Dual Needle Disc Delivery Tool via Sub-ligamentous Space

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Solution Overview

Problem

Current methods for delivering therapeutic materials to intervertebral discs are inefficient due to material expulsion under intradiscal pressure and potential damage to the endplate, which is crucial for nutrient and oxygen supply to the avascular disc.

Innovation Solution

A tool with a first needle and a second needle system that allows for delivery of therapeutic materials through a sub-ligamentous space, minimizing damage to the annulus fibrosus and endplate, using a spring system to control the deployment of the second needle for precise placement within the intervertebral disc.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a needle delivers therapeutic material directly to the intervertebral disc, then the therapeutic material can reach the target tissue, but the needle creates a pathway that allows therapeutic material to exit the disc under intradiscal pressure

Engineering Contradiction:
Improvetherapeutic material retentionVSAvoidmaterial expulsion through needle pathway
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The delivery system is divided into two separate needles: a first needle for delivering therapeutic material to the sub-ligamentous space, and a second needle for delivering therapeutic material to the intervertebral disc. This segmentation allows the first needle to create a sealable pathway while the second needle provides controlled delivery, reducing material expulsion through the use of multiple specialized delivery paths rather than a single pathway.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The first needle acts as an intermediary by delivering therapeutic material to the sub-ligamentous space first, creating a sealed pathway that prevents direct expulsion. This intermediary delivery location serves as a buffer zone that allows controlled release into the disc while preventing backflow through the needle pathway.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If transosseous delivery via the endplate is used, then damage to the outer annulus fibrosus is avoided, but the endplate is impacted which compromises its function as the primary source of oxygen and nutrients

Engineering Contradiction:
Improveannulus fibrosus integrityVSAvoidendplate damage affecting nutrient supply
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The delivery approach is segmented into two options: sub-ligamentous space delivery via the first needle that avoids endplate penetration, or controlled transosseous delivery via the second needle when endplate access is necessary. This segmentation allows clinicians to choose the pathway that best preserves both annulus integrity and endplate function depending on the specific treatment requirements.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sub-ligamentous space serves as an intermediary delivery location that allows therapeutic material to reach the disc without directly impacting the endplate. By delivering material to this intermediate space first, the system avoids compromising the endplate's nutrient supply function while still achieving therapeutic delivery to the disc tissue.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If a single needle delivers therapeutic material to the intervertebral disc, then the delivery process is simple, but precise placement and controlled delivery are difficult to achieve

Engineering Contradiction:
Improvedelivery process simplicityVSAvoidneedle placement precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The delivery system is segmented into two needles with distinct functions: the first needle is optimized for accessing the sub-ligamentous space with specific positioning requirements, while the second needle is optimized for precise delivery into the intervertebral disc. This segmentation of functions allows each needle to be optimized for its specific task, improving overall placement precision while maintaining operational clarity through specialized design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system allows dynamic selection and coordination between two delivery pathways. The practitioner can dynamically switch between using the first needle for sub-ligamentous delivery, the second needle for direct disc delivery, or both in sequence, providing flexibility to achieve precise placement while adapting to anatomical variations and treatment requirements.

Inventive Principle:
Principle #15Dynamics

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

Enables effective and controlled delivery of therapeutic materials to the intervertebral disc, reducing material expulsion and minimizing damage to the endplate, thereby enhancing the retention and efficacy of the treatment.

Implementation Method 1

a second needle configured to be deployed from within the first needle

Methodology Applied
Scientific EffectSpring: Spring

Data Source

PatentEP3958763B1Tool for delivery of therapeutic material via sub-ligamentous space
Publication Date: 2024.07.10 WARSAW ORTHOPEDIC INC
  • EP3958763B1 patent drawingFigure 1A~1B
  • EP3958763B1 patent drawingFigure 2
  • EP3958763B1 patent drawingFigure 3A

AI summary

An approach is provided for delivering therapeutic materials to an intervertebral disc via a sub-ligamentous space. The approach includes positioning a tool at an interface of a longitudinal ligament and an outer surface of the intervertebral disc, in which the interface is the sub-ligamentous space. The tool may include a first needle and a second needle housed within the first needle. An insertion end of the first needle may include a shallow beveled end. The approach includes inserting the insertion end of the first needle into the sub-ligamentous space. The approach includes deploying the second needle from within the first needle into at least one of an annulus and a nucleus of the intervertebral disc. The approach includes delivering the therapeutic materials to the at least one of the annulus and the nucleus.