CA2500071C - Multiple capillary sensor analysis system - Google Patents
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- CA2500071C CA2500071C CA002500071A CA2500071A CA2500071C CA 2500071 C CA2500071 C CA 2500071C CA 002500071 A CA002500071 A CA 002500071A CA 2500071 A CA2500071 A CA 2500071A CA 2500071 C CA2500071 C CA 2500071C
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- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
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Abstract
A capillary sensor analysis system for analyzing a body fluid of humans or animals, comprising capillary sensors which have a capillary channel enclosed by at least two wall parts and containing reagents, and an evaluation instrument (2) which has a capillary sensor holder (23) to position a capillary sensor (14) in a measurement position (22) to perform an analysis in such a manner that its inlet opening (13) is accessible, in order to bring a sample liquid to be assayed in contact therewith, the sample liquid penetrating into the capillary channel, driven by capillary forces, and filling it.
The capillary sensors are implemented as multiple capillary sensor strips (3), each having a plurality of capillary sensors (14) positioned one after the other, a multiple capillary sensor strip (3) being guided and held in the capillary sensor holder (23) of the evaluation instrument (2) in such a manner that one capillary sensor (14) of the strip (3) at a time is located in the measurement position (22) and its inlet opening (13) is accessible for contact with sample liquid (19), and the multiple capillary sensor strip (3) being movable in the evaluation instrument (2) in such a manner that consecutive capillary sensors of the multiple capillary sensor strip (3) are transported one after the other into the measurement position (22).
The capillary sensors are implemented as multiple capillary sensor strips (3), each having a plurality of capillary sensors (14) positioned one after the other, a multiple capillary sensor strip (3) being guided and held in the capillary sensor holder (23) of the evaluation instrument (2) in such a manner that one capillary sensor (14) of the strip (3) at a time is located in the measurement position (22) and its inlet opening (13) is accessible for contact with sample liquid (19), and the multiple capillary sensor strip (3) being movable in the evaluation instrument (2) in such a manner that consecutive capillary sensors of the multiple capillary sensor strip (3) are transported one after the other into the measurement position (22).
Description
English translation of application text as filed Capillary sensor analysis system The present invention relates to a capillary sensor analysis system for analyzing a sample liquid for an analyte contained therein as well as a multiple capillary sensor strip suitable as a component of such a system.
Analysis systems, which comprise analysis elements intended for one-time use and evaluation instruments tailored to a specific type of analysis element, are used to a large extent for the qualitative and quantitative analysis of components of liquid samples, in particular body fluids of humans or animals. To perform an analysis, the analysis element, which is also referred to as a "biosensor" in the professional world, is brought into contact with the sample. The reaction of the sample with at least one reagent contained in the biosensor leads to a change of a measurable physical property (measurement variable) of the biosensor, which is characteristic for the analysis. The evaluation instrument contains a measurement and evaluation electronics for measuring the measurement variable and determining the desired analysis information (typically the concentration of the analyte) on the basis of the measured value.
In the early times of the development, test strips, which comprise a plastic carrier having at least one test field containing the reagents, were the most typical type of analysis elements. In order to analyze, for example, a blood drop obtained by finger pricking, the blood adhering to the finger is applied directly to the test field. The excess blood is then wiped off or washed off.
The reaction of the blood with the reagents contained in the test field leads to a change of its color, which may be evaluated using a photometer of the evaluation instrument.
However, this method has several disadvantages. In particular, the variation of the amount of sample which penetrates into the test field and is available for analysis is relatively high. In addition, for many users the handling is difficult. This is in particular true if the analysis system is intended for use by the patients themselves ("home monitoring"), because these users are frequently restricted in their movement precision due to illness and/or advanced age.
In order to overcome these problems, capillary sensors have been suggested - also since many years - which have a capillary channel, enclosed by at least two wall parts, having an inlet opening for the sample liquid and a vent opening. The capillary channel contains the reagents required for the analysis. During use of these capillary sensors, a drop of the sample liquid (typically blood) is brought into contact with the inlet opening and sucked by the capillary effect into the capillary channel, where the reaction characteristic for the analysis occurs.
Thereby easier handling and precise metering of the sample liquid participating in the reaction are achieved.
Colorimetric capillary sensors are described, for example, in the following publications:
1) US Patent 4,088,448 2) GB 2 090 659 A
3) EP 0 057 110.
In the publication 4) WO 86/00138, a capillary sensor is described in which the analysis is based on electrochemical principles. In this case, the capillary channel contains at least two electrodes (working electrode and counter electrode) and the reagents are selected so that as a result of the analysis reaction, a change (of a current or a voltage) occurs, which is electrically measurable by means of the electrodes. In order to provide the required connection to the evaluation instrument, these capillary sensors have sensor contacts which are connected to the electrodes on one side and, when the capillary sensor is plugged into the evaluation instrument, to mating device contacts on the other side, thus providing an electrical connection to the measurement and evaluation electronics of the device. Newer embodiments of such electrochemical capillary sensors are described, for example, in the following publications:
Analysis systems, which comprise analysis elements intended for one-time use and evaluation instruments tailored to a specific type of analysis element, are used to a large extent for the qualitative and quantitative analysis of components of liquid samples, in particular body fluids of humans or animals. To perform an analysis, the analysis element, which is also referred to as a "biosensor" in the professional world, is brought into contact with the sample. The reaction of the sample with at least one reagent contained in the biosensor leads to a change of a measurable physical property (measurement variable) of the biosensor, which is characteristic for the analysis. The evaluation instrument contains a measurement and evaluation electronics for measuring the measurement variable and determining the desired analysis information (typically the concentration of the analyte) on the basis of the measured value.
In the early times of the development, test strips, which comprise a plastic carrier having at least one test field containing the reagents, were the most typical type of analysis elements. In order to analyze, for example, a blood drop obtained by finger pricking, the blood adhering to the finger is applied directly to the test field. The excess blood is then wiped off or washed off.
The reaction of the blood with the reagents contained in the test field leads to a change of its color, which may be evaluated using a photometer of the evaluation instrument.
However, this method has several disadvantages. In particular, the variation of the amount of sample which penetrates into the test field and is available for analysis is relatively high. In addition, for many users the handling is difficult. This is in particular true if the analysis system is intended for use by the patients themselves ("home monitoring"), because these users are frequently restricted in their movement precision due to illness and/or advanced age.
