Strain-Hardened IPN Hydrogel Arthroplasty Device

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Solution Overview

Problem

Current joint replacement technologies are either highly bone-sacrificing or limited in their ability to effectively address cartilage damage, leading to complications such as excessive wear, periprosthetic bone resorption, and aseptic loosening, particularly in younger patients, who require multiple revisions and face challenges with metal ion release from bearing surfaces.

Innovation Solution

Development of a bone-sparing arthroplasty device utilizing a strain-hardened interpenetrating polymer network hydrogel that mimics the molecular structure and properties of natural cartilage, featuring a bearing region for articulation and a bone-interfacing region for integration with underlying bone, allowing for a biomimetic resurfacing procedure that replaces only the damaged cartilage while preserving bone stock.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If total joint arthroplasty is performed to replace damaged cartilage and bone, then pain relief and functional improvement are achieved, but extensive bone removal is required which makes revision difficult

Engineering Contradiction:
Improvepain relief and functional improvementVSAvoidbone stock
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The arthroplasty device is segmented into distinct regions: a bearing region made from interpenetrating polymer network hydrogel for articulation, and a bone-interfacing region made from another polymer for bone integration. This segmentation allows each region to perform its specific function optimally while preserving bone stock.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device utilizes composite material construction with an interpenetrating polymer network hydrogel for the bearing surface that mimics natural cartilage properties, combined with a different polymer for bone interfacing. This composite approach enables the device to provide both cartilage-like lubrication and bone integration capabilities without requiring extensive bone removal.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If conventional metal-on-polyethylene or metal-on-metal bearing surfaces are used, then joint function is restored, but excessive wear and periprosthetic bone resorption occur leading to aseptic loosening

Engineering Contradiction:
Improvejoint functionVSAvoidwear particles and bone resorption
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The bearing surface material parameters are changed from conventional metals and polyethylene to an interpenetrating polymer network hydrogel that mimics the molecular structure and properties of natural cartilage. This parameter change results in reduced wear and elimination of harmful wear particles that cause bone resorption, while maintaining joint function.

Inventive Principle:
Principle #35Parameter changes

3Loss of substance

If hip resurfacing is performed to preserve bone stock, then bone removal is reduced, but the procedure has a steep learning curve, takes longer than THA, and has complications such as femoral neck fractures and metal ion release

Engineering Contradiction:
Improvebone stock preservationVSAvoidsurgical complexity and complications
Core Design Contradiction:
Loss of substanceVSDevice complexity

Solution Approach 1:

The device applies local quality by using different materials in different regions: the bearing region uses interpenetrating polymer network hydrogel to mimic natural cartilage and reduce wear, while the bone-interfacing region uses another polymer optimized for bone integration. This localized material optimization reduces surgical complexity and complications compared to uniform metal resurfacing.

Inventive Principle:
Principle #3Local quality

4Reliability

If younger patients undergo THA to relieve unbearable pain, then pain relief is achieved, but implant lifetime is significantly shorter requiring multiple difficult revisions

Engineering Contradiction:
Improvepain reliefVSAvoidimplant lifetime
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The device employs a bone-sparing design that, while potentially requiring revision in younger patients, preserves bone stock for future revisions. The interpenetrating polymer network hydrogel bearing surface is designed to minimize wear and bone resorption, extending implant lifetime compared to conventional THA in younger, more active patients.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 device provides a durable, lubricious surface with enhanced mechanical strength and integration capabilities, reducing the need for extensive bone removal, minimizing wear and loosening issues, and potentially extending the lifespan of the implant while promoting bone ingrowth and integration.

Implementation Method 1

the bearing region is made from an interpenetrating polymer network hydrogel... providing a durable, lubricious surface

Methodology Applied
Scientific EffectLubrication: Lubrication

Implementation Method 2

promoting bone ingrowth and integration

Methodology Applied
Scientific EffectBone ingrowth:

Data Source

PatentEP3628275B1Hydrogel arthroplasty device
Publication Date: 2023.03.01 THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIV
  • EP3628275B1 patent drawingFigure 1
  • EP3628275B1 patent drawingFigure 2
  • EP3628275B1 patent drawingFigure 3A1~3B3

AI summary

An arthroplasty device is provided having an interpenetrating polymer network (IPN) hydrogel that is strain-hardened by swelling and adapted to be held in place in a joint by conforming to a bone geometry. The strain-hardened IPN hydrogel is based on two different networks: (1) a non-silicone network of preformed hydrophilic non-ionic telechelic macromonomers chemically cross-linked by polymerization of its end-groups, and (2) a non-silicone network of ionizable monomers. The second network was polymerized and chemically cross-linked in the presence of the first network and has formed physical cross-links with the first network. Within the IPN, the degree of chemical cross-linking in the second network is less than in the first network. An aqueous salt solution (neutral pH) is used to ionize and swell the second network. The swelling of the second network is constrained by the first network resulting in an increase in effective physical cross-links within the IPN.