Segmented Spinal Disc Annulus Closure Device

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Solution Overview

Problem

Existing devices for sealing spinal invertebral disc defects face challenges in resisting ejection forces and maintaining the integrity of the seal over time, while also allowing for a full range of spinal motion without fatigue failure.

Innovation Solution

An implant comprising a support member with inter-annulus support members and a proximal securing member, designed to occlude a significant portion of the spinal annulus, featuring a layered structure that provides resistance to ejection forces and flexibility for sagittal motion, potentially made from bio-compatible shape memory polymers with added therapeutic agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a tubular format device is used to seal the annulus defect, then the device can provide structural support to resist ejection forces, but it experiences difficulty with repeated sagittal flex and extension leading to fatigue failure

Engineering Contradiction:
Improveresistance to ejection forcesVSAvoidfatigue resistance during sagittal motion
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The implant is divided into multiple segments including a first section, a second section, and an intermediate section. Each section can independently accommodate sagittal motion while maintaining seal integrity. The segmented structure allows each component to flex during spinal motion rather than requiring the entire tubular structure to flex, thereby reducing fatigue stress on any single component.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The implant incorporates dynamic elements that allow controlled movement and deformation in response to spinal flexion and extension. The intermediate section acts as a hinge or pivot point that enables the first and second sections to move relative to each other during sagittal motion, transforming the rigid tubular structure into a more compliant, jointed mechanism that can withstand repeated motion without fatigue failure.

Inventive Principle:
Principle #15Dynamics

2Strength

If the device is designed to resist strong hydrostatic ejection forces of up to 20 atmospheres, then sealing effectiveness is improved, but the device complexity increases

Engineering Contradiction:
Improveresistance to hydrostatic ejection forcesVSAvoidstructural complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

Rather than making the entire implant structure complex to withstand 20 atmospheres of pressure, the design applies local reinforcement at critical areas. The first and second sections have enhanced structural properties at their distal ends where they contact the annulus walls, while the intermediate section remains more flexible. This localized strengthening provides the necessary pressure resistance without requiring complex structures throughout the entire device.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The implant utilizes composite material construction combining rigid components for pressure resistance with flexible components for motion accommodation. The first and second sections may use materials with higher mechanical strength to resist ejection forces, while the intermediate section uses more compliant materials that allow sagittal flexion. This composite approach achieves both high pressure resistance and运动 compliance without excessive overall complexity.

Inventive Principle:
Principle #40Composite materials

3Reliability

If the implant occludes a significant portion of the spinal annulus to seal the defect, then sealing effectiveness is improved, but the flexibility for spinal motion is reduced

Engineering Contradiction:
Improveseal integrityVSAvoidrange of spinal motion
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

By dividing the implant into multiple sections with the intermediate section acting as a flexible joint, the device can occlude large portions of the annulus while maintaining spinal flexibility. Each section can move independently during flexion and extension, allowing the implant to conform to changing spinal geometry without compromising seal integrity at the defect site.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The implant incorporates flexible components, particularly in the intermediate section, that can deform and adapt to spinal motion. These flexible elements maintain contact with the annulus walls throughout the range of motion, ensuring continuous sealing of the defect even as the spinal curvature changes during flexion and extension movements.

Inventive Principle:
Principle #30Flexible shells and thin films

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 implant effectively seals the annulus defect, resisting ejection forces and allowing for full spinal motion without fatigue, while providing a platform for potential therapeutic delivery and improved tissue interaction.

Implementation Method 1

potentially made from bio-compatible shape memory polymers

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Polymer

Data Source

PatentUS9526623B2Spinal disc annulus closure device
Publication Date: 2016.12.27 SPINOL LTD
  • US9526623B2 patent drawing
  • US9526623B2 patent drawing
  • US9526623B2 patent drawing

AI summary

An implant (300) for repair of a spinal inter-vertebral disc, constituted of a first section and a second section, each having: a support member section (110); a proximal support member secured to the proximal end of the support member section and arranged to extend proximally thereof, the proximal support member (170) arranged in a deployed configuration to distend in the direction of the first face (130) of the support member section (110); and a pair of one inter-annulus support members (170), each of the pair of inter-annulus support members optionally exhibiting a plurality of stacked layers, arranged so as to cooperating under ejection forces to act as a single layer, the support member section of the first section secured to the support member section of the second section such that the second face of the first section faces the second face of the second section.