In order to overcome these problems, capillary sensors have been suggested - also since many years - which have a capillary channel, enclosed by at least two wall parts, having an inlet opening for the sample liquid and a vent opening. The capillary channel contains the reagents required for the analysis. During use of these capillary sensors, a drop of the sample liquid (typically blood) is brought into contact with the inlet opening and sucked by the capillary effect into the capillary channel, where the reaction characteristic for the analysis occurs.
Thereby easier handling and precise metering of the sample liquid participating in the reaction are achieved.
Colorimetric capillary sensors are described, for example, in the following publications:
1) US Patent 4,088,448 2) GB 2 090 659 A
3) EP 0 057 110.
In the publication 4) WO 86/00138, a capillary sensor is described in which the analysis is based on electrochemical principles. In this case, the capillary channel contains at least two electrodes (working electrode and counter electrode) and the reagents are selected so that as a result of the analysis reaction, a change (of a current or a voltage) occurs, which is electrically measurable by means of the electrodes. In order to provide the required connection to the evaluation instrument, these capillary sensors have sensor contacts which are connected to the electrodes on one side and, when the capillary sensor is plugged into the evaluation instrument, to mating device contacts on the other side, thus providing an electrical connection to the measurement and evaluation electronics of the device. Newer embodiments of such electrochemical capillary sensors are described, for example, in the following publications:
5) US Patent 5,437,999 6) WO 99/32881 7) US Patent 6,103,033 8) Patent Abstract of Japan 2000-258382 9) US Patent 6,071,391 On this basis, the present invention addresses the technical problem to further improve, in particular with respect to simple handling, the analysis of body fluids, in particular blood, by means of capillary sensors,.
This object is achieved by a capillary sensor analysis system of the type explained above wherein the capillary sensors are implemented as multiple capillary sensor strips each having a plurality of capillary sensors positioned one after the other in the capillary sensor strip, the multiple capillary sensor strips are guided and held in the capillary sensor holder of the evaluation instrument in such a manner that the inlet opening of one capillary sensor of the strip at a time is accessible for contact with sample liquid, and the multiple capillary sensor strip is movable in the evaluation instrument so that consecutive capillary sensors of the capillary sensor strip are transported one after the other into the measurement position. The invention also refers to i5 corresponding multiple capillary sensor strips.
The system of the invention preferably operates with electrochemical capillary sensors. Especially simple handling is achieved according to a preferred embodiment if the evaluation instrument has a cutting device, by which, after each measurement, the capillary sensor used during the measurement is cut off from the multiple capillary sensor strip.
In the field of conventional colorimetric analysis elements, without a capillary channel, several design proposals have already been made where a plurality of analysis elements are assembled into a strip. For example, the publication 10) EP 0 299 517 A2 describes an analysis system in which a band-shaped analysis film is used, which contains a plurality of multilayered analysis elements. In the instrument the band-shaped analysis film is kept ready on a first spool and wound onto a second spool after use. A similar design is described in 11) DE 198 19 407 Al 5 Examples of multiple strips which comprise an arrangement of colorimetric analysis elements connected to one another are known from the publications 12) US Patent 5,757,666 13) DE 197 14 674 Al, and 14) US Patent 6,027,689.
These designs are, however, not suitable for capillary sensors, in which specific problems arise which result, for example, from the integration of the capillary channel, the requirements of the manufacturing process connected therewith, and the requirements of use (e.g., accessibility of the inlet opening). Additional special problems result in electrochemical capillary sensors, for example due to the requirements of the electrical contact.
In accordance with one aspect of the present invention, there is provided a capillary sensor analysis system for analyzing a sample liquid with respect to an analyte contained therein, comprising: capillary sensors; including a capillary channel, which is delimited by at least two wall parts and has an inlet opening for the sample liquid and a vent opening; the capillary channel containing reagents, the reaction of the sample liquid with the reagents resulting in a measurable change of a measurement variable which is characteristic for the analysis; and an evaluation instrument, which includes a capillary sensor holder suitable for positioning a capillary sensor for performing an analysis in a measurement position in such a manner that its inlet opening is accessible for bringing a sample liquid to be assayed into contact with the inlet opening, whereby 5a the sample liquid enters and fills, driven by capillary forces, the capillary channel; and a measurement and evaluation electronics for measuring the measurement variable and determining the desired analysis information on the basis of the measured value resulting from the measurement; wherein the capillary sensors are shaped as multiple capillary sensor strips comprising a plurality of capillary sensors arranged one after the other; the capillary channels of the multiple capillary sensor strip lo include a flow obstruction formed by a recess which extends through at least one of the wall parts and over the width of the capillary channel, by which flow obstruction the flow of a sample liquid entering via its inlet opening is stopped and the sample liquid is thus prevented from advancing into the next following capillary sensor of the multiple capillary sensor strip; the multiple capillary sensor strip being guided and held in the capillary sensor holder of the evaluation instrument in such a manner that one capillary sensor of the strip at a time is located in the measurement position and its inlet opening is accessible for contact with sample liquid; and the multiple capillary sensor strip is movable in the evaluation instrument in such a manner that consecutive capillary sensors of the multiple capillary sensor strip are transported one after the other into the measurement position.
The present invention will be explained in greater detail hereafter on the basis of exemplary embodiments schematically illustrated in the figures. The features shown therein may be used individually or in combination to provide preferred embodiments of the present invention. In the figures Fig. 1 shows a capillary sensor analysis, system according to the present invention in a side view, partially as a block diagram, Fig. 2 shows a multiple capillary sensor strip while a blood sample is being applied, Fig. 3 shows a perspective illustration of a multiple capillary sensor strip, Fig. 4 shows a partially cutaway perspective illustration of a multiple capillary sensor strip, Fig. 5 shows a cross-section through a multiple capillary sensor strip, io Fig. 6 shows an illustration of the electrical connection between a multiple capillary sensor strip and the measurement and evaluation electronics, Fig. 7 shows a perspective illustration of an alternative embodiment of a multiple capillary sensor strip having sliding contacts, Fig. 8 shows a schematic diagram of an alternative embodiment of a capillary sensor analysis system according to the present invention, Fig. 9 shows an illustration of the layout of different layers of a multiple capillary sensor strip for use in a system according to figure 8, Fig. 10 shows a detail view of an electrode arrangement of figure 9.
The capillary sensor analysis system 1 shown in figure 1 comprises an evaluation instrument 2 and multiple capillary sensor strips 3, which may be inserted replaceably into the evaluation instrument 1. In the case shown, the multiple capillary sensor strip 3 is implemented as a flexible sensor band 4, which is wound up in a bent state in the housing 5 of the evaluation instrument 2 using a hollow rotatable drum 6.
