SBIR-STTR Award

Bioadhesive Membrane Construct To Augment Tendon Repair
Award last edited on: 2/5/13

Sponsored Program
SBIR
Awarding Agency
NIH : NIAMS
Total Award Amount
$2,014,465
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Bruce P Lee

Company Information

Kensey Nash Corporation

735 Pennsylvania Drive
Exton, PA 19341
   (484) 713-2100
   info@kenseynash.com
   www.kenseynash.com
Location: Multiple
Congr. District: 06
County: Chester

Phase I

Contract Number: 1R43AR056519-01A1
Start Date: 4/1/09    Completed: 9/30/09
Phase I year
2009
Phase I Amount
$134,053
The frequency with which tendon injuries are occurring is increasing due to medical advances that allow an increasingly aging population to remain physically active longer than previously possible. There is a great deal of controversy among the orthopedic community regarding the best and most effective method of treating such injuries. While progress has been made in improving the method of fixation of torn tendons, there remains a need to further enhance the currently employed methods to allow for earlier rehabilitation and fewer incidences of post-operative pain, surgical complications, and rerupture of the repaired tissues. Conventional methods of augmentation secure the injured tissue and/or graft at only a few points via suture, thus placing a great strain at the suture sites. By better securing the graft to the repair, and dispersing the tension over the entire graft surface, the patient can potentially begin post-operative rehabilitation much sooner. Early mobilization has been found to be critical in regenerating well-organized and functional (fibers in) tendons. Marine mussels provided the inspiration for the new technology presented in this proposal. By releasing rapidly hardening, tightly binding adhesive proteins, marine mussels have the ability to anchor themselves to various surfaces in a wet, turbulent, and saline environment. Both natural proteins and their synthetic mimics have been shown to bind strongly to various substrates ranging from biological tissues to metal surfaces. In this proposal, biomimetic synthetic adhesives will be combined with a natural scaffold to create a novel bioadhesive membrane. The intent of such a construct is to create a repair that is stronger than sutures alone by securing the material over the entire surface area being repaired. The feasibility of using such a material as an augmentation device for tendon repair will be tested.

Public Health Relevance:
Injuries of tendons have been occurring with increasing prevalence over the last several decades. Current fixation methods and materials have exhibited mixed success, but each has limitations. The development and evaluation of a novel bioadhesive membrane construct to augment tendon repair is described here.

Public Health Relevance:
Project Narrative Bioadhesive Membrane Constructs to Augment Tendon Repair Injuries of tendons have been occurring with increasing prevalence over the last several decades. Current fixation methods and materials have exhibited mixed success, but each has limitations. The development and evaluation of a novel bioadhesive membrane construct to augment tendon repair is described here.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

Phase II

Contract Number: 2R44AR056519-02
Start Date: 7/1/08    Completed: 8/31/13
Phase II year
2011
(last award dollars: 2012)
Phase II Amount
$1,880,412

The frequency with which tendon ruptures occur is increasing due to medical advances that allow an aging population to remain physically active longer than previously possible. There is a great deal of controversy in the orthopaedic community regarding the most effective way to treat such injuries. While progress has been made in improving the method of fixation of torn tendons, further advancements are needed to allow for earlier and more aggressive rehabilitation with fewer complications such as rerupture or tendon stretching. Some tendon repair techniques include use of a graft to reinforce conventional primary suture repair of the rupture. These grafts are secured to the injured tissues at only a few points via suture. Thus, loads in the tendon are concentrated at these suture points, as well as at the primary repair suture site. By securing the graft to the repair, and distributing the load over the entire graft/tendon interface, the patient can potentially begin postoperative rehabilitation much sooner. Early mobilization has been found to be critical in regenerating well-organized and functional tendons. Marine mussels provide the inspiration for the new technology presented in this proposal. By releasing rapidly hardening, tightly binding adhesive proteins, marine mussels have the ability to anchor themselves to various surfaces in a wet, turbulent, and saline environment. Both natural proteins and their synthetic mimics have been shown to bind strongly to various substrates ranging from metal surfaces to biological tissues. In this proposal, biomimetic synthetic adhesives will be combined with natural scaffolds to create a novel bioadhesive membrane. The intent is to secure such a construct over the entire surface area of a ruptured tendon, reinforcing traditional suture repair, and creating a repair that is stronger than with sutures alone. The feasibility of using such a construct as an augmentation device for tendon repair will be developed and tested.

Public Health Relevance:
The incidence of tendon injuries has been increasing over the past several decades. Tendon ruptures require a prolonged period of recovery, and dramatically affect a patient's quality of life. Numerous surgical and rehabilitative treatments have been introduced, but none have been overwhelmingly successful and widely accepted. In an effort to enhance and accelerate tendon healing, a novel bioadhesive membrane construct to augment tendon repair is proposed and developed herein.

Thesaurus Terms:
Acute;Address;Adhesions;Adhesives;Affect;Animal Model;Animal Models And Related Studies;Area;Back;Biliary Or Urinary Stones;Binding;Binding (Molecular Function);Biological;Biological Mimetics;Biomimetics;Body Tissues;Breathing;Calcanean Tendon;Calculi;Cells;Chronic;Communities;Development;Devices;Domestic Rabbit;Dorsum;Drug Formulations;Early Mobilizations;Environment;Evaluation;Fixation;Formulation;Frequencies (Time Pattern);Frequency;Future;Gfac;Government;Growth Agents;Growth Factor;Growth Substances;Healed;Incidence;Inflammatory;Inhalation;Inhaling;Injury;Ischemia;Marines;Medical;Medical Rehabilitation;Membrane;Metals;Methods;Modeling;Molecular Interaction;Mussels;Natural Regeneration;Operative Procedures;Operative Surgical Procedures;Orthopedic;Orthopedic Surgical Profession;Orthopedics;Oryctolagus Cuniculus;Ovis;Oxidants;Oxidizing Agents;Patients;Pattern;Persons;Phase;Physical Health Services / Rehabilitation;Polymers;Post-Operative;Postoperative;Postoperative Period;Procedures;Proteins;Proteins Growth Factors;Protocol;Protocols Documentation;Psychological Reinforcement;Qol;Quality Of Life;Rabbits;Rabbits Mammals;Recovery;Regeneration;Regimen;Rehabilitation;Rehabilitation Therapy;Reinforcement;Reinforcement (Psychology);Research;Respiratory Aspiration;Respiratory Inspiration;Rupture;Saline;Saline Solution;Secure;Sheep;Site;Staging;Sterilization;Stone;Stretching;Surface;Surgical;Surgical Interventions;Surgical Procedure;Surgical Sutures;Sutures;Techniques;Technology;Tendon Injuries;Tendon Structure;Tendons;Testing;Time;Timeline;Tissues;Achilles Tendon;Adhesive Polymer;Adhesive Protein (Mussel);Aging Population;Base;Biocompatibility;Biomaterial Compatibility;Cost;Developmental;Electron Acceptor;Experiment;Experimental Research;Experimental Study;Gene Product;Healing;Improved;In Vivo;Injured;Inspiration;Membrane Structure;Minimally Invasive;Model Organism;Mussel Glue Protein;Neglect;New Technology;Novel;Novel Technologies;Polyphenolic Protein;Population Aging;Regenerate;Rehabilitative;Repair;Repaired;Research Study;Sample Fixation;Scaffold;Scaffolding;Soft Tissue;Standard Of Care;Surgery