Profiled Lead Anchor for Stimulation Leads

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Solution Overview

Problem

Existing lead anchors for securing stimulation leads in patients exert high compressive forces, leading to potential fractures and difficulty in adjusting the lead position due to compression of the central lumen.

Innovation Solution

A lead anchor with a first and second clamp surface and an adjustable fastener, where the clamp surfaces are profiled to apply clamping force while maintaining an open internal lead lumen, allowing for secure retention of the lead without causing damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Force

If high compressive force is applied by the lead anchor to secure the lead, then the lead is firmly retained, but the central lumen of the lead is compressed and may fracture

Engineering Contradiction:
Improveclamping forceVSAvoidlumen compression
Core Design Contradiction:
ForceVSObject-affected harmful factors

Solution Approach 1:

The clamp surfaces are profiled with a curved geometry that contacts the lead at multiple points around its circumference. This distributes the clamping force in multiple dimensions rather than concentrating it at a single point, preventing lumen compression while maintaining secure retention. The curved profile redirects compressive forces laterally around the lead rather than directly inward.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The clamp surfaces feature localized high-compliance regions with curved profiles that conform to the lead's outer surface. These localized features apply force only at specific contact points away from the central lumen, allowing strong anchoring without compressing the lumen. The differential compliance allows the anchor to adapt to the lead's geometry while protecting the lumen.

Inventive Principle:
Principle #3Local quality

2Stability of the object's composition

If the lead anchor exerts prolonged stress to secure the lead, then the lead remains fixed, but fractures can occur in the lead

Engineering Contradiction:
Improvelead fixationVSAvoidlead integrity
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The lead anchor incorporates compliant elements and flexible clamp surfaces that can dynamically adapt to the lead's position and movements. This dynamic compliance allows the anchor to maintain secure fixation while accommodating physiological movements without exerting excessive static stress that could lead to fracture. The system transitions from rigid fixation to adaptive fixation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The anchor design includes stress-distributing features and compliant elements that cushion against peak loads before they can transmit damaging forces to the lead. The curved clamp surfaces and flexible components act as mechanical buffers, absorbing stress spikes from patient movement or lead migration attempts, thereby preventing fracture while maintaining fixation.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Force

If the central lumen is compressed by the lead anchor, then the lead is secured, but adjustment of the lead position becomes difficult

Engineering Contradiction:
Improveretention forceVSAvoidlead adjustability
Core Design Contradiction:
ForceVSEase of operation

Solution Approach 1:

The lead anchor is designed as a segmented system with modular components including adjustable fasteners and separate clamp elements. This segmentation allows the anchor to be adjusted or removed without permanently damaging the lead, facilitating lead repositioning if needed. The modular design enables maintenance of the lead's structural integrity while achieving secure retention.

Inventive Principle:
Principle #1Segmentation

4Adaptability or versatility

If stylet insertion is required to adjust the lead, then the lumen must be accessible, but the anchor may have closed the lumen

Engineering Contradiction:
Improvelead repositioning capabilityVSAvoidlumen closure
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The anchor's curved clamp surfaces are specifically designed to apply force away from the central lumen, creating a protective effect that prevents lumen closure before it can occur. This preliminary protective action ensures the lumen remains patent and accessible for stylet insertion if lead adjustment is required, while still providing secure retention.

Inventive Principle:
Principle #9Preliminary anti-action

Data Source

PatentUS12324922B2Lead anchor
Publication Date: 2025.06.10 SALUDA MEDICAL PTY LTD
  • US12324922B2 patent drawing
  • US12324922B2 patent drawing
  • US12324922B2 patent drawing

AI summary

A lead anchor (1) to secure a stimulation lead (3) with an internal lead lumen (5), the lead anchor (1) comprising: a first clamp surface (7); a second clamp surface (9) opposed to the first clamp surface (7); and an adjustable fastener (11) to selectively draw the first clamp surface (7) towards the second clamp surface (9) to secure the stimulation lead (3) located between the first clamp surface (7) and the second clamp surface (9), wherein the first clamp surface (7) and the second clamp surface (9) are profiled to apply clamping force (13) to secure the stimulation lead (3) while maintaining an open internal lead lumen (5).