Encoded biosensors and methods of manufacture and use thereof.
Abstract
An analyte test sensor strip is disclosed having information coded thereon as well as a method of forming the same and conducting an analyte test using the analyte test sensor strip. Information relating to an attribute of the strip or batch/lot of strips may be coded based on resistance values pertaining to electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, the secondary resistive element having one of a plurality of states defined by a location of a closed tap to form a unique resistive path for the secondary resistive element that includes a portion of the primary resistive element depending on the location of the closed tap. The states may be formed on the strip by a secondary processing step in the manufacture of the strip in which a plurality of taps are severed leaving only one tap in a closed state.

Term
5.8 yearsleft in the term
Expires 25 July 2032.
- Priority
- Filed
- Granted
- Today
- Expires
7 claims: 2 independent, 5 dependent
- 1REIVINDICACIONES Habiéndose descrito la invención como antecede, se reclama como propiedad lo contenido en las siguientes reivindicaciones:1. Una tira sensora para pruebas de analitos, caracterizada porque comprende: un sustrato no conductor;una pluralidad de electrodos de medición formados sobre el sustrato no conductor, en donde la pluralidad de electrodos de medición comprende al menos un electrodo de trabajo y un contraelectrodo;un reactivo que puentea el electrodo de trabajo y el contraelectrodo;un circuito de información formado en el sustrato no conductor, en donde el circuito de información comprende.· un elemento resistivo primario que tiene un primer extremo y un segundo extremo que tiene una configuración predeterminada entre el primer y segundo extremos, en donde el elemento resistivo primario tiene una resistencia que cae dentro de un primer intervalo predeterminado, y un elemento resistivo secundario entre el primer extremo del elemento resistivo primario y un tercer extremo, en donde el elemento resistivo secundario comprende una 43Trn)TO MFXiCANO DE LA PROFIEDAD INDUSTRIAL pluralidad de derivaciones cerradas, en donde las derivaciones cerradas conectan selectivamente el tercer extremo con el elemento resistivo primario cada uno en una ubicación predeterminada definiendo de este modo una pluralidad de trayectorias resistivas únicas seleccionables entre el primer extremo y el tercer extremo a través de al menos una porción del elemento resistivo primario, en donde cada una de la pluralidad de trayectorias resistivas únicas seleccionables tiene una segunda resistencia que cae dentro de un segundo intervalo predeterminado;y una pluralidad de almohadillas de contacto formadas sobre el sustrato no conductor, en donde al menos una primera almohadilla de contacto de la pluralidad de almohadillas de contacto está conectada al primer extremo del elemento resistivo primario, una segunda almohadilla de contacto de la pluralidad de almohadillas de contacto está conectada al segundo extremo del elemento resistivo primario, y una tercera almohadilla de contacto de la pluralidad de almohadillas de contacto está conectada a una porción del elemento resistivo secundario;en donde una relación de la primera resistencia y la segunda resistencia se correlaciona selectivamente con un atributo de la tira sensora para pruebas de analitos.
- 2La tira sensora para pruebas de analitos de conformidad con la reivindicación 1, caracterizada porque la INSTITUTO MEXICANO DE LA FROrlíDAD INDUSTRIAL configuración predeterminada del e1emento” resis11vo primario comprende una configuración en serpentina que tiene una pluralidad de extremos proximales y una pluralidad de extremos distales.
- 3La tira sensora para pruebas de analitos de conformidad con la reivindicación 2, caracterizada porque cada una de la pluralidad de derivaciones cerradas del elemento resistivo secundario está conectada a un extremo proximal respectivo del elemento resistivo primario.
- 4La tira sensora para pruebas de analito de conformidad con la reivindicación 1, caracterizada porque cada una de la pluralidad de derivaciones cerradas puede seleccionarse como una función de un atributo de la tira sensora para pruebas de analitos.
- 5La tira sensora para pruebas de analitos de conformidad con la reivindicación 1, caracterizada porque comprende además un código óptico sobre el sustrato no conductor.
- 6La tira sensora para pruebas de analito de conformidad con la reivindicación 5, caracterizada porque el código óptico contiene al menos un atributo de información asociado con la tira sensora para pruebas de analitos seleccionado del grupo consistente en una fecha de caducidad de producto, una identificación de producto, intercepciones de sangre e información de solución de control, una ·- > ν - -- ·:«*· tMsmvro mzccaho Di LA F3CKEEAD INDUSTRIAL identificación de lote de tira, y algoritmo de desempeño de tira. medir 7 . Un método para analito en una muestra de fluido comprende: un’ identi f icador dé una concentración de caracterizado porque insertar la tira sensora para prueba de analitos de conformidad con la reivindicación 10 en un medidor de prueba, en donde el electrodo de trabajo, el contraelectrodo, el elemento resistivo primario y el elemento resistivo secundario se conectan al medidor de prueba a través de la pluralidad de almohadillas de contacto;determinar un atributo asociado con la tira sensora para pruebas de analitos como una función de una medición asociada con al menos el valor de resistencia asociado con al menos una de la pluralidad de trayectorias resistivas únicas seleccionables;configurar el medidor de prueba como una función del atributo;aplicar la muestra de fluido y medir la concentración del analito;y presentar visualmente una medición de la concentración de analito en un presentador visual del medidor de prueba;en donde el elemento resistivo primario tiene un valor de resistencia de elemento primario y el atributo se resistencia de al menos determina como una función de una determinada comparando el valor de una de la pluralidad de trayectorias resistivas únicas seleccionables con el valor de resistencia de elemento 5 primario. 8. El método de conformidad con la reivindicación
- 77, caracterizado porque un extremo del elemento resistivo primario está conectado con el contraelectrodo.
Independent claims7
331 paragraphs in 35 sections, as filed
(54) Title: CODIFIED BIOSENSORS AND METHODS FOR THEIR PRODUCTION AND USE.
(54) Title: ENCODED BIOSENSORS AND METHODS OF MANUFACTURE AND USE THEREOF.
(57) Summary
The present invention relates to an analyte test sensor strip having information encoded therein as well as a method of forming it and conducting an analyte test using the test sensor strip. Information related to an attribute of the strip or group / batch of strips can be coded based on the resistance values pertaining to the electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, The secondary resistive element has one of a plurality of states defined by a location of a closed connector to form a unique resistive path for the secondary resistive element that includes a portion of the primary resistive element depending on the location of the closed connector. States can be formed on the strip by means of a secondary processing step in strip manufacture where a plurality of connectors are separated leaving only one connector in the closed state.
(57) Abstract
An analyte test sensor strip is disclosed having Information coded thereon as well as a method of forming the same and conducting an analyte test using the analyte test sensor strip. Information relating to an attribute of the strip or batch / lot of strips may be coded based on resistance valúes pertaining to electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, the secondary resistive element having one of a plurality of States defined by a location of a closed tap to form a unique resistive path for the secondary resistive element that ineludes a portion of the primary resistive element depending on the location of the closed tap. The States may be formed on the strip by a secondary Processing step in the manufacture of the strip in which a plurality of taps are severed leaving only one tap in a closed State.
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PATENT TITLE No. 356609
ΙΜΡΙ £ 'C
Headlines):
Home:
Denomination:
Classification:
Inventor (s):
F. HOFFMANN-LA ROCHE AG Grenzacherstrasse 124, CH-4070, Basel, SWITZERLAND
CODED BIOSENSORS AND METHODS FOR THE PREPARATION AND USE.
