SBIR-STTR Award

Field Medical Sterilizer to be used in Austere Environments
Award last edited on: 12/10/2008

Sponsored Program
SBIR
Awarding Agency
DOD : Navy
Total Award Amount
$820,000
Award Phase
2
Solicitation Topic Code
N06-075
Principal Investigator
Gary L Moore

Company Information

Phygen Inc (AKA: Phygen Coatings Inc)

1400 Marshall Street NE
Minneapolis, MN 55413
   (888) 749-4361
   tech@phygen.com
   www.phygen.com
Location: Single
Congr. District: 05
County: Hennepin

Phase I

Contract Number: N00014-06-M-0301
Start Date: 8/7/2006    Completed: 5/7/2007
Phase I year
2006
Phase I Amount
$70,000
The current Navy steam autoclave used in the field is large, heavy, and obsolete. Spare parts are no longer available and it is not suited to today's austere environments. Replacing the autoclave sterilizer with a device using a similar means of sterilization will not meet the requirements of modern Medical Devices used for new surgical and exploratory procedures because these devices are constructed of materials that cannot tolerate 120 to 130 C temperatures. The autoclave is minimally portable because of heavy chamber design materials and the volume and weight of water required. The replacement device sterilizes using Low Temperature Discharge Plasma and requires only several milliliters of peroxide for each cycle versus approximately five gallons of distilled water with the autoclave. Power consumed by the replacement device is expected to require approximately 8 to 15% of that required by the autoclave and uses single phase 120/220 VAC or 24 to 28 VDC versus three-phase 220 VAC power. Sterilization occurs at ~55C over a period of 38 to 58 minutes. Weight can be reduced by 50 to 70%, based on final user requirements, resulting in at least a two fold portability improvement.

Benefits:
As a replacement for the Steam Method of sterilization, particularly in austere environments, Low Temperature Plasma Sterilization is ideal. The elimination of the need for water is one of the primary advantages over the current autoclave, and provides for reduced size and weight, increased ease of transportability, shorter set-up times and significantly less power consumption. In addition, Low Temperature Plasma Sterilization enables a broader range of heat sensitive materials and devices to be sterilized and provides a much safer environment for operators using the machine and touching sterilized product or chamber surfaces. Phygen will position the Plasma Sterilization Device as the “next generation solution” for medical sterilization. Commercial market applications that Phygen will pursue include: • Military field applications and base hospitals • Emergency response and disaster recovery applications • Inpatient hospitals • Outpatient surgical facilities and medical clinics • Medical device and instrument manufacturers • Reprocessors - third-party service companies that sterilize for reuse both multiple-use and single-use medical instruments.

Keywords:
Medical, Sterilization, Plasma, Discharge, Portable, Austere, Low-Temperature, Peroxide

Phase II

Contract Number: N00014-08-C-0140
Start Date: 2/19/2008    Completed: 7/31/2009
Phase II year
2008
Phase II Amount
$750,000
The current Navy steam autoclave used in the field is large, heavy, and obsolete. Spare parts are no longer available, and it is difficult to use in austere environments. Replacing the autoclave sterilizer with a device using a similar means of sterilization will not meet the requirements of modern medical devices used for new surgical and exploratory procedures because these devices are constructed of materials that cannot tolerate 120 to 130 C temperatures. The autoclave is minimally portable because of heavy chamber design materials and the volume and weight of water required. The replacement device sterilizes using low temperature discharge plasma and requires only several millileters of hydrogen peroxide for each cycle versus approximately five gallons of distilled water with the autoclave. Power consumed by the replacement device is expected to require approximately 15% of that requried for the autoclave and uses single phase 120/220 VAC or 24 to 28 VDC versus three-phase 220 VAC power. Sterilization occurs at ~55C over a period of less than one hour. Weight can be reduced by approximately 50%, depending on final user requirements, resulting in signficant portability improvements.

Keywords:
Medical, Sterilization, Plasma, Discharge, Portable, Austere, Low-Temperature, Peroxide