The sensor band 4 and the drum 6 are located inside a sealed cassette 8, which may be inserted replaceably into the evaluation instrument 2. The front end of the sensor band 4 projects out of the cassette 8 through an outlet opening 10, provided with flexible seals 9. The band is clamped between two transport rollers 11 and projects out of an aperture 12 of the housing 2 in such a manner that an inlet opening 13 provided at the front edge of the multiple capillary sensor strip is accessible, so that it may be contacted with a sample liquid.
Figure 2 shows a schematic diagram of this part of the procedure. The multiple capillary sensor strip 3, shown in plan view, comprises a plurality of individual capillary sensors 14a-14d, arranged one after the other, which are formed by consecutive sections of the sensor band 4. The capillary sensors 14 each contain a capillary channel 15a-15d, each having an inlet opening 13a-13d for the sample liquid and a vent opening 17a-17d.
In the preferred embodiment shown, the capillary channels 15 of the capillary sensors run in the longitudinal direction of the multiple capillary sensor strip and adjoin one another in alignment in such a manner that their inlet and outlet openings are located diametrically opposite one another. The required separation of the capillary channels 15 is achieved by means of flow obstructions, which are in the shown embodiment formed by recesses 16 that penetrate the entire sensor strip 4 and extend over at least the entire width of the capillary channel 15. The recesses 16 simultaneously form the inlet openings 13 and the vent openings 17.
The shown embodiment, having capillary channels adjoining one another in alignment and (therefore) diametrically opposing inlet and vent openings, is especially advantageous for manufacturing. Such a multiple capillary sensor strip may, as will be explained in greater detail below, be manufactured simply in a continuous method. All production steps can be performed on a band running in the lengthwise direction of the strips. No motions io transverse to the production direction are necessary.
Flow obstructions in the form of recesses which penetrate at least one of the wall parts and extend over the entire width of the capillary channel are especially advantageous with regard to both function and production.
A flow obstruction may, however, be provided by other means, for example by making the respective section of the capillary channel hydrophobic.
In order to perform an analysis, a drop of sample liquid, for example a blood drop 19 obtained by pricking a finger 18, is brought into contact with the inlet opening of the forwardmost capillary sensor of the multiple capillary sensor strip 3 in such a manner that the sample liquid is sucked into the capillary channel of the forwardmost sensor 14a of the strip 3. When this capillary channel 15a has been filled, the reaction with reagents contained therein takes place and subsequently the measurement of a measurement variable characteristic for the analysis is performed. The present invention does not differ from known capillary sensors with respect to the biochemical analysis methods used, so that no further explanation thereof is necessary.
After performing the measurement the used forwardmost capillary sensor 14a is cut off by means of a cutting device 20 from the multiple capillary sensor strip 3, and disposed of. Subsequently, the multiple capillary sensor strip 3 is transported further using the transport rollers 11, so that the next following capillary sensor 14b is brought into the measurement position 22. In the illustrated embodiment the cassette 8 and the transport rollers 11 thus form a capillary sensor holder identified as a whole by 23, in order to position one capillary sensor 14 at a time in the measurement position 22 in such a manner that its inlet opening 13 is accessible, so that a sample can be contacted with it in such a manner that the sample liquid penetrates, driven by capillary forces, into the capillary channel 15 and fills it. The multiple capillary sensor strip 3 is guided and held in is the capillary sensor holder 23 in such a manner that in each case the forwardmost capillary sensor 14a of the strip 3 is located in the measurement position 22, in which its inlet opening 13a is accessible for contact with sample liquid. It is movable inside the evaluation instrument 2 in such a manner that consecutive capillary sensors 14 are transported one after the other into the measurement position 22.
The multiple capillary sensor strip 3 illustrated in figure 1 comprises electrochemical capillary sensors having electrodes which must be connected to a measurement and evaluation electronics 25 to perform a measurement. For this purpose, the electrodes (as will be explained further below) are connected to wires 26 wound up inside the hollow drum 6. The other ends of wires 26 are soldered to corresponding sensor contacts 27 on the floor of the cassette 8. The sensor contacts extend to the external side of the cassette 8 and, when the cassette 8 is inserted into the evaluation instrument 2, are connected to corresponding device contacts (shown dashed in figure 1), which are in turn connected to the measurement and evaluation electronics 25 via fixed lines 29 in the device. The length of the wires 26 is so dimensioned that the sensor strip 4 may be wound up s completely.
Details of a preferred construction of the multiple capillary sensor strip according to the present invention may be seen more clearly in figures 3 to 5. The multiple 10 capillary sensor strips 3 illustrated therein may be embodied as straight elongated rods 30. However, if flexible materials of relatively low thickness are used, a flexible sensor band 4, as shown in figure 1, may also be designed using the same principles.
Structural elements of the construction shown are a lower tape 32, an upper tape 33, and two spacer tapes 34 with adhesive on both sides. The tapes 32 and 33 may be fixed by means of spacer tapes 34 at the desired distance from one another in such a manner that a continuous capillary channel 35 is formed. The continuous capillary channel 35 is divided by the recesses 16 into the individual capillary channels of the capillary sensors 14a, 14b, etc. It is delimited on the top and bottom by the tapes 32, 33 and laterally by the spacer tapes 34. The elements 32 to 34 are made of plastic materials as typically used in biosensor technology, such as polyester or polyamide.
In the shown preferred embodiment of electrochemical biosensors the working electrodes 36 of the sensors 14 (whose separation lines 37 are indicated dashed in figure 3) are formed by a layer 38 of a conductive material, vapor-deposited onto the lower tape 32, and by a reagent layer 39 above the conductive layers and containing the necessary reagents (to determine glucose, typically the enzyme glucose oxidase and a suitable mediator). The layer 38 may in particular be made of a metal, such as gold, silver, palladium, or platinum, or of graphite. The counter electrode 41 may be formed, for example, by a Ag/AgCl layer 42, which is only shown in figure 5.
A construction of this type may be manufactured cost-effectively as an endless band using coating and bonding io techniques used for manufacturing typical biosensors.
