Abstract: Devices and methods for sterilizing lumens involve a booster that is attached to the lumen. In preferred embodiments, the contact area between the lumen and the booster enhances the penetration of an antimicrobial agent to the contact area.

Abstract: Devices and methods for sterilizing lumens involve a booster that is attached to the lumen. In preferred embodiments, the contact area between the lumen and the booster enhances the penetration of an antimicrobial agent to the contact area.

Abstract: A chemical indicator of an aurin moiety in a substrate to detect the presence of an oxidizing agent.

Abstract: Disclosed herein are methods of sterilizing a device in a sterilizer, methods of sterilizing a device in an enclosure in a sterilizer, and enclosures for retaining a device capable of being sterilized in a sterilization process. The sterilization process comprises hydrogen peroxide vapor or gas. The sterilization load may include an enclosure, which can be a tray or a container. The tray or container comprises at least a volume of aluminum oxide. The ratio of the amount of hydrogen peroxide gas or vapor introduced into the sterilizer to the volume of aluminum oxide is at least 24 mg/cm3.

Abstract: The invention provides a method for single-step surface modification, grafting and sterilization for bio-active coating on materials and biomaterials used in medical devices, such as catheters, tissue engineering scaffolds, or drug delivery carrier materials. This may include any medical device or implantable that could benefit from improved antithrombogenic and biocompatible surfaces. Other relevant device examples may include heparin or urokinase coated stents to reduce clotting and restenosis, dental or ophthamological implants. These materials may be comprised of a variety of polymeric compositions such as, polyurethane, polyester, polytetrafluoroethylene, polyethylene, polymethylmethacrylate, polyHEMA, polyvinyl alcohol, polysiloxanes, polylactic or glycolic acids, polycaprolactone, etc. The substrates can also be metal, ceramics or biologically derived materials.

Abstract: The invention provides a method for single-step surface modification, grafting and sterilization for bio-active coating on materials and biomaterials used in medical devices, such as catheters, tissue engineering scaffolds, or drug delivery carrier materials. This may include any medical device or implantable that could benefit from improved antithrombogenic and biocompatible surfaces. Other relevant device examples may include heparin or urokinase coated stents to reduce clotting and restenosis, dental or ophthamological implants. These materials may be comprised of a variety of polymeric compositions such as, polyurethane, polyester, polytetrafluoroethylene, polyethylene, polymethylmethacrylate, polyHEMA, polyvinyl alcohol, polysiloxanes, polylactic or glycolic acids, polycaprolactone, etc. The substrates can also be metal, ceramics or biologically derived materials.

Abstract: An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.

Abstract: A method monitors the concentration of an oxidative gas or vapor during a sterilization process in a sterilization chamber. A sensor formed of a chemical reactive with the oxidative gas or vapor coupled to a temperature probe is positioned inside of an enclosure containing an item to be sterilized. The enclosure is defined by a barrier impermeable to contaminating microorganisms and having at least a portion thereof which is permeable to the oxidative gas or vapor. The sensor is electrically connected through the barrier to contacts located exterior of the enclosure and connected to a control system thereby.

Abstract: Disclosed herein are methods of sterilizing a device in a sterilizer, methods of sterilizing a device in an enclosure in a sterilizer, and enclosures for retaining a device capable of being sterilized in a sterilization process. The sterilization process comprises hydrogen peroxide vapor or gas. The sterilization load may include an enclosure, which can be a tray or a container. The tray or container comprises at least a volume of aluminum oxide. The ratio of the amount of hydrogen peroxide gas or vapor introduced into the sterilizer to the volume of aluminum oxide is at least 24 mg/cm3.

Abstract: Devices and methods for sterilizing lumens involve a booster that is attached to the lumen. In preferred embodiments, the contact area between the lumen and the booster enhances the penetration of an antimicrobial agent to the contact area.

Abstract: A chemical indicator of an aurin moiety in a substrate to detect the presence of an oxidizing agent.

Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Abstract: A method for sterilizing the interior of the lumen, where a dry booster which does not contain liquid and which has a volume at least 2 times the volume of the lumen is attached to the end of the lumen. The lumen and dry booster are placed in a sterilization chamber, and germicide is introduced into the chamber. A higher pressure is created outside the booster than inside the booster. The empty dry booster draws germicide into the lumen, sterilizing the interior of the lumen. The method can be enhanced by reducing the pressure in the chamber before introducing the germicide.

Abstract: An apparatus for monitoring the concentration of an oxidative gas or vapor includes a first thermocouple junction and a chemical substance coupled to the first thermocouple junction. The chemical substance is reactive with the oxidative gas or vapor to produce heat. The apparatus further includes a second thermocouple junction coupled in series to the first thermocouple junction. A net voltage is generated across the first and second thermocouple junctions upon exposure of the chemical substance to the oxidative gas or vapor. The net voltage corresponds to the concentration of the oxidative gas or vapor.

Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Abstract: A method monitors a concentration of an oxidative gas or vapor in a diffusion-restricted region in fluid communication with a sterilization chamber during a sterilization process. The method includes providing a concentration monitor responsive to the oxidative gas or vapor by generating a parameter corresponding to the concentration of the oxidative gas or vapor. The concentration monitor includes a temperature sensing device coupled to a chemical substance reactive with the oxidative gas or vapor to produce heat. The method further includes placing at least a portion of the concentration monitor comprising the chemical substance within the diffusion-restricted region. The method further includes introducing the oxidative gas or vapor into the sterilization chamber. The method further includes monitoring the parameter generated by the concentration monitor during the sterilization process.

Abstract: A chemical indicator of an aurin moiety in a substrate to detect the presence of an oxidizing agent.

Abstract: An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.