CIP: G01N27 / 327; G01N33 / 487
CPC: G01N27 / S272; G01N3 »4877 <
JOHN T. AUSTERA; TERRY A. BEATY; ABI'tóW. .ÍÍOSEPH; NATHAN E. MANLOVE; STEVEN K. MOORE; JAMES LíWWbfiXUlR .; RA1 <DALI | K. RIGGLES
Number:
MX / a / 2017/007746
Country:
US .v International:
' . ' ' - · ” 0 2012
Divisional; ^ \ 2Kdd ^; give «0li
Validity: Twenty years, or
Date of Veaeiniientoi 25 <December 2032. <sub>ψ s</sub>. >
Issue Date: Jun 6, 2018
The patent of reference «Mrga based on these articles« 1<sup>0</sup>, 2 "'i 1 í¡ r;
Núynero:
13/194,031
-®: · :: -ce v * »„ „. ¿Jg frátx lártfW ftafcA «y. and torda la Industrial.
the artitsjfc φ4 · the Leyide ls PropiedwHndtoSto ^ jwítonte pfeftejrfedria ^ igenfliLde veiqte áfi ^ tororrogables. The inteffncipnsl request will be counted for filing and will be subject to the »gcwWf» issue »» «« lwener vlgenwsáOerechos.
Pursuant to (as of the filing date
Those who subscribe to this title do so based on the difference (Official Gazette of the Federation f®sÓ.R)> 06/27/1991. Amended on 01/25/2006, 05/06/2009, 06/01/2010, 06/18/2 <H0, ¡$ / 06/2010, aW¡g012
Regulations of the Mexican Institute of Industrial Property (I articles 1, 3, 4, 5, section V, subsection a), 1ff fraoeqfif »». J fUlly <sup>30</sup> deTj 12/27/1999, amended on 10/10/2002, 07/29/2004, -54 / 0 ^ 2004 Deputy Generals, Coordinator, Directors Divdáehatfrif Wula
Departmental and other subordinates of the Instituto Mexicáho-Cte la Ptopl ^ tod'TitouStrial.x 08/04/2004 and 09/13/2007). 'A · »„' mteftwcpnaly will be subject |
Rfirtfticulfe e * 1IJceio »We lll yXÍI ^ Íffe the Industrial Property Law 994, Z / iadaM. 12/12/1 ^, 1X05 / 1999, 01/26/2004, 06/16/2005, '2012f aptMÍsfl °, WraífcifeVj ^ iÍó<sup>to</sup>). 4th and 12th fractions I and III of 12/4/1999 ÁwFormadQ on 01®7, ''
0 ^ W07 / 2004, 07/28/2004 and 09/07/2007); Mexican Industrial Property (DOF TÁcWdo that delegates powers to the Divisional Directors Subdirectors, Coordinators '15 / 12/1999, amended on 02/04/2000, 07/29/2004,
This letter is signed with advanced electronic signature (SKIN), based on articles 7 BIS 2 of the Industrial Property Law; 3rd of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.
THE DIVISIONAL DIRECTOR OF PATENTS
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NAHANNY CANAL REYES
Original string:
NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service
Tax it | 1695 || MX / 2018/46781 | MX / a / 2017/007746 | Normal patent title with divisional PCT | 1220 | RRGO | Page (s) | DY5zSkl32nc36cgWAz + xqBd6qW4 =
Digital stamp:
Rtj / n50XMCXtxKgkBLKUpQ0Jr3Ed + ePxx7og5JJ8Zswsh75 / YTpprZCxZcwedVehML2wjKJ09C4y¡FsU73c1NQiqhU RzOBGzrNR1qzgQym / KBO + IYQLgNe5JctjQ¡IQLUqaf + 1 JloOGR4twgl3yQS7zDF2VWhyVyqOgyEBwgtXOVipa1qWBk n5zWkfHlnAazB¡OwoSZok9 / 6fdwlrjbSLi7zQGeAaYdCs¡Q2DDQttzy + Rre / OzlRLOrZB6VChUUzYwZmOyDf¡LMObw vbjnKujjlTPqTc3Ljbxk1Mx9k261Zlcdf9lmfpN7vwqkuk / == 5nb76fmYUNU9yBnLVdk8jeCQA
Arenal No. 550. Floor 1, Pueblo Santa María Tepepan. Xochimilco, 16020,
Mexico City.
(55) 53340700 www.gob.mx/hnpi
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MX / 2018/46781
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CODED BIOSENSORS AND METHODS FOR THE PREPARATION AND USE
DESCRIPTION OF THE INVENTION
The present invention relates generally to an analyte test sensor for use in measuring concentrations of an analyte in a biological fluid and, more particularly, to an analyte test strip having encoded information formed therein.
Biosensors provide an analysis of a biological fluid, such as whole blood, urine, or saliva. Measuring the concentration of substances in biological fluids is an important tool for the diagnosis and treatment of many medical conditions. For example, the measurement of glucose in body fluids, such as blood, is crucial for the effective treatment of diabetes. The biological fluid sample can be collected directly or it can be a derivative of a biological fluid. Typically, biosensors have a non-disposable measuring device or meter that is used to analyze the biological fluid sample that is placed on the test strip.
Many biosensor systems provide calibration information to the measurement device prior to analysis. The measurement device typically uses this information to adjust the analysis of the biological fluid in response to one or more parameters. The accuracy and
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Analysis accuracy is improved by the use of calibration information. If the calibration information is not used, the measurement device may not complete the analysis or may erroneously analyze the concentration of the analyte in the biological fluid.
It is common practice in such meter / test strip systems to ensure proper identification of the test strip in order to ensure proper test results. For example, an individual meter may be able to analyze several different types of test strips, where each type of test strip is designated to test for the presence or absence of a different analyte in the biological fluid. In order to properly conduct the test, the meter must know the type of test to be performed for the test strip currently in use.
Also, batch-to-batch variations in test strips typically require calibration information to be loaded into the meter in order to ensure accurate test results. A common practice to download such calibration information to the meter is to use a memory (ROM) that is inserted into a corresponding slot or receptacle on the meter. Because these calibration data can only be accurate for a particular test strip production batch, the user is usually asked to confirm that the number of
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match the batch of the test strip currently in use to match the batch number for which the ROM was programmed.
Many other instances where information about the test strip is desired are known to the person skilled in the art. Attempts by the prior art to read the code information on the test strip by means of the measurement have suffered from many problems, including a severely limited amount of information that can be encoded and the use of relatively large amounts of surface area of the test strip. test strip for information encoding function.
In this way, a system and method are necessary that will allow encoding the information in a biosensor to read the information through the meter.
One aspect of the present invention describes an analyte test sensor strip that is used to measure the presence or concentration of an analyte in a fluid sample. The test sensor strip includes a non-conductive substrate. Furthermore, the test sensor strip includes an outer or primary resistive element formed in the non-conductive substrate having a first end and a second end. The primary resistive element has a predetermined configuration, which is a serpentine configuration in a shape having a plurality of proximal ends and a plurality of distal ends. In addition, an internal resistive element or
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the non-conductive substrate having a connector connected to the primary resistive element at a predetermined connection point in the predetermined configuration thereby defining a single resistive path through at least a portion of the predetermined configuration.
The single resistive path through the predetermined configuration has associated therewith a resistance falling within one of the plurality of respective resistance ranges. Resistance is determined based on, or as a function of a default connection point location in the default configuration. The unique resistive path is associated with an attribute of the analyte test sensor strip. An attribute of the strip should be broadly understood to refer to any information related to the strip, such as the type of strip, calibration information, manufacturing information, country information, etc. Essentially any information pertaining to the strip that may be desirable to transport to a meter that is used with the strip.
