Segmented Nucleus Pulposus and Annulus Fibrosus Disc Implant

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Solution Overview

Problem

Current surgical treatments for degenerative intervertebral disc disease are not effective and cannot be optimized further, leading to chronic pain and significant healthcare costs, with a need for alternative therapies that can regenerate tissues to replace damaged or deficient intervertebral discs.

Innovation Solution

Development of an integrated intervertebral disc implant comprising a continuous layer of nucleus pulposus tissue integrated with a substrate and surrounded by multiple layers of annulus fibrosus tissue, mimicking the structure of a natural intervertebral disc, using engineered biomaterials and scaffolds such as polyurethane or silk, to facilitate weight-bearing and integration with native tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current surgical treatments are used for degenerative intervertebral disc disease, then the treatment can be performed with existing methods, but the treatment is not effective and cannot be optimized further

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidoptimization capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The intervertebral disc is segmented into its two main functional components - the nucleus pulposus (NP) and annulus fibrosus (AF) - which are engineered and implanted as separate constructs. This segmentation allows each tissue type to be optimized independently with appropriate cellular and structural characteristics, resolving the limitation of treating the disc as a single不可优化的 unit.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The NP and AF tissues are pre-engineered in the laboratory before implantation, allowing for controlled tissue development, structural organization, and functional maturation. This preliminary action enables optimization of tissue properties prior to surgical implantation, overcoming the inability to optimize treatments after they are administered.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If an integrated intervertebral disc implant with multiple tissue layers is created, then the structural viability and integration with native tissues is improved, but the complexity of the implant increases

Engineering Contradiction:
Improvetissue integration capabilityVSAvoidimplant structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The complex intervertebral disc structure is divided into separable NP and AF constructs that can be engineered independently and then assembled. This segmentation manages complexity by allowing each component to be developed separately with appropriate cellular and structural properties before integration into the final implant.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The separately engineered NP and AF constructs are merged into an integrated implant that mimics the native disc structure. This merging combines the functional benefits of each tissue type while maintaining their distinct structural characteristics, achieving reliable tissue integration without requiring a single overly complex monolithic structure.

Inventive Principle:
Principle #5Merging (Combining)

3Strength

If multiple layers of annulus fibrosus tissue with oblique fibre orientations are engineered, then the structural strength and native disc mimicry are improved, but the manufacturing complexity increases

Engineering Contradiction:
Improvestructural strength of AF tissueVSAvoidfibre orientation control
Core Design Contradiction:
StrengthVSManufacturing precision

Solution Approach 1:

The annulus fibrosus is divided into multiple separate layers, each engineered with a specific fibre orientation. This segmentation allows precise control of fibre alignment in each layer independently, achieving the required manufacturing precision for oblique orientations while managing the complexity through modular layer construction.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The AF implant comprises multiple layers with different fibre orientations arranged in a composite structure that mimics the native disc. This composite approach achieves superior structural strength through the synergistic arrangement of layers with varying fibre angles, while the modular nature simplifies the manufacturing of each individual layer.

Inventive Principle:
Principle #40Composite materials

Data Source

PatentUS10195044B2Intervertebral disc implant
Publication Date: 2019.02.05 SINAI HEALTH SYST
  • US10195044B2 patent drawing
  • US10195044B2 patent drawing
  • US10195044B2 patent drawing

AI summary

The disclosure relates to an intervertebral disc implant comprising a first construct comprising a continuous layer of nucleus pulposus (NP) tissue directly or indirectly on and integrated with a substrate, and a second construct surrounding the first construct comprising one or more continuous layers of annulus fibrosus (AF) tissue on and adherent to a scaffold, wherein the AF tissue, which is composed of single or multiple adherent layers, is integrated with the NP tissue. The disclosure also relates to methods of preparing the multi-tissue intervertebral disc and using the intervertebral disc as an implant.