Implantable Pulse Generator Header with Composite Shield

Solution Overview

Problem

The existing header designs for implantable pulse generators face challenges in material selection, as non-compliant high durometer materials complicate the placement of electrical connectors, while compliant materials are prone to damage during implantation procedures, and there is a need for improved sealing and protection against surgical tools.

Innovation Solution

A header design comprising a compliant silicone inner component and a non-compliant shield component, along with an antenna component for RF communication, which provides sealing, protection against punctures, and enhanced communication range by facilitating tissue coupling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a non-compliant high durometer material is selected for the header, then the header can resist punctures and damage, but the placement of electrical connectors becomes unduly difficult and additional complexity is provided to the header design

Engineering Contradiction:

Improveresistance to puncturesVSAvoidheader design complexity

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The header is divided into two distinct components: an inner compliant component that holds electrical connectors and an outer shield component that provides puncture resistance. This segmentation allows each component to be optimized for its specific function without compromising the other, resolving the contradiction between ease of connector placement and puncture resistance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The header uses a composite structure combining two different materials with contrasting properties: a compliant inner material (such as silicone or rubber) and a non-compliant outer shield material (such as hard plastic or metal). This composite approach allows the header to simultaneously exhibit both compliance for easy connector placement and hardness for puncture resistance.

Inventive Principle:

Principle #40Composite materials

2Ease of manufacture

If a compliant material is selected for the header, then the electrical connectors can be easily placed, but the header can be easily punctured or damaged by surgical tools during implantation

Engineering Contradiction:

Improveease of connector placementVSAvoidresistance to punctures

Core Design Contradiction:

Ease of manufactureVSStrength

Solution Approach 1:

The header is divided into two distinct components: an inner compliant component that holds electrical connectors and an outer shield component that provides puncture resistance. This segmentation allows each component to be optimized for its specific function without compromising the other, resolving the contradiction between ease of connector placement and puncture resistance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The header uses a composite structure combining two different materials with contrasting properties: a compliant inner material (such as silicone or rubber) and a non-compliant outer shield material (such as hard plastic or metal). This composite approach allows the header to simultaneously exhibit both compliance for easy connector placement and hardness for puncture resistance.

Inventive Principle:

Principle #40Composite materials

3Strength

If a non-compliant high durometer material is selected for the header, then the header can resist punctures, but additional complexity is typically provided to the header design to hold the electrical connectors in place

Engineering Contradiction:

Improveresistance to puncturesVSAvoidease of connector placement

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The header is divided into two distinct components: an inner compliant component that holds electrical connectors and an outer shield component that provides puncture resistance. This segmentation allows each component to be optimized for its specific function without compromising the other, resolving the contradiction between ease of connector placement and puncture resistance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The header uses a composite structure combining two different materials with contrasting properties: a compliant inner material (such as silicone or rubber) and a non-compliant outer shield material (such as hard plastic or metal). This composite approach allows the header to simultaneously exhibit both compliance for easy connector placement and hardness for puncture resistance.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS8938298B2Header design for implantable pulse generator

Publication Date: 2015.01.20 ADVANCED NEUROMODULATION SYSTEMS INC

AI summary

In one embodiment, an implantable pulse generator for electrically stimulating a patient comprises: a metallic housing enclosing pulse generating circuitry; a header mechanically coupled to the metallic housing, the header adapted to seal terminals of one or more stimulation leads within the header and to provide electrical connections for the terminals; the header comprising an inner compliant component for holding a plurality of electrical connectors, the plurality of electrical connectors electrically coupled to the pulse generating circuitry through feedthrough conductors, wherein the plurality of electrical connectors are held in place in recesses within the compliant inner component, the header further comprising an outer shield component adapted to resist punctures, the outer shield component fitting over at least a portion of the inner compliant component.