Vented Needle Biomaterial Injection for Spinal Disc Leakage
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Solution Overview
Problem
Current methods for injecting biomaterials into spinal spaces often result in leakage due to high pressure requirements, which can damage adjacent tissues and require invasive procedures, whereas existing solutions either leave balloons inside the disc space or necessitate multiple breaches of the annulus.
Innovation Solution
A method involving an extraforaminal approach to access the spinal disc, removing a portion of the nucleus pulposus, and introducing a curable biomaterial under low pressure through a sealed needle, with a vent to ensure complete filling and minimal leakage, using a non-compliant balloon for distraction that is later removed, allowing natural ligament stretching to maintain vertebral spacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If high pressure is used to inject biomaterial into the disc space, then the disc space can be filled effectively, but material leakage into adjacent areas occurs
Solution Approach 1:
A balloon is inserted into the disc space and inflated with fluid to distract the vertebral bodies and create space before biomaterial injection. This preliminary distraction allows subsequent low-pressure injection of biomaterial without requiring high pressure, thereby preventing material leakage into adjacent areas while still achieving effective disc space filling
Solution Approach 2:
The balloon acts as an intermediary device that temporarily occupies the disc space and maintains distraction. It serves as a mediator between the injection system and the disc space, enabling controlled low-pressure biomaterial delivery while preventing direct high-pressure injection that would cause leakage
2Force
If a balloon is used for distraction and injection, then vertebral bodies can be distracted, but the balloon and fluid permanently remain in the disc space
Solution Approach 1:
The balloon is initially inserted and inflated to distract the vertebral bodies, then deflated and removed after serving its purpose. The fluid used for inflation is discarded, and the balloon is recovered/removed from the disc space. This allows temporary use of the balloon for distraction without permanent retention of foreign material in the disc space
3Ease of manufacture
If multiple devices are used for distraction and injection, then functions are separated, but device complexity and procedural steps increase
Solution Approach 1:
A single device is designed to perform both distraction and injection functions. The device includes a balloon for distraction and an integrated injection system that can deliver biomaterial through the same access point. This multi-functional approach eliminates the need for separate distraction and injection devices, reducing overall device complexity and procedural steps
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
This approach allows for the effective introduction of biomaterials into spinal discs with reduced leakage and minimal tissue damage, facilitating a minimally invasive procedure by maintaining vertebral distraction without external distractors, ensuring complete filling and curing of the biomaterial within the disc space.
Implementation Method 1
a curable biomaterial is injected into the intradiscal space... The matrix may then be allowed to cure
Data Source
AI summary
A method for treating a diseased or damaged spinal disc comprises the steps of: (a) providing access to the nucleus pulposus through the annulus; (b) removing at least a portion of the nucleus pulposus to create an intradiscal space; determining the size of the intradiscal space; and (c) sealably introducing under pressure a curable biomaterial through the annulus directly into the intradiscal space. The method may include the additional steps of applying a force to distract the opposing vertebral bodies about the intradiscal space and then removing the distraction force after the biomaterial has cured. The step of determining the size of the intradiscal space may be accomplished by expanding a compliant balloon within the intradiscal space using a contrast medium capable of visualization under fluoroscopy. The curable material is sealably introduced through a vented needle inserted through the opening. The curable biomaterial is introduced until a quantity of the material flows into the vent.