Leadless Cardiac Pacing Device with Expandable Anchoring
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Solution Overview
Problem
Conventional pacemakers require leads that extend from a pulse generator to an electrode, which can be invasive and may not provide optimal positioning for cardiac pacing, especially in areas like the Bundle of His, limiting the effectiveness of cardiac pacing and sensing.
Innovation Solution
A leadless cardiac pacing device with a housing, power source, and circuitry configured for pacing and sensing, featuring a distal extension with a helical or curved tine electrode that can be positioned near the Bundle of His, and an expandable anchoring mechanism for secure placement within the vasculature, allowing for direct electrical stimulation and sensing without external leads.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pacemakers with leads are used, then cardiac pacing and sensing can be performed, but the procedure becomes invasive and optimal positioning for areas like the Bundle of His is limited
Solution Approach 1:
The patent combines the pulse generator, battery, and electrodes into a single integrated leadless device that can be implanted directly into the heart chamber. This eliminates the need for separate leads connecting an external pulse generator to electrodes, thereby reducing invasiveness while maintaining pacing functionality. The device integrates all necessary components (housing, power source, circuitry, electrodes) into one unit that can be positioned optimally near the Bundle of His.
Solution Approach 2:
The leadless device is segmented into distinct functional components: a housing containing the power source and circuitry, multiple electrodes positioned at specific locations, and an expandable anchoring mechanism. This segmentation allows each component to be optimized for its specific function while working together as an integrated system, enabling effective pacing without invasive leads.
2Reliability
If leads are used to extend from pulse generator to electrode, then electrical connection can be established, but the device complexity and invasiveness increase
Solution Approach 1:
The patent merges the electrical connection function directly into the device housing by integrating electrodes with the pulse generator housing. The electrodes are positioned to establish direct electrical contact with cardiac tissue, eliminating the need for separate lead structures. This integration simplifies the overall device architecture while maintaining reliable electrical connection for pacing and sensing.
3Object-affected harmful factors
If a leadless device is used, then invasiveness is reduced, but secure positioning and anchoring become more challenging
Solution Approach 1:
The expandable anchoring mechanism transitions from a compressed delivery state to an expanded deployed state, dynamically adapting to secure the device. During delivery, the anchoring mechanism is compressed to navigate vasculature; upon deployment, it expands to engage with the endocardial surface, providing stable positioning. This dynamic transformation allows the device to achieve secure anchoring without increasing invasiveness during the implantation procedure.
Solution Approach 2:
The anchoring mechanism changes its physical parameters (volume, surface area, engagement force) by transitioning from a compressed to an expanded configuration. This parameter change enables the device to achieve stable positioning on the cardiac surface while maintaining a small profile during delivery through the vasculature, thus resolving the contradiction between invasiveness and positioning stability.
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 effective pacing and sensing of cardiac activity, particularly in the Bundle of His, with improved positioning and reduced invasiveness, enhancing treatment of cardiac arrhythmias and providing modular implantation options for various cardiac chambers.
Implementation Method 1
an expandable anchoring mechanism releasably coupled to the elongated housing, the expandable anchoring mechanism having a collapsed configuration for delivery and an expanded configuration that locates the leadless cardiac device within the patient's vasculature
Implementation Method 2
a distal electrode positioned at distal end of the distal extension and operatively coupled to the circuitry and configured to provide pacing pulses to the Bundle of His
Data Source
Figure 1
Figure 2A
Figure 2B
AI summary
A lead less pacing device may include a housing having a proximal end and a distal end, and a set of one or more electrodes supported by the housing. The housing may include a first a distal extension extending distally from the distal end thereof. The distal extension may include a retractable and/or rotatable distal electrode. The distal electrode may be configured to be delivered to and pace at the Bundle of His. The leadless pacing device may be releasably coupled to an expandable anchor mechanism.