Cochlear Implant Electrode Array Molding with Strain Relief

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Solution Overview

Problem

Conventional cochlear implant electrode arrays face challenges during molding processes due to their preset spiral shape, making handling and positioning difficult, and are prone to lead wire detachment or breakage when straightened for insertion.

Innovation Solution

A method involving a contact assembly with strain relief elements and a molding process using a shell and resilient materials to form a flexible electrode array body, which includes positioning the contact assembly in a mold and introducing a second resilient material to create a flexible body with reduced likelihood of lead wire detachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the electrode array is given a preset spiral shape, then it can be inserted into the cochlea, but it becomes difficult to handle and position during the molding process

Engineering Contradiction:
Improveease of insertionVSAvoidease of handling during molding
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by pre-forming the resilient material shell in the mold before inserting the contact assembly. This allows the shell to be prepared in advance with the correct cochlear-shaped geometry, while the contact assembly with lead wires can be handled and positioned separately in a more manageable straight configuration. The shell is then cured around the contacts, achieving both easy manufacturing handling and proper insertion shape.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If the electrode array is straightened for insertion, then it can be inserted into the cochlea, but the lead wires may detach or break

Engineering Contradiction:
Improveease of insertionVSAvoidlead wire integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies beforehand cushioning by incorporating strain relief elements into the resilient material shell before the insertion process. These strain relief features are pre-formed in the mold and positioned around the lead wires to absorb and distribute mechanical stresses during straightening and insertion. This protective structure is established in advance, preventing lead wire detachment or breakage when the array is straightened for cochlear insertion.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Ease of manufacture

If conventional molding processes are used, then the electrode array can be manufactured, but the lead wires are prone to detachment or breakage

Engineering Contradiction:
ImprovemanufacturabilityVSAvoidlead wire attachment
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies local quality by creating regions of different material properties within the resilient material shell. The shell includes strain relief elements with specific local geometries that concentrate flexibility and shock absorption at critical locations where lead wires pass through or attach to the array. This localized variation in material structure provides enhanced protection precisely where needed, while maintaining overall manufacturability through a single-mold process.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS11471668B2Apparatus and methods for making cochlear implant electrode arrays
Publication Date: 2022.10.18 ADVANCED BIONICS AG
  • US11471668B2 patent drawing
  • US11471668B2 patent drawing
  • US11471668B2 patent drawing

AI summary

A method that may include the steps of positioning a contact assembly, including a plurality of electrically conductive contacts that are respectively connected to a plurality of lead wires, on a shell formed from a first resilient material to form an electrode array sub-assembly, positioning the electrode array subassembly in a cochlear implant electrode array mold, and introducing a second resilient material into the mold to form a cochlear implant electrode array flexible body, on which the contacts are located, that is defined by the first and second flexible materials.