Cross-linked Hydrogels for Disc Repair via Fine-Needle Injection

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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 and potential expulsion of the implant, with few minimally invasive techniques available to restore the disc's mechanical properties.

Innovation Solution

Development of hydrogels suitable for safe injection through fine gauge needles (17-gauge or smaller) at a temperature of about 65°C, using a mixture of polyvinyl alcohol, polyvinylpyrrolidone, and polyethylene glycol, which provide a mechanical modulus of 0.1 to 5.0 MPa, allowing for effective tissue implantation without causing substantial tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If pre-heated hydrogels are injected through large gauge needles, then the hydrogel can be injected, but severe patient discomfort and potential implant expulsion occur

Engineering Contradiction:
Improveinjection capabilityVSAvoidpatient discomfort and implant expulsion
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical parameters of the hydrogel by adjusting its viscosity and gelation characteristics. The hydrogel is formulated to remain injectable at lower temperatures without requiring pre-heating, thereby enabling injection through fine gauge needles while avoiding tissue damage and implant expulsion

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses composite hydrogel formulations combining multiple polymers (polyvinyl alcohol, polyvinylpyrrolidone, and polyethylene glycol) to achieve the desired balance between injectability and mechanical properties. This composite approach allows the hydrogel to be injected through fine needles while maintaining sufficient structural integrity

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If hydrogels are injected through fine gauge needles, then patient discomfort and implant expulsion are reduced, but the hydrogel must provide sufficient mechanical properties to support the intervertebral disc

Engineering Contradiction:
Improvepatient discomfort and implant expulsionVSAvoidmechanical modulus
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent optimizes the gelation kinetics and mechanical properties of the hydrogel to ensure that upon injection through fine gauge needles, the hydrogel rapidly forms a stable gel structure with sufficient mechanical modulus (0.1 to 5.0 MPa) to support the intervertebral disc

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The composite polymer system enables the hydrogel to achieve both injectability through fine needles and adequate mechanical strength. The combination of polymers provides synergistic effects that enhance both flow characteristics during injection and structural properties after implantation

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If high temperature is used for hydrogel injection, then injection is possible, but substantial tissue damage occurs

Engineering Contradiction:
Improveinjection capabilityVSAvoidtissue damage
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent fundamentally changes the temperature parameter for hydrogel injection, formulating the hydrogel to be injectable at lower temperatures (without requiring pre-heating to high temperatures). This eliminates thermal damage to surrounding tissues while maintaining injection capability through fine gauge needles

Inventive Principle:
Principle #35Parameter changes

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 implantation in the nucleus pulposus, providing the necessary mechanical properties to support the intervertebral disc, reducing pain and preventing further deterioration, while minimizing patient discomfort and implant expulsion.

Implementation Method 1

hydrogels that are flowable when heated above their melting temperature and that provide an elastic solid at physiological temperature

Methodology Applied
Scientific EffectPhase change: Phase Change

Implementation Method 2

hydrogels that are flowable when heated above their melting temperature

Methodology Applied
Scientific EffectMelting: Melting

Data Source

PatentUS10507264B1Cross-linked hydrogels and method of making the same
Publication Date: 2019.12.17 REGELTEC INC
  • US10507264B1 patent drawing
  • US10507264B1 patent drawing
  • US10507264B1 patent drawing

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 or supplementing 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.