Composite Header Seal Rings for Low-Force Lead Insertion
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Solution Overview
Problem
Existing implantable medical systems face challenges in achieving efficient and reliable connections between implantable leads and connector ports due to varying industry standards, leading to issues with proper functioning and increased insertion forces.
Innovation Solution
The use of a composite seal ring formed through dual-shot moulding, combining materials with different properties such as silicone and polymer or ceramic, to enhance concentricity and reduce insertion force within the connector bore, while maintaining electrical isolation and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If traditional single-material seal rings are used in connector ports, then manufacturing is simpler, but insertion force is high and alignment is poor
Solution Approach 1:
The seal ring is constructed as a composite structure with an inner core section made of a first material (e.g., silicone) and an outer seal section made of a second material (e.g., polymer or ceramic). This multi-material approach allows optimization of each material's properties for specific functions: the inner core provides structural support and alignment, while the outer seal provides sealing and low-friction surfaces, thereby reducing insertion force and improving alignment without excessive complexity
Solution Approach 2:
Different sections of the seal ring are made from different materials with different properties. The inner core section and outer seal section each have tailored material characteristics suited to their specific functional requirements. This local differentiation allows the seal ring to simultaneously achieve low insertion force, good alignment, and effective sealing, resolving the contradiction between performance and structural complexity
2Adaptability or versatility
If connector ports are designed to comply with multiple industry standards, then versatility is improved, but connection reliability varies
Solution Approach 1:
The connector port subassembly is designed with a standardized core structure that can accommodate different lead configurations and industry standards (IS-1, IS-4, DF-4, etc.). The composite seal ring and core assembly provide universal compatibility while maintaining consistent connection reliability across different standards through optimized material properties and geometric design
3Strength
If seal rings use harder materials for durability, then strength is improved, but insertion force increases
Solution Approach 1:
The seal ring combines harder materials (e.g., polymer or ceramic outer seal) for durability and sealing with softer or more compliant materials (e.g., silicone inner core) for insertion. This composite structure achieves both high strength and low insertion force by distributing mechanical loads across materials with complementary properties
Solution Approach 2:
The material selection and geometric parameters of the seal ring are optimized to balance hardness and compliance. The inner core section may use a softer material that deforms during insertion to reduce force, while the outer seal uses harder material for durability. This parameter optimization resolves the contradiction between strength and insertion force
Data Source
Figure 1
Figure 2A~2B
Figure 3
AI summary
Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a connector port subassembly for a medical device. The connector port subassembly may include a connector bore arranged within the core subassembly including a proximal end and a distal end; one or more connector blocks arranged within the connector bore; and one or more seal rings moulded to an interior surface of the connector bore and arranged adjacent to the one or more connector blocks.