Dissolvable Stiffening Element for Soft Tissue Implantable Devices

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Solution Overview

Problem

Existing medical devices for soft tissue implantation, such as those in the central nervous system, face challenges in minimizing tissue displacement due to body movements and ensuring selective stimulation and recording of nerve cells without causing significant tissue damage.

Innovation Solution

A medical device comprising a micro electrode and a micro light source with a stiffening element that dissolves or swells in aqueous body fluid, allowing the device to adapt to tissue movements while maintaining functionality, and a flexible non-conducting polymer coat to prevent tissue contact, enabling both optical and electrical stimulation and recording.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a stiffening element is used to maintain device structure during insertion, then structural stability is improved, but tissue displacement increases due to rigidity

Engineering Contradiction:

Improvestructural stabilityVSAvoidtissue displacement

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The stiffening element changes its physical parameters from rigid to flexible through dissolution or degradation in aqueous body fluid. This parameter change allows the device to maintain structural stability during insertion, then adapt to tissue movements after the stiffening element dissolves, resolving the contradiction between structural stability and tissue displacement

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The device transitions from a static rigid structure to a dynamic flexible structure. The stiffening element provides rigidity during insertion, then degrades to allow flexibility and movement with tissue, enabling the device to adapt to physiological movements without causing displacement

Inventive Principle:

Principle #15Dynamics

2Object-affected harmful factors

If a flexible polymer coat is applied to prevent tissue contact, then tissue damage is reduced, but light transmission is blocked

Engineering Contradiction:

Improvetissue damageVSAvoidlight transmission

Core Design Contradiction:

Object-affected harmful factorsVSIllumination intensity

Solution Approach 1:

A thin flexible polymer coat is applied to the device surface to provide protection while maintaining light transmission. The thin film structure allows optical signals to pass through while still providing a protective barrier between the device and surrounding tissue

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The device employs composite material structure combining flexible polymer coating with optically transparent properties. This composite approach provides both tissue protection and light transmission capabilities simultaneously

Inventive Principle:

Principle #40Composite materials

3Reliability

If the device structure is made rigid for stable insertion, then insertion stability is improved, but adaptability to tissue movements deteriorates

Engineering Contradiction:

Improveinsertion stabilityVSAvoidadaptability to tissue movements

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The stiffening element is pre-applied to the device to provide rigidity during the insertion phase. After insertion is complete, the stiffening element dissolves or degrades, allowing the device to adapt to tissue movements. This preliminary action resolves the contradiction between insertion stability and adaptability

Inventive Principle:

Principle #10Preliminary action

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

The device effectively adapts to tissue movements, minimizes displacement, and allows for precise stimulation and recording of nerve cells, enhancing therapeutic and diagnostic capabilities in soft tissue environments.

Implementation Method 1

a stiffening element comprising a material dissolvable or degradable in aqueous body fluid in an amount sufficient to make the stiffening element collapse in contact with aqueous body fluid

Methodology Applied

Scientific EffectDissolution:

Implementation Method 2

b) a material swellable in aqueous body fluid to form a transparent gel

Methodology Applied

Scientific EffectSwelling:

Implementation Method 3

a coat of a flexible non-conducting polymer material on the stiffening element preventing or at least delaying contact between the electrode and soft tissue

Methodology Applied

Scientific EffectElectrical insulation:

Implementation Method 4

a micro light source capable of emitting light in a distal direction

Methodology Applied

Scientific EffectLight emission:

Data Source

PatentUS11583233B2Medical device comprising an electrode and a light source

Publication Date: 2023.02.21 NEURONANO AB

AI summary

A device for insertion into soft tissue including a micro electrode, a micro light source; a stiffening element having a material dissolvable or degradable in aqueous body fluid or a material swellable in such fluid to form a transparent gel; a coat of a flexible non-conducting polymer material on the stiffening element; a base disposed at the rear end of the device. The flexible coat has a distal opening allowing light emitted from the light source to leave the device upon said collapse or dissolution or swelling. Also disclosed is a therapeutic or diagnostic device formed in the tissue from the insertable device, uses thereof, and a method of disposing the insertable device in soft tissue.