Flexible Hinge Electrical Stimulation Lead for Dorsal Root Ganglia

Solution Overview

Problem

Current implantable electrical stimulation systems face challenges in effectively targeting and stimulating dorsal root ganglia due to the rigidity of existing leads, which limits flexibility and precise positioning during implantation, leading to potential tissue damage and reduced therapeutic efficacy.

Innovation Solution

The development of an implantable electrical stimulation lead with a flexible hinge formed from a lower durometer material than the adjacent regions, allowing for coiled conductors and a bellows-like construction, enabling greater flexibility and precise positioning around dorsal root ganglia, along with segmented electrodes for enhanced current steering.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a rigid lead structure is used, then structural strength and stability are improved, but flexibility and positioning precision deteriorate

Engineering Contradiction:

Improvestructural strengthVSAvoidflexibility and positioning precision

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The lead structure implements different mechanical properties in different regions: the proximal portion maintains higher rigidity for structural support, while the distal portion incorporates a flexible hinge with lower rigidity for enhanced flexibility. This local differentiation allows the lead to simultaneously achieve structural strength where needed and flexibility for precise positioning around the dorsal root ganglia.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The lead is divided into distinct segments with different mechanical characteristics - a proximal portion with higher rigidity and a distal portion containing a flexible hinge with lower rigidity. This segmentation allows each portion to perform its specialized function: the rigid proximal portion provides structural support while the flexible distal portion enables precise positioning and conformability to anatomical structures.

Inventive Principle:

Principle #1Segmentation

2Adaptability or versatility

If a flexible lead structure is used, then positioning precision and adaptability are improved, but structural strength and stability deteriorate

Engineering Contradiction:

Improvepositioning precision and adaptabilityVSAvoidstructural strength

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The lead structure implements different mechanical properties in different regions: the proximal portion maintains higher rigidity for structural support, while the distal portion incorporates a flexible hinge with lower rigidity for enhanced flexibility. This local differentiation allows the lead to simultaneously achieve structural strength where needed and flexibility for precise positioning around the dorsal root ganglia.

Inventive Principle:

Principle #3Local quality

3Ease of manufacture

If a uniform lead structure is used, then manufacturing simplicity is improved, but positioning precision and therapeutic efficacy deteriorate

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidpositioning precision

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The lead structure implements different mechanical properties in different regions: the proximal portion maintains higher rigidity for structural support, while the distal portion incorporates a flexible hinge with lower rigidity for enhanced flexibility. This local differentiation allows the lead to simultaneously achieve structural strength where needed and flexibility for precise positioning around the dorsal root ganglia.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The lead is divided into distinct segments with different mechanical characteristics - a proximal portion with higher rigidity and a distal portion containing a flexible hinge with lower rigidity. This segmentation allows each portion to perform its specialized function: the rigid proximal portion provides structural support while the flexible distal portion enables precise positioning and conformability to anatomical structures.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS10716935B2Electrical stimulation leads, systems and methods for stimulation of dorsal root ganglia

Publication Date: 2020.07.21 BOSTON SCI NEUROMODULATION CORP

AI summary

An implantable electrical stimulation lead includes a lead body having a proximal portion and a distal portion; electrodes disposed along the distal portion of the lead body; terminals disposed along the proximal portion of the lead body; conductor extending along the lead body and electrically coupling the electrodes to the terminals; and a flexible hinge forming part of the distal portion of the lead body and disposed proximal to the electrodes, wherein the flexible hinge is structurally distinguishable from adjacent regions of the lead body and more flexible than the adjacent regions.