Low-Profile Burr Hole Plug With Flexible Elastomeric Lead Retention
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Solution Overview
Problem
Conventional burr hole plugs fail to adequately secure implantable leads, leading to lead migration, skin erosion, and potential infection due to their large size, rigidity, and high profile, which can result in repositioning of the leads and require additional surgical procedures.
Innovation Solution
A burr hole plug design featuring a low-profile, flexible base and cover with lead retention members and a locking mechanism that securely holds the lead in place, reducing the risk of migration and skin irritation, while minimizing the number of edges to prevent skin erosion and infection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional burr hole plugs are used to secure implantable leads, then lead retention is provided, but the large size and high profile cause skin erosion and lead migration
Solution Approach 1:
The burr hole plug employs a flexible base made of elastomeric material that conforms to the curved skull surface, eliminating the need for a large rigid structure. This flexible shell provides secure lead retention while maintaining a low profile that prevents skin erosion and irritation.
Solution Approach 2:
The invention changes the physical parameters of the burr hole plug by using a soft, compliant material with elastic modulus in the range of 0.1 to 10 MPa, transforming it from a rigid high-profile device to a flexible low-profile device that adapts to the skull contour and prevents skin damage.
2Stability of the object's composition
If conventional rigid burr hole plugs are used, then structural stability is provided, but lead migration occurs due to inability to conform to skull curvature
Solution Approach 1:
The flexible elastomeric base conformally adheres to the curved skull surface, providing stable positioning that prevents lead migration while maintaining structural integrity through the elastic properties of the material.
Solution Approach 2:
The burr hole plug uses composite construction with an elastomeric base material combined with embedded retention features, achieving both flexibility for conformal fitting and structural stability for reliable lead positioning.
3Strength
If multiple edges are present in burr hole plug design, then structural integrity is maintained, but skin irritation and infection risk increase
Solution Approach 1:
The flexible elastomeric base eliminates sharp edges by conforming smoothly to the skull contour, providing structural integrity through material elasticity while preventing skin irritation and infection risks associated with rigid edged structures.
Solution Approach 2:
The burr hole plug features curved, edge-free surfaces that conform to the skull's curvature, eliminating sharp edges that could cause skin irritation while maintaining structural strength through the elastomeric material properties.
Data Source
Figure 1~2
Figure 3
Figure 4~5B
AI summary
A burr hole plug includes a base having a flange configured to rest on the skull of a patient and a sidewall configured to extend into a burr hole. The burr hole plug also includes a flexible cover configured to be disposed entirely over, and coupled to, the base. The flexible cover includes a skirt to fit around an outer perimeter of the base and a rim that fits inside the sidewall of the base. Between the skirt and the rim is an inset region having a shape corresponding to a shape of the flange of the base. Alternatively or additionally, the burr hole plug may include two lead retention members, each of the lead retention members including a lead engagement surface to engage and hold a lead; and a locking member for locking the two lead retention members in the base.