Leadless Biostimulator Fixation With Backstops Against Tissue Back-Out
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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 at the interface between the pulse generator and electrode leads, along with difficulties in implantation and adjustment, especially for sub-muscular placement.
Innovation Solution
A leadless biostimulator with a fixation element featuring a helix extending along a helical axis, including a leading point and backstop elements to anchor securely within cardiac tissue, reducing the need for external leads and minimizing tissue penetration depth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a conventional pulse generator is implanted subcutaneously, then electrical stimulation can be provided to the heart, but it creates a visible bulge under the skin that patients find unsightly and irritating
Solution Approach 1:
The invention extracts the pulse generator from its traditional subcutaneous pocket location and relocates it to the cardiac chamber, eliminating the skin bulge problem. The generator is now implanted within the heart chamber where it does not create external visible deformity, while still providing electrical stimulation through electrodes in direct contact with cardiac tissue.
Solution Approach 2:
The invention introduces a leadless intermediate structure that integrates the pulse generator housing with fixation elements (such as expandable frames or anchors) that can be securely attached to the cardiac chamber wall. This intermediary structure allows the generator to be positioned within the chamber without requiring a subcutaneous pocket, thereby eliminating the skin bulge while maintaining secure implantation.
2Reliability
If electrode leads are used to connect the pulse generator to the heart, then electrical stimulation can be delivered, but the connection interface becomes complex and prone to disconnection, infection, and insulation damage
Solution Approach 1:
The invention merges the pulse generator housing with the electrode assembly into a single integrated unit. The generator is positioned in direct contact with the cardiac chamber, and electrodes are mounted on or near the generator housing, eliminating the need for separate leads and connectors. This integration removes the complex connection interface that was previously prone to disconnection, infection, and insulation damage.
Solution Approach 2:
The invention extracts and removes the lead and connector components from the pacing system. By eliminating the external leads that extend from the generator through the venous system to the heart, the system removes the vulnerable connection points that were susceptible to disconnection, infection, and insulation damage, while maintaining effective electrical stimulation delivery.
3Object-affected harmful factors
If the pulse generator is placed sub-muscularly or abdominally to reduce skin bulge, then patient appearance improves, but surgical implantation and adjustment become more difficult and recovery is prolonged
Solution Approach 1:
The invention extracts the generator from both subcutaneous and sub-muscular locations and relocates it directly to the cardiac chamber. This eliminates the need for complex dissection through muscle layers and reduces surgical trauma, while achieving the cosmetic benefit of no visible skin bulge. The procedure becomes less invasive as it avoids extensive soft tissue dissection.
Solution Approach 2:
The invention introduces a delivery catheter as an intermediary tool that enables minimally invasive placement of the generator directly into the cardiac chamber through vascular access. This intermediary delivery system avoids the need for open surgical exposure of the chest wall and muscle layers, simplifying the implantation procedure and reducing recovery time while achieving the cosmetic goal of eliminating skin bulge.
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.