Portable hand-held device with a biosensor

Details Portable hand-held device with a biosensor Portable hand-held device with a biosensor

1998-03-09

2001-01-09

O'Connor, Cary (Department: 3736)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C600S366000, C073S863010, C073S864810, C073S864830, C204S400000, C204S403060

Reexamination Certificate

active

06171238

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention concerns a hand-held equipment for the examination of biological liquids such as whole blood, liquor, urine and serum with the aid of electrochemical biosensors without costly preceding analysis being carried out.
2. Description of the Related Art
For a fairly long time biosensors have been applied as sensitive and selective detection methods in analysis, in particular of medical diagnostics. For this purpose, respective biosensors are installed in analyzers which allow to carry out a fast inexpensive and notably proper examination of the respective parameters in central laboratories where many samples have to be examined. This requires, as a rule, a sample throughput of 80 180/h.
The analyzers are based on various principles. For the most part, they are operated with a continuous air segmented flow of the respective, highly diluted laboratory samples, i.e. this method requires the preparation of the solutions to be examined (e.g. whole blood) with a dilution of the analysis material being required. It is very costly to analyze individual samples by means of this equipment as the efficiency of analyzers becomes effective only in the case of a high number of samples being examined (ESAT® 6660 and ECA 180 from Pr{umlaut over (u)}fger{umlaut over (a)}te-Werk Medingen GmbH, EBIO (Eppendorf® from Eppendorf-Netheler-Hinz GmbH).
Furthermore, there are instructions known to measure individual samples also without preceding analysis being carried out which, however, are very immovable owing to a high integrated measuring comfort, thus being unsuited for a local application (YSI 2300 STAT of YSI Incorporated and STAT Profile PLUS of NOVA BIOPMEDICAL GmbH).
From EP-A-0 520 443 a portable sensor equipment is known which consists of a waste collector, liquid canals and intakes and an electrochemical sensor in a case and an external calibration unit.
For the time being, commercialized mobile systems with integrated biosensors are too expensive owing to the high measuring comfort (internal calibration), require too much maintenance and are operated with too long transport ways for the sample to be measured. For this reason, in addition to a comparatively high price, delays and pollution will result which have detrimental effects on the quality of analyzing.
All measuring systems applied locally to determine parameters such as glucose and lactate are at present based on nonreusable consumables (test strips, photometric; strip electrode, amperometric). Thus the analysis is determined by the price of the test strip and the test strip is not calibratable as it may be used just once.
BRIEF SUMMARY OF THE INVENTION
That is why it was the task of the invention to provide a technical solution for implementing a locally applicable equipment for the examination of blood, urine, liquor without preceding analysis being carried out and a re-usable biosensor which is marked by a low price and also lowest maintenance costs.
The task will be solved by the construction of a hand-held equipment.
The hand-held equipment consists of a rigidly anchored electrode which is covered by a replaceable biodiaphragm, equipped with a system solution supply bag and a waste bag, a pump, a hose transport system, an operating lever with valve function, three operating elements, a display and a control unit for signal recording and the whole process. The equipment works with a temperature compensation. Thus, modified sensitivities of the biosensor are compensated through variations of the ambient temperature in the range between 15° C. and 35° C. on the basis of a signal-temperature function. Welded PE foils are preferentially used for the system solution and the waste, with the storage volume totalling approx. ⅓ and the waste volume approx. ⅔ of the total volume. In a preferential variant of execution the two bags are welded with each other. They are arranged one above the other and disposed jointly upon consumption of the buffer stock. The bag is opened when being installed the hand-held equipment through a hollow needle. When putting in a new supply bag the second half of the PE bag will be empty. In the same way as the stock will be consumed for purifying the measuring cell the waste bag will be filled. After having consumed the system solution completely the whole bag will be disposed.
The rigidly anchored electrode is a Pt-Ag/AgCl electrode of a CLARK electrode type. By combining it with a ready-made biodiaphragm by placing simply this the electrode is converted into a biosensor which may register various substances in accordance with the biomolecule used.
To execute a measurement the operating lever will be changed front idle position B (
9
) to position A (
10
), thus opening the flow system. By turning the pump into position I the electrode will be put into the state ready for measurement with the system solution in front of it having been sucked off.
The sample to be analyzed will be supplied with adjusting the freshly taken sample in a capillary tube to the sample opening of the hand-held equipment which is directly above the biosensor. Subsequently the pump is set in position II and the sample to be measured is transported by it in front of the biosensor. After effecting the measurement the result will be shown on the display and the operator will be requested to purify the system. The capillary tube is taken off by the user. By putting back the operating lever to position B the purification system is again closed. Purification itself is effected by turning the pump slowly until “ready for use” will appear on the display which is regarded to be a confirmation that the purification is completed and the pump will be in position III.
A hose pump is preferentially used as pump.
The three operating elements will be responsible for the following functions:
B
1
: on/off
B
2
: menu functions
B
3
: set key
Power supply will be possible through an internal 9V accumulator as well as an external solar cell or a supply unit. Depending on the biomolecule used a biodiaphragm has a limited lifetime which totals, in general, 10 to 30 days. The user will be shown the expiry of lifetime on the display. Upon expiry of its service life the biodiaphragm will be replaced by a new one.
The biodiaphragm is replaced by unlocking the respective sealing cap, taking off the worn-out diaphragm and simply placing a new diaphragm. By the information on the display the user will be informed on the steps necessary to take until the new diaphragm will be operative.
Signal recording and the whole process are controlled through a control unit. The whole process involves the beginning of signal recording (start), the end of signal recording, filing and storing of measured values, the calibration of the equipment and display information for the operator as regards the steps.
The hand-held equipment in conformity with the invention allows to carry out a minimum of 300 measurements without replacing the supply bag. A special advantage is that the equipment is usable in a temperature range between 15° C. and 35° C., independent of its place and time of use. In addition, the weight of the equipment is less than 500 g.


REFERENCES:
patent: 3787291 (1974-01-01), Deuringer et al.
patent: 4533456 (1985-08-01), Kratochvil et al.
patent: 4786394 (1988-11-01), Enzer et al.
patent: 5074157 (1991-12-01), Marsoner et al.
patent: 5089421 (1992-02-01), Dieffenbach
patent: 5405510 (1995-04-01), Betts et al.
patent: 4115792 (1992-11-01), None
patent: 0520443 (1992-12-01), None
patent: 2535964 (1984-05-01), None

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