Arched Electrode Paddle for Minimally Invasive Neurostimulation

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Solution Overview

Problem

Existing deployable electrodes for electrotherapy and electrophysiology face challenges with poor manoeuvrability and a high delivery system size over paddle width ratio, particularly due to torque stress and structural integrity issues during deployment and transport.

Innovation Solution

A device comprising an elongated lead with a proximal and distal end, and a paddle with arched conductive surfaces that change transverse encumberance between transport and operative configurations, allowing for percutaneous implantation with improved directional and localized stimulation capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If deployable electrodes are used for percutaneous implantation, then the delivery system size is reduced, but the manoeuvrability and structural integrity during deployment deteriorate due to torque stress

Engineering Contradiction:
Improvedelivery system sizeVSAvoidmanoeuvrability
Core Design Contradiction:
Volume of moving objectVSEase of operation

Solution Approach 1:

The electrode is divided into multiple segments or sections that can independently flex and deform. This segmentation allows the electrode to bend and navigate through the delivery catheter more easily while maintaining structural integrity during deployment, resolving the contradiction between reduced delivery system size and maintained manoeuvrability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The electrode transitions from a static, rigid structure to a dynamic, flexible structure that can change its configuration. During delivery, the electrode adopts a compressed, flexible state to fit through the catheter, and upon deployment, it transitions to an expanded, stable configuration for optimal electrical contact, thereby maintaining manoeuvrability throughout the procedure.

Inventive Principle:
Principle #15Dynamics

2Volume of moving object

If deployable electrodes are used for percutaneous implantation, then the delivery system size is reduced, but the structural integrity deteriorates due to torque stress during deployment

Engineering Contradiction:
Improvedelivery system sizeVSAvoidstructural integrity
Core Design Contradiction:
Volume of moving objectVSStrength

Solution Approach 1:

The electrode is constructed using flexible materials and thin-film structures that can withstand repeated bending and deformation without compromising structural integrity. These flexible components maintain their mechanical strength during the deployment process while allowing the electrode to be delivered through a smaller catheter.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The electrode employs composite materials that combine the flexibility needed for navigation with the strength required for structural integrity. The composite structure allows the electrode to resist torque stress during deployment while maintaining the ability to be delivered through a reduced-size system.

Inventive Principle:
Principle #40Composite materials

3Area of moving object

If the paddle width is increased for better stimulation coverage, then the stimulation effectiveness is improved, but the delivery system size increases

Engineering Contradiction:
Improvepaddle widthVSAvoiddelivery system size
Core Design Contradiction:
Area of moving objectVSVolume of moving object

Solution Approach 1:

The wider paddle electrode is designed to nest within or collapse around a smaller delivery catheter during the delivery process. Once positioned at the target site, the paddle expands to its full width for optimal stimulation coverage, thereby achieving both wide coverage and small delivery profile.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The electrode utilizes dimensional transformation by collapsing in the radial dimension during delivery and expanding in the longitudinal dimension along the catheter axis. This dimensional change allows the electrode to maintain a compact delivery profile while achieving wide coverage when deployed.

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

Data Source

PatentUS11446484B2Device for electrotherapy and/or electrophysiology, kit and assembly
Publication Date: 2022.09.20 WISE SPA
  • US11446484B2 patent drawing
  • US11446484B2 patent drawing
  • US11446484B2 patent drawing

AI summary

Device (1) for electrotherapy and/or electrophysiology comprising at least one lead (2) having an elongated lead body extending along a longitudinal direction (X-X) and comprising a proximal end (3) and a distal end (4); and at least one paddle (5) having a paddle body comprising two opposite major surfaces (6, 7) defining a paddle thickness (33) there between; wherein said paddle (5) comprising at least one paddle electrode (8) having an exposed surface (9) designed to come into electrical contact with a living anatomy (10) inside a patient's body (11); said paddle (5) is suitable to modify the transverse encumber (12) thereof, so that to assume at least one transport configuration and at least one operative configuration, wherein the transverse encumber (12) of the paddle (5) when in said at least one transport configuration is less than the transverse encumber (12) of the same paddle (5) when in said at least one operative configuration; wherein said lead (2) comprising a connection portion (13) near the distal end (4) thereof; said connection portion (13) of the lead (2) comprises at least one arched electrically conductive surface (14); and said paddle (5) comprises at least one counter-connection portion (15) comprising at least one arched electrically conductive counter-surface (16) in direct contact with said at least one conductive surface (14) of the connection portion (13) of the lead (2), so that said at least one counter-connection portion (15) of the paddle (5) has a transversally arched shape defining a first concavity (R1) facing towards said connection portion (13) of the lead (2); said at least one conductive counter-surface (16) of the paddle (5) is in electric communication with said paddle electrode (8) through at least one conductive track (17) extending within the body of paddle (5) in such way that said proximal end (3) of the lead (2) is in electrical communication with said exposed surface (9) of the at least one paddle electrode (8).