Split Bore Header for Implantable Device Lead Insertion

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Solution Overview

Problem

The increasing demand for implantable medical devices with higher electrode counts and reduced size poses challenges in lead insertion, as higher channel counts require greater insertion force, and smaller leads have decreased axial stiffness, making insertion more difficult and potentially damaging.

Innovation Solution

The implementation of a header system with a higher density of electrical contacts allows for a smaller device size and reduced insertion force, featuring a positioning feature for lead alignment and a lead securing mechanism that eliminates the need for set screws, thereby minimizing damage during insertion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the number of contacts in the header is increased to achieve higher channel count, then the functionality and electrode count of the implantable medical device is improved, but the insertion force required to push the lead into the bore increases significantly

Engineering Contradiction:
Improvechannel countVSAvoidinsertion force
Core Design Contradiction:
Adaptability or versatilityVSForce

Solution Approach 1:

The header is divided into multiple bores, each containing a subset of contacts. The lead is segmented into multiple sections with lead contacts that interface with corresponding bore contacts. This segmentation distributes the connection points across multiple locations, reducing the concentration of forces at any single insertion point and allowing for easier lead insertion while maintaining high channel count capability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a traditional linear arrangement of contacts to a multi-dimensional configuration where contacts are distributed across multiple bores in three-dimensional space. This spatial distribution allows contacts to be arranged in a compact volume while maintaining adequate spacing, reducing insertion force requirements while achieving high channel counts.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Volume of moving object

If the size of the implantable medical device is reduced to improve patient comfort and implantation, then the device becomes smaller and less invasive, but the insertion force required increases due to reduced bore size and increased contact density

Engineering Contradiction:
Improvedevice sizeVSAvoidinsertion force
Core Design Contradiction:
Volume of moving objectVSForce

Solution Approach 1:

Multiple bores are arranged in a nested or closely packed configuration within the header body. The bores are positioned to utilize space efficiently, with some bores potentially nested within or adjacent to others. This nesting arrangement maximizes the number of contacts that can be accommodated within a reduced device volume while maintaining sufficient spacing between contacts to reduce insertion force requirements.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent employs flexible or compliant contact elements and lead interface structures that can deform during insertion. These flexible components accommodate the reduced bore dimensions in smaller devices while requiring lower insertion forces, as the compliance allows for easier deformation during the insertion process compared to rigid structures.

Inventive Principle:
Principle #30Flexible shells and thin films

3Length of moving object

If the lead size is decreased to accommodate smaller implantable devices, then the lead becomes thinner and less invasive, but the axial stiffness of the lead decreases resulting in decreased pushability

Engineering Contradiction:
Improvelead sizeVSAvoidaxial stiffness
Core Design Contradiction:
Length of moving objectVSStrength

Solution Approach 1:

The lead and header are designed with pre-configured alignment features including positioning elements on the lead and corresponding receptacles in the header bores. These preliminary alignment features guide the lead into proper orientation before insertion, reducing the force required to initiate insertion and making the insertion process easier despite the reduced axial stiffness of thinner leads.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Positioning features and alignment structures act as intermediaries between the lead and header during insertion. These features provide mechanical guidance and support during the insertion process, compensating for the reduced axial stiffness of thinner leads by distributing insertion forces through multiple contact points and guiding the lead along a predetermined insertion path.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3943031B1Header connection system for implantable medical device
Publication Date: 2025.02.12 GREATBATCH LTD
  • EP3943031B1 patent drawingFigure 1
  • EP3943031B1 patent drawingFigure 2
  • EP3943031B1 patent drawingFigure 3A~3B

AI summary

In various examples, a header of an implantable device includes a first header portion and a second header portion at least partially disengageable from the first header portion. In a closed configuration, the first header portion is fully engaged with the second header portion, and in an open configuration, the first header portion is at least partially disengaged from the second header portion. At least one bore within the header is sized and shaped to accommodate a proximal end of a lead. The bore is split substantially longitudinally to form a first bore portion and a second bore portion. With the proximal end of the lead disposed within the bore and a positioning feature interacting with a lead feature, at least one lead contact aligns with at least one header contact to allow the at least one lead contact to electrically couple to the at least one header contact.