Set Screw-less Pacemaker Header with Molded Lead Lock
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Solution Overview
Problem
Existing implantable medical device header designs rely on labor-intensive procedures and are prone to leaks and failures due to the use of set screws and complex molding processes, which compromise reliability and safety.
Innovation Solution
A polymer housing with molded lead bores and an internally threaded anchor member that locks leads in place without set screws, utilizing a lead lock member with apertures and a fastener to restrict the lock member within the bores, ensuring secure encapsulation and insulation of components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If set screws and seal plug cavities are used to retain leads in the header, then leads can be securely held in position, but leak paths and failures occur due to imperfect sealing and the need for backfilling with silicone or epoxy
Solution Approach 1:
The patent removes set screws and seal plug cavities from the header structure entirely. Instead of using traditional set screw retention mechanisms that require sealing, the invention uses the molded polymer header housing itself to directly retain leads through integrated lead bores and retention features, eliminating the problematic sealing interfaces
Solution Approach 2:
The patent combines the lead retention function and sealing function into a single integrated molded polymer header structure. The lead bores, retention features, and insulation are all formed as one piece through molding, eliminating separate sealing components and interfaces that could create leak paths
2Ease of operation
If set screws are used to hold leads in position, then leads are securely retained, but labor-intensive procedures are required for assembly and the need for backfilling increases manufacturing complexity
Solution Approach 1:
The patent incorporates lead retention features directly into the molded header structure during manufacturing. The lead bores and retention mechanisms are pre-formed as integral parts of the header housing, eliminating the need for separate assembly steps involving set screws and backfilling operations
Solution Approach 2:
The molded polymer header structure provides self-contained lead retention through its integrated design. The header housing itself, with its molded lead bores and retention features, automatically secures leads without requiring external set screws or additional sealing materials, simplifying both manufacturing and assembly
3Adaptability or versatility
If wire channels are molded or formed in the outer surface of the header body, then leads can be routed and retained, but difficult molding tasks and backfilling requirements create potential failure locations
Solution Approach 1:
The patent nests leads within enclosed lead bores that are formed as integral cavities within the molded polymer header housing. This nested structure protects leads and connections within the header body, eliminating exposed wire channels on the outer surface that would require backfilling and create potential failure points
Data Source
AI summary
A method for manufacturing a header for an implantable medical device such as a pacemaker which contains an advantageous molded design with encapsulated wires and conductive features. The header including a specifically formed lead lock member in which a plurality of collets residing in bores in the molded housing are used to retain and lock implantable leads in place without the use of set screws.