Abstract: A sterilization process challenge device has a sterilization indicator contained within a container; and a variable diffusion restriction into said container.

Abstract: A sterilization process challenge device has a sterilization indicator contained within a container; and a variable diffusion restriction into said container.

Abstract: A sterilization process challenge device has a sterilization indicator contained within a container; and a variable diffusion restriction into said container.

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: A packaging enclosure for receiving a flexible endoscope during a sterilization procedure and sterile storage thereafter has a portion thereof which is semi-permeable. Provision is made for hanging the packaging enclosure over a hook or peg. In one embodiment the packaging enclosure conforms to the endoscope so that its two flexible portions may hang over opposite sides of the hook. Alternatively, a hook or aperture may be provided on the packaging enclosure for hanging it over the hook.

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: A packaging enclosure for receiving a flexible endoscope during a sterilization procedure and sterile storage thereafter has a portion thereof which is semi-permeable. Provision is made for hanging the packaging enclosure over a hook or peg. In one embodiment the packaging enclosure conforms to the endoscope so that its two flexible portions may hang over opposite sides of the hook. Alternatively, a hook or aperture may be provided on the packaging enclosure for hanging it over the hook.

Abstract: A sterilization process challenge device has a sterilization indicator contained within a container; and a variable diffusion restriction into said container.

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: An apparatus for monitoring the concentration of an oxidative gas or vapor includes a chemical substance which reacts with the oxidative gas or vapor to produce a heat change. A temperature probe is coupled to the chemical substance and adapted to respond to the heat change. The temperature probe can be coupled to the chemical substance by a carrier, and can include a reference temperature probe. Additionally, a method of using the apparatus is described, as well as a sterilization system which utilizes the apparatus.

Abstract: A monitor of the concentration of an oxidative gas or vapor comprises a chemical coupled to a temperature probe, such as by a carrier. Addtionally, the monitor is used in a method of monitoring the concentration of an oxidative gas or vapor and in a sterilization system operated by a user. By utilizing an output signal from the temperature probe to measure the heat produced in an exothermic reaction between the monitored oxidative gas or vapor and the chemical of the monitor, the concentration of the monitored oxidative gas or vapor can be determined. The present invention represents an improvement over the monitors described in the prior art since it is more simplified, and can provide information on the local concentration of an oxidative gas or vapor at various positions within a chamber, and can be operated in size-restricted volumes. Additionally, a method of using the monitor is described, as well as a sterilization system which utilizes the monitor.

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 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: An apparatus for monitoring the concentration of an oxidative gas or vapor includes a chemical substance which reacts with the oxidative gas or vapor to produce a heat change. A temperature probe is coupled to the chemical substance and adapted to respond to the heat change. The temperature probe can be coupled to the chemical substance by a carrier, and can include a reference temperature probe. Additionally, a method of using the apparatus is described, as well as a sterilization system which utilizes the apparatus.

Abstract: Medical instruments incorporating solid lubricants are shown to survive an oxidizing sterilization process if they employ solid lubricants free from disulfide and diselenide compounds such as molybdenum disulfide and the instrument is kept free from such compounds. PTFE, powdered graphite and boron nitride are preferred solid lubricants. Of particular importance are flexible endoscope employing solid lubricants on fiber optic bundles encased in elastomeric coverings.