Paddle Lead Assembly With Four Electrode Columns

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Solution Overview

Problem

Current implantable electrical stimulation systems face challenges in providing effective stimulation coverage for larger areas due to limited electrode density and compatibility with conventional connectors, which can lead to sub-therapeutic outcomes and increased patient discomfort during implantation.

Innovation Solution

The development of a paddle lead assembly with four columns of electrodes, each coupled to distinct lead bodies via an extension element and junction, allowing for increased electrode density and compatibility with conventional connectors, along with a method for implanting the paddle lead assembly that facilitates easier identification and separation of lead bodies for connection to a control module.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If conventional connectors are used with limited electrode density, then compatibility with existing systems is maintained, but stimulation coverage for larger areas is insufficient

Engineering Contradiction:
Improvestimulation coverage areaVSAvoidelectrode density
Core Design Contradiction:
Area of stationary objectVSQuantity of substance

Solution Approach 1:

The lead is divided into multiple lead bodies (first lead body, second lead body, etc.) with electrodes arranged in multiple columns. Each lead body can be independently connected to conventional connectors, allowing the system to maintain compatibility while providing increased overall electrode density and coverage area through the segmented multi-column configuration

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a single-column lead configuration to a multi-column lead body arrangement. By organizing electrodes into multiple columns across separate lead bodies, the system expands the stimulation coverage in the lateral dimension while maintaining compatibility with conventional single-port connectors through selective connection of individual lead bodies

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Quantity of substance

If multiple lead bodies are used to increase electrode density, then stimulation coverage is improved, but identification and separation of lead bodies for connector connection becomes more difficult

Engineering Contradiction:
Improveelectrode densityVSAvoidlead body identification and separation
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent employs visual differentiation of lead bodies through distinct features such as colored insulation, markings, or physical characteristics that allow easy identification and differentiation of each lead body during implantation and connection procedures, thereby maintaining ease of operation despite increased electrode density

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The lead bodies are pre-configured with identification features and separation mechanisms (such as weakened regions or distinct connectors) before implantation, allowing for easy identification and separation during the surgical procedure without requiring complex manipulation or identification processes

Inventive Principle:
Principle #10Preliminary action

3Reliability

If electrode density is increased for better stimulation coverage, then therapeutic outcomes are improved, but patient discomfort during implantation increases

Engineering Contradiction:
Improvetherapeutic outcomeVSAvoidpatient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

By segmenting the lead into multiple lead bodies that can be independently handled and connected, the implantation process becomes less complex and more manageable, reducing surgical time and patient discomfort while maintaining high electrode density for improved therapeutic outcomes

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lead assembly is pre-configured with identification features and separation mechanisms that facilitate easier implantation and connection procedures, reducing surgical complexity and patient discomfort during the implantation process while preserving the high electrode density required for effective therapy

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2616137B1Paddle lead assembly for electrical stimulation systems
Publication Date: 2016.12.21 BOSTON SCI NEUROMODULATION CORP
  • EP2616137B1 patent drawing
  • EP2616137B1 patent drawing
  • EP2616137B1 patent drawing

AI summary

A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body. The paddle body includes four columns of electrodes, each column including at least one electrode. The columns include two outer columns flanking two inner columns. The paddle lead assembly further includes a plurality of lead bodies coupled to the paddle body. At least one terminal is disposed on each of the plurality of lead bodies. A plurality of conductive wires couple each of the electrodes to at least one of the plurality of terminals.