Implantable Device Header Adhesion via Surface Roughening
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Solution Overview
Problem
Current implantable medical devices (IMDs) face challenges in achieving strong and reliable connections between the device container and the header, particularly in terms of adhesion and durability, which can lead to premature failure under side load conditions.
Innovation Solution
The use of a thermoset polymer header, such as epoxy, molded onto a textured surface of the metallic device container, which enhances adhesion through surface roughening techniques like laser treatment and dry blasting, and controlled curing processes to achieve high fracture toughness and failure strength.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a thermoset polymer header is molded onto a smooth metallic device container surface, then the manufacturing process is simpler, but the bond strength and adhesion between header and container are insufficient under side load conditions
Solution Approach 1:
The metallic device container surface is pre-treated with surface roughening techniques (laser treatment, dry blasting) before molding the thermoset polymer header onto it. This preliminary action creates a textured surface that enhances mechanical interlocking and adhesion, resolving the contradiction by preparing the surface in advance to achieve both strong bonding and manufacturing feasibility.
Solution Approach 2:
The solution combines the thermoset polymer header material with the metallic device container, creating a composite structure. The thermoset polymer provides fracture toughness and chemical adhesion, while the metal provides structural strength. This composite approach enables the bond to withstand side load conditions while maintaining manufacturing practicality.
2Reliability
If the header material is made more brittle to increase fracture toughness, then resistance to crack propagation improves, but the overall strength and durability under side load decreases
Solution Approach 1:
The patent optimizes the chemical composition and curing parameters of the thermoset polymer to achieve the desired balance between fracture toughness and overall strength. By controlling crosslink density, molecular weight, and curing conditions, the material exhibits enhanced crack resistance while maintaining sufficient ductility and strength to withstand side load conditions without premature failure.
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
The solution significantly increases the side load failure strength of the IMD by improving the bond between the header and the device container, ensuring the integrity and longevity of the device under mechanical stress.
Implementation Method 1
The use of a thermoset polymer header, such as epoxy, molded onto a textured surface of the metallic device container, which enhances adhesion through surface roughening techniques
Implementation Method 2
surface roughening techniques like laser treatment
Implementation Method 3
surface roughening techniques like laser treatment and dry blasting
Implementation Method 4
controlled curing processes to achieve high fracture toughness and failure strength
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Systems and methods for implantable medical devices and headers are described. In an example, an implantable medical device includes a device container including an electronic module within the device container. A header core includes a bore hole portion and at least two electronic connection features disposed within the bore hole portion. The bore hole portion includes at least one cavity configured to allow placement of at least one of the electronic connection features within the bore hole portion. The at least two electronic connection features are electrically coupled to the electronic module within the device container. The header core is configured to allow location of the at least two electronic connection features in a selected configuration within the bore hole portion. A header shell is disposed around the header core and attached to the device container.