Retainer Assembly for Implantable Pulse Generator Lead
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Solution Overview
Problem
The existing set screw and silicone septum arrangement in implantable medical pulse generators is prone to coring, leading to electrical faults and device failure due to fluid leakage and hex socket stripping, necessitating an improved method for securing lead connector ends.
Innovation Solution
A retainer assembly with coaxially aligned collars and a gap in the inner circumferential surface, where a member reduces the gap distance to decrease the collar's inner diameter, eliminating the need for a septum and preventing fluid leakage by clamping the lead connector end outside the seal zone.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a set screw and silicone septum arrangement is used to secure the lead connector end, then the lead connector end is retained in the header, but the septum is cored by the torque wrench causing fluid leakage and electrical faults
Solution Approach 1:
The patent removes the silicone septum from the system entirely, replacing it with a retainer assembly that secures the lead connector end through a different mechanism. The retainer assembly includes a collar with a gap that can be compressed by a torque wrench to grip the lead connector end directly, eliminating the need for a septum and thus preventing septum coring and associated fluid leakage problems.
Solution Approach 2:
The retainer assembly acts as an intermediary component between the header and the lead connector end. Instead of using a septum that is vulnerable to coring, the retainer assembly provides a mechanical interface that secures the lead connector end through compression of the collar gap, preventing fluid leakage without requiring a septum.
2Reliability
If a set screw and silicone septum arrangement is used to secure the lead connector end, then the lead connector end is retained in the header, but the hex socket of the set screw is stripped by the torque wrench
Solution Approach 1:
The patent eliminates the set screw and its hex socket from the system, replacing it with a retainer assembly that is secured to the header through alternative means (such as interference fit or adhesive). The retainer assembly then uses a collar with a gap that can be compressed by the torque wrench to grip the lead connector end, removing the vulnerable hex socket component that is prone to stripping.
Solution Approach 2:
The retainer assembly serves as an intermediary that transfers the securing function from the set screw to a collar mechanism. The collar with its compressible gap provides a new interface for the torque wrench, eliminating the need for a hex socket and preventing socket stripping while maintaining the ability to securely retain the lead connector end.
3Object-affected harmful factors
If a silicone septum is used to insulate the metal block and set screw from body fluid, then electrical insulation is provided, but the septum allows fluid leakage when cored
Solution Approach 1:
The patent removes the silicone septum from the system, eliminating the trade-off between electrical insulation and fluid leakage. The retainer assembly provides mechanical retention without requiring a septum, and electrical insulation is maintained through other means such as the insulating properties of the lead connector end itself or the design of the electrical contacts within the header.
Data Source
AI summary
An implantable medical pulse generator is disclosed herein. The pulse generator is for administering electrotherapy via an implantable medical lead having a lead connector end on a proximal end of the lead. The pulse generator includes a can and a header coupled to the can. The header includes a first lead connector end receiving receptacle and a retainer configured to secure the lead connector end within the first receptacle. The retainer includes a member and a first collar, which is coaxially aligned with the first receptacle. The first collar includes an inner circumferential surface and a gap in the inner circumferential surface. The inner circumferential surface extends generally continuous and unbroken between a first face of the gap and a second face of the gap. The member is configured such that acting on the member causes a gap distance between the first face of the gap and second face of the gap to decrease, thereby reducing an inner circumferential diameter of the first collar.