Chemistry: analytical and immunological testing – Optical result – With claimed manipulation of container to effect reaction or...
Reexamination Certificate
1999-04-21
2003-08-12
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Optical result
With claimed manipulation of container to effect reaction or...
C436S045000, C436S047000, C436S048000, C436S063000, C436S163000, C436S164000, C436S174000, C422S051000, C422S051000, C422S067000, C422S064000, C422S081000, C422S082050, C422S082080, C422S105000, C422S105000
Reexamination Certificate
active
06605471
ABSTRACT:
The present invention relates to a method for determining at least one parameter of samples of physiological liquids, to test devices which may be used in the method, to a holder comprising a plurality of such test devices, and to a measuring apparatus adapted to accommodate the holder and to be used in the method and to a system comprising the apparatus and the holder.
In particular, the present invention relates to methods and systems in which an operator, after sample taking, is protected from contact with physiological liquids, such as blood, plasma, urine, etc.
In human medicine, it has hitherto been customary practice to send samples of physiological liquids, e.g. blood, plasma or urine, for analysis to a specialized clinical laboratory possessing the necessary technical equipment and trained staff.
In the past, clinical chemical analysis systems have tended to be large in size, expensive and complex to operate, and in general only relatively large medical institutions have been able to afford the purchase, operation and maintenance of such systems. Smaller hospitals, clinics, general practitioners etc. usually have had to employ centralized commercial or hospital laboratories for clinical chemical analyses, leading to unavoidable delays in the procedure.
Since abnormal values of certain clinical chemical parameters are indicative of serious danger to health, the rapid and reliable determination of clinical chemical parameters in general is of crucial importance for proper and effective medical treatment. Furthermore, quite apart from the acute aspects of medical treatment, it is clearly an advantage, both for patients from a psychological viewpoint and for medical staff from an administrative viewpoint, that clinical analysis results are accessible as quickly as possible.
Thus, increasing demands for reduction in costs, more rapid turnover, greater decentralisation and increased staff flexibility in clinical chemical analysis have provided an incentive for the development of easy-to-use, easy-to-maintain, reliable, relatively cheap, compact and, if possible, portable equipment, based in part on discardable components, for the bedside measurement of those characteristics of chemical species which constitute fundamental clinical chemical parameters of physiological liquids.
In WO 89/04474, a portable apparatus for measuring the electrochemical characteristics of a sample is disclosed, which apparatus includes a shell which houses a cartridge bay adapted to receive, from a U-shaped clip, a plurality of disposable cartridges for receiving samples. A desired number of cartridges are manually loaded onto the clip and the clip is manually loaded into the cartridge bay whereby the cartridges are loaded into the apparatus. After loading, the clip is removed and discarded. A blood sample may now be dispensed into a specific cartridge in a measurement position in the apparatus from a sample containing syringe. After a measurement, the used cartridge is ejected from the apparatus.
It is a disadvantage of the above-mentioned apparatus that an operator and the environment of the apparatus is exposed to contact with the sample in a used cartridge after ejection of the cartridge from the apparatus.
The AVL Scientific Corporation has introduced the AVL OPTI 1 portable blood gas analyzer in which a disposable cassette adapted to receive a blood sample is inserted into the analyzer during a measurement. The blood sample may be supplied from a syringe or a capillary, which may be attached to the cassette and discarded with the cassette after a measurement. The disengagement and subsequent handling of this contaminated cassette is performed manually and, thus, subjects the operator to a risk of getting into contact with the sample.
It is an object of the present invention to provide a method and an apparatus for analysis of physiological liquids that provide maximum protection of laboratory staff from contact with a physiological liquid after sample taking.
It is another object of the present invention to provide a method and apparatus for analysis of physiological liquids in which a plurality of test devices can be inserted into the measuring apparatus in one operation and can be removed from the measuring apparatus in one operation whereby the number of manual operations needed to perform a determination of parameters of physiological liquids are minimized.
It is yet another object of the invention to provide a test device for use in a holder for holding the test device that both protect the environment from spills of samples and both provide maximum protection of laboratory staff from contact with physiological liquid after sample taking.
It is a further object of the invention to provide a test device adapted to receive and hold at least a part of a sampling device supplying the sample to the test device, so that the at least part of the sampling device can be discarded with the test device.
In a first aspect, the present invention relates to a method for determining at least one parameter of samples of physiological liquids, the method comprising
arranging a plurality of test devices in a holder,
loading, to at least one of the test devices, a sample of a physiological liquid,
determining the at least one parameter of the sample loaded to the at least one test device, the at least one test device being retained in the holder after the determination,
and discarding the holder with the at least one test device retained therein in such a manner that the at least one test device is substantially separated from the ambience, thus reducing the risk of contact between an operator and sample loaded to the at least one test device.
Parameters of physiological liquids of particular interest are, for example:
pH,
concentrations of electrolytes, such as Li
+
, Na
+
, K
+
, Ca
2+
, Mg
2+
, Cl
−
, HCO
3
−
and NH
3
(NH
4
+
),
concentrations of dissolved gases, notably oxygen and carbon dioxide (conventionally reported in the form of partial pressures, e.g. pO
2
, pCO
2
),
haemoglobin concentration, concentration of haemoglobin derivatives,
concentrations of metabolic factors, such as glucose, creatinine, urea (BUN), uric acid, lactic acid, pyruvic acid, ascorbic acid, phosphate, protein, bilirubin, cholesterol, triglycerides, phenylalanine and tyrosine,
concentrations of enzymes, such as lactic acid dehydrogenase (LDH), lipase, amylase, choline esterase, alkaline phosphatase, acid phosphatase, alanine amino transferase (ALAT), aspartate amino transferase (ASAT) and creatinine kinase (CK),
and concentrations of ligands, such as antibodies and nucleotide fragments.
According to the present invention a parameter of a physiological liquid may be determined by any known suitable method, such as optical methods, such as measurement of absorption, scattering, diffraction, reflection, refraction, luminescence, fluorescence, phosphorescence, etc., in specific wavelength ranges of the electromagnetic spectrum, sensor response measurement methods, etc.
The term “sensor” as used here denotes any kind of organ of which some part, in the present context called the sensing part, is capable
either of
selective interaction with the chemical species of interest, thereby producing a well-defined and measurable response which is a function of the desired characteristic of that chemical species, the desired characteristic thus being derivable therefrom,
or of
response to a bulk property of a liquid, the response not being selective with respect to any specific chemical species, but being a function of the total concentration of one or more chemical species in the liquid, the desired characteristic thus being derivable therefrom.
Relevant types of sensors are those adapted to determine any of the previously mentioned clinical chemical parameters, for example:
potentiometric sensors for use in aqueous media, such as ion-selective electrodes for specific measurement of the concentration of selected ionic chemical species [a description of non-limiting examples of some ion-sel
Andersen Willy
Frischauf Peter Aage
Kagenow Henrik
Lundsgaard Finn C.
Bex Kathryn
Bryan Cave LLP
Radiometer Medical A/S
Stiefel Maurice B.
Warden Jill
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