Totally Implantable Electroneuromodulation Device with Tissue Swelling Placement

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Solution Overview

Problem

Current implantable electric stimulation devices for tissues, such as the stomach, require surgical operations, visible subcutaneous pockets, and electrocatheters, which lead to complications like tissue erosion, increased surgical times, and the need for battery replacement, causing discomfort and inefficiency.

Innovation Solution

A totally implantable device with an internal microgenerator and piezoelectric energy harvesting, along with an implantation tool using a needle and fluid injection to create a localized tissue swelling for device placement, eliminating the need for electrocatheters and surgical operations, and providing independent energy production.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional implantable electric stimulation devices are used with electrocatheters and subcutaneous pockets, then electrical stimulation function is achieved, but surgical complexity and complications increase

Engineering Contradiction:
Improvedevice reliabilityVSAvoidimplantation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts and eliminates the electrocatheter component from the traditional implantable stimulation system. The device is implanted directly into the target tissue without requiring separate electrocatheter wires, thereby removing the source of many complications such as wire breakage, displacement, and tissue erosion while maintaining the essential electrical stimulation function.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention merges the pulse generator and electrode functions into a single integrated device. Instead of having separate components (battery, pulse generator, and electrocatheter with electrodes), all functions are combined in one unit that is implanted directly into the tissue, simplifying the overall system architecture and reducing implantation complexity.

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If electrocatheters are used for connecting pulse generator and electrodes, then electrical connection is established, but tissue erosion and perforation risks increase

Engineering Contradiction:
Improveelectrical connection reliabilityVSAvoidtissue erosion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention removes the electrocatheter component that causes tissue erosion and perforation risks. By implanting the device directly into the target tissue without requiring long electrocatheter wires to traverse through tissue, the harmful mechanical stresses and erosion risks associated with electrocatheters are eliminated while maintaining reliable electrical connection through direct contact electrodes.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If subcutaneous pocket is created for pulse generator placement, then device housing is provided, but surgical time and patient discomfort increase

Engineering Contradiction:
Improvedevice stabilityVSAvoidsurgical time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention eliminates the subcutaneous pocket creation step by implanting the device directly into the target tissue. This removes the need for extensive dissection and pocket formation surgery, significantly reducing surgical time and patient discomfort while the device itself provides its own housing and stabilization structures within the tissue.

Inventive Principle:
Principle #2Taking out (Extraction)

4Use of energy by moving object

If traditional battery-powered devices are used, then continuous power supply is provided, but battery replacement surgery is required

Engineering Contradiction:
Improveenergy supplyVSAvoiddevice lifespan
Core Design Contradiction:
Use of energy by moving objectVSDuration of action of moving object

Solution Approach 1:

The invention changes the energy supply parameter from finite battery power to renewable body-heat-powered energy conversion. By utilizing the temperature difference between the body and the environment through thermoelectric generators, the device achieves continuous energy supply without the need for battery replacement, effectively extending the device lifespan to match the patient's lifetime.

Inventive Principle:
Principle #35Parameter changes

5Ease of operation

If visible abdominal scar is created for implantation, then device access is achieved, but cosmetic appearance deteriorates

Engineering Contradiction:
Improveimplantation accessibilityVSAvoidscar visibility
Core Design Contradiction:
Ease of operationVSShape

Solution Approach 1:

The invention changes the implantation approach from external abdominal access (requiring visible scars) to internal luminal access through the gastrointestinal tract. By delivering the device through the esophagus and stomach into the duodenum, the procedure utilizes the body's existing luminal pathways, eliminating the need for external incisions and visible scars while maintaining implantation accessibility.

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

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

Enables effective electric stimulation of nervous tissues without surgical intervention, reduces complications, and provides long-term operation without battery replacement, improving patient comfort and reducing surgical burdens.

Implementation Method 1

The device (1) has an independent production means of electrical energy necessary for the generation of electric pulses for stimulation and/or for other functions, preferably in the form of at least one piezoelectric element

Methodology Applied
Scientific EffectPiezoelectric effect: Piezoelectric Effect

Data Source

PatentEP3074085B1Set comprising a totally implantable device for electroneuromodulation and an implantation tool of said device
Publication Date: 2017.12.13 CIGAINA VALERIO
  • EP3074085B1 patent drawingFigure 1
  • EP3074085B1 patent drawingFigure 2
  • EP3074085B1 patent drawingFigure 3~4

AI summary

The set comprises a totally implantable device (1) for electroneuromodulation for the electric stimulation of the nervous tissue of the wall of the stomach and/or another neuroreceptive biological tissue and an implantation tool (2) of the device (1), the tool (2) comprising an axially hollow longitudinal containment body (6) for said device (1) and a needle (12) incorporated into said containment body (6) and having a tip (13) that projects forwards to a sharp front end (7) of the containment body (6), said needle (12) being connected to a supply conduit (15) of a fluid injectable from said needle (12) into the tissue for the creation of a localised tissue swelling (4) in which said device (1) can be positioned.