First the tapes 32 and 33 are coated with the layers 38, 39 and/or 42 and then are bonded together using the spacer tapes 34 having adhesive on both sides.
is After the sandwich assembly is manufactured, the recesses 16 are stamped in, each of which forms a flow obstruction 44 in the continuous capillary channel 35. By these flow obstructions 44, the flow of a sample liquid penetrating through the inlet opening 13a into the forwardmost 20 capillary sensor 14a is stopped and the sample liquid is reliably prevented from penetrating into the next following capillary sensor 14b of the multiple capillary sensor strip 3. At the same time, the displaced air escapes through the recess 16, which simultaneously forms 25 the vent opening 17 of the prior capillary sensor 14a and (after the forwardmost capillary sensor is cut off along the separation line 37b) forms the inlet opening 13 of the next following capillary sensor 14. In the embodiment shown manufacturing is also simplified by the fact that 30 the position in the lengthwise direction relative to each other of the tapes bonded to form the sandwich is not important in the production process.
In the shown preferred embodiment, the wall parts 47, 48, 35 which delimit the capillary channels 15 of the capillary sensors 14, are formed by flat, non-profiled films and extend over the entire length of the multiple capillary sensor strip 3. Such a design has the explained production advantages. In addition, a high flexibility may be achieved, so that the capillary sensor strips may be rolled with a low radius of curvature and thus integrated into the analysis system in a space-saving manner. The multiple capillary sensor strips may in principle, however, also be manufactured from profiled parts, such as deep-drawn profiled films. Preferably the profiling should, however, not be so pronounced that the desired flexibility is no longer achieved.
In any case, the wall parts which enclose the capillary channel are preferably made of plastic film bands, which are drawn off from rolls and may be bonded to one another in a continuous method in such a manner that the capillary gap remains between them. The required separation of the capillary gaps of consecutive capillary sensors from one another may also be achieved - instead of by the recesses 16 - in that, in the course of such a production process, spacer strips are applied which run not only along the lengthwise edges, but rather also have transverse webs, by which the capillary channels of the individual sensors may be separated from one another. In this case venting may be provided by a vent hole located in the upper film strip at the end of the capillary channel of each sensor.
In the shown embodiment the printed leads formed by the gold layer 38 and/or the Ag/AgCl layer 42 each extend without electrical separation over all capillary sensors 14 of the multiple capillary sensor strip 3 and are connected via a common sensor contact 27 to a corresponding device contact 28 and thus to the measurement and evaluation electronics of the evaluation instrument (figure 1). Figure 6 shows a suitable construction of the electrical contact between the multiple capillary sensor strip 3 and the connection wires 26 leading to the measurement and evaluation electronics. During assembly the multiple capillary sensor strips 3 are pushed into a guide 50, which may be a component of the drum 6 shown in figure 1. When the strip 3 penetrates into a contacting device 51, two io wedge-shaped contact edges, which are positioned opposite to one another and are electrically insulated from one another, penetrate into the capillary channel 35 of the strip 3, split it open, and at the same time contact its conductive interior walls. The two contact edges 52, 53 are connected to the wires 26.
The multiple capillary sensor strip 3 shown in figure 7 differs from the embodiment shown in figures 3 to 5 in that the electrical contact to the electrodes 36, 41 is provided by means of sliding contacts 55, 56 which are fixed to the device and are in direct contact with the corresponding printed electrode leads.
In the alternative embodiment shown in figures 9 and 10, two-dimensional electrode structures in a plane are used instead of electrodes extending over the entire surface in opposing arrangement. Such a multiple capillary sensor strip may also be embodied as a sandwich construction having three structural layers, where the wall parts, which delimit the capillary channel on top and bottom, can be formed from film tapes.
The layout of the layers is shown in figure 9. Partial figures a, b, and c show plan views of the lower tape 32 in three manufacturing steps. Partial figure a shows a conductor structure 58 for the electrodes. A reagent layer 39 running over it is shown in partial figure b.
Partial figure c shows the lower tape 32 after two spacer tapes 34 have been attached. Finally, partial figure d shows an upper film tape 33 having punched-out holes 59 and 60. Holes 60 are used for sample supply and holes 59 are used as vents. Vent hole 59 simultaneously forms a flow obstruction, by which the flow along the capillary channel is stopped and the sample liquid is prevented from penetrating into the neighboring capillary sensor.
To this end it is sufficient to provide a recess which penetrates at least one of the wall parts up to the capillary channel and extends over its entire width.
Alternatively, however, both the vent recess and the recess used for sample supply may extend through both wall parts, i.e., through the entire sensor.
As may be seen more clearly from figure 10, in this embodiment additional electrodes 61 and 62, in addition to the working electrode 36 and the counter electrode 41, are provided which may, for example, be used to check the filling status. Figure 10 also shows (dashed) the preferred position of the holes 59 and 60. When a blood drop is brought into contact with the hole 59 used as the filling opening, it is sucked into the capillary channel 15, contacting the electrodes 36 and 41 first. As it penetrates further, the sample contacts the control electrodes 61 and 62. This causes a drop of the electrical resistance between these electrodes. This resistance change may be measured in known manner as an indication that the capillary channel 15 is filled up to the region of the control electrodes 61, 62 and thus sufficient sample contact to the working electrode 36 and the counterelectrode 41 is ensured. In order to provide this function, the control electrodes 61, 62 must be positioned between the electrodes 36, 41 and the vent opening 59. The relatively complex electrode structure shown may be produced efficiently in a continuous "laser ablation process".
In the embodiment of a corresponding analysis system 1 schematically shown in figure 8, the multiple capillary sensor strip 3 is moved continuously step-by-step past the measurement position 22. At the measurement position 10 22, a mechanically movable lancet 63 is provided, which pricks the finger 18. The blood drop thus obtained penetrates through a hole 65 into the capillary sensor located in the measurement position 22. The resulting electrical signal is tapped via electrode contact 64 and is fed to the measurement and analysis circuit. The multiple capillary sensor strip 3 used here may be designed as shown in figures 9 and 10, but may also have a design having reagent layers over the entire surface, as is shown in figures 3 through 5. In any case, the recess used as the inlet opening must extend through all layers of the sensor, so that the lancet 63 may pierce through this recess into the finger.
A sensor in which the lancets are integral components of the sensor construction is known from US Patent 5,047,044. However, this requires that the sensor is made from complexly-shaped molded parts, having many individual elements. Such a design may in practice only be manufactured by an injection molding process. In relation thereto, the design shown in figure 10 is much simpler and more cost-effective.
This object is achieved by a capillary sensor analysis system of the type explained above wherein the capillary sensors are implemented as multiple capillary sensor strips each having a plurality of capillary sensors positioned one after the other in the capillary sensor strip, the multiple capillary sensor strips are guided and held in the capillary sensor holder of the evaluation instrument in such a manner that the inlet opening of one capillary sensor of the strip at a time is accessible for contact with sample liquid, and the multiple capillary sensor strip is movable in the evaluation instrument so that consecutive capillary sensors of the capillary sensor strip are transported one after the other into the measurement position. The invention also refers to i5 corresponding multiple capillary sensor strips.
