Anchoring Units for Implantable Leads Preventing Migration

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Solution Overview

Problem

Implantable electrical stimulation systems face challenges in maintaining the position of electrodes within patient tissue due to migration over time, leading to reduced efficacy and potential need for surgical re-implantation.

Innovation Solution

The development of anchoring units for implantable leads, which include various designs such as spiral, helical, and tapered anchoring members that anchor to patient tissue, preventing migration and enhancing the stability of the lead within the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional leads without anchoring members are used, then the implantation procedure is simpler, but the leads migrate over time leading to reduced therapeutic efficacy

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidlead structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The lead is divided into functional segments: a shaft portion and a separate anchoring unit with multiple anchoring members. This segmentation allows the anchoring function to be added independently to secure the lead while maintaining the simplicity of the stimulation function, thereby improving reliability without proportionally increasing overall complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The anchoring members are pre-formed on the lead in specific configurations (spiral, helical, tapered) before implantation. This preliminary preparation ensures that when the lead is implanted, the anchoring members are already positioned to engage tissue effectively, preventing migration and maintaining therapeutic efficacy without requiring complex intraoperative adjustments.

Inventive Principle:

Principle #10Preliminary action

2Stability of the object's composition

If anchoring members are added to the lead, then migration is prevented and stability is enhanced, but the device complexity increases

Engineering Contradiction:

Improvelead stabilityVSAvoidlead structure

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The anchoring members utilize curved geometries including spiral and helical configurations that naturally engage with tissue through their curved shape. These curved forms provide mechanical interlocking with surrounding tissue, enhancing lead stability and preventing migration while maintaining a relatively simple structural design that integrates smoothly with the lead shaft.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The anchoring unit combines different materials with complementary properties: the shaft portion may use flexible biocompatible materials while anchoring members use harder, more rigid materials (such as alloys) that provide mechanical strength for tissue engagement. This composite construction achieves enhanced stability without excessive complexity by selecting materials that fulfill specific functional requirements.

Inventive Principle:

Principle #40Composite materials

3Reliability

If multiple anchoring members are used, then anchoring effectiveness is improved, but the manufacturing complexity increases

Engineering Contradiction:

Improveanchoring effectivenessVSAvoidmanufacturing process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

Multiple anchoring members are combined into a single integrated anchoring unit that can be manufactured as one piece or pre-assembled component. This merging approach maintains anchoring effectiveness through multiple engagement points while simplifying manufacturing by reducing the number of separate fabrication steps and quality control checks required compared to manufacturing multiple independent anchoring components.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The anchoring members are designed with universal geometries (spiral, helical, tapered forms) that can be manufactured using standard machining or forming processes. These multi-functional shapes simultaneously provide anchoring, structural support, and tissue compatibility, reducing manufacturing complexity by eliminating the need for specialized custom components.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS9610435B2Anchoring units for implantable electrical stimulation systems and methods of making and using

Publication Date: 2017.04.04 BOSTON SCI NEUROMODULATION CORP

AI summary

An anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.