Cam Lock Burr Hole Plug for Secure Lead Retention
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Solution Overview
Problem
Existing burr hole plugs for securing elongated medical devices like catheters or leads within cranial burr holes during deep brain stimulation procedures face issues such as inadequate retention force, limited compatibility with varying lead sizes, and potential rotation of the retainer, leading to lead displacement and complications in securing the plug base.
Innovation Solution
A cranial burr hole plug design featuring a plug base with an inner and outer annular flange, a retainer with a movable clamping mechanism and cam system that provides a variable clamping force, and a cam follower element to securely anchor the lead and plug base, ensuring stability and compatibility with different lead sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional burr hole plug with fixed retainer is used, then the structure is simple, but the retention force is insufficient and lead displacement occurs
Solution Approach 1:
The retainer mechanism transitions from a fixed static structure to a dynamic adjustable system. The movable retainer can be positioned at multiple locations along the lead, and the cam mechanism allows dynamic adjustment of clamping force. This dynamic capability enables the system to adapt to different lead sizes and provide sufficient retention force where needed, resolving the contradiction between reliability and complexity.
Solution Approach 2:
The invention changes the parameter of clamping force from fixed to variable. The cam mechanism transforms rotational motion into linear compression, allowing continuous adjustment of the clamping force applied to the lead. This parameter change enables the retainer to maintain reliable contact with leads of varying diameters while preventing lead displacement, addressing the retention reliability issue.
2Adaptability or versatility
If a fixed clamping mechanism is used, then the device complexity is low, but it cannot accommodate varying lead sizes
Solution Approach 1:
The movable retainer mechanism provides universal compatibility with different lead sizes. By allowing the retainer to move along the lead and adjust its position, the same clamping mechanism can accommodate various lead diameters and lengths. This multi-functional capability enables a single device design to work with multiple lead specifications, achieving adaptability without requiring multiple specialized devices.
Solution Approach 2:
The dynamic retainer mechanism allows the system to adapt to varying lead sizes through movement and adjustment. The movable retainer can be repositioned along the lead to accommodate different diameters, and the cam mechanism can adjust the clamping force accordingly. This dynamic adaptability resolves the contradiction between versatility and complexity by using a single adjustable mechanism rather than multiple fixed designs.
3Reliability
If a simple retainer structure is used, then the ease of manufacture is high, but the retainer may rotate and lead positioning is compromised
Solution Approach 1:
The cam mechanism acts as an intermediary element between the retainer and the lead. It transforms rotational motion into linear compression, providing a controlled and reliable clamping action. This intermediary mechanism prevents direct rotation of the retainer while maintaining stable lead positioning. The cam's geometric design ensures that force is applied consistently without allowing rotational movement, resolving the contradiction between positioning stability and structural complexity.
4Reliability
If adequate clamping force is applied to secure the lead, then lead displacement is prevented, but the risk of damaging the lead increases
Solution Approach 1:
The cam mechanism enables continuous adjustment of clamping force as a variable parameter. By controlling the cam's position and geometry, the system can apply sufficient force to prevent lead displacement while avoiding excessive force that would damage the lead. The movable retainer allows distribution of clamping force along different portions of the lead, optimizing the balance between securing reliability and preventing damage.
Solution Approach 2:
The dynamic retainer system allows for controlled and distributed application of clamping force. The movable retainer can be positioned to target specific areas of the lead, and the cam mechanism can adjust the force magnitude in real-time. This dynamic control enables the system to apply adequate force for securement while avoiding the harmful effects of excessive or concentrated force, resolving the contradiction between reliability and harm prevention.
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
The design enhances the securement of stimulation leads by providing a robust and adjustable mechanism that minimizes lead migration, ensures proper positioning, and facilitates easy installation, even in constrained spaces, thereby maintaining effective therapy delivery.
Implementation Method 1
a cam mechanism that converts rotational motion into linear motion to apply variable clamping force to the lead
Implementation Method 2
a cam follower element to securely anchor the lead and plug base
Implementation Method 3
Friction between the clamping mechanism and lead surfaces prevents lead migration and maintains positioning stability
Data Source
AI summary
A burr hole plug comprises a plug base configured for being mounted around a cranial burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base. The retainer includes a retainer support, a slot formed in the retainer support for receiving the medical device, and a clamping mechanism having a movable clamping element and a cam configured for being rotated relative to the retainer support to linearly translate the movable clamping element into the slot, thereby securing the medical device. The retainer further comprises another clamping mechanism having another movable clamping element and another cam configured for being rotated relative to the retainer support to linearly translate the other movable clamping element, thereby laterally securing the retainer within the plug base.