In order to provide an opportunity to define the unique resistive path from among more than one possible unique resistive path each associated resistance correlated with a different attribute, the element
IMPI
CÍ57ÍTUTO MEXICANO Dt LA PROPIEDAD INDUSTRIAL
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secondary resistive includes a plurality of connectors. The respective connector that connects with the predetermined configuration at the predetermined connection point is formed or maintained in a closed state and all other connectors of the plurality of connectors are open or are formed in an open state.
The first end of the primary resistive element is connected to a first contact pad, and the second end is connected to a second contact pad. The secondary resistive element has a third end connected to a third contact pad. The single resistive path runs from the third contact pad through the secondary resistive element and then into the primary resistive element at the predetermined connection point and then through at least a portion of the primary resistive element to one of the first and second contact pads.
Another aspect of the present invention describes an analyte test sensor strip that is used to measure the concentration of an analyte in a fluid sample. The test sensor strip includes a non-conductive substrate. A primary resistive element is formed on the non-conductive substrate in a predetermined configuration with a first end connected to a first contact pad and a second end connected to a second contact pad.
MEXICAN INSTITUTE ΓΈ IA PRO? '- DAD
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Contact. A secondary resistive element is also formed on the non-conductive substrate with a plurality of connectors. A connector of the plurality of connectors connects to the primary resistive element at a predetermined location thus being formed and / or maintained in a closed state and defining a single resistive path through at least a portion of the primary resistive network. The other connectors of the plurality of connectors are open or are formed in an open state thus being disconnected from the primary resistive network. A portion of the secondary resistive element is connected to a contact pad of the secondary resistive element.
In one way, the contacts that are in the open state are removed with a laser. The unique resistive path is associated with an attribute of the analyte test sensor strip. In one form, the attribute is associated with one or more algorithm variables, such as a gradient and / or intersection for a linear correlation algorithm, associated with the test sensor strip. In yet another form, the analyte test sensor strip includes an optical code formed in the non-conductive substrate. The optical code may contain information related to the test sensor strip such as a product expiration date, product identification (countries or regions), intersection of blood and control solutions, batch identification of
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strips, and other features. Furthermore, the test sensor strip may also include a first resistance cycle formed on the non-conductive substrate that comprises a first measurement sense electrode in a separate relationship from a first measurement electrode. In one form, the first measurement electrode connects to the second end of the primary resistive element.
Another aspect of the present invention describes a method of forming a biosensor test strip that is used to measure the concentration of an analyte. In this regard, a primary resistive element is formed on a non-conductive substrate that has a predetermined configuration including a first end and a second end. Furthermore, a secondary resistive element is formed on the non-conductive substrate with at least one connector connected to a predetermined connection location on the primary resistive element thereby defining a single resistive path through at least a portion of the primary resistive element that it has associated with it a resistance that falls within one of the plurality of respective resistance ranges.
The secondary resistive element is formed to include a plurality of connectors. All of the plurality of connectors except the connector connected to a predetermined location in the primary resistive element are separated
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therefore disconnecting the separate connectors from the primary resistive element. The primary resistive element includes a plurality of predetermined connection locations. A connection site to be connected to the connector is selected as a function of an attribute associated with the biosensor test strip. The unique resistive path through the primary and secondary resistive elements is associated with an attribute of the biosensor test strip. Furthermore, each resistance interval contained in the plurality of resistance intervals is associated with a unique attribute of the biosensor test strip.
Still another aspect of the present invention describes an analyte test sensor strip that is used to measure the concentration of an analyte. The test sensor strip includes a non-conductive substrate. In addition, the test sensor strip includes means for conducting a quantitative or qualitative analysis of the analyte on a fluid sample. An information circuit is provided on the non-conductive substrate. The information circuit includes a primary conductive path between a first end and a second end with a predetermined configuration between the first and second ends. The conductive primary path has a resistance that falls within a first predetermined interval. The information circuit also
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In one form, a ratio of the first resistance and the second resistance is selectively correlated with an attribute of the analyte test sensor strip. The first end is connected to a first contact pad, the second end is connected to a second contact pad, and the third end is connected to a third contact pad. In one form, the predetermined configuration comprises a serpentine configuration with a plurality of proximal ends and a plurality of distal ends. The closed connector connects to a respective proximal end of the serpentine configuration. The connector comprising the closed connector is selected as a function of an attribute of the analyte test sensor strip.
IMPIOS Mexican Institute OF. THE PROPERTY
INDUSTESAL
Another aspect describes a method of measuring a concentration of an analyte in a fluid sample. The method comprises the steps of providing a meter; By providing a test strip, the test strip comprises: a non-conductive substrate; an operating electrode on the non-conductive substrate connectable to the meter; a counter electrode on the non-conductive substrate connectable to the meter; a reactive part forming a bridge between the operating electrode and the counter electrode; a primary resistive element on the non-conductive substrate with a first end connectable to the meter and a second end connectable to the meter, where the primary resistive element has a predetermined configuration; and a secondary resistive element on the non-conductive substrate with a third end connectable to the meter, where the secondary resistive element has a connector connected to the primary resistive element at a predetermined connection point in the predetermined configuration thus defining a single resistive path through at least a portion of the predetermined configuration with a resistance value; receiving the test strip on the meter; operatively connecting the operating electrode, the counter electrode, the primary resistive element, and the secondary resistive element to the meter; and determine an attribute associated with the test strip as a function of
IMPIOS
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FROM INDUSTRIAL PROPERTY at least the value of single resistive resistance.
resistive element Drimario has a measurement associated with associated with the path
In one form, the resistance value of the primary element and the attribute is determined as a function of a resistance ratio determined by comparing the resistance value of the single resistive path with the resistance value of the primary element. The meter is adjusted to produce a concentration measurement result associated with the analyte as a function of the attribute. In one form, one end of the primary resistive element connects to the counter electrode.
The invention is further illustrated below on the basis of illustrative embodiments shown in the figures.
Fig. 1 illustrates a test strip inserted into a meter.
Fig. 2 is an enlarged view of a representative test strip.
Fig. 3a illustrates a test strip for use in measuring the concentration of an analyte of interest in a biological fluid.
Figs. 3b and 3c illustrate alternative embodiments of a portion of the test strip illustrated in Fig. 3a.
Fig. 4 illustrates a portion of the test strip.
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illustrate a portion 'of r ^' TTra ·<sup>1</sup>aS ”Fig. 3a with a plurality of illustrates another test strip illustrated in Fig. 3a.
Figs. 5a-5g test illustrated on separate connectors.
Representative Fig. 6 for use in measuring the concentration of an analyte of interest in a biological fluid.
Fig. 7 illustrates another representative test strip for use in measuring the concentration of an analyte of interest in a biological fluid.
Fig. 8 illustrates another representative test strip for use in measuring the concentration of an analyte of interest in a biological fluid.
Fig. 9 illustrates a portion of another representative test strip for use in measuring the concentration of an analyte of interest in a biological fluid.
Fig. 10 is a flow chart of a representative process used to measure an analyte in a biological fluid.
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to
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INSTITUTO MEXICANO Dí LA PROPIEDAD INDUSTWAL modality illustrated in the figures, and a specific language will be used to describe that modality. However, it is understood that no limitation is provided to the scope of the invention. Alterations and modifications in the illustrated device and additional applications of the principles of the invention as illustrated herein, as would ordinarily occur to one skilled in the art to which the invention pertains, are contemplated, and desired to be protected. In particular, although the invention is explained in terms of a blood glucose meter, it is contemplated that the invention can be used with devices to measure other analytes and other types of samples. Such alternative modalities require certain adaptations to the modalities explained herein that would be obvious to those skilled in the art.
