Leadless Pacemaker Delivery via Negative Pressure Suction
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Solution Overview
Problem
Conventional cardiac pacemakers face issues such as unsightly bulges, erosion, infection, and complex connection malfunctions, while leadless pacemakers have challenges with delivery systems that can lead to spontaneous release and undesirably long lengths.
Innovation Solution
A catheter-based delivery system using a guide catheter with a suction attachment feature that adheres to the leadless pacemaker via negative pressure, allowing for secure implantation and explantation without displacement, and eliminating the need for tether-based docking features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional pulse generator is implanted subcutaneously, then cardiac pacing function is provided, but it creates unsightly bulges and risks erosion, extrusion, and infection
Solution Approach 1:
The patent extracts the pulse generator from its traditional subcutaneous pocket location and relocates it to an intrapericardial position. This removes the device from the harmful external environment, eliminating skin erosion and infection risks while maintaining pacing functionality through leadless electrodes in direct cardiac contact
Solution Approach 2:
The pericardial space serves as an intermediary location between the external skin surface and the internal cardiac tissue. By placing the pulse generator in this intermediate space, the device achieves reliable cardiac pacing contact while being isolated from harmful external factors affecting subcutaneous implants
2Reliability
If conventional electrode leads are used to connect pulse generator to heart, then cardiac pacing is achieved, but the connection interface provides multiple opportunities for malfunction
Solution Approach 1:
The patent merges the pulse generator and electrode functions into a single integrated leadless device. The generator housing directly incorporates pacing electrodes, eliminating separate leads and complex connector interfaces. This unified structure removes multiple potential failure points while maintaining effective cardiac pacing
Solution Approach 2:
The patent extracts and eliminates the separate electrode leads and connector components from the pacing system. By removing these intermediate elements, the design simplifies the overall system architecture and eliminates the complex male-female connector interfaces that prone to malfunction
3Reliability
If leadless pacemaker uses actively engaging fixation mechanism, then secure implantation is achieved, but the delivery system becomes complex and expensive with risk of spontaneous release
Solution Approach 1:
The patent replaces complex mechanical active fixation mechanisms with a simpler adhesive-based attachment system. The generator housing incorporates adhesive material that bonds directly to cardiac tissue, providing secure implantation without requiring complex mechanical anchors or elaborate delivery system mechanisms
Solution Approach 2:
The patent changes the fixation mechanism from mechanical engagement to chemical adhesion. By using adhesive materials with specific bonding properties, the device achieves reliable tissue attachment while simplifying both the generator structure and delivery system requirements
4Ease of operation
If leadless pacemaker includes tether-based docking features, then delivery is enabled, but the overall length becomes undesirably long
Solution Approach 1:
The patent extracts and eliminates tether-based docking features from the leadless pacemaker design. By removing these protruding delivery interface components, the device achieves a more compact form factor while maintaining delivery capability through alternative integrated attachment mechanisms
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 reduces manufacturing costs, enhances safety by minimizing spontaneous release, and allows for shorter pacemaker lengths, enabling additional electronics and increased battery capacity, while providing a simpler and safer implantation process.
Implementation Method 1
The suction attachment feature is located at the distal end of the catheter shaft and configured to selectively negative pressure adhere (e.g., suction attach) with the housing of the leadless pacemaker
Data Source
AI summary
Disclosed herein is a system for delivering a leadless pacemaker having a housing with a proximal end. The system includes a guide catheter. The guide catheter includes a catheter shaft and a negative pressure attachment feature. The catheter shaft includes a distal end and a proximal end opposite the distal end. The negative pressure attachment feature is located at the distal end of the catheter shaft and configured to selectively negative pressure adhere with the housing of the leadless pacemaker.