Implant Housing Header Molding with Heat-Activated Polyurethane Film

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Solution Overview

Problem

The existing methods for forming headers on implantable medical devices using liquid media like 2-part epoxy resins or silicone adhesives are difficult to automate, involve high costs due to mechanical rework, and require long curing times, while differential pressure molding is complex and temperature management is challenging.

Innovation Solution

A method involving a thermally activatable connecting film, such as a polyurethane film, is applied to the housing surface, allowing injection molding of a header directly onto the housing, forming a sealed composite without additional joining steps, using thermoplastic polyurethane and titanium components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If liquid media (2-part epoxy resins or 2-part silicone adhesives) are used for bonding header to housing, then adhesion between components is achieved, but automation difficulty increases and mechanical rework is required

Engineering Contradiction:
Improveautomation of header assemblyVSAvoiddifficulty of processing liquid media
Core Design Contradiction:
Extent of automationVSEase of manufacture

Solution Approach 1:

The patent changes the state of the adhesive from liquid to solid film form, and from room-temperature curing to heat-activated bonding. The thermoplastic polyurethane film is applied in solid form and activated by heating during injection molding, eliminating the difficulties of handling and automating liquid adhesive application.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the chemical bonding process of liquid adhesives with a physical bonding process using heat-activated thermoplastic film. The thermoplastic film melts and bonds to both surfaces through thermal activation during injection molding, eliminating the need for chemical curing processes.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If 2-part epoxy resins or 2-part silicone adhesives are used for bonding, then adhesion is achieved, but curing time increases to hours

Engineering Contradiction:
Improvebonding speedVSAvoidcuring time
Core Design Contradiction:
ProductivityVSDuration of action of moving object

Solution Approach 1:

The patent changes the curing mechanism from slow chemical reaction at room temperature to rapid thermal activation. The thermoplastic polyurethane film bonds within seconds when heated to melting temperature during injection molding, reducing curing time from hours to seconds.

Inventive Principle:
Principle #35Parameter changes

3Strength

If inserts with plasma polymer layers are heated to melting temperature in injection mold, then bonding to thermoplastic header is achieved, but temperature management complexity increases

Engineering Contradiction:
Improvebond strength between header and housingVSAvoidtemperature management system
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent extracts the complex temperature management requirement by changing the bonding approach. Instead of heating inserts to melting temperature, the thermoplastic polyurethane film is activated by the heat of the injected thermoplastic material itself, eliminating the need for separate heating circuits for the inserts.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The injected thermoplastic material serves dual purposes: it forms the header structure and simultaneously provides the heat needed to activate the thermoplastic polyurethane film for bonding. The process uses the energy already present in the system rather than requiring external heating for the bonding function.

Inventive Principle:
Principle #25Self-service

4Strength

If inserts with plasma polymer layers are heated in injection mold, then bonding is achieved, but cycle time increases

Engineering Contradiction:
Improveadhesion between header and housingVSAvoidcycle time
Core Design Contradiction:
StrengthVSLoss of time

Solution Approach 1:

The patent merges the bonding function with the injection molding process itself. The thermoplastic polyurethane film is activated during the injection cycle by the hot material, so bonding occurs simultaneously with header formation rather than as a separate heated step, reducing cycle time.

Inventive Principle:
Principle #5Merging (Combining)

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 enables a media-tight connection between the header and housing, allowing automated assembly and reducing process steps, eliminating the need for manual rework and additional bonding, thus improving efficiency and reducing costs.

Implementation Method 1

injection molding of the header by filling the cavity with a thermoplastic material, such that the connecting film bonds to said surface and to the thermoplastic material

Methodology Applied
Scientific EffectThermal activation: Heating

Implementation Method 2

the thermally activatable connecting film forms a duromer (e.g., in the seconds range) under low heat and exhibits good adhesion to both partners

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 3

injection molding of the header by filling the cavity with a thermoplastic material

Methodology Applied
Scientific EffectInjection molding:

Implementation Method 4

the thermally activatable connecting film is a thermally activatable polyurethane film

Methodology Applied
Scientific EffectThermal activation: Heating

Data Source

PatentEP4644082A1Injection molding of a thermoplastic polyurethane header onto a housing of an implantable medical device with the aid of a thermally activatable polyurethane film
Publication Date: 2025.11.05 BIOTRONIK SE & CO KG
  • EP4644082A1 patent drawingFigure 1~2
  • EP4644082A1 patent drawingFigure 3
  • EP4644082A1 patent drawing

AI summary

The present invention relates to a method for forming a header (1) on a housing (2) of an implantable medical device (100), the method comprising: providing a housing (2) having a surface (2a) to which the header (2) is to be connected, wherein a thermally activatable connecting film (3) is arranged on said surface (2a), arranging the housing (2) with respect to a mold (6) for injection molding such that said surface (2a) with the connecting film (3) thereon delimits a cavity (60) of the mold (6), and injection molding of the header (2) by filling the cavity (60) with a thermoplastic material, such that the thermally activatable connecting film (3) bonds to said surface (2a) and to the thermoplastic material.