The system of the invention preferably operates with electrochemical capillary sensors. Especially simple handling is achieved according to a preferred embodiment if the evaluation instrument has a cutting device, by which, after each measurement, the capillary sensor used during the measurement is cut off from the multiple capillary sensor strip.
In the field of conventional colorimetric analysis elements, without a capillary channel, several design proposals have already been made where a plurality of analysis elements are assembled into a strip. For example, the publication 10) EP 0 299 517 A2 describes an analysis system in which a band-shaped analysis film is used, which contains a plurality of multilayered analysis elements. In the instrument the band-shaped analysis film is kept ready on a first spool and wound onto a second spool after use. A similar design is described in 11) DE 198 19 407 Al 5 Examples of multiple strips which comprise an arrangement of colorimetric analysis elements connected to one another are known from the publications 12) US Patent 5,757,666 13) DE 197 14 674 Al, and 14) US Patent 6,027,689.
These designs are, however, not suitable for capillary sensors, in which specific problems arise which result, for example, from the integration of the capillary channel, the requirements of the manufacturing process connected therewith, and the requirements of use (e.g., accessibility of the inlet opening). Additional special problems result in electrochemical capillary sensors, for example due to the requirements of the electrical contact.
In accordance with one aspect of the present invention, there is provided a capillary sensor analysis system for analyzing a sample liquid with respect to an analyte contained therein, comprising: capillary sensors; including a capillary channel, which is delimited by at least two wall parts and has an inlet opening for the sample liquid and a vent opening; the capillary channel containing reagents, the reaction of the sample liquid with the reagents resulting in a measurable change of a measurement variable which is characteristic for the analysis; and an evaluation instrument, which includes a capillary sensor holder suitable for positioning a capillary sensor for performing an analysis in a measurement position in such a manner that its inlet opening is accessible for bringing a sample liquid to be assayed into contact with the inlet opening, whereby 5a the sample liquid enters and fills, driven by capillary forces, the capillary channel; and a measurement and evaluation electronics for measuring the measurement variable and determining the desired analysis information on the basis of the measured value resulting from the measurement; wherein the capillary sensors are shaped as multiple capillary sensor strips comprising a plurality of capillary sensors arranged one after the other; the capillary channels of the multiple capillary sensor strip lo include a flow obstruction formed by a recess which extends through at least one of the wall parts and over the width of the capillary channel, by which flow obstruction the flow of a sample liquid entering via its inlet opening is stopped and the sample liquid is thus prevented from advancing into the next following capillary sensor of the multiple capillary sensor strip; the multiple capillary sensor strip being guided and held in the capillary sensor holder of the evaluation instrument in such a manner that one capillary sensor of the strip at a time is located in the measurement position and its inlet opening is accessible for contact with sample liquid; and the multiple capillary sensor strip is movable in the evaluation instrument in such a manner that consecutive capillary sensors of the multiple capillary sensor strip are transported one after the other into the measurement position.
The present invention will be explained in greater detail hereafter on the basis of exemplary embodiments schematically illustrated in the figures. The features shown therein may be used individually or in combination to provide preferred embodiments of the present invention. In the figures Fig. 1 shows a capillary sensor analysis, system according to the present invention in a side view, partially as a block diagram, Fig. 2 shows a multiple capillary sensor strip while a blood sample is being applied, Fig. 3 shows a perspective illustration of a multiple capillary sensor strip, Fig. 4 shows a partially cutaway perspective illustration of a multiple capillary sensor strip, Fig. 5 shows a cross-section through a multiple capillary sensor strip, io Fig. 6 shows an illustration of the electrical connection between a multiple capillary sensor strip and the measurement and evaluation electronics, Fig. 7 shows a perspective illustration of an alternative embodiment of a multiple capillary sensor strip having sliding contacts, Fig. 8 shows a schematic diagram of an alternative embodiment of a capillary sensor analysis system according to the present invention, Fig. 9 shows an illustration of the layout of different layers of a multiple capillary sensor strip for use in a system according to figure 8, Fig. 10 shows a detail view of an electrode arrangement of figure 9.
The capillary sensor analysis system 1 shown in figure 1 comprises an evaluation instrument 2 and multiple capillary sensor strips 3, which may be inserted replaceably into the evaluation instrument 1. In the case shown, the multiple capillary sensor strip 3 is implemented as a flexible sensor band 4, which is wound up in a bent state in the housing 5 of the evaluation instrument 2 using a hollow rotatable drum 6.
The sensor band 4 and the drum 6 are located inside a sealed cassette 8, which may be inserted replaceably into the evaluation instrument 2. The front end of the sensor band 4 projects out of the cassette 8 through an outlet opening 10, provided with flexible seals 9. The band is clamped between two transport rollers 11 and projects out of an aperture 12 of the housing 2 in such a manner that an inlet opening 13 provided at the front edge of the multiple capillary sensor strip is accessible, so that it may be contacted with a sample liquid.
Figure 2 shows a schematic diagram of this part of the procedure. The multiple capillary sensor strip 3, shown in plan view, comprises a plurality of individual capillary sensors 14a-14d, arranged one after the other, which are formed by consecutive sections of the sensor band 4. The capillary sensors 14 each contain a capillary channel 15a-15d, each having an inlet opening 13a-13d for the sample liquid and a vent opening 17a-17d.
In the preferred embodiment shown, the capillary channels 15 of the capillary sensors run in the longitudinal direction of the multiple capillary sensor strip and adjoin one another in alignment in such a manner that their inlet and outlet openings are located diametrically opposite one another. The required separation of the capillary channels 15 is achieved by means of flow obstructions, which are in the shown embodiment formed by recesses 16 that penetrate the entire sensor strip 4 and extend over at least the entire width of the capillary channel 15. The recesses 16 simultaneously form the inlet openings 13 and the vent openings 17.
The shown embodiment, having capillary channels adjoining one another in alignment and (therefore) diametrically opposing inlet and vent openings, is especially advantageous for manufacturing. Such a multiple capillary sensor strip may, as will be explained in greater detail below, be manufactured simply in a continuous method. All production steps can be performed on a band running in the lengthwise direction of the strips. No motions io transverse to the production direction are necessary.
Flow obstructions in the form of recesses which penetrate at least one of the wall parts and extend over the entire width of the capillary channel are especially advantageous with regard to both function and production.
