Overmolded Lead Connector for Medical Devices
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Solution Overview
Problem
Existing medical devices, particularly implantable ones, face challenges in manufacturing due to the need for high tolerances and expensive materials like titanium and thermoplastic urethane, while external devices for short-term use may not require the same standards, necessitating alternative manufacturing methods for cost-effective and efficient production.
Innovation Solution
The development of medical devices with a lead connector mounted to a printed circuit board, sealed with a polymeric housing to prevent polymer ingress during over-molding, using a connector with a housing and feedthrough assembly that includes a polymeric housing and conductor to electrically couple the lead to the printed circuit board, and employing polymers with molding temperatures below 250°C to ensure compatibility and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional implantable medical device manufacturing methods are used with materials like titanium and thermoplastic urethane, then device reliability and hermetic sealing are improved, but manufacturing cost and complexity increase significantly
Solution Approach 1:
The patent changes the material parameters by substituting traditional titanium and thermoplastic urethane materials with a polymeric housing and overmold composite structure. The housing uses materials like polyetheretherketone (PEEK) or polyphenylene sulfide (PPS) with different mechanical and thermal properties, allowing for simplified manufacturing processes while maintaining adequate reliability for external and short-term implantable devices
Solution Approach 2:
The patent employs a composite material system consisting of a polymeric housing combined with an overmold layer. This composite structure integrates multiple material properties into a single component, achieving hermetic sealing and mechanical strength without requiring traditional hermetic feedthroughs, thereby reducing manufacturing complexity and cost
2Reliability
If high precision tolerances are maintained for lead connector manufacturing, then electrical connection reliability is improved, but manufacturing time and cost increase
Solution Approach 1:
The patent merges the lead connector housing, sealing structure, and electrical contact support into a single integrated polymeric component. The overmold process simultaneously forms the housing and creates hermetic seals, eliminating the need for separate assembly steps and high-precision tolerances on multiple components, thus improving manufacturing efficiency while maintaining connection reliability
Solution Approach 2:
The patent adopts a disposable connector design where the entire lead connector assembly is manufactured as a single-use component. This approach relaxes the requirement for long-term durability and reusability, allowing for simpler manufacturing processes and reduced tolerances compared to implantable devices designed for long-term use, thereby improving productivity
3Reliability
If hermetic feedthroughs are used to couple device electronics to lead connector contacts, then hermetic sealing is improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The patent extracts and eliminates the hermetic feedthrough component from the traditional lead connector design. Instead of using separate hermetic feedthroughs to couple electronics to lead contacts, the invention integrates the sealing function directly into the polymeric housing through the overmold process, simplifying the overall device structure while maintaining hermetic protection
Solution Approach 2:
The overmolded polymeric material serves as an intermediary that simultaneously provides structural support, electrical insulation, and hermetic sealing functions. This single material mediates multiple functions that traditionally required separate components including hermetic feedthroughs, reducing device complexity while maintaining sealing reliability
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 allows for cost-effective manufacturing of medical devices with reliable electrical and mechanical coupling of leads to printed circuit boards, suitable for both short-term external and long-term implantable devices, while ensuring the safety and integrity of electronic components.
Implementation Method 1
The housing is sealed relative to the polymer during the over-molding process
Implementation Method 2
The conductor electrically couples the contact with the printed circuit board
Implementation Method 3
When a lead is properly received by the bore, the contact couples the lead to the printed circuit board via the conductor
Implementation Method 4
the feedthrough opening is configured to receive the conductor via interference fit
Data Source
AI summary
A medical device includes a printed circuit board, a connector mounted on the printed circuit board, and a polymeric body molded over the connector and the printed circuit board. The connector is configured to receive a medical lead and electrically and mechanically couple the lead to the printed circuit board. The connector comprises a housing and feedthrough assembly that includes a polymeric housing and a conductor. The housing defines a bore configured to receive the lead and defines a feedthrough opening through which the conductor extends. The housing and feedthrough assembly is sealed except for an aperture in communication with the bore. The connector further includes a contact disposed in the bore. The conductor electrically couples the contact with the printed circuit board. When a lead is properly received by the bore, the contact couples the lead to the printed circuit board via the conductor.