SBIR-STTR Award

An absorbable monofilament suture will be prepared from a biomaterial known as poly-4-hydroxybutyrate (P4HB). The P4HB will be derived using a genetically engineered fermentation system that is based on a class of natural polyesters, known as PHAs (or polyhydroxyalkanoates). This fermentation system is ideally suited for the production of P4HB based polymers. The new suture will be prepared by melt extrusion and is anticipated to have better handling properties than the existing monofilament sutures, and a longer retention of strength. The latter is expected to allow the use of a monofilament absorbable suture for patients previous requiring long-term wound support with a non- absorbable suture for patients with conditions that compromise wound healing, such as malignancy, compromised immune system, obesity, nutritional impairment, and diabetes. It may also be useful in the treatment of orthopedic patients and for fascia closure. The specific aims of this research are to: (1) produce the biomaterial P4HB, (2) prepare sutures/fibers of P4HB, (3) characterize the P4HB sutures, and (40 determine the break the break strength retention of the sutures in vivo as well as tissue reaction and the absorption rate. PROPOSED COMMERCIAL APPLICATIONS: The research will provide a new monofilament fiber that will be used in the development of bioabsorbable, medical products, such as sutures, tissue engineering scaffolds, surgical meshes and fabrics.

Thesaurus Terms:
biodegradable product, biomaterial development /preparation, biomaterial evaluation, polymer, surgery material /equipment biomaterial interface interaction, chemical structure, tensile strength, wound healing laboratory rabbit

The objective of this research is to develop a monofilament absorbable suture with a 50% retention of strength three months after implantation. This product is expected to meet an unmet need in the suture market for a device that can provide longer term wound support. Such a product could be used in the treatment of patients with diabetes, compromised immune systems, nutritional impairment, obesity, or conditions that compromise wound healing such as malignancy or infection. The suture is also expected to find application in fascia closure, and in orthopedic procedures for ligament and tendon repair. The approach involves the use of a new proprietary absorbable biomaterial known as poly-4-hydroxybutyrate (P4HB). The specific aims of the project are to: (1) produce an extrudable form of P4HB; (2) optimize the production of a monofilament of P4HB; (3) prepare sutures of P4HB; (4) characterize the P4HB suture properties; (5) determine the in vivo strength retention of P4HB; (6) develop an in vitro model for P4HB strength retention; (7) evaluate the suture's biocompatibility; (8) demonstrate the surgical functionality of the P4HB suture; (9) analyze the biodistribution and pharmacokinetics of P4HB; and (10) determine the suture stability and shelf life. In addition to developing a useful new product, the research is also expected to assist in the introduction of a new medical biomaterial that is expected to have application in other medical devices, such as surgical meshes, tissue engineering scaffolds and drug release matrices.

Thesaurus Terms:
biodegradable product, biomaterial development /preparation, biomaterial evaluation, polymer, surgery material /equipment, tissue engineering biomaterial interface interaction, chemical structure, polyhydroxy compound, tensile strength, wound healing bioengineering /biomedical engineering, laboratory rabbit