Leadless Cardiac Pacing Device Delivery and Fixation
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Solution Overview
Problem
There is a need for improved delivery and fixation means for compact implantable cardiac pacing devices, which often face mechanical complications and MRI compatibility issues with conventional leads.
Innovation Solution
The use of a delivery device and method for deploying a compact dual chamber intra-cardiac pacing device, which includes a leadlet pacing device (LPD) and a leadlet, allowing for secure attachment to cardiac tissue without conventional leads, using a T-shaped or hooped leadlet design with a helical tip for fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional leads are used for cardiac pacing, then electrical connection to cardiac tissue is achieved, but mechanical complications and MRI compatibility issues occur
Solution Approach 1:
The patent removes the conventional lead component from the pacing system entirely. The leadless pacemaker device is implanted directly into the cardiac chamber, eliminating the need for separate leads that connect to cardiac tissue. This extraction of the lead component resolves the mechanical complications and MRI compatibility issues associated with conventional lead-based systems.
Solution Approach 2:
The patent combines the pacemaker generator and the electrode into a single integrated leadless device. Instead of having separate components (generator in the chest connected by lead to electrode in heart), the entire pacing function is merged into one implantable unit that is placed directly in the cardiac chamber, eliminating the lead interface that causes mechanical problems.
2Reliability
If compact implantable devices are used, then lead-related mechanical complications are reduced, but delivery and fixation complexity increases
Solution Approach 1:
The patent incorporates fixation tines and delivery mechanisms pre-integrated into the pacemaker device before implantation. The tines are prepared in a compressed or retracted state within the delivery system, ready to deploy automatically upon reaching the target site. This preliminary preparation simplifies the implantation process despite the device's compact complexity.
Solution Approach 2:
The patent uses a specialized delivery catheter system that acts as an intermediary between the operator and the compact pacemaker device. The delivery system provides mechanical advantage and control mechanisms to manipulate the small device during implantation, including deploying fixation tines and positioning the device accurately in the cardiac chamber without requiring complex manual manipulation of the tiny device itself.
3Object-affected harmful factors
If leadless pacing devices are used, then MRI compatibility is improved, but fixation and repositioning capabilities must be enhanced
Solution Approach 1:
The patent employs dynamic fixation mechanisms where the fixation tines can transition between a retracted state during delivery and a deployed state for secure anchoring. The tines are designed to be flexible and adaptable, allowing the device to be securely fixed when needed while maintaining the capability for retrieval or repositioning by reversing the deployment process.
Solution Approach 2:
The patent incorporates retrieval mechanisms that allow the leadless pacemaker to be recovered or repositioned if necessary. The fixation tines can be engaged or disengaged, and the device can be grasped by a retrieval tool through the delivery catheter, allowing for recovery and repositioning capabilities despite the device being firmly anchored in the cardiac chamber.
Data Source
AI summary
Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.