Implantable Surface Electrodes with Anchoring for Esophageal Stimulation

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Solution Overview

Problem

Conventional electrical stimulation leads for treating conditions like gastroesophageal reflux disease (GERD) require electrodes to be stitched into the thin muscle wall of the lower esophageal sphincter (LES), which is cumbersome, costly, and prone to electrode migration or erosion.

Innovation Solution

The design features an implantable electrical stimulation lead with a surface electrode that is placed on top of the tissue surface in contact with it, but not embedded, and an anchor that covers the electrode, eliminating the need for stitching and reducing the risk of electrode migration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrodes are stitched into the thin muscle wall of the lower esophageal sphincter, then the electrode can be securely anchored, but the surgical procedure becomes cumbersome, time-consuming, and prone to electrode migration or erosion

Engineering Contradiction:

Improveelectrode anchoring securityVSAvoidsurgical procedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The lead assembly is divided into separate functional components: the electrode portion and the anchor portion. The anchor is a separate element that can be independently deployed to secure the lead, while the electrode remains distinct. This segmentation allows the anchor to provide secure anchoring without requiring complex stitching procedures involving the electrode itself, thereby reducing surgical complexity while maintaining anchoring reliability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The anchor acts as an intermediary element between the lead and the tissue. Instead of directly stitching the electrode into the tissue, the anchor serves as a mediating structure that secures the lead to the tissue surface, thereby eliminating the need for complex electrode stitching procedures while ensuring reliable positioning and preventing migration.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Manufacturing precision

If electrodes are stitched into the tissue, then the electrode can be positioned accurately, but endoscopic checks and stitching procedures increase surgical time and cost

Engineering Contradiction:

Improveelectrode positioning accuracyVSAvoidsurgical time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The anchor is designed to be deployed first to establish the correct positioning and secure the lead in place before the electrode is activated or connected. This preliminary anchoring action ensures accurate positioning is achieved through the anchor's placement rather than through time-consuming stitching procedures, thereby reducing surgical time while maintaining positioning accuracy.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If electrodes are stitched into the thin muscle wall, then electrical stimulation can be delivered, but the electrode may erode into the esophagus lumen

Engineering Contradiction:

Improveelectrical stimulation deliveryVSAvoidelectrode erosion risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode is extracted from the stitching process entirely. Instead of incorporating the electrode into the stitching procedure, the electrode is positioned separately on the tissue surface while the anchor provides the securing function. This extraction eliminates the risk of electrode erosion into the esophagus lumen that is inherent in stitching procedures, while still enabling reliable electrical stimulation delivery through the anchor's secure attachment.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The conventional approach is inverted: instead of securing the electrode directly to the tissue through stitching, the anchor is secured to the tissue surface and the electrode is then attached to the anchor. This inversion separates the electrode from the tissue penetration process, eliminating erosion risk while maintaining stimulation reliability.

Inventive Principle:

Principle #13The other way round (Inversion)

4Reliability

If conventional stitching methods are used, then the electrode can be anchored, but additional clips and tethers are required to prevent backing out

Engineering Contradiction:

Improveelectrode anchoringVSAvoidanchoring components

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The anchoring function and the electrode positioning function are merged into a single integrated anchor structure. The anchor simultaneously provides secure attachment to the tissue and maintains proper electrode positioning, eliminating the need for separate clips and tethers that would otherwise be required to prevent electrode backing out. This merging reduces the number of components while maintaining anchoring reliability.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS20250032780A1Implantable Surface Electrodes and Method of Implantation

Publication Date: 2025.01.30 PARAS HOLDINGS LLC

AI summary

An implantable electrical lead for use in the stimulation of biological tissues is provided. The lead has at least one surface electrode comprising a distal end and a proximal end. The at least one surface electrode is placed on the surface of tissue at an implant site, and at least one anchoring element with a distal end and a proximal end for holding the electrode at a desired position on the implant site is placed above the electrode at the implant site.