Referring to Fig. 1, a concentration measurement device or meter 10 is described with an analyte test sensor strip 12 mounted therein which is used to measure the presence or concentration of an analyte in a biological fluid, such like whole blood, urine or saliva. In this way, test strip 12 is removably inserted into a connection terminal 14 of meter 10.
After insertion of test strip 12, meter 10 is configured to automatically turn on and start the measurement process, as exemplified in greater detail.
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later. Meter 10 includes an electronic display 16 that is used to display various types of information to the user including the test results.
Referring to Fig. 2, a general test strip 12 is inserted for background purposes and includes various components. Test strip 12 comprises a small body defining a chamber where the sample fluid is received for testing. This test receiving chamber is filled with the sample fluid by suitable means, preferably by capillary action, but also optionally aided by pressure or vacuum. The sample receiving chamber includes electrodes and adequate chemistry to produce an electrochemical signal indicative of the analyte in the sample fluid.
In this illustrated form, the test strip 12 includes a base substrate 20, a separation layer 22, and a cover layer 24 comprising a body cover 26 and chamber cover 28. The separation layer 22 includes a hollow portion 30 to provide a sample receiving chamber that extends between the base substrate 20 and cover layer 24. The base substrate 20 carries an electrode system 32 including a plurality of electrodes 34 and electrode traces 36 ending in contact pads 38. Electrodes 34 are defined as those portions of electrode traces 36 that are placed within
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The body cover 26 and the chamber cover 28 lie on the separation layer 22 defining a slot between them, the slot defines a discharge opening that communicates with the sample receiving chamber to allow air to escape from the chamber as a sample fluid entering the chamber from the rim opening or opening receiving the fluid. Test strip 12 therefore includes a metering end 42 and an insertion end in gauge 44. The shape of the dosing end 42 typically differs from the insertion end in gauge 44 to assist the user. The body cover 26 and the chamber cover 28 are preferably secured to the separation layer 22 by an adhesive layer 46. In addition, a second adhesive layer 48 secures the separation layer 22 to the base substrate 20. A more detailed explanation of test strip 12 illustrated in Fig. 2 can be found in US Patent Common Property No. 7,829,023, which is incorporated herein by reference in its entirety.
Referring to Fig. 3a, a more detailed image of a preferred shape of a test strip 50 that is configured for use with meter 10 is illustrated with
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the spacer, cover and adhesive layers removed to reveal the electrode system 32 of the test strip 50. The test strip 50 includes a non-conductive base substrate 52 having a plurality of electrodes, traces and pads formed thereon. contact, as will be explained in more detail later. Such training can be accomplished through the use of any of a number of known techniques, such as screen printing, lithography, laser tracing, or laser ablation. For illustration purposes, training using a wide-field laser ablation technique is described herein in general.
Before the formation of the electrodes, traces and contact pads, the non-conductive substrate is covered on its upper surface with a conductive layer (by spraying or vapor deposition, for example). The electrodes, traces, and contact pads are then stamped into the conductive layer formed on the non-conductive substrate by a laser ablation process using a cover that defines the desired design for the electrical aspects of the test strip. A more detailed explanation of the laser ablation process is determined in US Patent No. 7,601,299, which is incorporated herein by reference in its entirety.
The conductive layer may contain pure metals or
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Pl
MEXICAN INSTITUTE OF LA PRCTIEDAD
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<img file="MX356609B_D0018.tif" />
alloys, or other materials, that are metallic conductors. The conductive material is generally absorbent at the wavelength of the laser used to form the electrodes, traces, and contact pads on the non-conductive substrate 52. Non-limiting examples include aluminum, carbon, copper, chromium, gold, indium oxide- tin, palladium, platinum, silver, tin / gold oxide, titanium, their mixtures, and alloys or metallic compounds of these elements. In some forms, the conductive material includes noble metals or alloys or their oxides.
Test strip 50 includes an operating electrode 54, an operating sensor signal 56, a counter electrode 58, and a counter-perception signal 60 formed in the non-conductive substrate 52. Test strip 50 includes a distal end or zone Reaction 62 and a proximal end or contact zone 64 extending along a longitudinal axis. As determined in more detail below, test strip 50 includes a trace of the operating electrode 54a that is used to connect the operating electrode 54 to a contact pad 70. In addition, test strip 50 includes a signal to counter electrode 58a which is used to connect counter electrode 58 to a contact pad 80. As illustrated, proximal end 64 of test strip 50 includes a plurality of contact pads that are
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configured to be conductively DC connection terminal 14 of meter 10. In one form, meter 10 is configured to determine the type of test strip 50 inserted into meter 10 based on the configuration, including, for example, any interconnects, of the contact pads. The distal end 62 of the test strip 12 includes a reagent layer 66 that covers at least a portion of the operating electrode 54 and the counter electrode 58.
Reagent layer 66 of test strip 50 may comprise reagents of a chemical or biochemical nature to react with a target analyte to produce a detectable signal representing the presence and / or concentration of the target analyte in a sample. The term reagent, as used herein, is a chemical, biological, or biochemical reagent to react with the analyte and / or target to produce a detectable signal representing the presence or concentration of the analyte in the sample. Suitable reagents for use in different detection systems and methods include a variety of selected active components to determine the presence and / or concentration of various analytes, such as glucose for example. Selection of appropriate reagents is well within the skill of the art. As is well known in the art, there are numerous chemicals
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MEXICAN INSTITUTE available for use with each (^ B £ targets. Reagents are selected, target to evaluate. For example, reagents may include one or more enzymes, co-enzymes, and co-factors that can be selected to determine the presence glucose in the blood.
Reactive chemistry can include a variety of adjuvants to improve the properties or characteristics of the reagent. For example, chemistry may include materials that facilitate placement of the reactive composition on test strip 50 and to improve its adhesion to strip 50, or to increase the degree of hydration of the reactive composition by the sample fluid.
Additionally, the reagent layer may include components selected to improve the physical properties of the resulting dry reagent layer 66, and the absorption of a liquid test sample for analysis. Examples of adjuvant materials to be used with the reactive composition include thickeners, viscosity modulators, film formers, film openers, coloring agents, and agents that provide thixotropy.
As further illustrated in Fig. 3a, a proximal end 68 of the trace of the operating electrode 54a is connected to a contact pad 70 for measurement of the operating electrode. A distal end 72 of the trace
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of the working electrode 54a is connected to the working electrode 54. A proximal end 74 of the running sense trace 56 connects to a contact pad for the running sense measurement 75. As further illustrated, a distal end 76 of the running sense trace 56 connects to the distal end 72 of the trace of the operating electrode 54a thus defining an operating resistance cycle.