A flow obstruction may, however, be provided by other means, for example by making the respective section of the capillary channel hydrophobic.
In order to perform an analysis, a drop of sample liquid, for example a blood drop 19 obtained by pricking a finger 18, is brought into contact with the inlet opening of the forwardmost capillary sensor of the multiple capillary sensor strip 3 in such a manner that the sample liquid is sucked into the capillary channel of the forwardmost sensor 14a of the strip 3. When this capillary channel 15a has been filled, the reaction with reagents contained therein takes place and subsequently the measurement of a measurement variable characteristic for the analysis is performed. The present invention does not differ from known capillary sensors with respect to the biochemical analysis methods used, so that no further explanation thereof is necessary.
After performing the measurement the used forwardmost capillary sensor 14a is cut off by means of a cutting device 20 from the multiple capillary sensor strip 3, and disposed of. Subsequently, the multiple capillary sensor strip 3 is transported further using the transport rollers 11, so that the next following capillary sensor 14b is brought into the measurement position 22. In the illustrated embodiment the cassette 8 and the transport rollers 11 thus form a capillary sensor holder identified as a whole by 23, in order to position one capillary sensor 14 at a time in the measurement position 22 in such a manner that its inlet opening 13 is accessible, so that a sample can be contacted with it in such a manner that the sample liquid penetrates, driven by capillary forces, into the capillary channel 15 and fills it. The multiple capillary sensor strip 3 is guided and held in is the capillary sensor holder 23 in such a manner that in each case the forwardmost capillary sensor 14a of the strip 3 is located in the measurement position 22, in which its inlet opening 13a is accessible for contact with sample liquid. It is movable inside the evaluation instrument 2 in such a manner that consecutive capillary sensors 14 are transported one after the other into the measurement position 22.
The multiple capillary sensor strip 3 illustrated in figure 1 comprises electrochemical capillary sensors having electrodes which must be connected to a measurement and evaluation electronics 25 to perform a measurement. For this purpose, the electrodes (as will be explained further below) are connected to wires 26 wound up inside the hollow drum 6. The other ends of wires 26 are soldered to corresponding sensor contacts 27 on the floor of the cassette 8. The sensor contacts extend to the external side of the cassette 8 and, when the cassette 8 is inserted into the evaluation instrument 2, are connected to corresponding device contacts (shown dashed in figure 1), which are in turn connected to the measurement and evaluation electronics 25 via fixed lines 29 in the device. The length of the wires 26 is so dimensioned that the sensor strip 4 may be wound up s completely.
Details of a preferred construction of the multiple capillary sensor strip according to the present invention may be seen more clearly in figures 3 to 5. The multiple 10 capillary sensor strips 3 illustrated therein may be embodied as straight elongated rods 30. However, if flexible materials of relatively low thickness are used, a flexible sensor band 4, as shown in figure 1, may also be designed using the same principles.
Structural elements of the construction shown are a lower tape 32, an upper tape 33, and two spacer tapes 34 with adhesive on both sides. The tapes 32 and 33 may be fixed by means of spacer tapes 34 at the desired distance from one another in such a manner that a continuous capillary channel 35 is formed. The continuous capillary channel 35 is divided by the recesses 16 into the individual capillary channels of the capillary sensors 14a, 14b, etc. It is delimited on the top and bottom by the tapes 32, 33 and laterally by the spacer tapes 34. The elements 32 to 34 are made of plastic materials as typically used in biosensor technology, such as polyester or polyamide.
In the shown preferred embodiment of electrochemical biosensors the working electrodes 36 of the sensors 14 (whose separation lines 37 are indicated dashed in figure 3) are formed by a layer 38 of a conductive material, vapor-deposited onto the lower tape 32, and by a reagent layer 39 above the conductive layers and containing the necessary reagents (to determine glucose, typically the enzyme glucose oxidase and a suitable mediator). The layer 38 may in particular be made of a metal, such as gold, silver, palladium, or platinum, or of graphite. The counter electrode 41 may be formed, for example, by a Ag/AgCl layer 42, which is only shown in figure 5.
A construction of this type may be manufactured cost-effectively as an endless band using coating and bonding io techniques used for manufacturing typical biosensors.
First the tapes 32 and 33 are coated with the layers 38, 39 and/or 42 and then are bonded together using the spacer tapes 34 having adhesive on both sides.
is After the sandwich assembly is manufactured, the recesses 16 are stamped in, each of which forms a flow obstruction 44 in the continuous capillary channel 35. By these flow obstructions 44, the flow of a sample liquid penetrating through the inlet opening 13a into the forwardmost 20 capillary sensor 14a is stopped and the sample liquid is reliably prevented from penetrating into the next following capillary sensor 14b of the multiple capillary sensor strip 3. At the same time, the displaced air escapes through the recess 16, which simultaneously forms 25 the vent opening 17 of the prior capillary sensor 14a and (after the forwardmost capillary sensor is cut off along the separation line 37b) forms the inlet opening 13 of the next following capillary sensor 14. In the embodiment shown manufacturing is also simplified by the fact that 30 the position in the lengthwise direction relative to each other of the tapes bonded to form the sandwich is not important in the production process.
In the shown preferred embodiment, the wall parts 47, 48, 35 which delimit the capillary channels 15 of the capillary sensors 14, are formed by flat, non-profiled films and extend over the entire length of the multiple capillary sensor strip 3. Such a design has the explained production advantages. In addition, a high flexibility may be achieved, so that the capillary sensor strips may be rolled with a low radius of curvature and thus integrated into the analysis system in a space-saving manner. The multiple capillary sensor strips may in principle, however, also be manufactured from profiled parts, such as deep-drawn profiled films. Preferably the profiling should, however, not be so pronounced that the desired flexibility is no longer achieved.
In any case, the wall parts which enclose the capillary channel are preferably made of plastic film bands, which are drawn off from rolls and may be bonded to one another in a continuous method in such a manner that the capillary gap remains between them. The required separation of the capillary gaps of consecutive capillary sensors from one another may also be achieved - instead of by the recesses 16 - in that, in the course of such a production process, spacer strips are applied which run not only along the lengthwise edges, but rather also have transverse webs, by which the capillary channels of the individual sensors may be separated from one another. In this case venting may be provided by a vent hole located in the upper film strip at the end of the capillary channel of each sensor.
