Curable Nucleus Implant Balloon Curing Pressure Control

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Solution Overview

Problem

Current methods for replacing the nucleus pulposus in intervertebral discs face challenges in accurately determining the size and shape of the disc space during discectomy, leading to potential improper placement and expulsion of implants, which can cause further pain and tissue irritation.

Innovation Solution

A method involving a catheter-delivered expandable balloon with inlet and outlet ports, where a radiopaque solution is used to assess the disc space, followed by the injection of a curable nucleus replacement material, ensuring accurate filling and minimizing tissue damage, and the balloon is designed to maintain constant pressure to prevent volume change during curing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a curable implant material is injected into the disc space, then the disc space can be filled to restore cushioning and shock absorption, but volume expansion during curing can cause annular fissures and lead to implant expulsion

Engineering Contradiction:
Improveimplant material volumeVSAvoidimplant retention
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent applies parameter changes by controlling the curing process under constant pressure conditions. The implant material is cured while maintaining isobaric conditions, which prevents volume expansion and the associated harmful effects of annular fissure formation and implant expulsion.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs beforehand cushioning by using a compliant balloon as a containment structure during the curing process. The balloon absorbs and accommodates any volume changes that occur during curing, preventing direct transmission of expansion forces to the annulus fibrosus and eliminating the risk of fissure formation.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

2Manufacturing precision

If the disc space is accurately determined and filled, then implant placement precision is improved, but the complexity of the implantation procedure increases

Engineering Contradiction:
Improvedisc space filling accuracyVSAvoidimplantation procedure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent applies universality by designing a multi-functional catheter system that combines several functions in a single device: the catheter serves as both the delivery conduit for the implant material and the pressure control mechanism. The compliant balloon also serves dual purposes as both the implant containment structure and the volume displacement mechanism, simplifying the overall procedure while maintaining precision.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 precise determination and filling of the disc space, reducing the risk of implant expulsion and tissue irritation, while maintaining the structural integrity of the annulus fibrosus, thereby providing a stable and effective nucleus replacement.

Implementation Method 1

The implant material is introduced into the balloon in a first state and cured to a second state

Methodology Applied
Scientific EffectPolymerization: Photopolymerisation

Data Source

PatentUS11045324B2Method of implanting a curable implant material
Publication Date: 2021.06.29 DEPUY SYNTHES PROD INC
  • US11045324B2 patent drawing
  • US11045324B2 patent drawing
  • US11045324B2 patent drawing

AI summary

A method of replacing a nucleus pulposus material wherein curable nucleus pulposus material is injected into a balloon in an intervertebral space.