IMD Header Core Fixation Scaffold Assembly Design

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Solution Overview

Problem

Existing implantable medical devices (IMDs) face challenges in securely positioning and supporting circuit components, such as antennas and electrodes, within the header assembly, which can lead to unintended movement and disengagement from integrated circuitry, affecting the devices' performance and reliability.

Innovation Solution

A scaffold assembly is integrated within the header to position and support circuit components, including a break-away section for precise alignment and securement of electrodes, and conduits for electrical connectors to ensure stable and controlled operation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If circuit components are positioned within the header assembly using conventional methods, then the device structure remains simple, but the circuit components may move unintentionally and disengage from integrated circuitry, reducing reliability

Engineering Contradiction:
ImprovereliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces a scaffold assembly as an intermediary component between the header and circuit components. This scaffold provides a stable platform with positioning features that securely hold circuit components (antenna, electrode) in place, preventing movement and disengagement while maintaining overall device reliability without excessive complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The header assembly is segmented into distinct functional components: the header itself, the scaffold assembly, and the circuit components. This segmentation allows each part to be optimized independently - the scaffold can focus on positioning and support functions while the header provides structural integrity, resolving the contradiction between reliability and complexity

Inventive Principle:
Principle #1Segmentation

2Manufacturing precision

If circuit components are securely fixed within the header, then movement and shorting are prevented, but the positioning precision and alignment accuracy decrease

Engineering Contradiction:
Improvepositioning precisionVSAvoidreliability
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The scaffold assembly incorporates pre-formed positioning features (recesses, protrusions, alignment notches) that are created during scaffold manufacturing. These features preliminarily establish precise positions for circuit components before final assembly, ensuring both manufacturing precision and reliable electrical connections without compromising either aspect

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If the header structure is simplified, then manufacturing ease improves, but the ability to support and position multiple circuit components reliably deteriorates

Engineering Contradiction:
Improveease of manufactureVSAvoidreliability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The scaffold assembly merges multiple functions into a single component: structural support, circuit component positioning, electrical connection provision, and alignment facilitation. This consolidation allows the header to remain relatively simple and easy to manufacture while the scaffold provides the necessary complexity for reliable multi-component support

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP4082605B1Header core fixation design for an imd
Publication Date: 2023.10.25 CARDIAC PACEMAKERS INC
  • EP4082605B1 patent drawingFigure 1
  • EP4082605B1 patent drawingFigure 2
  • EP4082605B1 patent drawingFigure 3A~3B

AI summary

Aspects of the present disclosure are directed toward apparatuses, systems, and methods that may comprise a medical device having a header, a core assembly, and a scaffold assembly. The scaffold assembly may be configured to interface with the core assembly and position and support one or more circuit component relative to one or more other circuit components.