A Photochemically 3D Printed High-Resolution Biodegradable Suture Retention Clip

Abstract: The goal of this SBIR Phase I project is to demonstrate the feasibility of creating a 3D printed, biosynthetic Pronged Anchor-Clip to overcome the problems associated with large suture knots (knots from #5 suture, tape suture, and mesh suture). Currently large suture knots risk skin erosion, palpability, pain, scarring, infection, and may even require re-operation for suture abscess. Replacing a knot with a much smaller device that has a similar surface area as a knot but a much smaller volume without interstices for bacterial growth and a better safety profile would have a significant impact in Surgery. Large sutures are typically used for tendon repair in thin skinned areas such as achilles, rotator cuff, or knee, and for abdominal wall reconstruction. Compared to competing anchoring technologies (e.g. staple, corkscrew, tack, and strap) the Pronged Anchor- Clip has several advantages: it withstands soft-tissue loads exceeding the strength of competing devices and the Pronged Anchor-Clip does not injure fascia when applied. The Pronged Anchor-Clip is easier and faster to apply than tying a knot, and its intuitive design fits easily into clinical practice. In addition to the surgical benefits of the project, we will create the first commercial biodegradable high- resolution medical device manufactured by 3D printing. The proprietary co-crosslinker used in this proposal will create a novel PPF resin that can then be 3D printed through digital light processing. This revolutionary new PPF material can be used to create medical devices with micro-features that will eventually be resorbed by the body. This would be unlike any other 3D printed biomedical device. Through our multi-disciplinary collaboration, we will: optimize PPF formulations for 3D printing and confirm design thresholds for the Pronged Anchor-Clip are met; characterize the 3D printed PPF Pronged Anchor-Clips in benchtop testing for: mechanical properties; in vitro degradation rates; potential for infection; and clinically relevant suture retention performance in cadaver tissue models; and lastly, demonstrate PPF Pronged Anchor- Clips respond appropriately for bioincorporation, inflammation, and in vivo degradation in swine relative to a predicate device, per FDA guidance document ISO 10993. At the completion of this proposal we will have established manufacturing and performance proof points; demonstrating the PPF Pronged Anchor-Clip is superior to a bulky knot. In a follow-on Phase II SBIR submission, we will complete validation and verification testing, packaging and sterilization, toxicity testing, ISO 10993-Biological Evaluation of Medical Devices testing and a chronic swine study for FDA 510(k) clearance of the class II device. Development of a biodegradable fixation device with enhanced anchoring strength and reduced inflammation is urgently needed in the field of soft-tissue repair and the proposed material has broader implications in the field of implantable devices.Project Narrative Hernia occurrence and recurrence and tendon reconstruction are major medical problems that affect hundreds of thousands of patients per year in the United States and cost billions of dollars annually. Broad suture (e.g. #5 suture, tape suture, and mesh suture) are commonly used in repairs but require large knots which are susceptible to pain, infection, foreign body response, and palpability. DBMA, Inc. proposes to develop a small biosynthetic Pronged Anchor-Clip to overcome the need for large knots.