Portable hand-held device with a biosensor

• US 6,171,238 B1
• Filed: 03/09/1998
• Issued: 01/09/2001
• Est. Priority Date: 07/10/1995
• Status: Expired due to Fees

• Current Assignee: ABT Advanced Bioanalytical Technology GmbH
• Original Assignee: BST Bio Senso Technologies GmbH
• Inventors: Nentwig, Jürgen, Scheller, Frieder, Szeponik, Jan, Pfeiffer, Dorothea, Klimes, Norbert
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US08/983,092
• Time in Patent Office: 1,037 Days
• Field of Search: 600/345, 600/352, 600/368, 600/300, 600/308, 600/309, 600/366, 600/365, 204/403, 204/415, 204/400, 204/409, 738/63, 738/648.1, 738/648.3
• US Class Current: 600/345
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Abstract

The invention pertains to a portable hand device with biosensor for the investigation of biological fluids such as whole blood, liquor, urine and serum. It is characterized by a securely fixed electrode, which is covered by a replaceable biomembrane, as reservoir bag containing system solution and a waste bag, a pump, a tube transport system, an operating lever with a valve function, three operating elements, a display, and a control unit signal capture and overall procedure.

Claims

1. Mobile hand-held equipment with biosensor, in particular for the local determination of original biological solutions, wherein

a case (15),

an amperometric biosensor (33) disposed in the case (15),

a measuring cell (11) disposed in the case (15),

a supply bag (19) and a waste bag (18) for fresh and waste system solution disposed in the case (15),

a pump (4) placed in the case (15),

a hose transport system (21) placed in the case (15),

a sample opening (24) and a sample canal (25) placed in the case (15),

an operating lever with valve function (8) attached to the case (15),

equipment for replacing diaphragms (26, 27, 28, 29) placed in the case (15),

a display (1) mounted to the case (15),

on/off key button (12) placed on the case (15),

menu function key button (13) placed on the case (15),

set key button (14) placed on the case (15),

a connector (3) for making a connection to a power supply (16),

a unit for signal recording and the whole measuring process (2), and wherein

welded PE foil is used for the supply bag (19) and the respective waste bag (18), the two bags are welded with each other, arranged one above the other and will be jointly disposed after the buffer stock will have been consumed.

2. Mobile hand-held equipment with biosensor according to claim 1, wherein the biosensor (33) is arranged directly below the sample opening (24).

3. Mobile hand-held equipment with biosensor according to claims 2 or 1, wherein the pump used (4) is operated by hand and without using electric energy.

4. Mobile hand-held equipment with biosensor according to claims 2 or 3, wherein the power supply of the electrode may be effected through a chargeable accumulator (16) as well as a solar cell, respectively, for forming a supply unit (3).

5. Mobile hand-held equipment with biosensor according to claims 2 or 1, wherein the weight of the equipment is less than 500 g.

6. Mobile hand-held equipment with biosensor according to claim 1, wherein the biosensor includes an electrode covered by a biodiaphragm.

7. A mobile hand-held equipment with a biosensor comprising

a case;

a connection for supplying power attached to the case;

an on/off button attached to the case and connected to the connection for supplying power;

a menu function key button attached to the case and connected to the on/off key button;

a control unit disposed in the case;

a set key button attached to the case and connected to the control unit;

a measuring cell disposed in the case;

a pump disposed in the case and connected to the measuring cell and to the menu function key button;

a sample opening furnished at the case;

a sample canal furnished at the case and led to the sample opening;

a supply bag for delivering fresh system solution, wherein PE (polyethylene) is used for the supply bag and wherein the supply bag will be disposed after the system solution has been consumed;

a valve disposed in the case;

an operating lever attached to the valve and for actuating the valve;

an amperometric biosensor disposed in the measuring cell;

a waste bag for receiving discharged waste system solution, wherein PE (polyethylene) is used for the waste bag and wherein the waste bag will be disposed together with the supply bag after the system solution has been consumed;

a hose transport system connected to the pump and to the supply bag;

equipment for replacing diaphragms disposed in the case;

a display disposed in the case and connected to the control unit;

a unit for signal recording and the whole measuring process connected to the control unit.

