| NSF Org: |
DMR Division Of Materials Research |
| Recipient: |
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| Initial Amendment Date: | August 10, 2020 |
| Latest Amendment Date: | May 17, 2023 |
| Award Number: | 2037636 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Nitsa Rosenzweig
nirosenz@nsf.gov (703)292-7256 DMR Division Of Materials Research MPS Directorate for Mathematical and Physical Sciences |
| Start Date: | September 1, 2020 |
| End Date: | August 31, 2024 (Estimated) |
| Total Intended Award Amount: | $100,000.00 |
| Total Awarded Amount to Date: | $100,000.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
2601 WOLF VILLAGE WAY RALEIGH NC US 27695-0001 (919)515-2444 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
1845 Entrepreneur Dr Raleigh NC US 27695-7115 |
| Primary Place of
Performance Congressional District: |
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| Unique Entity Identifier (UEI): |
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| Parent UEI: |
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| NSF Program(s): |
DMR SHORT TERM SUPPORT, BIOMATERIALS PROGRAM |
| Primary Program Source: |
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| Program Reference Code(s): |
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| Program Element Code(s): |
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| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.049 |
ABSTRACT
Non-Technical Summary:
This Scholar-in-Residence project will seek to better understand two new types of 3D printed bone replacements that are based on an inert bioceramic material, zirconia, and a biodegradable bioceramic material, calcium phosphate. Calcium phosphate is a compelling material for bone replacement implants (e.g., synthetic bone grafts) since it stimulates bone formation on the surface of medical device. A new type of calcium phosphate material will be 3D printed, which contains a gradient between (a) a form of calcium phosphate that rapidly releases bone-stimulating chemicals and (b) a form of calcium phosphate that can serve as long-lasting interface between an implant and the surrounding bone. Since zirconia surfaces with micro- and nano-roughened features exhibit better bone integration properties than smooth zirconia surfaces, a new type of patterned zirconia biomaterial will be created by 3D printing and laser texturing. A collaboration between NC State University and FDA researchers will seek to understand the relationships among the bioceramic processing parameters, physical properties, chemical properties, mechanical properties, and in vitro biological responses for the novel 3D printed ceramics. The results of this project will reduce knowledge gaps related to 3D printed ceramics and will lead to new types of synthetic bone grafts, which will provide an improved quality of life for patients who suffer from various orthopedic conditions. Science Saturday lectures and hands-on activities will disseminate results from the project to elementary school students, middle school students, high school students, and other visitors to the North Carolina Museum of Natural Sciences. Information on recent advances in medical 3D printing, including results from this project, will be disseminated to teachers across the state of North Carolina via an online workshop series.
Technical Summary:
The project will take advantage of the unique capabilities at NC State University related to processing and characterization of novel biomaterials and at the FDA related to biological characterization of novel biomaterials to systematically evaluate fabrication, post processing (e.g., patterning and sterilization), and the biological response to two new types of 3D printed bioceramics, patterned zirconia and functionally gradient calcium phosphate. Phase I of the project will involve understanding the physico-chemical properties of the 3D printed patterned zirconia and functionally gradient calcium phosphate parts. For example, scanning electron microscopy and atomic force microscopy will be used to assess the reproducibility and uniformity of the surface features of the 3D printed bioceramics. X-ray diffraction and X-ray photoelectron spectroscopy will be used to examine the microstructure and the presence of impurities in the 3D printed bioceramics, respectively. Phase II of the project will involve the use of nanoindentation and four-point bend testing to understand the mechanical properties of the 3D printed bioceramics. Phase III of the project will utilize FDA facilities to evaluate interactions between application-relevant cells (e.g., bone marrow stromal cells and osteoblast-like cells) and the 3D printed bioceramics through protein absorption, cell adhesion dynamics, cell morphology, cell proliferation, and osteogenic differentiation studies. This proposal is unique in that the PI team will systematically evaluate fabrication, post processing, material characteristics, mechanical properties, and biological response to two new types of 3D printed bioceramics. The data obtained in this Scholar-in-Residence project will be relevant to the development of 3D printed bioceramic medical devices and the improvement of international consensus standards that facilitate regulatory decision-making for 3D printed medical devices.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
PUBLICATIONS PRODUCED AS A RESULT OF THIS RESEARCH
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PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
The goals of this project involved understanding the physico-chemical, mechanical, and vitro biological characterization of ceramic parts.One study, which was entitled "Effect of Simulated Body Fluid Formulation on Orthopedic Device Bioactivity Assessment," which published in the Journal of Biomedical Materials Research Part A (DOI: 10.1002/jbm.b.35207). This study examined the exposure of Bioglass® (45S5 and S53P4) and non-bioactive Ti-6Al-4V to formulations of simulated body fluid that varied in terms of calcium ion and phosphate levels in addition to supporting ion concentrations. Scanning electron microscopy and X-ray powder diffraction were used to study the hydroxyapatite layers; these materials characterization studies indicated that the simulated body fluid enriched using double or quadruple the calcium and phosphate ion concentrations enhanced the hydroxyapatite crystal size and quantity when compared with the standard formulation; in addition, these formulations can induce hydroxyapatite crystallization on non-bioactive surfaces. Modifying the levels of other ions, including bicarbonate, changed the induction time, morphology, and quantity of the hydroxyapatite. This study showed that the test parameters should be appropriately considered to more carefully understand bioactivity performance.
In another completed study (DOI: 10.1016/j.pnsc.2020.10.001), direct ink writing was used to prepare woodpile constructs using composites that contained polycaprolactone and polyethylene oxide. The addition of polyethylene oxide to polycaprolactone was noted to increase the roughness and wettability of the scaffolds. This study showed the use of direct ink writing-based 3D printing of ceramic scaffolds for tissue engineering.
In another study, hydroxyapatite with a weight ratio of 55-85% was incorporated within an ink containing polycaprolactone and polyethylene oxide (DOI: 10.1111/jace.18048). The elastic modulus values of these scaffolds were noted to be in the range of 4 to 12 MPa. More marked shear-thinning behavior was noted via an increase in the concentration of hydroxyapatite. The scaffold containing hydroxyapatite weight ratio of 65% had better wettability and higher mechanical properties than the other scaffolds. In addition, vancomycin was used as a model drug; this drug was successfully encapsulated in the composite scaffold. In vitro drug release studies showed that the vancomycin-loaded scaffold was capable of releasing vancomycin. This study offers a new feedstock material for 3D printing scaffolds with antibacterial activity for bone tissue engineering.
In another study, a biocomposite was created with hydroxyapatite and Au/Ag nanoparticles (DOI: 10.1557/s43578-023-01132-4). The addition of Au/Ag NPs was noted to significantly enhanced the mechanical properties of hydroxyapatite. The viability of gram-positive Staphylococcus aureus bacteria and gram-negative Escherichia coli bacteria was noted to be inhibited by the biocomposite surfaces. Cell studies using commercially-purchased cells showed that the cell proliferation rate was greater for hydroxyapatite-Au/Ag nanoparticles than for pure hydroxyapatite. It is hoped that this material can be used as a feedstock material for 3D printing in future studies.
Understanding the material performance and biocompatibility issues associated with 3D printed bioceramic parts will aid the Food & Drug Administration in regulatory decision-making and the medical device industry in enhancing the functionality of commercially-distributed medical devices.
Last Modified: 09/08/2024
Modified by: Roger J Narayan
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