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Device for soft tissue repair

Reference

03498-01

Patents status

International patent application n°PCT/FR2011050108 filed on January 20, 2011 and entitled “Device for tissue repair”. 

Inventors

Laurent CORTÉ
Sabine CANTOURNET
Fabrice DETREZ
David N. KU
Mohammed CHERKAOUI
Frances BAXTER
Jason S. BACH

commercial status

Exclusive or non exclusive licenses, collaborative research agreement

Laboratory

Description

CONTEXT

Ligament rupture and especially the rupture of the anterior cruciate ligaments (ACL) in the knee is a frequently occurring sports-related injury affecting hundreds of thousands of people worldwide each year. Due to their poor healing ability, torn ligaments most often need to be replaced by an autograft obtained from a tendon sample. While the clinical output is satisfactory, this autograft reconstruction still has several limitations including residual donor site morbidity, long recovery times and the requirement of the additional harvest operation. Numerous artificial ligaments have been designed in the last fifty years but most if not all have been abandoned due to high rates of failure, loosening or chronic inflammation.

Today, the progress in surgical techniques and the development of novel biomaterials open new routes to make a biocompatible artificial ligament able to replace damaged ligaments durably. This invention is the result of a collaborative project that explored how biocompatible and low-friction hydrogel materials can be processed to replace native ligament tissues. Such a prosthetic alternative to the currently used biological grafts would provide advantages for patients and surgeons and would be a significant advance in the field of ligament reconstruction.

TECHNICAL DESCRIPTION

The LIGAGEL invention describes a novel type of artificial ligament using the promising performance of a hydrogel already developed at the Georgia Institute of Technology laboratories. Previous formulations of this material have shown excellent properties of biocompatibility causing no inflammation as a cartilage replacement. By means of a thorough study of the processing conditions and using hydrogel fibers, the mechanical performances of this material have been modified to mimic those of the fibrous collagen structure forming native ligaments.

Optimizing these modifications with mechanical tests and simulations, an artificial ligament was designed that reproduces closely the complex behaviour of native ligaments and fulfils the geometrical requirements for ligament reconstruction.

BENEFITS

The LIGAGEL systems are novel ligament substitutes that combine in one same material the excellent biocompatibility and low wear properties of hydrogels with the high tensile performances of fibers. Versatility of hydrogel characteristics and fiber assembly provides a wide range of complex mechanical performances with non-linearities and anisotropies of interest for both compliant and stiff tissues such as menisci, ligaments and tendons.

They provide the basis for unique non-degradable soft tissue implants combining:

– Enhanced biocompatibility,
– High resistance to wear,
– Tuneable mechanical behaviour reproducing the non-linear response, tensile stiffness, strength and large strain elasticity of biological tissues.
– Tuneable bulk porosity and surface functions for drug release, cell encapsulation and control of implant-tissue interface.
– Off-the-shelf availability.

INDUSTRIAL APPLICATIONS

The main application of this invention is the full or partial replacement of damaged ligaments and tendons. More generally, these innovative systems could be used for other soft tissue repair applications requiring permanent biocompatible implants matching closely the tensile behavior of native tissues. Applications also include phantom tissues for bioimaging and model tissues for in vitro studies.

DEVELOPMENT STAGE

Completed in vitro assays :

– Validation of chemical purity and molecular organization.
– Validation of mechanical properties reproducing those of native ligaments.
– Full-scale prototype design and fabrication for ACL replacement.
– Evaluation of long term stability and their resistance to fatigue for physiologically relevant loadings.
– Validation of a sterile fabrication process for small series.

Completed in vivo assays :

– Validation of biocompatibility in rodent model.
– In vivo response to wear debris in rodent model (on-going).

Next development steps :

– Fatigue evaluation on full prototypes including end-fixations and bone tunnels.
– In vivo evaluation of full ligament reconstruction in large animal models.
– Validation for surgery and biomechanical evaluation on cadaver knees.
For further information, please contact us (Ref 03498-01)

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