Cranial Plug Radial Fixation for Brain Stimulation Leads
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Solution Overview
Problem
Existing methods for securing medical leads in cranial burr holes during brain stimulation procedures are either cumbersome, mechanically complex, or risk damaging the lead, lacking a reliable and cost-effective solution for firm anchoring without traction forces.
Innovation Solution
A device featuring a circular socket element with resilient partition walls and a cap element that applies radial pressure to secure the lead within the burr hole, eliminating traction forces and ensuring a firm, reliable fixation without damaging the lead, using a cap element with protruding members to press the partition walls radially and expand the socket element for secure engagement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a socket and plug system is used to anchor the lead in the burr hole, then the lead can be secured, but the lead may be dislodged or pulled causing displacement
Solution Approach 1:
Instead of using a separate plug that pulls on the lead to secure it, the invention inverts the approach by using a socket with resilient partition walls that expand to grip the lead from the sides. The cap element expands the socket element radially outward against the burr hole walls, while the partition walls apply radial inward pressure on the lead, preventing displacement without traction forces.
Solution Approach 2:
The invention changes the physical state and dimensions of the socket element by expanding it radially outward when the cap is screwed onto the socket. This expansion is achieved through the protruding members of the cap pressing against the resilient partition walls, causing the socket element to expand and engage firmly with the burr hole walls, thereby securing the lead without causing displacement.
2Reliability
If a cap with suture groove is used to secure the lead, then the lead can be fixated, but the procedure becomes cumbersome for the surgeon
Solution Approach 1:
The invention extracts the complex suture-wrapping operation from the surgical procedure. Instead of requiring the surgeon to manually wrap sutures around the lead in grooves, the system uses an automated mechanical expansion mechanism where the cap element, when screwed onto the socket, automatically expands the resilient partition walls to grip the lead, eliminating the need for manual suture manipulation.
Solution Approach 2:
The socket and cap system is designed to self-secure the lead without requiring additional surgical manipulation. When the cap is screwed onto the socket, the protruding members automatically press against the resilient partition walls, causing them to expand and grip the lead in place. This self-service mechanism eliminates the need for the surgeon to perform complex suture-wrapping procedures.
3Reliability
If a compression screw system is used to anchor the lead, then the lead can be fixed, but the device becomes mechanically complicated and expensive to manufacture
Solution Approach 1:
The invention merges the anchoring function and the sealing function into a single integrated socket and cap system. The socket element with resilient partition walls serves both to anchor the lead through radial expansion and to seal the burr hole when the cap is attached. This eliminates the need for separate compression screws, washers, and sealing components, thereby reducing mechanical complexity and manufacturing costs.
Solution Approach 2:
The socket element is designed with multi-functionality: it provides lead passage, lead anchoring through resilient partition walls, burr hole engagement through radial expansion, and sealing when the cap is attached. The cap element similarly serves multiple functions: securing the socket to the burr hole, expanding the partition walls to grip the lead, and sealing the burr hole. This multi-functionality reduces the overall number of components and simplifies the mechanical system.
4Reliability
If traditional lead anchoring methods are used, then the lead can be secured, but traction forces may cause lead movement and unsatisfactory results
Solution Approach 1:
Instead of applying traction forces along the length of the lead to secure it, the invention inverts the approach by applying radial pressure forces perpendicular to the lead. The resilient partition walls expand radially outward to grip the lead from the sides, preventing movement without exerting any traction forces that could cause displacement or damage to the lead or brain tissue.
Solution Approach 2:
The invention transitions from one-dimensional traction forces (pulling along the lead axis) to two-dimensional radial pressure forces (pressing perpendicular to the lead axis). The resilient partition walls apply pressure in the radial direction, gripping the lead from multiple sides simultaneously. This dimensional change eliminates traction forces while providing secure anchoring through radial compression.
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 solution provides a reliable, easy-to-manufacture, and traction-free fixation of medical leads within the burr hole, preventing lead dislodgement and ensuring stable electrode placement during deep brain stimulation procedures, while being cost-effective and minimizing risk of damage.
Implementation Method 1
at least one resilient partition wall extending from an inner wall of the circular socket element
Implementation Method 2
apply a radial pressure on the at least one resilient partition wall such that a lead passing through the passage is fixated in the passage by a resulting radial pressing force
Data Source
AI summary
The present invention relates to a device for securing medical leads in a cranial burr hole, in particular, for securing a brain stimulation lead within such a burr hole. The device includes a circular socket element adapted to be secured within a burr hole of the skull of a patient, the circular socket element having a through lead passage arranged to have the lead pass therethrough, the lead passage including passage walls including at least one resilient partition wall extending from an inner wall of the circular socket element, and the circular socket element having at least one inner compartment delimited by the partition wall. Further, the device includes a cap element having a circular upper portion being arranged to mate with the socket element, the circular upper portion having at least one protruding member arranged to co-operate with the at least one inner compartment when placed into the compartment so as to apply a radial pressure on the at least one resilient partition wall such that a lead passing through the passage is fixated in the passage by a resulting radial pressing force.