In one form, the operating resistance cycle has a resistance value within a predetermined range of resistance values, the range of which corresponds to an attribute of test strip 12. Formation of the operating resistance cycle to have a resistance value falling within one or another predetermined range of resistance values is within the skill of the art to form thin conductive layers. However, for purposes of illustration, conductive materials, such as thin layers of metals such as gold and palladium, are known to have a characteristic sheet strength that depends on the thickness of the conductive layer. Sheet resistance is essentially a multiplier to calculate a predicted resistance across a path of a particular configuration (eg, length and width) for a particular material of a particular thickness. In this way, the
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Thus, for example, a gold layer having a thickness of 50 nm has a foil resistance of 1.6 ohms / square. A square is a unitless measure of the aspect ratio of the conductive path, separated into the number of square sheets (based on width) that can currently or theoretically be determined in the conductive path. In one sense, the effective surface area of the conductive path is approximated as a number of squares. The number of squares that can be determined in the conductive path is multiplied by the resistance of the sheet to give a calculation for a predicted conductive resistance.
through that trajectory
In the context of the present invention, illustrative and exemplary embodiments will typically be described in the context of a layer with a thickness of 50 nm e gold, thus a sheet resistance of 1.6 ohms / square. In this way, in order to manipulate resistance along any conductive path in the various contexts of this disclosure (as will be clear to one skilled in the art), the length or
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width of the conductive path (in this way ·. cabling the number of squares) or the thickness or material of the conductive layer can be altered (thus changing the resistance of the sheet) in order to increase or decrease a resistance value predicted for that particular conductive path to fall within a desired range of resistance values, where the range of such values is indicative of an attribute of the test strip. Determination of the number of squares for a particular conductive path in a variety of different patterns and configurations of straight line paths in general is within the skill of the art and does not require further explanation herein.
As will further be described, current measured resistance values across the identified conductive path variables included in the embodiments of the present invention are used in various ways for purposes of indicating one or more attributes of a test strip. In this regard, it will be understood that the measured resistance values, or predetermined resistance value ranges on which a · measured resistance value is based, or the proportions of the measured resistance values between different conductive paths, may correspond to an attribute particular. Regardless of the form used for the value
<img file="MX356609B_D0024.tif" />
Corresponding resistance of a conductive path for an attribute is within the discretion of the skilled artisan.
Generally, the measured resistance value by itself is useful in the case of a current measured resistance value that closely corresponds to the predicted resistance value (calculated as described above). If the manufacturing tolerances are such that the measured value does not correspond well to the predicted value, then it may be advisable to predetermine a range of resistance values within which a conductive path having a certain predicted resistance value will almost certainly have a value of resistance measured. In this case, the system measurements of the current resistance value of a conductive path identifies the predetermined interval on which the resistance value is based, and corresponds to the predetermined interval identified with the attribute of the test strip. Finally, if manufacturing tolerances are simply non-conductive to accurately forecast the current measured resistance value for a conductive path, or simply as desired, it may be useful to relate one measured resistance value to another resistance value measured through of a different conductive path, in order to determine an essentially normalized value. The value
<img file="MX356609B_D0025.tif" />
Normalized can be similarly used as a measured resistance value or compared against one or more predetermined ranges of values in order to identify a corresponding attribute of the measured, predicted and normalized resistance values that the present invention further describes and understands.
For illustrative purposes only, in one form the operating resistance cycle having a resistance value of approximately 380.8 Ohms. (In this illustrative form, it is assumed that 50mm thick gold is used to form the traces and contact pads and that the surface area associated with the traces and contact pads of the operating resistance cycle is equal to approximately 238 squares . That is, the resistance cycle in operation has a resistance value of approximately 380.8 Ohms.) In one embodiment, this resistance value is within a predetermined range, for example 250-450 Ohms, and corresponds to an attribute such as the strip type, that is, a reagent deposited on a strip that is configured for the determination of glucose concentration. By way of example, a different predetermined range, for example 550-750 Ohms, for the resistance value of the resistance cycle in operation may correspond to a different type of strip, such as for determining the ketone concentration. As with all
MEXICANI INSTITUTE
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the shapes, and as described above. The resistance value of the resistance cycle in operation as well as all the resistance values described herein can be adjusted by various methods, such as, for example, adjusting the length, width and thickness of the trace felt in operation 56 thus as the material from which the trace made in operation 56 is manufactured. See, for example, US Patent No. 7,601,299, the disclosure of which is incorporated by reference herein.
A proximal end 78 of the trace of the counter electrode 58a connects to a contact pad for measurement of the counter electrode 80. A distal end 82 of the trace of the counter electrode 58a connects to "
the counter electrode 58. In addition, a proximal end 84 of the counter trace 60 is connected to a contact pad for the counter sense measurement 86. A distal end of the counter trace 60 connects to the distal end 82 of the trace of the counter electrode 58a by therefore defining a cycle of counter resistance. In one form, the counter resistance cycle has a resistance value within a predetermined range of resistance values, the range of which corresponds to an attribute of test strip 50. For illustrative purposes only, in one form the counter resistance cycle has a resistance value of about 384 Ohms, based on one layer
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gold with a thickness of 50 nm and an area setting of
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surface of approximately 240 squares. In one embodiment, this resistance value is within a predetermined range, for example 250-450 Ohms, the range of which corresponds to an attribute of the test strip. In other modalities, the resistance value of the operating resistance cycle is related to the resistance value of the counter-resistance cycle where the ratio value corresponds to an attribute of the strip, the type of strip or geographic distribution market.
As it will be understood in general] electrode as an electrode '' counter electrode is merely a <
particular default functionality;
an electrode during the electrochemical measurement method as either an anode or cathode in the presence of a particular electric field or applied potential. Those skilled in the art will similarly understand the reference to such electrodes generically as first and second measurement electrodes (and traces, perception traces, contact pads, etc.). corresponding), as such electrodes participate in the measurement of a particular analyte or target, in contrast to, for example, electrodes that are specifically designed only to be used as electrodes for dose detection and / or sufficient as
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samples according to known techniques, see, eg, US Patent No. 7,905,997, the disclosure of which is incorporated herein by reference. In view of these notions, the designations in operation and against are used only for illustration and conceptual description, and are not intended to limit the scope of the present invention, whether recited or not in the claims, for a functionality of the electrode of particular measurement.
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<td colspan="2">test, the test sensor 5 0 is</td><td>inserted into</td><td>the</td><td>terminal</td><td>of</td>
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to the contact terminals inside the connection terminal 14. The operating electrode 54 and counter electrode 58 remain in an open state relative to each other (ie, generally electrically isolated from each other) until a suitable amount of the fluid, such as blood, is placed in the test sensor 50. The application an adequate amount of fluid on reagent layer 66 creates an electrochemical reaction that can be detected by meter 10.
In a general sense, the meter 10 applies a predetermined voltage across the contact pad for measurement of the operating electrode 70 and the contact pad for measurement of the counter electrode
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MEXICAN INSTITUTE with FRcrtepAf, ·
INDUSTRIAL _ to create a potential difference between operating electrode 54 and counter electrode 58, and then measures the resulting current flow. The magnitude and direction of the voltage is selected based on the electrochemical activation potential for a kind of electrical measurement to be detected, which is generated from the electrochemical reaction of reagent 66 and the applied fluid. For glucose, for example, an applied potential difference is typically between approximately +100 mV and +550 mV when a DC potential is used. When AC potentials are used, they can be between approximately +5 mV and + 100 mV RMS but they can also have a greater amplitude depending on the purpose for applying the AC potential. The measured amount of current flow, particularly resulting from a DC potential or AC potential of sufficient large amplitude, is indicative of the analyte concentration to be measured. The exact way in which this process works is beyond the scope of the present invention, but known to those skilled in the art. See, for example, US Patent Nos. 7,727,467; 5,122,244; and 7,276,146, the disclosure of which is incorporated by reference herein.
In order to compensate for the parasitic IR drop (current x resistance) on the electrode trace in operation 54a and the counter electrode trace 58a, the test sensor 5 0 includes the trace sense in operation 56 and the (Λ **
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inconsistent trace 60. As determined above, the trace in operation 56 connects to the trace of the operating electrode 54a at the distal end 62 of the test sensor 50 and the measurement contact pad in operation 75 at the end next 64 test sensor 50. The nonsense cup 60 is connected to the counter electrode trace 58a at the distal end 62 of the test sensor 50 and the contact pad for the nonsense measurement 86 at the proximal end 64 of the test sensor 50.
