Elastomeric Tissue Prosthesis for Minimally Invasive Disc Replacement

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Solution Overview

Problem

Current methods for treating intervertebral disc degeneration, such as discectomy and fusion, are invasive, have limited success, and fail to restore complete function to the spinal column, leading to ongoing degenerative issues and pain.

Innovation Solution

A tissue prosthesis comprising an elastomeric envelope and filler material, both made of silicone rubber, which can expand to conform to the disc cavity, absorb shock, and withstand forces, forming a unified structure that mimics natural cartilaginous tissue, allowing for minimally invasive intervertebral disc nucleus replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If discectomy or fusion is performed to treat intervertebral disc degeneration, then pain relief or structural stability is achieved, but the procedure becomes invasive and complete disc function is not restored

Engineering Contradiction:
Improvesuccess rate of treatmentVSAvoidinvasiveness of procedure
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs an elastomeric envelope that expands to conform to the disc cavity, creating a flexible containment structure that mimics natural disc tissue. This envelope can be minimally invasively inserted and then expanded within the target site, avoiding the need for open surgery while providing reliable structural support and function restoration.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The prosthesis utilizes materials that change physical state or properties - the elastomeric envelope transitions from a compressed insertion state to an expanded functional state within the disc cavity. This parameter change enables minimally invasive delivery through small incisions while achieving the volume and pressure characteristics of natural disc tissue for reliable treatment outcomes.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If fusion is performed to eliminate motion segments, then structural stability is improved, but adjacent segments experience increased stresses leading to further degeneration

Engineering Contradiction:
Improvestructural stability of spineVSAvoidincreased stresses at adjacent segments
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The prosthesis is constructed from materials of the same class (elastomeric/silicone rubber) for both the envelope and filler material, creating a unified structure that mimics the homogeneous properties of natural disc tissue. This homogeneity allows the prosthesis to distribute mechanical loads evenly across the disc space, maintaining structural stability without creating stress concentrations that would harm adjacent segments.

Inventive Principle:
Principle #33Homogeneity

Solution Approach 2:

The prosthesis is designed to be dynamic rather than rigid - the elastomeric envelope and filler material can deform and adapt to physiological movements and loads. This dynamic characteristic allows the prosthesis to move with the spine, maintaining structural stability while avoiding the transmission of excessive stresses to adjacent motion segments, thereby preventing further degeneration.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If an envelope and filler material prosthesis is used, then complete disc function is restored and pain is reduced, but the risk of delamination between components must be prevented

Engineering Contradiction:
Improverestoration of disc functionVSAvoidintegrity of unified structure
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

Both the envelope and filler material are made from the same class of material (elastomeric/silicone rubber), creating a unified homogeneous structure. This material homogeneity eliminates the interface between dissimilar materials that would be prone to delamination, while still allowing the envelope-filler system to provide complete disc function restoration through their coordinated mechanical properties.

Inventive Principle:
Principle #33Homogeneity

4Ease of operation

If minimally invasive approach is used for nucleus replacement, then patient recovery is accelerated and surgical trauma is reduced, but the complexity of delivering and deploying the prosthesis increases

Engineering Contradiction:
Improverecovery time and surgical traumaVSAvoidcomplexity of delivery equipment
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The delivery system employs a nested configuration where the envelope is positioned within a delivery catheter, and the filler material is contained within the envelope. This nested doll arrangement allows all components to be delivered through a single minimally invasive access point, reducing surgical trauma and accelerating recovery while managing the complexity of the delivery system through integrated, space-efficient design.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The envelope is pre-formed and prepared before insertion, with the filler material already positioned within it in a compressed or contained state. This preliminary preparation allows the complex multi-component prosthesis to be delivered as a single integrated unit through minimally invasive access, reducing surgical trauma and accelerating patient recovery while the pre-arranged configuration simplifies the deployment process.

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 solution provides a minimally invasive method for restoring spinal biomechanics, reducing pain, and maintaining disc function by forming a unified, integrated prosthesis that resists delamination and distributes forces effectively, promoting nutrient influx and waste removal, thus addressing the limitations of existing treatments.

Implementation Method 1

a filler material received in a fluent state in the envelope, the filler material being of the same class of material as the envelope to form, when cured, together with the envelope, a unified structure

Methodology Applied
Scientific EffectCuring: Phase Change

Implementation Method 2

an envelope of a biologically inert, elastically deformable material capable of being expanded to conform to an interior surface of a cavity formed at a site in a patient's body

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS9216092B2Tissue prosthesis and method of, and equipment for, forming a tissue prosthesis
Publication Date: 2015.12.22 KUNOVUS PTY LTD
  • US9216092B2 patent drawing
  • US9216092B2 patent drawing
  • US9216092B2 patent drawing

AI summary

A tissue prosthesis 100 comprises an envelope 38 of a biologically inert, elastically deformable material capable of being expanded to conform to an interior surface of a cavity 36 formed at a site 10 in a patient's body. A filler material 60 is received in a fluent state in the envelope 38. The filler material 60 is of the same class of material as the envelope 38 to form, when cured, together with the envelope 38, a unified structure.