Non-Union Fracture Repair System

Transcription

1 Non-Union Fracture Repair System Nicholas Calistri, Aimon Iftikhar, Yvonne Nanakos, and Kelly Stratton Team 21 Client: Dr. Yusuf Khan, Institute for Regenerative Engineering Faculty Advisor: Dr. Gielo-Perczak December 5, 2012

2 Background 10 % of all fractures can be classified as non-union 80% of non-union fractures heal after the first operation, but the success rate with subsequent surgeries is less Of the 6,000,000 estimated bone fractures that occur in the US each year, approximately 300,000 will be non-union Traditional solutions: autografts, allografts, and xenografts Figure 1: Nonunion fracture Figure 2: Nonunion fracture Xray 2

3 Background: Other Designs Patent search resulted in 0 identified product matches Only 3 Similar Products Found The U.S. CMF OL1000 Bone Growth Stimulator Smith & Nephew Exogen U.S. DBX Bone Graft Substitute Figure 3: U.S.CMF OL 1000 Bone Growth Stimulator Figure 4: Exogen Bone Healing System Figure 5: U.S. DBX Bone Graft Substitute 3

4 Client Statement This project is designing a non-union fracture repair implant system that can be seeded with an individual's own cells and injected into the fracture site. 4

5 Design Process Client-Modified Request Figure 6: Part one of the flow chart detailing components of the Non-Union Fracture Repair System 5

6 Design Process, cont. Design Methodology Figure 7: Part two of the flow chart detailing design methods of the Novel Fracture Repair System 6

7 Testing with the TX Instruments H3 Rheometer Rheology - the study of the flow of matter (in response to a force) Elastic Modulus Graph 1: Storage modulus over time Figure 15: Texas Instruments for 0.1% collagen H3 Rheometer 15

8 Stimulation by Ultrasound Ultrasound frequency is used to stimulate the cells in the scaffold and enhance bone growth at non-union fracture sites Figure 16: Ultrasound setup containing waveform generator, power amplifier, and transducer Figure 17: Transducer head used in the ultrasound setup 16

9 Budget Total Hydrogel Scaffold Construction: $690 Use of Ultrasound setup for 1 Hour: ~ $2 Total Cost: $692 18

10 Impacts Economic: Affordable Manufacturing: Easy to Construct Ethical and Health/Safety: Proper Disposal 19

11 Conclusions Final product is the injectable scaffold as a component of a non-union fracture repair system. Less-invasive, biocompatible approach to mechanically stimulate bone growth in non-union fractures. 20

12 Future Directions - Further testing of mechanical properties - Quantification of deformation (Volocity) - Manufacturing of non-union fracture repair system - Mass producing of system - Marketing of system to medical device companies 21

13 Acknowledgements We would like to thank -Dr. Yusuf Khan -Dr. Krystyna Gielo-Perczak -Sarah Brittain -James Veronick -Craig Hanna for their assistance in developing our project. 22

14 Thank You! Questions?

15 References [1] Khan Y, Laurencin CT. Fracture Repair with Ultrasound: Clinical and Cell-based Evaluation.J Bone Joint Surg Am Feb;90 Suppl 1: [2] Elisseeff J, Sharma B, Puleo C, Yang F. Advances In Skeletal Tissue Engineering With Hydrogels. Orthod Craniofacial Res April; [3] Sharma B, Elisseeff JH. Engineering structurally organized cartilage and bone tissues. Ann Biomed Eng 2004;32: [4] DBX Bone Graft Substitute (2007). [Brochure]. MTF: Musculoskeletal Transplant Foundation. [5] CMF OL1000 Bone Growth Stimulator (2007). [Brochure]. DJO Incorporated [6] Annalia Asti, Giulia Gastaldi, Rossella Dorati, et al., Stem Cells Grown in Osteogenic Medium on PLGA, PLGA/HA, and Titanium Scaffolds for Surgical Applications, Bioinorganic Chemistry and Applications, vol. 2010, Article ID , 12 pages, (2010). [7] Karageorgiou, Vassilis, Kaplan, David, Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, vol. 26, Issue 27, (2005): [8] Texeira, S., Pena, R., De Aza, A.H., De Aza, S., Ferraz, M.P., Monteiro, F.J., Physical characterization of hydroxyapatite porous scaffolds for tissue engineering. Materials Science and Engineering, vol. 29, Issue 5, (2009): [9] Ramay, H., Zhang, M., Preparation of porous hydroxyapatite scaffolds by combination of the gel-casting and polymer sponge methods. Biomaterials, vol. 24, Issue 19, (2003): [10] Gervaso, F., Scalera, F., Kunjalukkal Padmanabhan, S., Sannino, A. and Licciulli, A., High-Performance Hydroxyapatite Scaffolds for Bone Tissue Engineering Applications. International Journal of Applied Ceramic Technology, (2012): [11] West, Erin R., Min Xu, Teresa K. Woodruff, and Lonnie D. Shea. "Physical Properties of Alginate Hydrogels and Their Effects in Vitro Follicle Development." Biomaterials 39th ser. 28 (2007): [12] Cancan Xu, Wei Lu, Shaoquan Bian, Jie Liang, Yujiang Fan, and Xingdong Zhang, Porous Collagen Scaffold Reinforced with Surfaced Activated PLLA Nanoparticles, The Scientific World Journal, vol. 2012, Article ID , 10 pages, 2012 [13] Function Generator: PI Roseville: PASCO Scientific, PASCO, 9. 23