Overmolded Biostimulator Header Assembly for Electrical Isolation

Solution Overview

Problem

Conventional pacemakers face issues such as lead or feedthrough assembly breakage, complex connections, and infection risks due to separate leads and pulse generator components, which are addressed by the development of a leadless biostimulator with a header assembly that includes an overmolded helix mount for improved mechanical stability and electrical reliability.

Innovation Solution

The leadless biostimulator features a header assembly with an overmolded helix mount on an electrical feedthrough assembly, which integrates components using few parts and adheres to a flange and insulator for robust mechanical stability and reliable electrical performance, eliminating the need for additional sealing components like gaskets or adhesives.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If gaskets or adhesives are used to provide electrical isolation between components of the feedthrough assembly, then electrical isolation is achieved, but assembly complexity and manufacturing costs increase

Engineering Contradiction:

Improveelectrical isolationVSAvoidassembly complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the electrical isolation function and mechanical structural support into a single integrated insulating member. This insulating member is formed as one piece with the feedthrough assembly, eliminating the need for separate gaskets or adhesives to provide electrical isolation. The integration reduces the number of components and assembly steps while maintaining the electrical isolation function.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The insulating member serves multiple functions simultaneously: it provides electrical isolation between conductive components, mechanical support for the feedthrough assembly, and structural integrity. By making the insulating member multi-functional, the patent eliminates the need for additional dedicated components for each function, thereby reducing assembly complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If gaskets or adhesives are used to provide electrical isolation between components of the feedthrough assembly, then electrical isolation is achieved, but manufacturing costs increase

Engineering Contradiction:

Improveelectrical isolationVSAvoidmanufacturing cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent combines the electrical isolation function and mechanical structural support into a single integrated insulating member. This insulating member is formed as one piece with the feedthrough assembly, eliminating the need for separate gaskets or adhesives to provide electrical isolation. The integration reduces the number of components and assembly steps while maintaining the electrical isolation function.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The insulating member serves multiple functions simultaneously: it provides electrical isolation between conductive components, mechanical support for the feedthrough assembly, and structural integrity. By making the insulating member multi-functional, the patent eliminates the need for additional dedicated components for each function, thereby reducing manufacturing costs.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If separate leads and pulse generator components are used, then electrical connection is achieved, but infection risk and morbidity increase

Engineering Contradiction:

Improveelectrical connectionVSAvoidinfection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent merges the pulse generator and lead into a single integrated leadless biostimulator device. The device is implanted directly into the heart chamber, eliminating the need for separate leads that would penetrate the heart wall. This integration eliminates the infection risk associated with lead penetration while maintaining electrical connection functionality.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent extracts the lead function from the traditional separate lead component and integrates it directly into the pulse generator housing. The electrodes are formed as integral parts of the device housing, eliminating the need for separate leads that create infection pathways. This extraction and integration removes the harmful infection risk while preserving the electrical connection function.

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS12576278B2Leadless biostimulator having overmolded header assembly

Publication Date: 2026.03.17 PACESETTER INC

AI summary

A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes overmolded components, is described. The header assembly includes a helix mount overmolded on a flange of an electrical feedthrough assembly. A fixation element is mounted on the helix mount. The overmolded helix mount fills a recess in an outer surface of the flange to robustly join the header assembly components. The electrical feedthrough assembly includes an electrode contained within the flange to deliver electrical impulses to a target anatomy, and an insulator that separates the electrode from the flange. The overmolded helix mount can conform or adhere to the outer surfaces of the flange and the insulator to electrically isolate the electrode from the flange. Other embodiments are also described and claimed.