8. The mobile hand-held equipment with biosensor according to claim 7,

wherein the biosensor is arranged directly below the sample opening;

wherein the pump used is operated by hand and without using electric energy;

wherein welded PE foil is used for the supply bag and the waste bag, welded to each other, wherein the supply bag and the waste bag are arranged one above the other and wherein the supply bag and the waste bag will be jointly disposed after the buffer stock will have been consumed;

wherein the power supply of the electrode is furnished by a chargeable accumulator and by a solar cell forming a supply unit;

wherein the weight of the equipment is less than 500 g;

wherein the sample opening is adapted to receive a capillary tube.

9. The mobile hand-held equipment with biosensor according to claim 7,

wherein welded PE foil is used for the supply bag and the waste bag, welded to each other, wherein the supply bag and the waste bag are arranged one above the other and wherein the supply bag and the waste bag will be jointly disposed of after the system solution will have been consumed.

10. A mobile hand-held equipment with biosensor comprising

a case;

an electrode rigidly anchored in the case;

a replaceable biodiaphragm covering the electrode and including a system solution supply bag and a waste bag;

a pump attached to the case;

a hose transport system attached to the case;

an operating lever including a valve function supported at the case;

three operating elements attached to the case;

a control unit attached to the case for signal recording;

a temperature compensation system for modifying sensitivities of the biosensor by furnishing compensation through variations of the ambient temperature the range between 15 degrees centigrade and 35 degrees centigrade on the basis of a signal temperature function.

11. The mobile hand-held equipment with biosensor according to claim 10 wherein a hose pump performs the functions of the pump.

12. The mobile hand-held equipment with biosensor according to claim 10 further comprising

an electrical power supply;

an on/off switch attached to the case for activating an electrical power supply;

a menu function switch attached to the case for selecting operating modes of the mobile hand-held equipment with biosensor;

a set key attached to the case for setting values for the operation of the mobile hand-held equipment with biosensor.

13. The mobile hand-held equipment with biosensor according to claim 12, wherein the power supply is an internal 9 volt accumulator.

14. A mobile hand-held equipment with biosensor comprising

a case;

an electrode rigidly anchored in the case;

a replaceable biodiaphragm covering the electrode and including a system solution supply bag and a waste bag;

a pump attached to the case;

a hose transport system attached to the case;

an operating lever including a valve function supported at the case;

three operating elements attached to the case;

a control unit attached to the case for signal recording;

wherein the system solution bag is made of polyethylene and wherein the waste bag is made of polyethylene;

wherein the storage volume is approximately one third of the total volume and wherein the waste volume is approximately one third of the total volume;

wherein the electrode is a Pt-Ag/AgCl electrode of a Clark electrode type.

15. A method for operating a hand-held-equipment with biosensor comprising

installing a system solution supply bag in a hand-held equipment;

opening the system solution supply bag with a needle;

installing a waste bag in the hand-held equipment;

opening the waste bag with a needle;

consuming the system solution supply for purifying a measurement cell;

installing a replacement system solution supply bag when the currently installed system supply bag is substantially empty;

filling the waste bag in the same way as the system solution supply is being consumed from the system solution supply bag;

covering the electrode with a biodiaphragm and thereby converting the electrode into a biosensor, which registers various substances in accordance with the biomolecule used by combining a Pt-Ag/AgCl electrode of a Clark electrode type covered with a ready made biodiaphragm.

16. The method for operating a hand-held-equipment with biosensor according to claim 15, further comprising

changing an operating lever from an idle position (B) to an operating position (A);

opening thereby the flow system;

turning a pump into a first position;

putting thereby the electrode into a state ready for measurement;

sucking off system solution in front of the electrode;

adjusting a freshly taken sample in a capillary tube to a sample opening of the hand-held equipment, wherein the sample opening is disposed immediately above the biosensor;

turning the pump into a second position;

transporting the sample to be measured with the pump in front of a biosensor;

performing a measurement;

displaying a result on a display;

requesting the operator to purify the system;

manually taking off the capitary by the user;

returning the operating lever into the idle position (B) and thereby closing the purification system.

