Leadless Pacemaker Radial Fixation Helix
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Solution Overview
Problem
Conventional cardiac pacemakers face issues such as unsightly bulges, erosion, infection, and complex connection malfunctions due to subcutaneous placement, and the pacing leads can become sites of infection and morbidity, necessitating the development of a more efficient and secure attachment method for cardiac pacing devices.
Innovation Solution
A leadless cardiac pacemaker with a hermetic housing, a pacing electrode, and a radial fixation mechanism that includes a helix or hooks for secure attachment to heart tissue without perforating the myocardium, allowing for minimal invasive implantation and retrieval, and reducing fibrotic tissue formation by decoupling the fixation and stimulation sites.
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 is prone to erosion, extrusion, and infection
Solution Approach 1:
The patent extracts the pulse generator from the subcutaneous space and relocates it directly into the cardiac chamber, eliminating the subcutaneous interface that causes erosion, extrusion, and infection. The generator is now implanted intracardially where it can be secured to the myocardium without external skin contact issues.
Solution Approach 2:
The patent integrates the pulse generator within the cardiac chamber environment, nesting it among the heart structures themselves. The generator is positioned within the chamber and secured to the myocardium, effectively nesting the device within the body's natural anatomy rather than placing it in subcutaneous tissue.
2Reliability
If conventional pacemakers use separate pulse generators and pacing leads, then cardiac pacing is achieved, but the leads become sites of infection and malfunction
Solution Approach 1:
The patent merges the pulse generator and pacing leads into a single integrated unit. The generator contains built-in electrodes that directly contact the myocardium, eliminating the separate lead component that serves as a potential infection site and source of malfunction. The generator itself performs both the pacing function and the electrical stimulation function.
3Reliability
If a fixation mechanism with multiple turns is used, then secure attachment to myocardium is achieved, but the mechanism may perforate the heart tissue
Solution Approach 1:
The patent changes the geometric parameters of the fixation mechanism by limiting the helical turns to less than two complete rotations. This parameter modification provides sufficient fixation security through the engaged helical portion while preventing the mechanism from extending far enough to perforate the myocardium. The constrained rotation angle balances fixation strength with tissue safety.
4Reliability
If conventional connectors with multiple components are used, then electrical connection is achieved, but multiple opportunities for malfunction increase
Solution Approach 1:
The patent merges the electrical connection function into the integrated generator-electrode assembly, eliminating separate connectors, terminal blocks, and wiring harnesses. The electrodes are directly attached to the generator housing, creating a simplified, monolithic structure that removes multiple potential failure points associated with connector interfaces and lead-wire connections.
Data Source
AI summary
A leadless cardiac pacemaker having a radial fixation mechanism is provided. The cardiac pacemaker can include fixation mechanism separate from a pacing electrode and having a diameter equal to or less than the outer diameter of the pacemaker. The fixation mechanism can allow the pacemaker to be inserted into tissue with less than 2 rotations of the pacemaker to place the pacing electrode in contact with the tissue. In some embodiments, the fixation mechanism can comprise a plurality of hooks or protrusions positioned near a distal portion of the pacemaker. The fixation mechanism(s) can be configured to penetrate the endocardium of the patient and reside mostly within the myocardium. Methods of delivering the leadless cardiac pacemaker into the heart are also provided.