Self-Winding Implantable Probe With Perforated Elastomer Sleeve

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Solution Overview

Problem

Existing implantable sleeves for stimulating or detecting elongate cylindrical organs like the vagus nerve face challenges during implantation, including excessive stress on nervous tissue, potential nerve damage, manufacturing reproducibility issues, and the creation of virtual electrodes leading to unwanted stimulations or blockages.

Innovation Solution

A self-winding sleeve made of elastomer with prestressed sheets that feature beveled edges and perforations to reduce stress, prevent nerve distortion, and eliminate virtual electrodes, allowing for easier implantation and improved anatomical integrity while maintaining contact with the nerve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a self-winding spiral sleeve is used for implantation, then the ease of operation during implantation is improved, but the stress on nervous tissue at the sleeve ends increases causing potential damage

Engineering Contradiction:
Improveease of implantationVSAvoidstress on nervous tissue
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sleeve is divided into multiple segments or sections along its length, with each section having optimized properties. The ends of the sleeve are specifically designed with different characteristics (reduced stiffness, different geometry) compared to the central portion, allowing easy implantation while reducing stress concentration on the nerve tissue at the implantation sites.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the sleeve have different mechanical and geometric properties tailored to their specific functions. The central portion maintains optimal stiffness for nerve contact and stimulation, while the end portions are designed with reduced stiffness and modified geometry to minimize stress during implantation and prevent nerve damage.

Inventive Principle:
Principle #3Local quality

2Manufacturing precision

If the sleeve is made with sharp edges for precise positioning, then the manufacturing precision is improved, but the harm to nervous tissue increases due to potential distortion and damage

Engineering Contradiction:
Improvepositioning precisionVSAvoidnerve distortion
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The sleeve incorporates asymmetric features such as beveled edges at specific locations rather than uniform sharp edges throughout. These asymmetric geometric modifications allow for precise positioning and orientation during implantation while the beveled (angled) surfaces distribute mechanical stress more evenly, preventing nerve distortion and tissue damage.

Inventive Principle:
Principle #4Asymmetry

3Stability of the object's composition

If the sleeve material is made rigid for structural stability, then the stability of the object is improved, but the adaptability to nerve diameter variations decreases

Engineering Contradiction:
Improvestructural stabilityVSAvoidadaptability to nerve diameter
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The sleeve transitions from a static rigid structure to a dynamic structure that can adapt its mechanical properties. The material composition and geometric design allow the sleeve to exhibit different stiffness characteristics under different conditions - maintaining structural stability when needed while enabling flexibility to accommodate natural variations in nerve diameter through controlled deformation.

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If the sleeve is made thin for flexibility, then the adaptability to nerve shape is improved, but the manufacturing precision decreases due to difficulty in controlling thickness uniformity

Engineering Contradiction:
ImproveflexibilityVSAvoidthickness uniformity
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The sleeve employs composite material construction combining multiple layers or material types with complementary properties. This composite structure provides the necessary flexibility and thin profile for nerve adaptation while the layered architecture enables better control over overall thickness uniformity during manufacturing, as each layer can be controlled independently and defects in one layer can be compensated by others.

Inventive Principle:
Principle #40Composite materials

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

Facilitates quick and stress-free implantation, reduces the risk of nerve damage, enhances reproducibility in manufacturing, and eliminates unwanted stimulations by minimizing virtual electrodes, ensuring effective and safe nerve stimulation.

Implementation Method 1

a self-winding sleeve... comprising a sheet of elastically deformable material that supports at least one electrode

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

The sheet is prestressed in such a way as to allow it to self-wind from an initial position, in which the sheet is kept stressed in the deployed state, to a final position, in which the sheet is wound freely in a spiral

Methodology Applied
Scientific EffectPrestressing: Stress Relaxation

Data Source

PatentUS10864369B2Implantable probe comprising a perforated sleeve
Publication Date: 2020.12.15 SORIN CRM
  • US10864369B2 patent drawing
  • US10864369B2 patent drawing
  • US10864369B2 patent drawing

AI summary

The disclosure relates to implantable probes. An implantable probe includes a sleeve capable of being wound around an elongate organ of cylindrical shape, and includes a sheet of elastically deformable material that supports at least one electrode. The sheet is prestressed in such a way as to allow it to self-wind from an initial position, in which the sheet is kept stressed in the deployed state, to a final position, in which the sheet is wound freely in a spiral to form a sleeve around the organ, with the first face, which supports the electrodes, being directed towards the inside. The sheet is delimited by an outer lateral edge of the sleeve after winding, an inner lateral edge of the sleeve after winding, and a first transverse edge and a second, opposite transverse edge. The sheet includes perforations located in proximity to the first and/or second transverse edge.