Biostimulator Header Assembly With Integrated Fixation Mount Sealing

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Solution Overview

Problem

Conventional pacemakers face issues such as lead or feedthrough assembly breakage, complex connections, infection risks, and increased device size due to threaded connections and additional components like gaskets and adhesives in leadless biostimulators.

Innovation Solution

A header assembly for leadless biostimulators with an integrated fixation element mount, utilizing a mounting ring on an insulator base and direct connections like brazing joints to eliminate threaded connections, reducing device size and complexity while ensuring hermeticity and electrical isolation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If threaded connections and gaskets are used to achieve hermetic sealing, then electrical isolation and hermeticity are improved, but device size and complexity increase

Engineering Contradiction:

ImprovehermeticityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The feedthrough assembly is merged with the header assembly to form an integrated unit. The feedthrough assembly includes a feedthrough body with a first end connected to the header assembly and a second end extending outward, eliminating the need for separate threaded connections and gaskets between these components while maintaining hermetic sealing.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The problematic threaded connections and separate gasket components are extracted/removed from the design. Instead of using traditional threaded mounts with separate sealing elements, the patent uses an integrated feedthrough assembly where hermeticity is achieved through the unified structure and sealing at the housing interface, reducing the number of potential failure points.

Inventive Principle:

Principle #2Taking out (Extraction)

2Strength

If threaded connections are used to attach fixation elements, then mechanical stability is improved, but device size increases due to minimum thread length requirements

Engineering Contradiction:

Improvemechanical stabilityVSAvoiddevice size

Core Design Contradiction:

StrengthVSLength of moving object

Solution Approach 1:

The fixation element mount is merged with the header assembly or flange structure. The mount includes a body with a first end connected to the header assembly and a second end extending outward to receive the fixation element, eliminating the need for separate threaded connections and reducing overall device length while maintaining mechanical stability.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

Traditional threaded mounting structures with minimum length requirements are extracted and replaced with a compact integrated mount design. The mount provides secure fixation element attachment through its integrated structure without requiring lengthy threaded sections, thereby reducing device size.

Inventive Principle:

Principle #2Taking out (Extraction)

3Ease of manufacture

If multiple separate components are used in the header assembly, then ease of manufacture is improved, but the risk of fluid and electrical leaks increases

Engineering Contradiction:

Improveease of manufactureVSAvoidfluid and electrical leaks

Core Design Contradiction:

Ease of manufactureVSObject-generated harmful factors

Solution Approach 1:

Multiple separate components (feedthrough assembly, fixation element mount, electrodes) are merged into an integrated header assembly structure. This unified design reduces the number of interfaces and potential leak paths while maintaining manufacturability through modular integration and standardized connection methods.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

Separate gasket and adhesive components that create additional failure pathways are extracted/removed. Hermetic sealing is achieved through the integrated structure of the feedthrough assembly and housing interface, eliminating the need for additional sealing components and reducing the risk of fluid and electrical leaks.

Inventive Principle:

Principle #2Taking out (Extraction)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution minimizes device size, reduces the risk of fluid and electrical leaks, and enhances mechanical stability and manufacturability by eliminating threaded connections and additional seal components.

Implementation Method 1

The mounting ring extends around the central axis within a groove of the insulator base

Methodology Applied

Scientific EffectMechanical support through groove integration:

Implementation Method 2

direct connections like brazing joints to eliminate threaded connections

Methodology Applied

Scientific EffectBrazing: Brazing

Data Source

PatentEP4647110A1Biostimulator header assembly having integrated fixation element mount

Publication Date: 2025.11.12 PACESETTER INC

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AI summary

A biostimulator system (200) includes a biostimulator (100) coupled to a biostimulator transport system (202). The biostimulator (100) includes a header assembly (109). The header assembly (109) includes a flange (111) having a central axis (108). A fixation element mount (112) is mounted on the flange (111). The fixation element mount (112) includes a mounting ring (404) on an insulator base (406). The mounting ring (404) extends around the central axis (108) within a groove (504) of the insulator base (406). A fixation element (114) is coupled to the mounting ring (404). Other embodiments are also described and claimed.