Pivoting Arm Lead Anchor for Consistent Clamping

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Solution Overview

Problem

Existing lead anchor systems for securing implantable cables to tissue face issues such as high migration rates, damage during removal, inconsistent clamping force due to suturing technique, and increased risk of lead damage from over-tightening or under-tightening, requiring a more reliable and consistent method for securing cables.

Innovation Solution

A lead anchor assembly with a pivotably secured arm that frictionally engages the lead cable, providing a consistent clamping force and audio/tactile confirmation of closure, allowing for easy positioning and repositioning without the need for multiple sutures, and designed for compactness and biocompatibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional suture sleeves are used to secure leads, then the lead can be anchored to tissue, but the clamping force is inconsistent due to suturing technique variations

Engineering Contradiction:
Improveclamping force consistencyVSAvoidsuturing technique complexity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The anchor assembly performs the clamping function automatically through its mechanical structure. The arm pivots to a closed position where it frictionally engages the lead cable, self-generating consistent clamping force without requiring complex suturing techniques. The system serves itself by using the anchor's own geometry and material properties to create reliable clamping.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention replaces the complex mechanical suturing system with a simpler pivot-based mechanical anchor. Instead of requiring multiple sutures tied around the lead, the anchor uses a single pivoting arm that locks into position through frictional engagement, substituting a more reliable mechanical locking mechanism for the less consistent suturing process.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Strength

If multiple sutures are used to secure the lead anchor, then the anchoring strength increases, but the risk of lead damage from over-tightening increases

Engineering Contradiction:
Improveanchoring strengthVSAvoidlead damage risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The anchor assembly changes the critical parameter of clamping force application. Instead of using multiple sutures that can be over-tightened, the design uses a single pivoting arm with controlled frictional engagement. The arm's geometry and material properties ensure consistent clamping force that is sufficient for anchoring but unlikely to cause lead damage, as the force is distributed through the arm's structure rather than concentrated by tight sutures.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The arm's frictional engagement mechanism provides a cushioning effect that prevents excessive forces from being transmitted to the lead. The friction-based locking naturally limits the maximum clamping force to a safe level, cushioning against the harmful effects of over-tightening that occur with traditional suture methods.

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

3Reliability

If a rigid anchor structure is used to provide strong clamping, then the anchoring reliability improves, but the ease of repositioning decreases

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidrepositioning ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The anchor assembly incorporates a dynamic pivoting arm that can transition between open and closed positions. When in the closed position, the arm provides strong frictional engagement for reliable anchoring. When repositioning is needed, the arm can be pivoted to the open position, allowing the lead to be easily repositioned along the channel before the arm is closed again to secure the new position. This dynamic mechanism combines the reliability of rigid anchoring with the flexibility of easy repositioning.

Inventive Principle:
Principle #15Dynamics

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 lead anchor assembly ensures a secure and consistent clamping force independent of suturing technique, reduces the risk of lead damage, and facilitates easy placement and revision surgeries, providing a reliable and efficient method for anchoring implantable leads.

Implementation Method 1

the arm intrudes into the channel to frictionally abut at least a portion of a length of lead disposed in the channel when the arm is disposed in the closed position to couple the lead to the body

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentEP2121120B1Lead anchoring assembly
Publication Date: 2013.09.18 BOSTON SCI NEUROMODULATION CORP
  • EP2121120B1 patent drawingFigure 1
  • EP2121120B1 patent drawingFigure 2~3
  • EP2121120B1 patent drawingFigure 4~5

AI summary

An electrical lead anchoring assembly comprising a body comprising at least one recess and at least one channel therethrough for receiving at least one electrical lead, at least one arm pivotably coupled to the body and moveable between an open and a closed position wherein the arm is at least partially disposed within the recess such that the arm intrudes into the channel and frictionally abuts at least a portion of the length of electrical lead disposed in the channel to couple the lead to the body.