Disclosed herein are sterilized medical coiled tubing and process for producing the same. One process comprises: helically winding a length of the medical tubing along a mandrel such that adjacent turns of the medical tubing are in contact with each other; applying solvent where the turns of the medical tubing contact each other to produce coiled medical tubing; allowing the solvent to dry; removing the medical tubing from the mandrel after the solvent has dried; and subjecting the medical tubing to a sterilization process using ethylene oxide with in-chamber aeration.

A system and method for recovering a sterilization agent from waste gaseous mixture, comprising a gas separator to wash waste gas comprising a gaseous mixture of a sterilization agent, insert dilution gases, and water vapor, from plurality sterilization chambers, with water, thereby producing a water-gaseous sterilization agent mixture collected at bottom section of the gas separator, and inert dilution gases exhausted at top section of the gas separator; a pressure reducing valve; a first tank or gas evaporator to produce gaseous sterilization agent and water vapor; a first condenser to produce condensed water vapor and separate the gaseous sterilization agent from the condensed water vapor; a water tank to receive the condensed water vapor; a separation pump for raising pressure of the gaseous sterilization agent; a second condenser to cool the gaseous sterilization agent causing the sterilization agent to condense into liquid; and a second tank for storing the liquid sterilization agent.

Disclosed herein are sterilized medical coiled tubing and process for producing the same. One process comprises: helically winding a length of medical tubing along a mandrel such that adjacent turns of the medical tubing are in contact with each other at tubing contact points; applying a UV adhesive to the tubing contact points to produce a medical coiled tubing; curing the tubing by applying UV light to the tubing contact points; and removing the medical tubing from the mandrel after the solvent has dried.

The present invention relates to a method for treating biological tissue and a biological tissue obtained by the treatment method, and specifically to a method for treating biological tissue so as to suppress the calcification, risk of biofilm adherent over pericardium and strength reduction of the tissue due to treatment. The invention is also directed to bioprosthesis and transcatheter heart valves containing the biological tissue.

The present invention provides a cartridge used for a sterilization device. The cartridge comprises a sterilant container configured to contain a sterilant used for sterilization and an injector receiving the sterilant contained in the sterilant container through the sterilization device and delivering the sterilant to an article to be sterilized.

Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

Compositions, devices and processes related to etching of a very thin layer or fine particles of a metal are disclosed for monitoring a variety of parameters, such as time, temperature, time-temperature, thawing, freezing, microwave, humidity, ionizing radiation, sterilization and chemicals. These devices have capabilities of producing a long and sharp induction period of an irreversible visual change. The devices are composed of an indicator comprising a very thin layer of a metal (e.g., polyester film having an extremely thin, e.g., about one hundred Angstroms layer of aluminum) and an activator, e.g., a reactant, such as water, water vapor, an acid, a base, oxidizing agent or their precursors, which is capable of reacting with the said indicator. The indicator retains its opacity and metallic luster, e.g., silvery white, mirror like finish of aluminum layer for a long time. The activator destroys the indicator layer including the naturally formed oxide layer. The indicator layer does not have a matrix/binder. As the device becomes transparent from being highly opaque, any color, message or image printed under it become visible at a pre-determined time, thus making the device self reading. A sealing tape or large label made from an activator and an indicator can be used for sealing boxes and monitoring self-life of perishables inside it. Ink formulations composed of a metal powder and a proper activator can be used for monitoring several sterilization processes, such as sterilization with steam. When water is used as an activator, a thin layer of metals, such as that of aluminum can be used as steam sterilization or humidity indicator. The process can also be used for making patterns, printing plates, electronic circuits and RFIDs (radio frequency identification devices).

Methods, devices and program products are provided for a medical instrumentation storage cabinet. First and second instrumentation retention trays are configured to receive surgical instruments. The housing includes a top plate, a bottom shelf and at least one intermediate shelf there between. The bottom and intermediate shelfs and the first and second instrumentation retention trays include a plurality of holes there through to allow passage of a sterilization medium during a sterilization process. Standoffs are distributed about a perimeter of the housing. The standoffs separate the intermediate shelf from the top plate and bottom shelf to define first and second tray storage areas there between. The first and second tray storage areas have a shape and dimension to receive the first and second instrumentation retention trays. The standoffs are spaced apart from one another to define tray passages there between. The tray passages re sized and located to allow both of the first and second instrumentation retention trays to be inserted into the housing and opened to an open position relative to the housing in at least three directions.

A sterilization process challenge device configured to test the efficacy of a sterilization process includes a tubular body for containing at least one sterilization indicator and a filter assembly including at least one filter member. The only flow path into the interior of the tubular body containing at least one sterilization indicator is provided through the filter assembly to control and restrict flow of a gaseous sterilization medium from an external environment.

The present disclosure provides a cover or sleeve for use with a sterilization container comprising a collapsible enclosure configured to conform to the shape and size of the sterilization container. The collapsible enclosure includes an inner layer configured to withstand a sterilization procedure and a protective layer bonded to the inner layer. The protective layer is configured to protect the inner layer and to withstand the sterilization procedure. The enclosure further comprises a scalable opening for receiving the sterilization container within the interior of the enclosure. The collapsible enclosure is universally adapted for use for a variety of validated sterilization methods, such as steam, hydrogen peroxide, gas plasma, ozone, ethylene oxide and the like and with various sterilization trays, baskets and the like.