Fluent material handling – with receiver or receiver coacting mea – Multiple passage filling means for diverse materials or flows – With valve
Reexamination Certificate
2001-10-22
2003-05-27
Douglas, Steve O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Multiple passage filling means for diverse materials or flows
With valve
C141S330000, C604S416000
Reexamination Certificate
active
06568439
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a container cap for a liquid-filled or empty container such as a vial or a bag and a liquid communication adapter attachable to a container mouth. The present invention also relates to a container cap and a liquid communication adapter attachable to a container mouth that are useful for mixing medicine used as a mixture with other medicine or medicine by being dissolved in a solvent immediately before an administration, for example, a powder or lyophilized antineoplastic agent, antibiotic or blood product, with the other liquid medicine or the solvent.
BACKGROUND ART
In general, when stored as a liquid medicine in a container such as a vial or a bag, an antineoplastic agent, antibiotics, a blood product or a lyophilized preparation have a problem of having reduced stability and efficacy. Therefore, in medical institutions such as hospitals, such a medicine conventionally has been dissolved immediately before being used for an instillation treatment. Such an operation conventionally has included filling a solvent etc. in a syringe to which a sharp needle is attached and piercing a rubber-like stopper of the vial etc. with the needle. However, in the case of using the sharp needle, even with great care being taken, users such as nurses sometimes prick themselves accidentally.
Furthermore, when a different type of liquid medicine is mixed/introduced through a three-way valve attached to some point partway along a liquid feed line of an infusion or blood transfusion set while giving an infusion or blood transfusion to a patient, the operation has involved drawing up the liquid medicine from a container such as a vial by a syringe with a needle attached thereto, removing the needle from the syringe and then fit-connecting a luer of the syringe to the three-way valve, which has been complicated. In addition, when the needle is attached to/removed from the syringe, there have been risks of accidental pricks and liquid medicine contamination.
Moreover, when the liquid medicine in the container such as the vial is drawn up with the syringe little by little and over and over again, a part of the rubber-like stopper that is degraded due to the many repeated piercings is removed by an opening at the tip of the needle, thus causing coring. The resulting fragment falls into the contents of the vial so as to contaminate the liquid medicine.
In order to solve these problems, inventive efforts have been made such as connecting a syringe to which a blunt cannula is attached and a vial using a communication tool such as an adapter or a connection tube, thus infusing or drawing up liquid medicine.
For example, JP 3(1991)-504571 A mainly discloses an injection site that supports within a housing a sealing member through which a blunt cannula can be inserted repeatedly.
JP 5(1993)-168679 A mainly discloses an adapter including a collar member engaging a neck of a vial, a cannula piercing a stopper of a container and a female receptor for receiving a male luer of a syringe provided at a distal end of the cannula. The male luer of the syringe is sealed and temporarily held in the female receptor by a rib formed in a circumferential direction in the female receptor and further an annular protrusion (an annular rib) formed at a site contacting a tip of the male luer.
Alternatively, JP 7(1995)-75663 A also discloses a method of using a rubber-like stopper provided with a piercing hole penetrating therethrough in a container mouth. This piercing hole penetrates the rubber-like stopper ark, using a metal needle having a diameter of about 1 mm and is small enough not to be observed easily with the naked eye from the surface. This piercing hole is closed because of the self-sealing characteristics of the rubber when a cannula is not piercing, while the surface of the piercing hole is in close contact with a circumference of the cannula because of the self-sealing characteristics of the rubber when the cannula is piercing.
However, the method disclosed in JP 3-504571 A requires a cannula exclusively for the insertion through the sealing member. Also, there is no description that a commonly used syringe can be used. Thus, a problem may arise in that a mixing/introducing operation is not possible with respect to an infusion or blood transfusion set having a three-way valve as a mixing/introducing port.
Also, in JP 5-168679 A, although a commonly used syringe can be used, there is a problem in air-tightness between the male luer of the syringe and the female receptor. In particular, when dissolving powder preparations, there are some cases where liquid medicine is filled in or taken out of the pierced syringe or the container such as the vial is inclined, raising a chance of liquid leakage during the operation. In addition, because of its concave shape, the female receptor is difficult to sterilize, raising the possibility of developing an insanitary condition.
Furthermore, JP 7-75663 A does not seem to be suitable for repeated uses. This is because the many repeated piercings of a cannula having a diameter of about 3 to 4 mm through the piercing hole having a diameter of about 1 mm generates a crack in some portion of the circumference of the piercing hole. If this piercing is repeated further, a gap is generated between the cannula and the rubber-like stopper, then the liquid may leak from this gap. Moreover, although this method is suitable for inserting a spike having a relatively sharp tip, it is not suitable for an insertion member such as a syringe luer having a flat end face at its tip. The reason is that a piercing resistance during the insertion is large and that the above-described crack of the rubber-like stopper is likely to occur. In addition, although the self-sealing characteristics of the rubber can bring the stopper described above into close contact with the circumference of the cannula, it is impossible to hold the inserted cannula stably so as not to move in a loose manner.
In order to solve the problems described above, it is an object of the present invention to provide a container cap or a liquid communication adapter, in which many repeated piercings do not cause degradation in a rubber-like stopper of a vial, that can be engaged with a luer of a commonly used syringe, reliably can keep air-tightness with the syringe luer when the luer is connected, reliably can prevent liquid leakage when the luer is not connected, and further can allow an easy and reliable sterilization of a piercing site.
DISCLOSURE OF INVENTION
In order to solve the problems described above, a container cap according to the present invention includes at least one disk-like valve provided with an insertion hole in a central portion thereof, and a cover for restraining the valve by covering at least an upper periphery of the valve. A lower periphery on a back surface of the valve is supported by a seating portion of a container mouth or a seating portion of a joint that is supported by the container mouth, and the container cap has an anchor means for anchoring an insertion member to the cap by using a peripheral edge forming a fitting hole in the cover, when inserting the insertion member into the insertion hole.
With this configuration, it is possible to carry out the above-described operations of preparing medicine without using a sharp needle at all. Also, even many repeated piercings do not cause degradation in a rubber-like stopper of a vial, thus reducing a possibility of liquid medicine contamination because of coring.
Furthermore, when drawing liquid medicine into a commonly used syringe and then mixing/introducing this liquid medicine into a blood circuit or an infusion or blood transfusion set to which a three-way valve or a mixing/introducing port capable of receiving an insertion member such as the commonly used syringe luer is attached, it is possible to perform a series of operations without using a sharp needle at all. Accordingly, the needle used for drawing up the liquid medicine etc. becomes unnecessary, thus reducing costs. Also, because the needle
Fujii Ryoji
Se Naomi
Yuki Takehiko
Douglas Steve O.
JMS Co. Ltd.
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