Solid Neuromodulation Lead Anchor for Slippage and Overtightening Control
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Solution Overview
Problem
Conventional lead anchors for neuromodulation leads in spinal cord stimulation suffer from issues such as axial slippage, damage from overtightening, loose fixation, insecure positioning, and user-unfriendly tool engagement, leading to potential patient risks and additional surgeries.
Innovation Solution
A lead anchor with a solid anchor block and fixing elements featuring stop features to prevent overtightening and slippage, combined with robust eyelets and projections for secure fixation, and a design that provides visual feedback during tool engagement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a screw fixing mechanism is used to secure the lead, then the lead fixation strength is improved, but the risk of overtightening and lead damage increases
Solution Approach 1:
The patent incorporates a mesh structure into the lead anchor before the lead is inserted. This mesh is pre-positioned to contact and distribute forces across the lead surface, preventing concentrated stress points that could cause damage during tightening operations.
Solution Approach 2:
The mesh acts as an intermediary element between the screw fixing mechanism and the lead. Instead of the screw directly contacting and potentially damaging the lead, the mesh mediates the force transmission, distributing the clamping force evenly across the lead surface while still maintaining secure fixation.
2Object-affected harmful factors
If the screw is tightened loosely to avoid lead damage, then lead damage risk is reduced, but lead slippage and insecure fixation occurs
Solution Approach 1:
The mesh structure is pre-installed in the lead anchor before lead insertion, creating a prepared force-distribution network that will actively engage with the lead during tightening. This preliminary preparation ensures that when the screw is tightened, the force is immediately distributed through the mesh rather than concentrating on single contact points.
Solution Approach 2:
The mesh serves as a mediator that enables reliable fixation at lower tightening forces. By distributing the clamping force across multiple contact points through the mesh structure, the system achieves secure lead retention without requiring high screw tightening forces that could damage the lead.
3Reliability
If the screw is covered by flexible silicone for retention, then accidental removal is prevented, but tool access and visual feedback during tightening becomes difficult
Solution Approach 1:
The lead anchor is segmented into distinct functional zones: a flexible silicone portion for tissue integration and accidental removal prevention, and a rigid exposed portion containing the screw and tool mount for easy access and visual feedback during tightening operations. This segmentation allows each zone to optimize its specific function without compromising the other.
Solution Approach 2:
Different portions of the lead anchor have different material properties and functions. The screw and tool mount area maintains rigid, exposed characteristics for ease of operation and visual feedback, while other portions use flexible silicone for retention and tissue compatibility. This local differentiation of material quality allows simultaneous optimization of conflicting requirements.
4Ease of operation
If conventional silicone anchor bodies are used, then ease of implantation is improved, but resistance to axial forces and prevention of lead migration is insufficient
Solution Approach 1:
The lead anchor uses a composite construction combining flexible silicone material for the implantation portion with a rigid mesh structure and screw fixing mechanism for force resistance. The silicone provides ease of implantation and tissue compatibility, while the rigid mesh and screw component provide resistance to axial forces and prevent lead migration, creating a composite structure that leverages the strengths of different materials.
Data Source
Figure 1~2
Figure 3A~3B
Figure 3C~5
AI summary
The present invention is generally directed to a lead anchor (100) for a neuromodulation comprising: a solid anchor block (5) having at least one opening (9) and a lumen (6), wherein said opening (9) is connected with said lumen (6) and has a longitudinal axis (L1), and wherein said lumen (6) is configured to receive a portion of the neuromodulation lead; an anchor body (4) at least partially covering said anchor block (5); and a fixing element (10) having a fastening portion (16) and a head portion (2). To achieve a lead anchor (100) which is more robust against axially acting forces, so that primarily a slippage of the lead or a slippage of the lead anchor (100) can be prevented, the fastening portion (16) is configured to be inserted along the axis (L1) into said opening (9) to fix the portion of the neuromodulation lead, wherein said head portion (2) comprises at least one first stop feature (18) having a dimension (D4) in a radial direction (R1) with respect to said axis (L1) which is greater than a diameter (D1) of said opening (9).