SBIR-STTR Award

Sterilization of Medical Devices with Atmospheric Plasma
Award last edited on: 10/16/07

Sponsored Program
SBIR
Awarding Agency
NIH : NIGMS
Total Award Amount
$938,379
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Kimberly Kelly-Wintenberg

Company Information

Atmospheric Glow Technologies Inc (AKA: TICE Corporation~AGT)

924 Corridor Park Boulevard
Knoxville, TN 37932
   (865) 777-3776
   awintenberg@atmosphericglow.com
   www.a-gtech.com
Location: Single
Congr. District: 02
County: Knox

Phase I

Contract Number: 1R43GM062678-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2001
Phase I Amount
$100,000
Atmospheric Glow Technologies, Inc. will investigate the efficacy of the patented One Atmosphere Uniform Glow Discharge Plasma (OAUGDP) in sterilizing medical devices and instruments. The OAUGDP has been shown to sterilize various surfaces against a number of microorganisms including viruses and spores. The use of atmospheric plasma to sterilize/decontaminate medical devices is, therefore, a new application of a proven baseline technology. Our goal is to develop and fabricate a prototype that will be commercially viable. We propose to inoculate stainless steel conventional surgical instruments with vegetative bacteria or spores and assess the conditions required to achieve sterilization of these devices. Currently available sterilization technologies have failed to consistently demonstrate sterilization success in rigid narrow-lumened instruments particularly against a challenge of organic debris. For this reason, we also propose to investigate the ability of OAUGDP to sterilize conventional and rigid lumened devices in the presence and absence of a protein and salt challenge. Preliminary evaluation of instrument surface changes will be made using SEM. Phase II work would include sterilization of flexible lumens, toxicity studies on potential instrument residues and further examination of any instrument surface alterations. Phase II efforts would also involve characterizing the active species generated by the OAUGDP. PROPOSED COMMERCIAL APPLICATION: The OAUGDP technology is a new sterilization/decontamination process. Samples are sterilized within seconds to several minutes at room temperature, without production of harmful byproducts or batch processing. The technology is relatively inexpensive and can be engineered in several configurations. Such a device would fulfill a market niche in hospitals, physician and dental offices, to name a few.

Phase II

Contract Number: 2R44GM062678-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2004
(last award dollars: 2006)
Phase II Amount
$838,379

The sterilization of complex medical devices is difficult due to narrow channels and the presence of optics and electronics. Atmospheric Glow Technologies will develop the Steriglow 210 for room temperature sterilization of these devices using the One Atmosphere Uniform Glow Discharge Plasma. Phase I work demonstrated the ability to neutralize 6 logs of resistant Bacillus endospores following a 4 minute exposure to the antimicrobial reactive species present in the exhaust from plasma devices. Recent advances by AGT have reduced that time to 2.5 min and the temperature to 25 degrees C, conditions that are certainly well-suited for the sterilization of complex medical devices. Tasks to be undertaken during this proposed work effort focus on characterizing the population of reactive chemical species present in the plasma exhaust both qualitatively and quantitatively. Additional studies will be performed to validate the broad-spectrum efficacy and consistency of the Steriglow 210 using ASTM and AOAC standard methods. In-depth materials studies as well as in vitro and in vivo biocompatibility assays will be undertaken to ensure the compatibility of our process with healthcare applications