Implantable Lead Manufacturing via Extrusion and Thermal Bonding

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Solution Overview

Problem

The manufacturing of traditional multipolar implantable leads requires precise and time-consuming laser ablation for small lead bodies, making the process expensive and inefficient.

Innovation Solution

A method involving the formation of an elongated lead body core with axially extending channels, positioning electrical conductors and dielectric insulator rings, and bonding them using heat to create an implantable lead that avoids the need for laser ablation, allowing for faster and less costly production.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If laser ablation is used to create areas on the lead body for electrode positioning, then the electrodes can be stacked up and aligned along the lead body, but the process becomes time consuming and expensive

Engineering Contradiction:

Improveprecision of electrode alignmentVSAvoidproduction speed

Core Design Contradiction:

Manufacturing precisionVSProductivity

Solution Approach 1:

The lead body is pre-formed with laser-ablated areas and electrode positioning features integrated into the extrusion process itself, rather than requiring subsequent laser ablation steps. This preliminary preparation of the lead body structure during manufacturing eliminates time-consuming post-processing while maintaining precise electrode alignment capabilities

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent combines multiple manufacturing steps into a single extrusion process, where the lead body, electrode positioning areas, and insulator structures are all formed simultaneously in one operation. This merging of processes eliminates sequential laser ablation steps and reduces overall manufacturing time while preserving precision

Inventive Principle:

Principle #5Merging (Combining)

2Manufacturing precision

If laser ablation is used on small lead body tubing, then the dimensions can be precisely controlled, but the process becomes extremely slow

Engineering Contradiction:

Improvedimensional precision of lead bodyVSAvoidmanufacturing time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The patent replaces the laser ablation process with a mechanical extrusion process that forms the lead body and its features in one step. The extrusion die mechanically creates the precise dimensional features and electrode positioning areas without requiring subsequent laser removal of material, thereby eliminating the time-consuming nature of laser ablation while maintaining dimensional precision

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

All dimensional precision features are prepared in advance during the extrusion process itself, including the lead body dimensions, electrode positioning areas, and channel structures. This preliminary formation eliminates the need for time-consuming laser ablation steps that would otherwise be required to achieve precise dimensions

Inventive Principle:

Principle #10Preliminary action

3Shape

If traditional multilumen extrusion is used with laser ablation, then the lead can be isodiametric with stacked electrodes, but the manufacturing process becomes expensive

Engineering Contradiction:

Improveisodiametric lead body shapeVSAvoidmanufacturing cost

Core Design Contradiction:

ShapeVSEase of manufacture

Solution Approach 1:

The patent merges the formation of the isodiametric lead body, electrode positioning areas, and insulator structures into a single extrusion process. This consolidation eliminates multiple expensive post-processing steps including laser ablation, thereby reducing manufacturing costs while maintaining the isodiametric shape and stacked electrode configuration

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

All structural features including the isodiametric shape and electrode positioning areas are pre-formed during extrusion. This preliminary preparation eliminates subsequent expensive processing steps while preserving the desired lead body geometry and electrode stacking capability

Inventive Principle:

Principle #10Preliminary action

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 manufacturing time and cost by eliminating the need for precise laser ablation, enabling more efficient and cost-effective production of implantable leads.

Implementation Method 1

heating the elongated lead body core and the dielectric insulator ring to bond the elongated lead body core and the dielectric insulator ring together

Methodology Applied

Scientific EffectHeating: Heating

Data Source

PatentUS11992673B2Implantable medical devices and methods of manufacture

Publication Date: 2024.05.28 OSCOR INC

AI summary

A method for manufacturing an implantable lead includes forming an elongated lead body core that defines a longitudinal axis. The elongated lead body core has a plurality of axially extending channels that are circumferentially spaced apart from one another around the elongated lead body core. The method also includes positioning an electrode ring around the elongated lead body core and electrical conductors. The method includes positioning a respective electrical conductor in each of the axially extending channels and positioning a dielectric insulator ring around the elongated lead body core and electrical conductors.