Adjustable Tether Delivery Catheter for Leadless Pacemaker Implantation
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Solution Overview
Problem
Conventional cardiac pacemakers face issues such as unsightly subcutaneous bulges, erosion, infection, and complex lead connections, which can lead to malfunction and prolonged recovery times, while leadless pacemakers require effective delivery and fixation mechanisms for intracardial implantation.
Innovation Solution
A delivery catheter system with adjustable tethers and locking features allows for precise alignment and fixation of a leadless pacemaker within the heart, utilizing a tether adjustment feature to switch between aligned and un-aligned configurations, and a docking cap for applying rotational torque to secure the pacemaker to the myocardium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pacemakers use subcutaneous pulse generators with leads, then cardiac pacing function is provided, but skin bulge, erosion, infection, and connection malfunction occur
Solution Approach 1:
The invention extracts and removes the external pulse generator and leads from the conventional pacemaker system, creating a leadless pacemaker where the generator is implanted directly in the cardiac chamber. This eliminates the subcutaneous bulge, lead connections, and associated infection risks while maintaining pacing functionality.
Solution Approach 2:
The invention merges the pulse generator, electrodes, and housing into a single integrated leadless pacemaker unit that is implanted directly in the heart. This consolidation eliminates separate leads and external components, reducing potential failure points and infection risks while providing complete pacemaker functionality in one device.
2Object-affected harmful factors
If leadless pacemaker is implanted intracardially, then infection risk is reduced, but precise delivery and fixation are required
Solution Approach 1:
The invention employs a delivery catheter system that allows dynamic adjustment of the pacemaker position during implantation. The catheter can be navigated through blood vessels to the target cardiac chamber, and the pacemaker can be repositioned before final fixation, enabling precise placement while maintaining flexibility throughout the procedure.
Solution Approach 2:
The invention uses a delivery catheter as an intermediary tool to transport and position the leadless pacemaker within the cardiac chamber. The catheter provides a controlled pathway for delivery and enables precise positioning before the pacemaker is released and fixed to the endocardial surface.
3Manufacturing precision
If tether length is adjustable, then alignment precision is improved, but device complexity increases
Solution Approach 1:
The invention incorporates an adjustable tether mechanism that allows the tether length to be modified during the implantation procedure. This dynamic adjustment capability enables precise alignment of the pacemaker with delivery catheter components while accommodating variations in patient anatomy and implantation conditions.
Data Source
AI summary
A delivery system for implanting a leadless cardiac pacemaker into a patient is provided. The cardiac pacemaker can include a docking or delivery feature having a through-hole disposed on or near a proximal end of the pacemaker for attachment to the delivery system. In some embodiments, the delivery catheter can include first and second tethers configured to engage the delivery feature of the pacemaker. The tethers, when partially aligned, can have a cross-sectional diameter larger than the through-hole of the delivery feature, and when un-aligned, can have a cross-sectional diameter smaller than the through-hole of the delivery feature. Methods of delivering the leadless cardiac pacemaker with the delivery system are also provided.