Surgery – Container for blood or body treating material – or means used... – Materials mixed within container
Patent
1996-03-05
1998-10-06
Clarke, Robert A.
Surgery
Container for blood or body treating material, or means used...
Materials mixed within container
366129, 132384, 604414, 251 4, A61B 1900
Patent
active
058170839
DESCRIPTION:
BRIEF SUMMARY
This application is a national filing in the US of International Application PCT/US94/06076 filed May 27, 1994 which in turn claims the priority of Application 105852 filed May 31, 1993 in Israel.
The present invention relates to a mixing device and also to clamp useful therein. The invention is particularly useful in a mixing device for mixing two pharmaceutical ingredients together, such as a drug with a diluent, or a liquid with a powder to be dissolved within the liquid. The invention is therefore described below particularly with respect to such an application.
Many drugs have to be mixed with a diluent or dissolved in a liquid before being administered to a patient. Various techniques and devices are presently used to enable mixing these materials while maintaining sterile conditions where necessary.
An object of the present invention is to provide a mixing device which enables materials to be mixed in an efficient and facile manner and which maintains sterile conditions where necessary.
Another object of the invention is to provide a mixing device which offers protection against tampering before the mixing device is used. A further object is to provide such a mixing device which can be produced in volume and at low cost.
According to the present invention, there is provided a mixing device for mixing first and second materials, comprising: a container for receiving the first material and having an inlet port and an outlet port; a flexible tube having one end connected to the inlet port; a cap secured to the opposite end of the flexible tube for attachment to a second container receiving the second material; and a clamp carried by the flexible tube and normally pinching the flexible tube closed, but being manually openable to permit, when the cap has been attached to the second container, the addition of the second material in the first container to the first material in the second container and mixing of the two materials together in the first container.
According to one preferred embodiment of the invention described below, the clamp includes an indicator element which indicates whenever the clamp has been once opened. According to a second preferred embodiment described below, the clamp includes a severable element which is severed when the clamp is opened thereby not only indicating that the clamp has been once opened, but also preventing reclosing of the clamp. Thus, both embodiments provide tamper-proof protection.
More particularly, in one preferred embodiment described below, the clamp is a slide clamp. The slide clamp is formed with a slot slidably receiving the flexible tube. The slot includes a narrow section which pinches the flexible tube closed when receiving the flexible tube, and a wide section which opens the flexible tube when receiving same. The clamp further includes an indicator element in the form of a membrane covering the wide section of the slot and ruptured when the slide clamp is moved to receive the flexible tube in the wide section of the slot.
In the second described embodiment the clamp is a hinge clamp integrally formed of plastic with two parts hinged together to either a closed position pinching the flexible tube closed, or to an open position opening the flexible tube. The hinge clamp further includes locking elements which are severed whenever the two parts are first moved from their closed positions to their open position.
According to a further feature, the flexible tube may further include a break-away valve which is normally closed but which may be broken away by opening the valve.
As will be described more particularly below, a mixing device constructed in accordance with the foregoing features permits mixing two ingredients in an efficient and facile manner and enables sterile conditions to be maintained whenever necessary. In addition, tamper-proof protection is provided since, by viewing the condition of the indicator on the clamp, the user can be assured that the clamp had not previously been opened, and therefore the materials are in their original, unmix
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Rogel Eitan
Shemesh Eli
Clarke Robert A.
Migda Inc.
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