Tissue Interface Augmentation Device for Ligament Reconstruction
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Solution Overview
Problem
Current tendon and ligament reconstruction techniques face challenges with poor anchorage and integration of grafts due to insufficient biological integration, leading to complications like graft failure and delayed healing, as conventional methods rely heavily on mechanical bonding without adequate biochemical precursors.
Innovation Solution
A tissue interface augmentation device comprising a tubular composite silk sheath with a backbone of degummed silk mesh and a porous silk sponge embedded with hydroxyapatite particles, serving as a scaffold for osteoconductive and osteoinductive factors, and optionally seeded mesenchymal stem cells to promote bone ingrowth and enthesis regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If mechanical fixation methods (staples, spiked washers, transfixation devices) are used to secure tendon grafts, then immediate anchorage is achieved, but poor biological integration and graft pull-out failure occur due to insufficient contact between bone substratum and graft tissue
Solution Approach 1:
A collagen sponge impregnated with bone morphogenetic protein (BMP) is introduced as an intermediary substance between the tendon graft and bone tunnel. This mediator promotes osteogenesis and biological integration while the graft heals, replacing the need for mechanical fixation devices and enabling direct bone-graft integration.
Solution Approach 2:
The invention replaces mechanical fixation systems (staples, spiked washers, transfixation devices) with a biochemical system using BMP-impregnated collagen sponge. The mechanical anchorage is substituted by biological osteogenesis induced by BMP, which promotes direct bone formation at the graft-bone interface.
2Duration of action of stationary object
If prolonged resting time with fixative methods is used to promote healing, then some integration is achieved, but delayed healing and poor integration outcomes persist
Solution Approach 1:
Bone morphogenetic protein (BMP) is pre-impregnated into the collagen sponge before implantation. This preliminary preparation ensures that osteogenic stimulation is immediately available at the graft-bone interface from the moment of surgery, eliminating the need for prolonged resting periods and accelerating the integration process.
Solution Approach 2:
The invention changes the biochemical parameters at the graft-bone interface by introducing BMP, which fundamentally alters the healing process. Instead of passive fibrous tissue formation, BMP induces active osteogenesis, transforming the healing trajectory from slow fibrous integration to rapid bone formation.
3Ease of manufacture
If conventional tendon transplantation is performed without biological augmentation, then surgical simplicity is maintained, but the enthesis region becomes the weakest point leading to revision surgeries
Solution Approach 1:
The invention merges the tendon graft with a BMP-impregnated collagen sponge at the enthesis region. This combination maintains surgical simplicity while adding biological functionality, as the sponge can be easily applied during the same surgical procedure without requiring separate complex steps.
Solution Approach 2:
The enthesis region is augmented with a composite material consisting of collagen sponge impregnated with bone morphogenetic protein. This composite provides both the structural framework of the sponge and the osteogenic stimulation of BMP, creating a synergistic enhancement at the critical graft-bone interface.
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 accelerates bone-graft integration, reducing complications like graft pull-out and tunnel widening, enabling earlier rehabilitation and reducing the need for revision surgeries by enhancing the biological attachment of tendon grafts to bone, thus improving the success rate of ligament and tendon reconstruction.
Implementation Method 1
a carrier material consisting of a porous silk sponge wherein said porous silk sponge comprises silk fibroin fibers and hydroxyapatite (HA; Ca10(PO4)6(OH)2) particles
Implementation Method 2
a backbone consisting of a tubular silk mesh, and b) a carrier material consisting of a porous silk sponge wherein said tubular silk mesh consists of degummed silk fibroin fibers
Data Source
AI summary
The present invention relates to a device for the interfacial augmentation of tissue grafts for the purpose of tendon and ligament reconstruction. The inventive device works both as a delivery vessel for osteoconductive and osteoinductive factors and as a scaffold to stimulate and support bone ingrowth and comprises a tubular composite silk sheath, said tubular composite silk sheath comprising: a backbone consisting of a tubular silk mesh, and a carrier material consisting of a porous silk sponge, wherein said tubular silk mesh consists of degummed silk fibroin fibers, wherein said porous silk sponge comprises silk fibroin fibers and hydroxyapatite particles and said tubular silk mesh and said porous silk sponge form a composite material. The present invention is also directed to a method for the manufacturing of such augmentation devices, a method for fixation of the thus fabricated tissue interface augmentation devices onto ligament or tendon grafts, a method for applying such devices for ligament and/or tendon reconstruction to tendon grafts, as well as their application in ligament and tendon reconstruction.