In one way, during a test procedure, a potential voltage is applied to the contact pad for measurement of counter electrode 80, which will produce a current between counter electrode 58 and operating electrode 54 that is proportional to the amount of analyte present in the biological sample applied to the reagent layer 66. To ensure that the proper voltage potential is applied to the counter electrode 58, the meter 10 includes circuits (not shown) that ensure that a potential voltage (or absolute potential difference) applied to the countersense trace 60 is the same as the desired voltage potential (or absolute potential difference) in the counter electrode 58. Typically, meter 10 will ensure that little or no current flows through the nonsense trace 60, thereby ensuring that the potential for
<img file="MX356609B_D0029.tif" />
(JDUSTX1AL voltage seen on counter electrode 58 corresponds to the desired voltage potential. For a more detailed explanation of the offset compensation functionality of the sense trace in operation 56 and the trace sense 60, refer to the common property US Patent No. 7,569,126, which is incorporated herein by reference in its entirety.
The ability to encode information directly onto test strip 50 can dramatically increase the capabilities of test strip 50 and improve its interaction with meter 10. For example, it is well known in the art to supply calibration information or data to meter 10. Applicable to multiple batches of test strips 50. Prior art systems have relied on read-only memory (ROM memory) that is supplied, for example, with each vial of test strips and inserted into a corresponding receptacle or slot in meter 10 when the vial of Applicable test strips are used by the user. Because this process relies on the user performing this task, there is no way to guarantee that it is done correctly or not every time a new strip vial is used. In order to eliminate the possibility of human error or negligence, the present invention provides various ways in which the code, such as a code corresponding to pre-calibration data31
<img file="MX356609B_D0030.tif" />
determined or pre-stored, can be placed directly on test strip 50. This information can then be read by meter 10, which has pre-determined, or pre-stored calibration data stored in internal memory, to adjust the meter 10 so that it can provide accurate measurements.
To obtain such encoding, in one embodiment, test strip 50 includes an internal or secondary resistive element 100 and an external or primary resistive element 102 that form a base resistance network 104 on the surface of substrate 52. One end of the resistive element secondary
100 connects to a contact pad of the secondary resistive element 103. The primary resistive element 102 has a first end 106, a second end 108, and a predetermined shape or configuration. In one form, the primary resistive element 102 has a serpentine shape or configuration that runs parallel to the longitudinal axis of the test strip 50. However, it is conceived that the primary resistive element 102 can have other shapes and configurations in different shapes. In one form, the primary resistive element 102 has a predicted resistance value associated therewith that falls within a predetermined range of resistance values that may be indicative of an attribute of test strip 50. The resistance value may be measured by meter 10
<img file="MX356609B_D0031.tif" />
using first and second contact pads 110 and 112 of the primary resistive element (as defined below).
In the embodiment of Fig. 3a, the second end 108 of the primary resistive element 102 is defined by the proximal end 78 of the trace of the counter electrode 58a, and thus the contact pad 112 is generally coextensive with the contact pad of the counter electrode 80. Unless specifically required otherwise for a particular use or purpose, it will be understood that either any end 106 or 108 of the primary resistive element 102 is defined by the proximal end 68 of the electrode trace in operation 54a or the proximal end 78 of the trace of the 58a counter electrode is a matter of design choice, and the present invention includes embodiments where the ends 106 and 108 are separated and have different structures from the aspects of the operating electrode 54 and the counter electrode 58 and the traces 54a, 58a and their proximal ends 68, 78. See, for example, Fig. 3b; in contrast, see the above description regarding the use of one or both sense traces 56, 60 for voltage compensation purposes in modalities where one or both contact pads 110, 112 may be coextensive with contact pads 70, 80 Reagent layer 66 has been removed from the other figures to facilitate
<img file="MX356609B_D0032.tif" />
for reference but it should be appreciated that each test strip 50 described herein will include a reagent layer 66 relevant to the particular analysis desired to be performed.
In particular, the meter 10 can measure the resistance value of the primary resistive element 102 by applying a voltage across the contact pads 110, 112 of the primary resistive element and then measuring the amount of current flowing through the element primary resistive 102. In one form, the surface area associated with the primary resistive element 102 equals approximately 1,372 squares. That is, for illustrative purposes only, for a 50 nm thick gold layer, the predicted resistance value associated with the primary resistive element 102 is approximately
2195.2 Ohms.
Referring to Fig. 3c, another representative portion of a test strip 50 described herein is illustrated wherein the secondary resistive element 100 and the primary resistive element 102 have a different predetermined configuration. As determined in detail below, the secondary resistive element 100 includes a plurality of connectors 120a-120g which is connected to the primary resistive element 102 at a plurality of predetermined connection points 122a-122g. All the other ζ / 3?
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INDUSTRIAL features and aspects of the representative mode remain the same as described below in connection with the illustrated mode in connection with Figs. 3a, 4 and
5a-g.
Referring to Fig. 4, which illustrates a simplistic view of the electrical aspects of the test strip 50 illustrated in Fig. 3a but without the non-conductive substrate 52, the secondary resistive element 100 includes a plurality of connectors 120a-120g which is connected to the primary resistive element 102 at a plurality of predetermined connection points 122a-122g. In the illustrated form, the primary resistive element 102 has a serpentine shape or configuration comprising a proximal end 124 and a distal end 126. Connectors 120a-120g connect to connection points 122a-122g at proximal end 124 of the primary resistive element 102. In particular, connectors 120a-120g connect at the proximal ends of each step of the serpentine configuration. However, it should be appreciated that connectors 120a-120g could be connected to primary resistive element 102 elsewhere as well, as illustrated in the
Figs. 3c and 6.
In the manner illustrated in Fig. 4, a first end 130 of the primary resistive element 102 connects to a first contact pad of the element "ΜΡΙ
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trace the second
102 to the primary resistive 110. A second end 132 of the primary resistive element 102 connects to counter electrode 58a, thereby connecting end 132 of the primary resistive contact pad to counter electrode 80. As determined above, in other forms, the second end 132 of the primary resistive element 102 could be connected to a different contact pad 112 different from the contact pad of the counter electrode 80. See, for example Fig. 3b.
As illustrated in Figs. 3a and 4, the base resistance network 104 is initially structured on the non-conductive substrate 52 by the original process that forms the global electrodes, traces and contact pads on test strip 50, such as by wide-field laser ablation . As determined in more detail below, during secondary processing a code may be placed on test strip 50 separating all but one of connectors 120a-120g from secondary resistive network 100. That is, the connectors separated by 120a-120g. they are placed in an open or non-conductive state while the remaining connector 120a-120g is placed in a closed or conductive state relative to the primary resistive element 102. Separation can be accomplished by manual means or other means, such as ablation or tracing
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During manufacturing, once a respective test strip batch 50 is produced with the base resistance network 104 formed therein, one or more relevant attributes of the batch are determined in order to encode each test strip 50 into the batch respectively to report attribute (s) to meter 10. For example, in one embodiment one or more of the test strips 50 in the batch are tested with a target analyte having a known concentration. Test results typically indicate an attribute that comprises the calibration data, such as the gradient and intersection values for an algorithm based on a generally linear relationship to measure the target analyte, whose calibration data should be used by the meter. in a final measurement determination using test strips 50. In secondary processing of the remaining test strip batch 50, the base resistance network 104 is modified in order to place a code on the test strip 50 that is associated with the calibration data for that batch of test strips 50 .
