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SBIR Phase I:Design and Development of Minimally-Invasive Orthopedic Fracture Fixation Using Intramedullary Sleeve and Injectable, Light-Triggered Bone Cement

Award Information
Agency: National Science Foundation
Branch: N/A
Contract: 2322411
Agency Tracking Number: 2322411
Amount: $273,563.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: BM
Solicitation Number: NSF 23-515
Timeline
Solicitation Year: 2023
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-10-01
Award End Date (Contract End Date): 2024-09-30
Small Business Information
2820 E Fort Lowell Rd
Tucson, AZ 85716
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Krishna Kolan
 (520) 292-3109
 krishna@medicarbone.com
Business Contact
 Krishna Kolan
Phone: (520) 292-3109
Email: krishna@medicarbone.com
Research Institution
N/A
Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the current challenges associated with an increase in the incidence of orthopedic injuries and surgeries.The technology will stabilize and repair broken bones in the US and globally. Trauma, degenerative bone diseases, and bone tumors often result in broken bones that require a procedure called intramedullary nailing. Intramedullary nailing involves nailing metallic implants to bones stabilize bone fractures. This procedure often results in complications such as infection, rotated limbs, and failure to achieve complete rigidity, which may eventually lead to patient discomfort and significantly increased costs due to revision surgeries. Consequently, there is an urgent need for an intramedullary nail technology that is less invasive, cost effective, and customizable to the patient’s anatomical requirements to enable improved bone fracture healing and avoid burdensome revision surgeries. When additional corrective surgery is required to treat any post-operative infections or surgical placement mistakes, the implant removal should be less invasive and not cause any additional morbidity. There are currently no such proven technologies available that meet the above criteria._x000D__x000D_
This project will primarily focus on the development of an intramedullary (IM) sleeve system with an in situ, photocurable, and removable polymeric resin system. There are four main objectives: 1) design and development of a multi-layered IM sleeve prototype, 2) synthesis and optimization of am in situ photopolymerizable polymeric resin system in the IM sleeve, 3) removal of the cured polymeric resin system from the IM sleeve using minimally invasive tools and methods, and 4) in vitro, in vivo biocompatibility, and demonstration of the customized IM prototype device in a sheep cadaveric tibia bone. The research will generate new knowledge in designing and synthesizing a novel polymer formulation with additives that helps in fast setting with improved mechanical properties.The project will also enable extraction of photocured polymers using existing removal technologies. For physicians, this research could result in novel, minimally invasive treatments that could drastically reduce the surgical time and improve the patient recovery times._x000D_
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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.

* Information listed above is at the time of submission. *

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