Chemical apparatus and process disinfecting – deodorizing – preser – Control element responsive to a sensed operating condition
Reexamination Certificate
1999-04-23
2002-12-24
Warden, Jill (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Control element responsive to a sensed operating condition
C422S051000, C422S105000, C221S025000, C221S079000, C221S087000, C206S569000
Reexamination Certificate
active
06497845
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
The invention concerns a storage container made of a rigid material for two or several analytical devices in which these can be accommodated individually chambers which are located with respect to one another in a regular geometric arrangement wherein each of the chambers has at least two opposite openings which are sealed by a foil. The invention also concerns a system for storing analytical devices containing a storage container according to the invention and two or several analytical devices.
Carrier-bound rapid tests have been established in specialised laboratories for the chemical and biochemical analysis of solid and liquid sample materials and also in particular for use outside permanent laboratories. Despite the often complex reactions involving sensitive reagents, such carrier-bound rapid tests that are based on a specially developed dry chemistry are simple and uncomplicated and can even be carried out by layman. The most prominent example of carrier-bound rapid tests are test strips for determining the content blood glucose in diabetics. Single or multizone test strips for urine analysis and diverse indicator papers are also known. Since other forms of carrier-bound rapid tests exist in addition to rapid tests in a strip form (test strips), they are generally referred to as “analytical test elements”.
Dry chemical carrier-bound rapid tests are usually multiply packaged for sale to the end user. The rapid test is usually in a first package which directly surrounds it (primary packaging) which is in turn placed in a further package (external packaging, secondary packaging) which, in addition to the primary packaging, usually contains handling instructions for rapid tests in the form of package inserts. The primary packaging is designed to fulfil the essential functions of maintaining the function of the chemical and biochemical components on the test element during a long period of storage. These functions are above all protection from the influence of light rays, protection from the ingress of atmospheric humidity, dirt, germs and dust as well as protection from mechanical impairment of the test elements.
One of the most frequently encountered forms of primary packaging is to offer test elements that have been loosely loaded into aluminium or plastic tubes which are sealed by a stopper that is pressed on or screwed on. The functions of the primary packaging mentioned above are satisfactorily fulfilled by these tube packages. These appear to be out-moded due to the complicated manual removal of individual test elements from the primary packaging which is why alternative packaging concepts have been developed. In addition to the aforementioned properties these additionally enable the test elements to be individually and automatically removed from the packaging and made directly available to a measuring instrument which measures and subsequently evaluates the test results.
EP-A 0 622 119 describes storage systems made of stiff, water-vapour-tight materials for strip-like test elements in which the test elements are individually stored in foil-sealed chambers (individual sealing). The chambers for the test strips—which is another term for strip-like test elements—are in the shape of tubes with a rectangular cross-section and which are oriented relative to one another in a geometric and regular manner resulting in the storage system being in the form of an essentially rectangular magazine or hinged case both having parallel chambers lying next to one another in one line or in the shape of an elongate cylinder or a flat circular disk with chambers grouped radially around a central axis. The test elements can be removed from the storage system either manually or by a mechanical device and the test elements remaining in the storage container continue to be protected by individual sealing. In addition EP-A 0 622 119 describes the possibility of providing desiccants for the test strips such as silica gels and molecular sieves within the chambers in order to absorb residual moisture resulting from the manufacturing process for the test strips or which has penetrated into the chambers despite the sealing and use of materials that are impermeable to water vapour. A data carrier can be attached to one of the outer sides of the storage system such as e.g. a label in readable type, a bar code label or a magnetic strip on which batch-specific data and optionally further information on the test elements in the system is stored and can be recalled. Some of the storage containers for test elements described in EP-A 0 622 119 are suitable for use in appropriately designed measuring systems composed essentially of a measuring instrument, storage container and test elements.
EP-A 0 732 590 and U.S Pat. No. 5,489,414 describe round, disk-shaped storage containers for test elements which are suitable for use in compact measuring instruments for example for blood sugar self-monitoring by diabetics. In this case the test elements are arranged radially in one plane around the centre of the disk and are individually sealed dirt-tight and moisture-tight in blisters such as those that are known for individually packaging tablets. A separate blister for a desiccant is provided for each test element in the storage container according to EP-A 0 732 590 and the desiccant blister and test element blister are linked together to ensure an effective desiccation of the test element blister.
Cylindrical test element magazines manufactured from plastic in an injection molding process are known from U.S. Pat. No. 5,510,266 and EP-A 0 738 666 in which the individual test elements are arranged similar to cartridges in a revolver cylinder in continuous chambers extending from the base of the cylinder to the opposite cover surface. As already described further above for EP-A 0 622 119, the test elements in this case are individually sealed into parallel, elongate, tube-shaped chambers arranged radially around a central longitudinal axis for which the circular base and cover surfaces of the cylindrical storage container are sealed with foils such as aluminium foil. In order to remove the test elements from the magazine, one of the sealing foils is pierced with a plunger and the test element to be removed is pushed out of its chamber through the opposite sealing foil and is thus made available for its intended use. Like EP-A 0 732 590 each test element chamber is provided with a separate desiccant chamber which is linked to the test element chamber via a channel so that the test element chamber can be reliably dehumidified by the desiccant. The test element magazines from U.S. Pat. No. 5,510,266 and EP-A 0 738 666 are also mainly designed for use in compact measuring instruments.
The storage containers described in the prior art have the disadvantage that the test elements are not optimally protected against environmental influences and in particular mechanical influences. The blister packages for test elements described in EP-A 0 732 590 and U.S. Pat. No. 5,489,414 are manufactured from relatively thin plastic foils and by their nature provide only an inadequate protection of the test elements against mechanical damage for example by unintentional pressing or bending the packaging. The test element storage containers from U.S. Pat. No. 5,510,266 and EP-A 0 738 666 provide better protection in this case since they are made of rigid solid materials which at least offer more resistance to pressure and bending stress than blister packages. However, the mechanical weak points of the drum-shaped packaging type disclosed in U.S. Pat. No. 5,510,266 and EP-A 0 738 666 are the sealing foils which seal the base and covering surfaces of the cylindrical drum in order to in this manner produce sealed test element chambers. These sealing foils are usually made of thin foils such as aluminium foils in order that they can be easily pierced when the test elements are removed and are easily damaged when the package is unintentionally dropped or not carefully placed on a support. Since slight
Bex Kathryn
Knauer Richard T.
Roche Diagnostics GmbH
Woodburn Jill L.
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