In one form, the attribute comprising calibration data for test strip batch 50 enables meter 10 to automatically adjust itself to provide accurate measurements of the target analyte. In
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INDUSTRIAL particular, the resistive network that is created in the ~ TlY ^ tfé '' ^ ragl3S<sup>n</sup>”<sup>: </sup>fifty during secondary processing it is used to convey information to meter 10 related to strip performance such as algorithm gradients and product type. In a particular embodiment, the secondary resistive element 100 is modified to display only one of a plurality of possible states, where each state comprises at least a portion of code on test strip 50.
In accordance with one aspect, the base resistance network 104 is formed in such a way that all connectors 120a-120g are in a preset closed state in manufacturing. The preset state conveys to the meter 10 the so-called nominal code for a particular test strip type, for example the nominal gradient and / or intersection values for a linear correlation algorithm. Each of the plurality of other possible states created by the previous separation or opening of all except one of the connectors 120a-120g (detected as determined above) can then convey the incremental setting values to the nominal code or the calculated values of the algorithm using the nominal code. For example, for connectors 120a-120g there are seven possible states in which only one connector remains closed. Each of such states can
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It is industsial to represent a positive or negative factor (pcnr ^^ j ^^ lo ^ and n ^ multiplier) which when transported to meter 10 is used by the meter to adjust the calculated response in ascending or descending order depending on how the batch is evaluated of strips particular compared to the nominal code.
In this way, states 1-3 can represent multipliers -1%, -2%, and -3% respectively, while states 4-7 can represent multipliers + 1%, + 2%, + 3%, and + 4% respectively. Such modalities provide an alternative to states that each represent a group of code values (eg, gradient and intersection) pre-stored in meter 10 that are then used by the meter in the correlation algorithm.
In an alternative way, all connectors
120a-120g can be detached or placed in an open state during primary processing. In this way, a respective connector 120a-120g is placed in a closed state during secondary processing on the test results of test strip batch 50. The connector 120a-120g that is required to be placed in the closed stat e can be placed in the closed state during secondary processing by ink jet printing, soldering, drip distribution, screen printing, conductive tape engraving, etc. In other alternative forms, covers are used to form test strips 50 that
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they can already be formed with a connector 120a-12Og -'- coioeedostate closed and the others in an open state thus eliminating the need for secondary processing of test strips 50.
Referring to Fig. 5a, during secondary processing of test strips 50, base resistor network 104 is modified such that code information indicative of an attribute associated with test strip 50 is placed in the test strips 50. As determined above, the modified base resistance network 104 can be used to transfer basic information to meter 10 related to strip operation such as algorithm gradients and product type. As illustrated in Fig. 5a, during secondary processing all except one of connectors 120a-120g, which are connectors 120a-120f in this illustrative example, have been separated by a laser, thereby defining a first state (State 1) in which the Test strip 50 can be produced. In particular, in State 1 only the connector 120g remains connected to the primary resistive element 102 in place 122g thus defining a unique first resistive path for the secondary resistive element 100 through a portion of the primary resistive element 102. The connectors separated 120a-120f therefore placed in an open state and the
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As illustrated in Fig. 5a, a unique first resistive path is defined from the contact pad of the secondary resistive element 103 through the secondary resistive element 100 including the non-separated connector 120g and a portion of the primary resistive element 102 between location 122g and contact pad 112 at second end 132. The first single resistive path is defined at least in part by the unconnected connector 120g and a portion of the primary resistive element 102. In one form, for purposes of illustration, in State 1 the first single resistive path has an associated resistance value with the same of approximately 38.4 Ohms. For illustrative clarity, the first unique resistive path is shown in Fig. 5a between the contact pads 103 and 112 in a shaded truncated line.
As with all the forms explained below, the resistance value associated with the first unique resistive path can be measured by the meter using the contact pad of the secondary resistive element 103 and the contact pad 112
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(which as illustrated is coextensive with the counter pad of the counter electrode 80). In particular, the resistance value can be measured by meter 10 by applying a predetermined voltage across the contact pad of the secondary resistive element 103 and the contact pad 112 and then by measuring the resulting current flow to through the first unique resistive path and then calculating the resistance according to Ohm's Law, R = U / I.
Alternatively, a second unique resistive path is defined by State 1 of the contact pad of the secondary resistive element 103 through the secondary resistive element 100 including the unconnected connector 120g and a portion of the primary resistive element 102 between location 122g and the contact pad of primary resistive element 110 at first end 130. In this alternative form, the second unique resistive path has a resistance value associated with it of approximately 2182.4 Ohms. As with all of the ways described below, the resistance value associated with the second unique resistive path for each state can be measured by meter 10 using the secondary resistive element contact pad 103 and the primary resistive element contact pad 110 . The resistance value can be measured by the meter 10 ivji PJ ^ §§ ^ 51
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D £ THE PUCICIITY V 'Y »industrial tob? Í rftJ by applying a predetermined voltage across the contact pad of the secondary resistive element 1Ó3 and the contact pad of the primary resistive element 110 and then by measuring the flow of resulting current through the second unique resistive path and calculating the resistance as described above.
Referring to Figs. 5b-5g, additional states (eg States 2-7) can be defined each including unique first and second resistive paths for each state on the basis of which connector 120a-120f remains unseparated. In each instance, a unique first resistive path is defined from the contact pad of the secondary resistive element 103 through the secondary resistive element 100 including the particular non-detached connector 120f-120a (as shown in Figs. 5b-5g, respectively) and a portion of the primary resistive element 102 between the particular location 122f-122a (respectively) and the contact pad 112 at the second end 132. (For illustrative clarity, the first unique resistive path in each of Figs. 5b-5g is shown between the contact pads 103 and 112 in truncated shaded lines). Conversely, in each instance a second unique resistive path is defined from the contact pad of the secondary resistive element 103 through the i «jr i» »^ ssisas Zb / yj secondary resistive 100 including the particular separate connector 120f-120a (as shown in Figs. 5b-5g, respectively) and a portion of the primary resistive element 102 between the particular location 122f-122a (respectively) and contact pad 110 at the first end 130.
For purposes of further illustration, the Table determines illustrative resistance values (in Ohms,
Ω) associated with the first (URP # 1) and second (URP # 2) unique resistive paths (URP) defined for each of States 1-7 shown in Figs. 5a-5g, where the paths are formed of gold having a thickness of 50nm. It will be understood that other materials, thicknesses and configurations of trajectories will have different values of associated resistances for each state.
Table 1: Associated Resistance Values (in Ohms
Ω) for the first (URP # 1) and second (URP # 2) unique resistive paths
<td></td><td>State one</td><td>State 2</td><td>State 3</td><td>State 4</td><td>State 5</td><td>State 6</td><td>State 8</td>
<td>URP # 1</td><td> 38.4</td><td> 332.8</td><td> 699.2</td><td> 1068.8</td><td> 1440</td><td> 1812.8</td><td> 2182.4</td>
<td>URP # 2</td><td> 2182.4</td><td> 1812.8</td><td> 1440</td><td> 1068.8</td><td> 699.2</td><td> 332.8</td><td> 38.4</td>
As previously determined with respect to
Figs. 5a-g, the test strip 50 described herein
<img file="MX356609B_D0038.tif" />
It can be configured during manufacturing to transmit a minimum of seven (7) basic product performance states and attribute information from comparative resistance trace analysis on test sensor strip 50. Despite having previously determined the discrete resistance values in the illustrative ways and as further described above with respect to the predicted resistance values, it should be appreciated that in some modes these values will vary in some way due to variations in the process manufacturing. That is, each state in which the test strip 50 can be manufactured during secondary processing will typically fall within a range of resistance values. Thus, in one embodiment, each discrete range of resistance values rather than the discrete resistance values themselves, will correspond to a state of test strip 50. For example, in one form, the resistance value of the first unique resistive path in State 1 could fall within a range of 20-150 Ohms, in State 2 it could fall within a range of 310-450 Ohms, etc. .