17. The method for operating a hand-held-equipment with biosensor according to claim 16, further comprising

turning the pump slowly into a third position until “

ready for use”

appears on the display and thereby effecting purification;

displaying an expiry of lifetime of a power supply on the display;

unlocking a respective sealing cap for replacing the biodiaphragm;

removing a worn-out biodiaphragm;

placing a new biodiaphragm.

18. The method for operating a hand-held-equipment with biosensor according to claim 15, further comprising

opening an operating lever;

putting a buffer segment into a first position by a pump;

placing a hollow needle with a sample to be analyzed into an opening;

putting the pump into a second position;

thereby positioning the sample in a sample canal above the biosensor;

starting a measurement;

completing the measurement;

showing a measurement value on a display;

requesting the operator to purify the system;

taking the hollow needle from the opening;

putting the operating lever into an idle position;

turning the pump;

moving thereby system solution from a supply bag through a hose transport system into a waste bag;

purifying the biosensor by contacting the biosensor with a buffer solution;

informing the operator about the termination of purification by a signal “

ready to use”

on a display;

placing the pump into a third idle position.

19. The method for operating a hand-held-equipment with biosensor according to claim 15, further comprising

replacing a biodiaphragm upon expiration of the lifetime of a biomembrane;

drawing the operating lever upwards through a spring;

turning the operating lever upward by 90 degrees;

swinging a cover of the measuring cell open by 90 degrees around an axis;

releasing a fixing device;

taking off a worn-out biodiaphragm;

putting a new biodiaphragm on the electrode equipped with a rubber joint;

swinging the cover of the measuring cell down again;

stopping the cover of the measuring cell;

placing the operating lever again in an idle position;

thereby closing again the flow system;

turning the pump;

thereby putting system solution on the biosensor for conditioning.

20. A mobile hand-held equipment with biosensor comprising

a case;

an electrode rigidly anchored in the case;

a replaceable biodiaphragm covering the electrode and including a system solution supply bag and a waste bag;

a pump attached to the case;

a hose transport system attached to the case;

an operating lever including a valve function supported at the case;

three operating elements attached to the case;

a control unit attached to the case for signal recording;

wherein welded PE foil is used for the supply (19) and the respective waste bags (18), the two bags are welded with each other, arranged one above the other and will be jointly disposed after the buffer stock will have been consumed.

21. Mobile hand-held equipment with biosensor, in particular for the local determination of original biological solutions, wherein

a case (15),

an amperometric biosensor (33) disposed in the case (15),

a measuring cell (11) disposed in the case (15),

supply (19) and waste bags (18) for fresh and waste system solution disposed in the case (15),

a pump (4) placed in the case (15),

a hose transport system (21) placed in the case (15),

a sample opening (24) and a sample canal (25) placed in the case (15),

an operating lever with valve function (8) attached to the case (15),

an equipment for replacing diaphragms (26, 27, 28, 29) placed in the case (15),

a display (1) mounted to the case (15),

on/off key button (12) placed on the case (15),

menu function key button (13) placed on the case (15),

set key button (14) placed on the case (15),

a connector (3) for making a connection to a power supply (16), consisting of an accumulator and a solar cell or another supply unit,

a plotting unit for signal recording and the whole measuring process (2), and wherein welded PE foil is used for the supply (19) and the respective waste bags (18), the two bags are welded with each other, arranged one above the other and will be jointly disposed after the buffer stock will have been consumed.

22. A method for operating a hand-held-equipment with biosensor comprising

installing a supply/waste system, consisting of a supply bag welded with a waste bag;

opening both bags with a needle;

consuming the system solution supply for purifying a measurement cell;

exchanging the supply waste system, when the currently installed system is nearly empty, which is indicated by a display reading;

covering the electrode with a biodiaphragm and thereby converting the electrode into a biosensor, which registers various substances in accordance with the biomolecule used by combining a Pt-Ag/AgCl electrode of a Clark electrode type covered with a ready made biodiaphragm.