Hydrogel Composition for Fine Needle Injection and Disc Support
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Solution Overview
Problem
Current hydrogel technologies for repairing or supplementing the nucleus pulposus of intervertebral discs require high temperatures and large gauge needles, leading to patient discomfort, risk of tissue damage, and a high likelihood of implant expulsion during physical activity, as they do not provide the necessary mechanical properties for effective disc support.
Innovation Solution
Development of hydrogels that can be safely injected through fine gauge needles at temperatures below 65°C, forming a contiguous implant with a Young's modulus of 0.1 to 5.0 MPa upon cooling, which provides mechanical support and reduces the risk of expulsion, using a composition of polyvinyl alcohol, polyethylene glycol, and polyvinylpyrrolidone, and optionally a contrast agent.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If hydrogels are injected through large gauge needles at high temperatures, then the hydrogel can be injected, but patient discomfort increases and tissue damage risk increases
Solution Approach 1:
The hydrogel composition parameters are optimized to enable injection at lower temperatures (below 65°C) through fine gauge needles while maintaining the required mechanical properties (Young's modulus of 0.1 to 5.0 MPa) after injection, thus resolving the contradiction between injection capability and patient safety
Solution Approach 2:
The patent uses a composite hydrogel system comprising polyvinyl alcohol, polyethylene glycol, and polyvinylpyrrolidone in specific ratios, which combines the advantages of each polymer to achieve both injectability through fine needles and sufficient mechanical strength for disc support
2Ease of operation
If hydrogels are injected through large gauge needles, then the hydrogel can be injected, but the likelihood of implant expulsion increases
Solution Approach 1:
By changing the composition parameters and molecular weight distribution of the hydrogel polymers, the patent achieves a balance between injectability and mechanical strength, allowing injection through fine gauge needles while forming a contiguous implant that resists expulsion during physical activity
Solution Approach 2:
The hydrogel formulation creates different local properties: a softer, more flowable state during injection through fine needles, and a firmer, more structured state after injection that provides mechanical support and prevents expulsion
3Ease of operation
If hydrogels are injected at high temperatures, then the hydrogel viscosity decreases for easier injection, but the risk of tissue damage increases
Solution Approach 1:
The patent optimizes the temperature parameter to below 65°C and adjusts the hydrogel composition (polymer types, molecular weights, and ratios) to achieve sufficient fluidity for injection through fine gauge needles at this lower temperature, thereby reducing tissue damage risk while maintaining injection capability
Solution Approach 2:
The composite hydrogel system with specific polymer combinations and ratios enables the material to maintain appropriate viscosity for injection at lower temperatures while still achieving the required mechanical properties after injection
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 hydrogels enable safe and effective injection and integration into the intervertebral disc, providing suitable mechanical properties for disc repair and supplementation, reducing the risk of implant expulsion and improving disc biomechanics, thus alleviating chronic back pain and disc degeneration.
Implementation Method 1
at a temperature of about 65°C the hydrogel is capable of injection through a fine gauge needle to provide a tissue implant having a Young's modulus of between about 0.1 to 5.0 MPa
Data Source
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AI summary
The present disclosure relates to hydrogels and their use for repairing or supplementing body tissue. The hydrogels are capable of safe injection into patients through fine gauge needles and are suitable for repairing, supplementing, or replacing the nucleus pulposus of an intervertebral disc. Methods of manufacturing and methods of using the hydrogels of the present disclosure to repair or replace tissues are also disclosed.