Self-Suturing Lead Anchor for Spinal Cord Stimulators

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Solution Overview

Problem

Conventional lead anchors for implantable spinal cord stimulators often fail to securely anchor leads, leading to lead migration, breakage, and loose connections, which can result in ineffective pain control and increased risk of infection due to variable suturing techniques.

Innovation Solution

A lead anchor design featuring a body with a lead lumen and a transverse lumen that uses a fastener to deform the lead and secure it in place, combined with biocompatible materials and suture tabs for anchoring to patient tissue, providing a consistent and stable fixation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional lead anchors use suturing techniques to secure the lead, then the lead can be anchored to tissue, but the holding force becomes variable and unreliable due to differences in suturing technique

Engineering Contradiction:

Improveholding force consistencyVSAvoidsuturing technique variability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The lead anchor system is self-suturing, automatically forming sutures without requiring manual suturing technique. The anchor device itself performs the suturing function through its mechanical structure, eliminating variability introduced by different physicians' suturing skills while maintaining reliable tissue anchoring

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The manual mechanical suturing process is replaced with an automated mechanical suturing mechanism integrated into the anchor device. The self-suturing mechanism uses mechanical components to automatically create and tighten sutures, replacing the variable human-operated suturing process with a consistent mechanical system

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If conventional lead anchors use excessive suturing to ensure secure anchoring, then the lead may be held more securely, but the operation time increases and infection risk increases

Engineering Contradiction:

Improveanchoring securityVSAvoidoperation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The self-suturing mechanism automatically performs the suturing function without requiring extended manual manipulation. The anchor device autonomously forms and tightens sutures through its mechanical design, reducing the time physicians spend on manual suturing while achieving secure anchoring in fewer steps

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The suturing mechanism is pre-configured and prepared within the anchor device before implantation. The self-suturing components are arranged in advance to enable automatic suturing immediately upon deployment, eliminating the need for time-consuming sequential manual suturing operations and reducing overall procedure time

Inventive Principle:

Principle #10Preliminary action

3Reliability

If conventional lead anchors rely on variable suturing techniques, then different physicians may achieve different anchoring strengths, but this leads to increased risk of lead migration and breakage

Engineering Contradiction:

Improveanchoring strength consistencyVSAvoidphysician technique dependency

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The anchor device performs suturing autonomously without requiring physician skill variation. The self-suturing mechanism ensures consistent anchoring strength across all implantations by using a standardized mechanical process rather than relying on individual physician techniques, eliminating the variability that leads to inconsistent anchoring outcomes

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The suturing parameters (tension, stitch pattern, depth) are controlled by the mechanical design of the self-suturing mechanism rather than physician judgment. This standardization of critical parameters ensures consistent anchoring strength across different physicians and patients, reducing the variability that causes lead migration and breakage

Inventive Principle:

Principle #35Parameter changes

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 effectively reduces lead migration and breakage, enhances long-term pain control, and minimizes the risk of infection by providing a secure and consistent anchoring mechanism for implantable spinal cord stimulators.

Implementation Method 1

The fastener anchors the lead to the body through the transverse lumen by deforming a portion of the lead

Methodology Applied

Scientific EffectDeformation: Deformation

Data Source

PatentUS10159833B2Torque lock anchor and methods and devices using the anchor

Publication Date: 2018.12.25 BOSTON SCI NEUROMODULATION CORP

AI summary

A lead anchor includes a body defining a lead lumen having a first opening and a second opening through which a lead can pass. The body further defines a transverse lumen that intersects the lead lumen. An exterior member is disposed around at least a portion of the body. The exterior member is formed of a biocompatible material. A fastener anchors the lead to the body through the transverse lumen by deforming a portion of the lead. The transverse lumen is configured and arranged to receive the fastener. At least at least two suture tabs extend from the exterior member and are configured and arranged for receiving a suture to suture the lead anchor to patient tissue.