Leadless Biostimulator Helix Fixation for Stable Cardiac 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, particularly with separately implanted pulse generators and pacing leads.
Innovation Solution
A leadless biostimulator with a helix mount and fixation element that includes a helix extending along a helical axis, featuring a leading point aligned within an alignment range, and optional backstop elements to resist backward movement, providing secure anchoring within cardiac tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional pulse generator is implanted subcutaneously, then it provides cardiac pacing function, but it causes skin bulge and increases risk of erosion and infection
Solution Approach 1:
The invention extracts the pulse generator from the subcutaneous space and places it entirely within the cardiac chamber, eliminating the skin bulge and associated complications while maintaining the cardiac pacing function
Solution Approach 2:
The invention combines the pulse generator and fixation elements into a single integrated leadless device that can be implanted entirely within the heart, eliminating the need for separate leads and subcutaneous housing
2Reliability
If pacemaker leads are used to connect pulse generator to heart, then electrical connection is established, but disconnection and insulation damage occur
Solution Approach 1:
The invention merges the pulse generator with the electrode components into a single leadless unit, eliminating the separate electrical leads that are prone to disconnection and insulation damage
Solution Approach 2:
The invention removes the vulnerable lead components from the system entirely, extracting only the essential pacing function and delivering it through a leadless device implanted directly in the heart
3Reliability
If fixation elements extend beyond the distal end of the biostimulator, then secure anchoring is achieved, but tissue damage and dislodgement risk increase
Solution Approach 1:
The invention applies local quality by configuring the fixation elements to extend only partially beyond the distal end of the biostimulator housing, providing sufficient anchoring grip on the tissue while limiting the extension length to prevent excessive tissue damage and dislodgement risk
Solution Approach 2:
The invention changes the geometric parameter of the fixation elements by controlling their extension length relative to the housing, optimizing the balance between anchoring stability and tissue safety
Data Source
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AI summary
A biostimulator (100, 2000) comprises a helix mount (206, 2006) having a helix mount flange (210, 2160). The helix mount flange (210, 2160) includes one or more marks (2150) defining an alignment range (2150). The biostimulator (100, 2000) also comprises a fixation element (105, 205, 2005) mounted on the helix mount (210, 2160). The fixation element (105, 205) includes a helix extending along a helical axis (1001) about a longitudinal axis (304, 2001) to a leading point (1052, 2052). The leading point (1052, 2052) is aligned with the alignment range (2150).