Percutaneous Lead Anchor Using Shape Memory Alloy Tines

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Solution Overview

Problem

Current spinal cord stimulator leads face challenges with migration due to inadequate anchoring, leading to diminished efficacy and complications requiring surgical correction, as existing methods either fail to securely anchor the leads or risk mechanical damage from over-compression.

Innovation Solution

A system and method for rapid fixation of a lead anchor using a percutaneous lead anchor with tines made of Nickel-Titanium 'memory metal' or biocompatible polymers, which deploy into the fascia to securely grasp the lead and prevent migration, eliminating the need for sutures and minimizing mechanical damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional anchoring methods are used, then leads may be securely anchored, but there is a risk of mechanical damage from over-compression

Engineering Contradiction:

Improveanchoring securityVSAvoidmechanical damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical state and properties of the anchor material by using shape memory alloys that undergo phase transitions. The material transitions from an austenite phase (high strength, rigid) during deployment to a martensite phase (more compliant, flexible) during anchoring, allowing secure fixation without excessive compression forces that would damage the lead.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material structures combining shape memory alloy with biocompatible polymers. This composite approach allows the anchor to exhibit both the structural integrity needed for secure anchoring and the compliance needed to avoid mechanical damage to the lead, resolving the contradiction between anchoring security and prevention of mechanical damage.

Inventive Principle:

Principle #40Composite materials

2Stability of the object's composition

If stronger anchoring forces are applied, then lead migration is prevented, but mechanical damage to the lead occurs

Engineering Contradiction:

Improvelead position stabilityVSAvoidlead structural integrity

Core Design Contradiction:

Stability of the object's compositionVSStrength

Solution Approach 1:

The patent introduces dynamic properties to the anchor through shape memory materials that can change their mechanical properties on demand. The anchor transitions from a rigid deployment state to a compliant anchoring state, providing strong initial positioning forces followed by gentle sustained anchoring forces that maintain lead position stability without causing structural damage.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent utilizes phase transitions of shape memory alloys (austenite-martensite transformation) to control the anchoring process. During deployment, the material is in the austenite phase providing high strength for insertion; during anchoring, it transitions to martensite phase providing compliance that prevents lead structural damage while maintaining position stability.

Inventive Principle:

Principle #36Phase transitions

3Reliability

If adequate anchoring is achieved, then lead migration is prevented, but the anchoring process becomes complex

Engineering Contradiction:

Improvemigration preventionVSAvoidanchoring mechanism complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs self-expanding anchor elements made of shape memory alloy that automatically deploy and expand upon release from the delivery catheter. The elastic recovery and phase transition of the material provide self-actuating anchoring action without requiring complex mechanical actuation mechanisms, reducing device complexity while ensuring reliable migration prevention.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces complex mechanical anchoring mechanisms with materials-based solutions using shape memory alloys. Instead of relying on intricate mechanical interlocking or suturing systems, the anchor utilizes the intrinsic phase transition and elastic recovery properties of the smart material to achieve reliable anchoring, simplifying the overall device design.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 repeatable and controlled lead body compression, reduces the risk of migration, and prevents mechanical damage, thereby enhancing the stability and longevity of spinal cord stimulator leads.

Implementation Method 1

tines made of Nickel-Titanium 'memory metal' or biocompatible polymers, which deploy into the fascia to securely grasp the lead

Methodology Applied

Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentUS20220023620A1System and method for percutaneous lead anchoring

Publication Date: 2022.01.27 WAVEGATE CORP

AI summary

The invention described is comprised of a system and method for rapid fixation of a lead anchor. The system includes a lead anchor and insertion device. The insertion device houses a lead anchor. A lead is threaded through the insertion device and the device is depressed against the fascia to insert the lead anchor and fix the lead in the desired position. This method produces repeatable amount of lead body compression grasp force, and controlled bend radius. This results in rapid lead anchoring, lowers the risk of lead migration, prevents mechanical damage to the lead due to over-compression and eliminates the need for tying a suture.