Intervertebral Disc Annulus Repair Using Dual-Plug Insertion

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Solution Overview

Problem

Current methods for repairing tears or closing openings in the annulus of intervertebral discs are inadequate, as they often fail over time or require difficult plug insertion, and may only cover the external side of the annulus, leaving internal openings vulnerable to reherniation.

Innovation Solution

A soft tissue repair system using a combination of plugs, including a flexible plug that conforms to the annulus and a flowable plug material that sets to form a secure, flexible material, along with various anchoring mechanisms such as clamping, inflatable balloons, and collapsible cages, to effectively close openings from both the exterior and interior surfaces of the annulus.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sutures are used to close the annulus tear, then the tear can be closed, but the repair can fail over time

Engineering Contradiction:
Improvedurability of repairVSAvoidlong-term stability
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The invention changes the physical state of the plug material from flowable to set/hardened form, creating a durable permanent repair structure that replaces sutures and provides long-term stability without degradation over time

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system combines flowable plug material with particulate matter to create a composite filling material that provides both structural support and durability, enhancing the long-term stability of the annulus repair

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If plugs are inserted from the exterior of the annulus, then the opening can be covered, but difficult positioning or enlarging of the tear is required

Engineering Contradiction:
Improveease of plug insertionVSAvoidinsertion procedure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

Instead of inserting plugs from the exterior surface, the invention delivers plugs from the interior surface of the annulus through the opening, reversing the traditional insertion approach and eliminating the need for difficult positioning or tear enlargement

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The invention uses an introducer device as an intermediary tool to deliver the plug from the interior surface through the annulus opening, simplifying the insertion procedure and avoiding the need for complex external positioning

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If only external side of the annulus tear is covered, then external opening is sealed, but internal openings remain vulnerable to reherniation

Engineering Contradiction:
Improvecompleteness of repairVSAvoidreherniation risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention transitions from two-dimensional external surface coverage to three-dimensional internal filling by delivering plug material through the interior surface and into the annulus opening, ensuring complete sealing and eliminating herniation risk from both surfaces

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The plug material is delivered directly to the specific location of the annulus opening from the interior surface, providing localized reinforcement and complete coverage of the defect area to prevent reherniation

Inventive Principle:
Principle #3Local quality

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 system provides a durable and flexible repair that withstands internal disc pressures and accommodates motion, securely closing openings and preventing reherniation, while being minimally invasive and adaptable to varying annulus sizes and shapes.

Implementation Method 1

the flowable plug material can set or harden to form a flexible plug material

Methodology Applied
Scientific EffectSetting or hardening: Phase Change

Implementation Method 2

The first plug can be arranged as an inflatable balloon having an inflated position configured to fill the opening in the annulus

Methodology Applied
Scientific EffectInflation: Pressure Increase

Implementation Method 3

The first plug is a collapsible cage having a pair of opposing ends and a plurality of arms extending between the opposing ends and fixedly secured thereto. This collapsible cage is configured to collapse and to expand to fill the opening in the annulus

Methodology Applied
Scientific EffectCollapsing and expanding: Deformation

Implementation Method 4

The first plug also includes a push rod that extends through the central cylindrical shaft. The push rod is configured to expel the second plug from the cylindrical shaft

Methodology Applied
Scientific EffectMechanical expulsion: Mechanical Force

Data Source

PatentUS9943297B2Soft tissue repair system
Publication Date: 2018.04.17 GLOBUS MEDICAL INC
  • US9943297B2 patent drawing
  • US9943297B2 patent drawing
  • US9943297B2 patent drawing

AI summary

A soft tissue repair system is provided for covering or filling openings in the annulus of an intervertebral disc. The soft tissue repair system uses a single plug or a combination of a first plug and a second plug. The second plug is a flowable plug such as an adhesive material or a material that hardens to a flexible plug material. Each plug is configured to close the opening in the annulus and can be positioned within the opening, over the opening at the exterior surface or over the opening at the interior surface. The plug can also be combined with a clamping mechanism that engages the annulus to secure the plug in the opening.