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Low temperature plasma sterilizing system and method

Organization:Gestion Univalor, Limited Partnership, Quebec, CA
I.P. Brief:System and method for sterilizing objects, in particular medical instruments and accessories, using gas plasma, also called ionized gas. The system and method provide the advantage of making it possible to treat heat-sensitive and thermolabile objects at temperatures less than 50°C using gases presenting no risks for the operator.
Summary of I.P.:The sterilization and the disinfection of medical devices (MD) play a major part in the control of the transmission of infectious diseases. However, the current MD sterilization techniques encounter several issues: 1) Most of them damage plastic MD; 2) flexible endoscopes can be highly disinfected but not sterilized; 3) they do not eliminate the prions, infectious agents responsible for the Creutzfeldt-Jakob disease. Gas plasma process (ionized gas) addresses theses issues it uses mechanisms combining the action of radiation UV and that of radicals (as oxygen) chemically reactive components. Target customers are hospital, private or public medical centers, dental medical centers. The incentive for the development of new sterilization techniques are: • Shorter sterilization cycles to maintain lowest level of instruments inventories; • More complex MD, especially related minimal intrusive procedures; • The advent of more severe standards and regulations, as regards to sterilization itself (prions, bio-films) as well as the potential exclusion of chemicals used within current processes; • The growing number of private clinics and medical center, leading to new markets; • The policy towards the management of medical care expenditures; • The incidence and the cost of nosocomial infections which give to sterilization a growing interest.
Patent:US 6,707,254: Low temperature plasma sterilizing system and method (Patent filed as well in other countries);
Keywords:Sterilization, Disinfection, Inactivation, Hospital, infectious_agents, Prion, Creutzfeldt-Jakob_disease, Plasma
Primary Industry:Health & Medical Devices
Specific Market:Worldwide Sterilization and Disinfection markets.
Market Size:The disinfection and the sterilization of MD is a billion dollar, with a 4% CAGR. This growth will be stimulated by the advent of new technologies enabling inactivation of non-conventional infectious agents, (prions), offering an efficient solution for t
State of the Art:Currently, sterilization is obtained by several processes : • High temperature and pressure (wet or dry autoclaves); • Chemical sterilization, with low temperature treatment (EtO, Ozone); • Gamma based processes. None of these processes offer a solution for below 50 minutes and below 50ºC, while being effective for sterilization.
Competition:The development of highly sophisticated medical processes using small devices, with hollow parts and partly made of plastics combined with the risk related to the Creutzfeldt-Jakob disease put a pressure on the develop of new technologies (such as Ozone types technologies) as well as improving current well-known techniques.
Figures of Merit:To our knowledge, this technology is the only one offering a potential solution to effective sterilization of MD, including prions issues, and addressing current needs (short cycle, non-damaging, hollow parts and treatment through packages). In addition, this concept proven technology comes along with a deep knowledge of sterilization mechanisms.
Tech.  Obstacles:- Integration (Integration of the know-how and IP into an attractive product addressing markets needs. Current goals is below 30 minutes sterilization cycle; - Extend the performances of the process: o Sterilization of MD through packages; o Sterilization of catheter types MD (having hollow parts); o Potential inactivation of prions.
Market Obstacles:Most of the commercial challenges are linked with our technical challenges : - Derive the technology into a range of products that could meet customers expectations, especially in term of price since a “one fits all” product shall not be compatible with the industry targeting - Being able to prove added-value over current technologies, not only by providing incremental advantages but offering a platform to revolutionize the industry; - Acceptance of the market since we see that while new technologies are developed, older processes such autoclave and EtO still dominate the market; - Standardization is mostly to be the highest barrier to entry, especially if the process confirms the potential inactivation of prions, meaning new standard will have to be presented to the market; - Finally, customers are various and depending on their geographic localization, pressures on medical care expenditures are so high that the commercial deployment will have to be adapted.
Patent Landscape:This technology is currently protected through 3 different patents: - US 6,707,254: Low temperature plasma sterilizing system and method (Patent filed as well in other countries); - US 2005/0158206: Processes and devices for sterilizing contaminated objects (patent filed as well in other countries); - US 11/142,904: Process for the plasma sterilization of dielectric objects comprising a hollow part (patent filed as well in other countries)
Publications:The first patent (US 6,707,254) is considered to pioneer the new sterilization industry. - M. Moisan, \"Recent development in the application of microwave discharges to sterilization of medical devices\", Invited paper, 5th International workshop on microwave discharges, Zinnowitz (Greifswald, Germany) (July 2005), Proceedings of the conference, pages 210-221. - M. Moisan, J. Barbeau, M.-C. Crevier, J. Pelletier, N. Philip, B. Saoudi, “Plasma sterilization: methods and mechanisms”, Pure and Applied Chemistry, 74, 349-358 (2002) - N. Philip, B. Saoudi, M. C. Crevier, M. Moisan, J. Barbeau, J. Pelletier, \"The respective roles of UV photons and oxygen atoms in plasma sterilization at reduced gas pressure : the case of N2-O2 mixtures\", IEEE Transaction on Plasma Science, 30, 1429-1436 (2002). - M. Moisan, J. Barbeau, S. Moreau, J. Pelletier, M. Tabrizian, L’H. Yahia, ″Low-temperature sterilization using gas plasmas : a review of the experiments and an analysis of the inactivation mechanisms″, International Journal of Pharmaceutics, 226, 1-21 (2001).
Research Team:Professor Moisan is a specialist in physics of plasma gases, who initiated the Sterilization activity at Université de Montréal in 1998. Jean Barbeau is a microbiologist specialized in sterilization, managing the Microbiology and Infection Control Laboratory. Bachir Saoudi is a research professional specialized in bio-surfaces interactions.

 

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