Implantable Electrode Array with Extraction Tether for Trial Evaluation

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Solution Overview

Problem

Current pain management therapies involving electrode arrays for spinal cord stimulation require a separate test array implantation and potential re-implantation of a permanent array, which can lead to inaccurate placement and increased trauma for patients.

Innovation Solution

A wirelessly powered and controlled electrode array assembly with an integrated extraction sleeve and tether allows for initial deployment, trial use, and seamless transition to permanent implantation or removal based on therapeutic efficacy, eliminating the need for a separate test array and minimizing surgical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a separate test array is implanted and then a permanent array is re-implanted, then therapeutic efficacy can be evaluated, but patient trauma increases and placement accuracy may be compromised

Engineering Contradiction:

Improvetherapeutic efficacy evaluationVSAvoidpatient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode array is designed to serve dual purposes: it functions as both a test array for evaluating therapeutic efficacy and as a permanent implant for long-term pain management. The array includes electrodes, hermetic seals, and connection mechanisms that enable it to be temporarily implanted for testing and then permanently retained if effective, eliminating the need for separate test and permanent implantations.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The electrode array is pre-assembled with all necessary components including electrodes, hermetic seals, and connection mechanisms before implantation. This preliminary preparation ensures that when the array is implanted for testing, it is fully functional and can be immediately evaluated for therapeutic efficacy without requiring additional surgical procedures for re-implantation.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If a separate test array is implanted and then a permanent array is re-implanted, then therapeutic efficacy can be evaluated, but placement accuracy decreases

Engineering Contradiction:

Improvetherapeutic efficacy evaluationVSAvoidplacement accuracy

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If an extraction sleeve and tether are integrated with the electrode array, then seamless transition to permanent implantation or removal is enabled, but device complexity increases

Engineering Contradiction:

Improvetransition flexibilityVSAvoiddevice structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The extraction sleeve and tether are integrated with the electrode array to enable the array to serve multiple functions: it can be easily removed if therapeutic efficacy is not achieved, or it can be transitioned to a permanent implant by severing the tether. This integration provides flexibility in the implantation process without requiring separate removal or permanent fixation procedures.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The extraction sleeve is designed to facilitate the removal of the electrode array from the implantation site. The sleeve can be engaged with the array during implantation and then used to extract the array if needed, providing a simple mechanical means for removal without requiring additional surgical procedures.

Inventive Principle:

Principle #2Taking out (Extraction)

4Object-affected harmful factors

If the electrode array is designed for easy extraction, then patient trauma is minimized, but implantation stability may be compromised

Engineering Contradiction:

Improvepatient traumaVSAvoidimplantation stability

Core Design Contradiction:

Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS9002451B2Implantable electrode array assembly with extraction sleeve/tether

Publication Date: 2015.04.07 STRYKER CORP

AI summary

An implantable electrode array including a carrier on which plural electrodes are disposed. Also disposed on the carrier is an array antenna over which signals are wirelessly received. A tether is connected to the carrier. A tether antenna is attached to the tether. After the electrode array is implanted, during a trial period instructions and power are transmitted to the array antenna over the tether antenna. If the trial is successful, the tether is disconnected from the electrode array. If the trial is not successful and extraction of the array is necessary, extraction is accomplished by pulling on the tether. Electrode array removal may be facilitated by the pulling of the array into an extraction tube disposed over the tether.