Superelastic Nickel Titanium Electrode Array Carrier for Minimizing Surgical Trauma

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Solution Overview

Problem

Existing electrode array assembly methods require surgical incisions for implantation, causing trauma and side effects due to the need for large openings, and lack efficient batch fabrication techniques for plural assemblies.

Innovation Solution

A method for assembling electrode arrays using a superelastic carrier formed from nickel titanium alloy, allowing for batch fabrication and deployment through a small portal, with conductive components bonded directly to the carrier, enabling precise positioning and minimization of tissue contact area.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If electrode arrays are assembled using conventional methods requiring large openings for implantation, then surgical access to target tissue is achieved, but surgical trauma and side effects increase

Engineering Contradiction:
Improvesurgical accessVSAvoidsurgical trauma
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The electrode array is nested within a delivery catheter that can be inserted through a small portal. The array is collapsed or folded within the catheter during insertion, then deployed at the target site, allowing access to deep tissue without large incisions.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The electrode array is divided into multiple segments or sections that can be collapsed or folded relative to each other, enabling the array to be compressed into a small delivery catheter while maintaining the ability to expand to full size at the implantation site.

Inventive Principle:
Principle #1Segmentation

2Reliability

If electrode arrays are fabricated individually, then customization and quality control are improved, but manufacturing efficiency and productivity decrease

Engineering Contradiction:
Improvequality controlVSAvoidmanufacturing efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

Multiple electrode arrays are fabricated simultaneously on a single substrate or support structure. The arrays share common fabrication steps and materials, enabling batch production while maintaining consistent quality across all arrays through centralized process control.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

A single fabrication process and substrate design serves multiple arrays, creating a universal manufacturing platform that can produce identical or variations of arrays in one operation, improving efficiency while maintaining quality standards.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Area of stationary object

If electrode arrays occupy large surface area, then current flow coverage is improved, but tissue contact area and potential side effects increase

Engineering Contradiction:
Improvecurrent flow coverageVSAvoidadverse effects
Core Design Contradiction:
Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The electrode array provides different functional zones with varying electrode densities and configurations. Areas of high current flow requirement have denser electrode spacing, while areas requiring minimal stimulation have sparser spacing, optimizing therapeutic effect while minimizing unnecessary tissue exposure.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The electrode array incorporates selectively activatable electrodes or electrode groups that can be turned on or off based on real-time patient response and therapeutic requirements, allowing the active treatment area to be dynamically adjusted to minimize side effects while maintaining coverage.

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

This method reduces surgical trauma by allowing electrode arrays to be implanted through small openings, facilitating precise current flow and minimizing adverse effects while enabling efficient batch fabrication of plural assemblies.

Implementation Method 1

The electrode array assembly of this invention includes a carrier formed from superelastic material. A superelastic material is a material that though rigid, will, after being subjected to relatively high degree of bending or folding, substantially return to its initial shape.

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Implementation Method 2

Another feature of using the nickel titanium alloy as the carrier is that this material is plastically deformable, the carrier can be formed into a particular shape without fracturing.

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Data Source

PatentUS10780262B2Method of assembling an electrode array that includes a plastically deformable carrier
Publication Date: 2020.09.22 STRYKER CORP
  • US10780262B2 patent drawing
  • US10780262B2 patent drawing
  • US10780262B2 patent drawing

AI summary

A method of assembling an implantable electrode array from a coupon (108) formed from plastically deformable material. Layers of material are disposed on the coupon to form the electrodes (48) and conductors (62) of one or more electrode arrays. Sections of the coupon on which the electrodes and conductors are removed, along with the electrodes and conductors to form the electrode arrays. The removed sections of the coupon thus function as plastically deformable carriers (74) for the arrays (40).