Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-03-01
2001-03-20
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S085000
Reexamination Certificate
active
06203522
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method and a connection unit for the sterile transfer of solution through a connector.
BACKGROUND OF THE INVENTION
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 sterilizing arrangement in which a solution is heated during transport in a conduit to a high temperature, for example about 130° 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° 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.
SUMMARY OF THE INVENTION
In accordance with the present invention, these and other objects have now been realized by the invention of a method for the sterile transfer of a solution from a first location associated with a penetrating element to a second location through a connector having an inlet, the method comprising sterilizing the inlet of the connector by flowing a sterilizing solution around the inlet of the connector, sterilizing the penetrating element by flowing a sterilizing solution around the penetrating element, and penetrating the sterilized inlet by the sterilized penetrating element so as to transfer the solution from the first location to the second location through a connector.
In accordance with one embodiment of the method of the present invention, the sterilizing of the inlet of the connector and the sterilizing of the penetrating element both comprise heat sterilizing. Preferably, the heat sterilizing is carried out at a temperature of greater than about 120° C. Most preferably, the heat sterilizing is also carried out at a pressure of greater than about 2 atmospheres (absolute pressure).
In accordance with another embodiment of the method of the present invention, the sterilizing of the inlet of the connector and the sterilizing of the penetrating element are carried out simultaneously by use of the same sterilizing solution. In a preferred embodiment, the method includes maintaining the penetrating element and the inlet of the connector within a common bore, and circulating the sterilizing solution in a closed circuit including a heater for the sterilized solution. Most preferably, the method includes sterilizing the common bore and sealing at least a portion of the sterilized common bore with the inlet of the connector during the penetrating step.
In accordance with the apparatus of the present invention, apparatus is provided for the sterile transfer of a solution from a first location associated with an inlet to the apparatus to a second location through a connector having an inlet, the apparatus comprising a housing defining a bore in fluid communication with the inlet, the connector being insertable into the bore, a penetrating element disposed within the bore, recirculation means for recirculating a sterilizing solution around the penetrating element and the inlet of the connector located within the bore, and activation means for causing the penetrating element to penetrate the inlet of the connector within the bore whereby the solution can be transferred from the first location to the second location.
In accordance with one embodiment of the apparatus of the present invention, the apparatus includes sealing means for sealing a portion of the penetrating element and the inlet of the connector sterilized by the sterilizing solution. In a preferred embodiment, the sealing means also acts to seal the recirculation means when the activation means causes the penetrating element to penetrate the inlet of the connector, thereby creating a closed sterilized region.
In accordance with another embodiment of the apparatus of the present invention, the apparatus includes heating means for heating the sterilizing solution to a temperature of greater than about 120° C. In a preferred embodiment, the apparatus also includes pressure means for increasing the pressure of the sterilizing solution to a pressure of greater than about 2 atmospheres (absolute pressure).
In accordance with another embodiment of the apparatus of the present invention, the sealing means comprises a cover over the inlet of the connector, whereby the penetrating element penetrates the cover when the activation means causes the penetrating element to penetrate the inlet of the connector.
The object of the present invention is to provide both a method and a connection unit which permit sterile connection for transfer of a sterilized solution to a previously sterilized disposable set of tubes in a manner such that bacterial contamination is completely eliminated. The set of tubes can end with a connection bag, or may lead to an infusion device or a dialysis machine or other medical equipment.
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patent: 4022205 (1977-05-01), Tenczar
patent: 4030494 (1977-06-01), Tenczar
patent: 4673400 (1987-06-01), Martin
patent: 5879328 (1999-03-01), Holmberg et al.
patent: 0 116 986 (1984-08-01), None
patent: 0 230 864 (1987-08-01), None
patent: 428009 (1991-05-01), None
patent: 0 428 009 (1991-05-01), None
patent: 0 588 375 (1994-03-01), None
Holmberg Bengt
Jonsson Sven
Gambro AB
Kennedy Sharon
Lerner David Littenberg Krumholz & Mentlik LLP
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