In the shown embodiment the printed leads formed by the gold layer 38 and/or the Ag/AgCl layer 42 each extend without electrical separation over all capillary sensors 14 of the multiple capillary sensor strip 3 and are connected via a common sensor contact 27 to a corresponding device contact 28 and thus to the measurement and evaluation electronics of the evaluation instrument (figure 1). Figure 6 shows a suitable construction of the electrical contact between the multiple capillary sensor strip 3 and the connection wires 26 leading to the measurement and evaluation electronics. During assembly the multiple capillary sensor strips 3 are pushed into a guide 50, which may be a component of the drum 6 shown in figure 1. When the strip 3 penetrates into a contacting device 51, two io wedge-shaped contact edges, which are positioned opposite to one another and are electrically insulated from one another, penetrate into the capillary channel 35 of the strip 3, split it open, and at the same time contact its conductive interior walls. The two contact edges 52, 53 are connected to the wires 26.
The multiple capillary sensor strip 3 shown in figure 7 differs from the embodiment shown in figures 3 to 5 in that the electrical contact to the electrodes 36, 41 is provided by means of sliding contacts 55, 56 which are fixed to the device and are in direct contact with the corresponding printed electrode leads.
In the alternative embodiment shown in figures 9 and 10, two-dimensional electrode structures in a plane are used instead of electrodes extending over the entire surface in opposing arrangement. Such a multiple capillary sensor strip may also be embodied as a sandwich construction having three structural layers, where the wall parts, which delimit the capillary channel on top and bottom, can be formed from film tapes.
The layout of the layers is shown in figure 9. Partial figures a, b, and c show plan views of the lower tape 32 in three manufacturing steps. Partial figure a shows a conductor structure 58 for the electrodes. A reagent layer 39 running over it is shown in partial figure b.
Partial figure c shows the lower tape 32 after two spacer tapes 34 have been attached. Finally, partial figure d shows an upper film tape 33 having punched-out holes 59 and 60. Holes 60 are used for sample supply and holes 59 are used as vents. Vent hole 59 simultaneously forms a flow obstruction, by which the flow along the capillary channel is stopped and the sample liquid is prevented from penetrating into the neighboring capillary sensor.
To this end it is sufficient to provide a recess which penetrates at least one of the wall parts up to the capillary channel and extends over its entire width.
Alternatively, however, both the vent recess and the recess used for sample supply may extend through both wall parts, i.e., through the entire sensor.
As may be seen more clearly from figure 10, in this embodiment additional electrodes 61 and 62, in addition to the working electrode 36 and the counter electrode 41, are provided which may, for example, be used to check the filling status. Figure 10 also shows (dashed) the preferred position of the holes 59 and 60. When a blood drop is brought into contact with the hole 59 used as the filling opening, it is sucked into the capillary channel 15, contacting the electrodes 36 and 41 first. As it penetrates further, the sample contacts the control electrodes 61 and 62. This causes a drop of the electrical resistance between these electrodes. This resistance change may be measured in known manner as an indication that the capillary channel 15 is filled up to the region of the control electrodes 61, 62 and thus sufficient sample contact to the working electrode 36 and the counterelectrode 41 is ensured. In order to provide this function, the control electrodes 61, 62 must be positioned between the electrodes 36, 41 and the vent opening 59. The relatively complex electrode structure shown may be produced efficiently in a continuous "laser ablation process".
In the embodiment of a corresponding analysis system 1 schematically shown in figure 8, the multiple capillary sensor strip 3 is moved continuously step-by-step past the measurement position 22. At the measurement position 10 22, a mechanically movable lancet 63 is provided, which pricks the finger 18. The blood drop thus obtained penetrates through a hole 65 into the capillary sensor located in the measurement position 22. The resulting electrical signal is tapped via electrode contact 64 and is fed to the measurement and analysis circuit. The multiple capillary sensor strip 3 used here may be designed as shown in figures 9 and 10, but may also have a design having reagent layers over the entire surface, as is shown in figures 3 through 5. In any case, the recess used as the inlet opening must extend through all layers of the sensor, so that the lancet 63 may pierce through this recess into the finger.
A sensor in which the lancets are integral components of the sensor construction is known from US Patent 5,047,044. However, this requires that the sensor is made from complexly-shaped molded parts, having many individual elements. Such a design may in practice only be manufactured by an injection molding process. In relation thereto, the design shown in figure 10 is much simpler and more cost-effective.
Claims (12)
1. A capillary sensor analysis system for analyzing a sample liquid with respect to an analyte contained therein, comprising:
capillary sensors;
including a capillary channel, which is delimited by at least two wall parts and has an inlet opening for the sample liquid and a vent opening;
the capillary channel containing reagents, the reaction of the sample liquid with the reagents resulting in a measurable change of a measurement variable which is characteristic for the analysis;
and an evaluation instrument, which includes a capillary sensor holder suitable for positioning a capillary sensor for performing an analysis in a measurement position in such a manner that its inlet opening is accessible for bringing a sample liquid to be assayed into contact with the inlet opening, whereby the sample liquid enters and fills, driven by capillary forces, the capillary channel; and a measurement and evaluation electronics for measuring the measurement variable and determining the desired analysis information on the basis of the measured value resulting from the measurement;
wherein the capillary sensors are shaped as multiple capillary sensor strips comprising a plurality of capillary sensors arranged one after the other;
the capillary channels of the multiple capillary sensor strip include a flow obstruction formed by a recess which extends through at least one of the wall parts and over the width of the capillary channel, by which flow obstruction the flow of a sample liquid entering via its inlet opening is stopped and the sample liquid is thus prevented from advancing into the next following capillary sensor of the multiple capillary sensor strip;
the multiple capillary sensor strip being guided and held in the capillary sensor holder of the evaluation instrument in such a manner that one capillary sensor of the strip at a time is located in the measurement position and its inlet opening is accessible for contact with sample liquid; and the multiple capillary sensor strip is movable in the evaluation instrument in such a manner that consecutive capillary sensors of the multiple capillary sensor strip are transported one after the other into the measurement position.
capillary sensors;
including a capillary channel, which is delimited by at least two wall parts and has an inlet opening for the sample liquid and a vent opening;
the capillary channel containing reagents, the reaction of the sample liquid with the reagents resulting in a measurable change of a measurement variable which is characteristic for the analysis;
and an evaluation instrument, which includes a capillary sensor holder suitable for positioning a capillary sensor for performing an analysis in a measurement position in such a manner that its inlet opening is accessible for bringing a sample liquid to be assayed into contact with the inlet opening, whereby the sample liquid enters and fills, driven by capillary forces, the capillary channel; and a measurement and evaluation electronics for measuring the measurement variable and determining the desired analysis information on the basis of the measured value resulting from the measurement;
wherein the capillary sensors are shaped as multiple capillary sensor strips comprising a plurality of capillary sensors arranged one after the other;
the capillary channels of the multiple capillary sensor strip include a flow obstruction formed by a recess which extends through at least one of the wall parts and over the width of the capillary channel, by which flow obstruction the flow of a sample liquid entering via its inlet opening is stopped and the sample liquid is thus prevented from advancing into the next following capillary sensor of the multiple capillary sensor strip;
the multiple capillary sensor strip being guided and held in the capillary sensor holder of the evaluation instrument in such a manner that one capillary sensor of the strip at a time is located in the measurement position and its inlet opening is accessible for contact with sample liquid; and the multiple capillary sensor strip is movable in the evaluation instrument in such a manner that consecutive capillary sensors of the multiple capillary sensor strip are transported one after the other into the measurement position.
