2. • The Baby Boomers (~75 million
Americans)
• The average baby boomer will be 65 by
the year 2020
• Osteoporosis
• 55% of people currently 50 years old
have low bone mass or Osteoporosis
• Osteoporosis causes 1.5 million fractures
a year
Curry, Linda C., Mildred O. Hogstel, Pamela J. Frable, and Charles Walker. "Bone Health Among Aging Baby Boomers.“ Internet Scientific
Publications. N.p.,n.d. Web. 09 Dec. 2014.
3. • Current bone grafting techniques require donor tissue
• New products (INFUSE®, Amplify®) use BMP-2
• Complications with holding BMP-2 together, burst release
• In a study of 151 patients who underwent spinal fusions using Infuse, 35 had
complications due to the high dosage use
• Bioventus solution: Hydrogel molds + Calcium Phosphate
granules + BMP-2
• Only problem is the homogenous
mixing of these components
Shields, Lisa, George Raque, Steven Glassman, Mitchell Campbell, Todd Vitaz, John Harping, and Christopher Shields. "Adverse Effects
Associated With High-Dose Recombinant Human Bone Morphogenetic Protein-2 Use in Anterior Cervical Spine Fusion." Adverse Effects
Associated With High-Dose Recombinant Human... : Spine. Spine, 1 Mar. 2006. Web. 02 Oct. 2014.
4. • Primary Concept
• Pros:
• Easily packaged
• Simple procedure
• Most promising design
• Cons:
• Small amount of waste
• Forces could shear gel
5. • Pros:
• Simple procedure
• No gel shearing
• Cons:
• No real mixing agent
6. • Pros:
• Simple procedure
• Cons:
• Low reproducibility
• Rotational forces could sheer gel
9. 1. Generate device concepts
• Completed
2. Evaluate designs through modeling and testing
• Computational modelling
• 3D printing prototypes
• Hydrogel characterization, Mechanical properties, Protein/Granule
uniformity using microscopy, and Preservation of bioactivity
3. Optimize device and procedure
• Reproducibility, Low cost, Ease of use
• *Incorporate porosity in mold for increased efficacy*
10. • Computational Modeling (Ansys Fluent)
• Hydrogel Characterization
• 3D printing prototypes
• Fluorescent Microscopy
• 5 μm thick slices taken at several points along length of mold
• BMP-2 Stained with fluorescently tagged antibody for viewing
• Comparative image analysis to ensure
uniformity (<10% deviation)
• Calcium phosphate granules also quantified
and compared between regions (<10%
deviation)
11. • Test for bioactivity preservation of BMP2 in final mold
• Test for mechanical uniformity of mold
• Optimization
• Simplify procedure
• Determine cost effective/biocompatible
materials
• Reproducibility
• Repeat experiments for statistical significance, consistency
• *Porosity within the mold*
12. • Device will be:
• Easy to use
• Cheap
• Disposable/Sterile
• Procedure will be:
• Highly repeatable
• Few steps
• Final mold will be:
• Homogenously mixed so that:
• BMP-2 evenly distributed throughout
mold and on granules (<10% deviation)
• Granules uniform throughout mold (<10%
deviation)
• Mechanical properties uniform (<10%
deviation)
• Preservation of BMP-2 bioactivity
within mold (pass/fail)
• *Porosity for blood vessel
penetration*
13. Task Completion Date Progress
Research Prior Art October 15th Completed
Create Concepts November 1st Completed
3D Render Concepts December 1st Completed
Characterize Hydrogel February 1st In Progress
Computational Modeling February 15th In Progress
Prototype Concepts February 15th In Progress
Fluorescence Microscopy March 15th Not Completed
MechanicalTesting March 15th Not Completed
Bioactivity Testing March 15th Not Completed
Repeatability April 1st Not Completed
Materials Research April 15th Not Completed
Procedure Optimization April 15th Not Completed
Incorporate Porosity* April 15th Not Completed
14. •Chris, Eric and the Bioventus team for their advice and
resources
•Dr. Xin Brown for her help with the TA AR 2000
Rheometer
•Dr. Phil Allen training us on some of the basics of
fluorescent microscopy
