The present invention is intended to be used in conjunction with an on-line sterilizing arrangement, such as described European Application No. 428,009. This application describes a continuous heat sterilising arrangement in which a solution is heated during transport in a conduit to a high temperature, for example about 130.degree. C., and is maintained at this temperature for a predetermined period in order to effect sterilization. Thereafter, the solution is cooled to the temperature at which it is to be used. The sterilization step takes place at a high pressure, which is achieved with a pump and throttle arrangement.
A heat exchanger is generally used in this system to provide the heat energy. The sterilization arrangement is used for sterilizing infusion solutions such as Ringer's solution, other medical solutions such as dialysis solutions, purified water to obtain sterilized water, or other such solutions.
The sterilizing arrangement according to European Application No. 428,009 is provided with a shunt conduit which in principle connects the inlet to the outlet so that the solution which is in the system can be circulated in a closed circuit. In this manner, the temperature of the circulating solution can be raised to, for example, 120.degree. C. in order to sterilize the device itself. The solution which has been sterilized with the above-described sterilizing arrangement can be used directly, for example in dialysis or infusion. In certain circumstances it is also desirable to transfer the sterilized solution to storage bags for later use, or for delivery to other departments within the hospital. For this purpose, disposable sets of tubes are available which terminate with a bag.
Normally, such bags are filled with a medical solution, whereafter the set of tubes is sealed and the disposable article is then sterilized in its entirety, i.e. with the medical solution within the bag. Such sterilizing can be effected with gamma-sterilization or by means of autoclaving.
Alternatively, the set of tubes can be provided with a medical solution after the set of tubes has been sterilized. In such cases, a sterile connector is normally used which comprises a membrane which is broken when used. Those parts which are connected together are sterile. With such a sterile connector, there is always the risk that bacteria which may reside on the outer side of the membrane are introduced with the connector device and contaminate the interior of the connector.
European Application No. 230,864 describes a sterile connection of two containers in which the connection takes place in a sterilized chamber which is maintained under aseptic conditions by means of a chemical disinfectant. Chemical disinfection, however, does not guarantee sterility, and at the same time the risk for bacteria contamination is still present.
USPTO Backgrounds
USPTO Backgrounds