2. Capillary sensor analysis system according to claim 1, wherein the evaluation instrument has a cutting device, by which, after performing a measurement, the capillary sensor used for that measurement is cut off from the multiple capillary sensor strip.
3. Capillary sensor analysis system according to any one of claims 1 to 2, wherein the capillary sensors of the multiple capillary sensor strip are electrochemical capillary sensors, each of which has a working electrode, a counter electrode, and sensor contacts connected to the electrodes via conducting leads, the sensor contacts being during the measurement in contact with corresponding mating contacts of the evaluation instrument for providing an electrical connection to the measurement and evaluation electronics.
4. Capillary sensor analysis system according to claim 3, wherein the conducting leads of at least one of the electrodes extend, without electrical separation, over all capillary sensors of the multiple capillary sensor strip for connection via a common sensor contact to a corresponding instrument contact and thus to the measurement and evaluation electronics of the evaluation instrument.
5. Multiple capillary sensor strip for an analysis system according to any one of claims 1 to 4, comprising a plurality of capillary sensors which are connected to one another and arranged one after the other, wherein the capillary sensors each include a capillary channel which is delimited by at least two wall parts and has an inlet opening for the sample liquid and a vent opening, the capillary channels of the multiple capillary sensor strip include a flow obstruction formed by a recess which extends through at least one of the wall parts and over the width of the capillary channel (15), by which flow obstruction the flow of a sample liquid entering via its inlet opening is stopped and the sample liquid is thus prevented from advancing into the next following capillary sensor of the multiple capillary sensor strip, and reagents are contained in the capillary channel of each of the capillary sensors, the reaction of the sample liquid with at least one of the reagents resulting in a measurable change of a measurement variable which is characteristic for the analysis.
6. Multiple capillary sensor strip according to claim 5, wherein the wall parts are formed from film bands.
7. Multiple capillary sensor strip according to any one of claims 5 or 6, which is implemented as a flexible band, wound up in the evaluation instrument in the curved state.
8. Multiple capillary sensor strip according to any one of claims 5 or 6, which has two continuous wall parts extending over the total length of the capillary sensors arranged one after the other and delimiting the capillary channels of all capillary sensors of the multiple capillary sensor strip.
9. Multiple capillary sensor strip according to any one of claims 5 to 8, wherein the capillary channels of the capillary sensors in the multiple capillary sensor strip adjoin one another in alignment in such a manner that their inlet openings and vent openings face one another.
10. Multiple capillary sensor strip according to any one of claims 5 to 9, which is an electrochemical capillary sensor and has a working electrode, a counter electrode, and sensor contacts connected to the electrodes for providing an electrical connection to a measurement electronics suitable for measuring the electrical measurement variable.
11. Multiple capillary sensor strip according to claim 10, wherein an electrical conducting lead of the working electrodes of the capillary sensors runs on the surface of one wall part and an electrical conducting lead of the counter electrodes of the capillary sensors runs on the surface of the other wall part.
12. Multiple capillary sensor system according to claim 1, wherein the system is adapted for analyzing a body fluid of humans or animals.
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DE10244775.6 | 2002-09-26 | ||
DE10244775A DE10244775A1 (en) | 2002-09-26 | 2002-09-26 | Capillary sensor analysis system |
PCT/EP2003/010378 WO2004030822A1 (en) | 2002-09-26 | 2003-09-18 | Multiple capillary sensor analysis system |
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CA2500071C true CA2500071C (en) | 2008-11-18 |
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CA002500071A Expired - Fee Related CA2500071C (en) | 2002-09-26 | 2003-09-18 | Multiple capillary sensor analysis system |
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US (1) | US7638023B2 (en) |
EP (1) | EP1542803B1 (en) |
JP (1) | JP4221372B2 (en) |
AT (1) | ATE377450T1 (en) |
AU (1) | AU2003283250A1 (en) |
CA (1) | CA2500071C (en) |
DE (2) | DE10244775A1 (en) |
WO (1) | WO2004030822A1 (en) |
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2002
- 2002-09-26 DE DE10244775A patent/DE10244775A1/en not_active Withdrawn
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2003
- 2003-09-18 CA CA002500071A patent/CA2500071C/en not_active Expired - Fee Related
- 2003-09-18 JP JP2004540642A patent/JP4221372B2/en not_active Expired - Fee Related
- 2003-09-18 AU AU2003283250A patent/AU2003283250A1/en not_active Abandoned
- 2003-09-18 EP EP03775159A patent/EP1542803B1/en not_active Expired - Lifetime
- 2003-09-18 AT AT03775159T patent/ATE377450T1/en not_active IP Right Cessation
- 2003-09-18 WO PCT/EP2003/010378 patent/WO2004030822A1/en active IP Right Grant
- 2003-09-18 DE DE50308556T patent/DE50308556D1/en not_active Expired - Lifetime
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2005
- 2005-03-24 US US11/088,305 patent/US7638023B2/en not_active Expired - Fee Related
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WO2004030822A1 (en) | 2004-04-15 |
EP1542803A1 (en) | 2005-06-22 |
AU2003283250A1 (en) | 2004-04-23 |
JP4221372B2 (en) | 2009-02-12 |
EP1542803B1 (en) | 2007-11-07 |
JP2006500595A (en) | 2006-01-05 |
ATE377450T1 (en) | 2007-11-15 |
US7638023B2 (en) | 2009-12-29 |
DE50308556D1 (en) | 2007-12-20 |
DE10244775A1 (en) | 2004-04-08 |
US20050230253A1 (en) | 2005-10-20 |
CA2500071A1 (en) | 2004-04-15 |
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