Implantable Pulse Generator Header Molding

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Solution Overview

Problem

There is a need for alternative designs for headers and associated components for implantable medical devices, such as implantable cardioverter-defibrillators and pacemakers, that can effectively isolate internal components from conductive bodily fluids and provide secure attachment to the device housing.

Innovation Solution

The method involves molding a header component onto a device housing using a silicone mold and epoxy material, where the header component can include seal plugs and suture anchors to seal and attach the device to tissue, eliminating the need for medical adhesive and enhancing the device's stability within the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If traditional headers and components are used in implantable medical devices, then assembly and integration with circuitry can be performed, but the device requires medical adhesive for attachment and has increased complexity in isolating internal components from conductive bodily fluids

Engineering Contradiction:

Improvecomplexity of isolating internal componentsVSAvoidisolation of internal components from conductive bodily fluids

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The header is integrated directly with the device housing through an injection molding process that forms the header as part of the housing structure. This merging eliminates the need for separate attachment components and medical adhesive, while the molded structure inherently provides fluid isolation between internal components and bodily fluids.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The header serves multiple functions simultaneously: it provides electrical connection points for leads, isolates internal components from conductive bodily fluids, and attaches to the device housing without requiring separate adhesive materials. This multi-functionality reduces overall device complexity while maintaining reliability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Strength

If medical adhesive is used to attach header components to the device housing, then secure attachment can be achieved, but the assembly process becomes more complex and time-consuming

Engineering Contradiction:

Improveattachment strength of header componentsVSAvoidassembly process complexity

Core Design Contradiction:

StrengthVSEase of manufacture

Solution Approach 1:

The injection molding process replaces the mechanical system of applying and curing medical adhesive with a direct material bonding process. The header material is injected and bonds directly to the housing and components during molding, eliminating the separate adhesive application step while maintaining secure attachment strength.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The header is pre-formed with attachment features during the injection molding process itself, before final assembly. The molding process creates integral bonds between the header and housing, eliminating the need for subsequent adhesive application and reducing assembly complexity.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If separate components are used for sealing and attachment in the header, then functional requirements can be met, but the number of parts increases and assembly efficiency decreases

Engineering Contradiction:

Improveassembly efficiency of header componentsVSAvoidnumber of header components

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

Multiple header components that would traditionally be separate (sealing elements, attachment features, electrical contacts) are merged into a single integrated header structure formed by injection molding. This reduces the number of parts while maintaining all necessary functions for sealing and attachment.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The integrated header performs multiple functions simultaneously: sealing against conductive fluids, providing attachment to the housing, and serving as an electrical connection interface. This multi-functionality reduces the number of separate components needed while improving assembly efficiency.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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

This approach provides a reliable and secure attachment of the header components to the device housing and tissue, reducing the risk of malfunction and fluid ingress, while avoiding the use of medical adhesives, thus enhancing the performance and longevity of implantable medical devices.

Implementation Method 1

Header material is injected into the header mold cavity to form the header such that the header is attached to the device housing and the header component is attached to the header

Methodology Applied

Scientific EffectAdhesive bonding: Adhesive

Data Source

PatentUS10850106B2Method of molding a header of an implantable pulse generator

Publication Date: 2020.12.01 CARDIAC PACEMAKERS INC

AI summary

An implantable pulse generator includes a device housing containing pulse generator circuitry and a header molded to the device housing. The header can be formed of an epoxy header material. A header component can have a first part molded in the header material to fix the header component to the header at a surface of the header and a second part extending out of the header material.