's body. The system includes a steerable delivery catheter, housing a flexible shaft and an electrical generator disposed on or embedded within the flexible shaft. Electrodes coupled to the shaft self-expand radially from a compressed position to an expanded position once the delivery catheter is withdrawn, thereby contacting a wall of the tissue of the patient's body to conduct electrical or other signals. The system may be inserted into the coronary sinus and tributary vein to provide physiological pacing to the His bundle and left ventricle. Further, the system provides for controlled passive transmission of normal electric impulses from the atria to the His bundle and ventricles without the need for an embedded generator.