Retainer Device for Secure Lead Engagement in Implantable Pulse Generators
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Solution Overview
Problem
The use of set screws to secure leads to implantable pulse generators (IPGs) can lead to issues such as loosening, insufficient contact, and damage, resulting in ineffective electrical stimulation or monitoring, and can cause lead damage due to restricted rotation during patient activity.
Innovation Solution
A retainer device with a looped or annular member is integrated into the IPG header, allowing for secure engagement and prevention of lead egress through a diameter change, providing tactile feedback and allowing rotational movement to prevent torsional stress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If set screws are used to secure the lead to the IPG, then the lead can be mechanically secured and electrically connected, but the set screws may rotate, loosen, or back off over time resulting in insufficient contact
Solution Approach 1:
The retainer device features a movable loop that transitions between an expanded state during insertion and a compressed state during operation. This dynamic mechanism allows the loop to actively engage and secure the lead, preventing loosening over time while maintaining reliable electrical contact without the rotational instability of set screws.
Solution Approach 2:
The invention removes the set screw component entirely from the lead securing mechanism. By extracting the problematic set screw and replacing it with a retainer device that uses a movable loop, the design eliminates the issues of rotation, loosening, and back-off while maintaining secure lead attachment.
2Reliability
If additional set screws are added to improve performance, then the lead connection may be more secure, but tightening the set screws becomes tedious and it becomes difficult to track which screws have been tightened
Solution Approach 1:
The retainer device consolidates multiple securing functions into a single integrated component. Instead of multiple set screws that must be individually tightened and tracked, the movable loop provides unified securement through a single operational mechanism, greatly simplifying the installation process.
Solution Approach 2:
The movable loop mechanism is designed to be self-securing through its expansion and compression states. The device automatically engages and locks the lead in place through its mechanical design, eliminating the need for complex tightening procedures and making it easy to determine when proper engagement has occurred.
3Reliability
If set screws are tightened to secure the lead, then the lead is mechanically secured, but the lead rotation is prevented which may result in lead damage during patient activity
Solution Approach 1:
The movable loop provides dynamic securement that allows for controlled movement. The loop maintains mechanical security while accommodating physiological movements and reducing torsional stress through its flexible engagement mechanism, preventing lead damage during patient activity.
Solution Approach 2:
The retainer device employs a flexible loop structure that can deform and adapt to movement. This flexibility allows the lead to be securely held while permitting necessary movements, reducing rigid constraints that would otherwise cause torsional stress and lead damage.
4Ease of operation
If the looped member is in the first position with a larger diameter, then the lead can be inserted into the bore, but the lead must be secured to prevent egress
Solution Approach 1:
The movable loop transitions between an expanded first position during insertion and a compressed second position for securement. This dynamic state change allows the same component to perform both functions: facilitating easy lead insertion when expanded and providing reliable retention when compressed, eliminating the need for separate mechanisms.
Data Source
AI summary
According to aspects of the present disclosure, an implantable pulse generator includes a housing, a header, and a retainer device. The housing includes circuitry and a battery. The header is coupled to the housing and includes a bore configured to receive an end of a lead, and a passage disposed transverse to the bore and extending between an exterior surface of the header and an anchor cavity that extends into the header from the bore. The header supports at least one electrical contact within the bore coupled to the circuitry. The retainer device includes a looped member arranged within the bore, a proximal end extending at least partially into the passage, and anchored at a distal end by the anchor cavity. The looped member has a first position defining a first loop diameter that permits egress of the lead into the bore and a second position defining a second loop diameter that occludes at least a portion of the bore and is configured to engage at least two opposing sides of the lead sufficiently to prevent egress of the lead from the bore. The first loop diameter is greater than the second loop diameter.