Leadless Cardiac Biostimulator Fixation With Backstop Anchoring
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Solution Overview
Problem
Conventional cardiac pacemakers face issues such as bulging under the skin, erosion, extrusion, infection, disconnection, and complex connections that can lead to malfunction, along with difficulties in implantation and adjustment, especially with separately implanted pulse generators and pacing leads.
Innovation Solution
A self-contained leadless biostimulator with a fixation element, such as a helix, is mounted on a housing, featuring a helical axis and a leading point for anchoring within the heart, along with backstop elements to resist backward movement and ensure secure fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional pulse generator is implanted subcutaneously, then it can provide electrical stimulation to the heart, but it creates a bulge in the skin that patients find unsightly and can lead to erosion, extrusion, and infection
Solution Approach 1:
The invention extracts the pulse generator from its conventional subcutaneous position and relocates it to an intrapericardial position within the pericardial space. This extraction from the problematic subcutaneous environment eliminates the bulge and associated complications while maintaining the device's essential function of providing electrical stimulation to the heart
2Reliability
If conventional pacemaker leads are used with separate pulse generators, then electrical connection can be established, but the complex connections provide multiple opportunities for malfunction including disconnection and insulation damage
Solution Approach 1:
The invention merges the pulse generator with the leads by providing leads that extend directly from the pulse generator housing. This integration eliminates separate connectors and terminal blocks, reducing the number of potential failure points while maintaining reliable electrical connection between the generator and heart
3Reliability
If conventional pacemaker leads are implanted, then electrical stimulation can be delivered to the heart, but the leads can become a site of infection and morbidity
Solution Approach 1:
The invention extracts the pulse generator from the subcutaneous environment where infection can occur along the lead path, and relocates it to the intrapericardial space. This extraction removes the external entry point and lead tract that serve as potential infection pathways, thereby reducing morbidity while maintaining stimulation delivery
4Object-affected harmful factors
If sub-muscular or abdominal placement is used to address skin concerns, then erosion and extrusion are reduced, but the surgical procedure becomes more difficult and patient recovery is prolonged
Solution Approach 1:
The invention uses the pericardial space as an intermediary location for the pulse generator, positioned between the subcutaneous tissue and the heart muscle. This intermediate position provides access to the heart for electrical stimulation while avoiding the complications of both subcutaneous and deep sub-muscular/abdominal placements, thereby simplifying the surgical procedure
Data Source
AI summary
A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.