The method used to measure resistance and other factors, such as the temperature of test strip 50 and the internal electronic configuration of meter 10, can also affect the resistance measured by meter 10 and thus minimize the size of each
MEXICAN INSTITUTE DF. THE PRO? IEDAV
INDUSTRIAL
<img file="MX356609B_D0039.tif" />
discrete range of resistances that pnpfjpr <sup>11f</sup>~ 1 i Fiiirpo-Ehr Example, the measured resistance may also include the resistance of at least one internal switch in meter 10, where the resistance of the switch varies depending on the switch temperature and manufacturing tolerances. In one embodiment, the resistors of the internal switch as well as the contact resistances (i.e. the contact resistance of a measured contact terminal to a particular contact pad) are taken into account for and are thus automatically compensated for. calculating resistance values for each primary resistive element 102 and secondary resistive element 100.
In other ways, meter 10 can be configured to determine the condition of test strip 50 in a way that the resistance value is related to, or proportionally compared to, at least one other resistance value on test strip 50. That is, meter 10 can be configured to measure the resistance value of the first or second unique resistive paths through the secondary resistive element 100 and primary resistive element 102 and then compare them to another measured resistive value of test strip 50. For example, meter 10 could relate the resistance value of the first or second unique resistive paths measured from the element? p <- <, <sC4
INSTITUTO MEXICANI DE LA PRCRÍECAD INDUSTRIAL secondary resistive 102 and primary resistive element 102 against the measured resistance of one or more of the primary resistive element 102, the resistance cycle in operation, and the counter resistance cycle to determine the condition of the test strip 50 .
Referring again to Fig. 3a, in another form, test strip 50 is provided with a two-dimensional optical code 200 at proximal end 64 of test strip 50. In some ways, meter 10 is provided with a optical code reader (not shown) allowing meter 10 to read optical two-dimensional code 200. Additional information that can be provided by the two-dimensional optical code 200 may be the product expiration date, product identification (countries or regions), blood and control solution intersections, strip lot identification, and other characteristics. .
Referring to Fig. 6, another representative form of a test strip 50 is described that can incorporate the features described herein. In this form, where the similar numbered elements correspond to the same characteristics, the primary resistive element 102 is formed with a different serpentine shape. In particular, instead of running parallel to the longitudinal axis of test strip 50, the wri configuration
MEXICAN INSTITUTE s4
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INDUSTRIAL, -Y ^ · serpentine runs perpendicular to the ongi-end axis 1 of test strip 50. This configuration is also modified where the connection points 122a-122g of the secondary resistive element 100 are connected to the primary resistive element 102. Furthermore, the connectors 120a-120g of the secondary resistive element 100 are oriented perpendicular to the longitudinal axis of the test strip 50.
In this form, the second end 132 of the primary resistive element 102 is connected to a second contact pad of the primary resistive element 210. In the previous shape illustrated in Fig. 3a, the second end 132 of the primary resistive element 102 is formed with the trace of the counter electrode 58a (with the contact pad of the counter electrode 80 shown as coextensive with the contact pad 112). However, as explained above, the second end 132 of the primary resistive element 102 may be connected to the contact pad 210 separated from the trace of the counter electrode 58a and the contact pad of the counter electrode 80, as illustrated in Fig. 6 As with the shape illustrated in Fig.
3a, during the secondary processing of the test strips 50, all but one of the connectors 120a-120g are removed to place the test strip 50 in a predefined state (eg - States 1-7). In this way, meter 10 is configured to determine the resistance of the
<img file="MX356609B_D0040.tif" />
primary resistive element 102 using the first contact pad of the primary resistive element 110 and the second contact pad 210 of the primary resistive element. All other features remain the same as explained in connection with the shape illustrated in Fig.
3a.
Referring to Fig. 7, another form of a test strip 50 is illustrated including an operating sense streamer 220 in the operating resistance cycle. In this way, the operational sense serpentine 220 is used to encode the additional information in test strip 50 related to an attribute of test strip 50. As described, the running sense trace 56 has been formed to include the operating sense serpentine 220, which in the illustrated embodiment is located at the distal end 62 of the test strip 50. The operating sense serpentine 220 allows the cycle of Operating resistance is selectively formed with a predetermined resistance value that falls within a range of resistances. The resistance value may depend on the presence or absence of an operating sense serpentine 220, and herewith also depends on the width, length, thickness and conductive material used to form an operating sense serpentine 220 on the test strip. The resistance value of the resistance cycle in operation can be
<img file="MX356609B_D0041.tif" />
INDUSTRIAL measured by meter 10 by applying a predetermined voltage across the contact pad for measurement felt in operation 75 and the contact pad for measurement of the electrode in operation 70 and then measuring the resulting current flow and calculating the resistance respectively.
Referring to FIG. 8, another form of a test strip 50 is illustrated that includes a nonsense serpentine 230 in the counter-resistance cycle. As with the form illustrated in Fig. 7, in this form the nonsense serpentine 230 is used to encode additional information in test strip 50 related to an attribute of test strip 50. Nonsense trace 60 has been formed to include nonsense serpentine 230, which in the illustrated embodiment is located at the distal end of test strip 50. Nonsense serpentine 230 allows the counterresistance cycle to be selectively formed with a resistance value default that falls within the resistance range. The resistance value of the counter resistance cycle can be measured by the meter 10 by applying a predetermined voltage across the countersense measurement contact pad 86 and the contact pad for measurement of the counter electrode 80 and then measuring the flow of resulting current.
Referring to Fig. 9, a
INSTITUTO MEXICANO ZZ ·. · DI LA PROPIEDAD Cv-,
INDUSTRIAL 'alternative form of a test strip 50 that is configured to test the concentration of an analyte that is encoded with information pertaining to at least two attributes of test strip 50. In this form, a first resistive element 300 is defined Enter a first contact pad 302, such as, for example, a contact pad of the counter electrode, and a second contact pad 304. As illustrated, a second resistive element 306 including a first group of connectors 308a-308l connects to the first resistive element 300. As with the previous forms, all but one of the first group of connectors 308a-308l has therefore been separated. placing connectors 308a-308b and 308d-308l in an open state. Connector 308c is in a closed state thus defining a unique first resistive path of a third contact pad 310 through the second resistive element 306 and at least a portion of the first resistive element 300 for the first contact pad 302. A unique second resistive path is also defined from the third contact pad 310 through the second resistive element 306 and at least a portion of the first resistive element 300 to the second contact pad 304. In this way, up to twelve can be defined ( 12) states by the first and second unique resistive paths depending on which connector 308a-3081 is placed on the
<img file="MX356609B_D0042.tif" />
MEXICAN INSTITUTE. . OF THE PROPERTY
INDUSTRIAL
<img file="MX356609B_D0043.tif" />
been closed.
A third resistive element 312 including a second group of connectors 314a-3141 is also connected to the first resistive element 300. Again, all but one of the second group of connectors 314a-314l have therefore been separated by placing connectors 314a-314d. and 314f-314l in an open state. For illustrative purposes only, connector 314e has been placed in a closed state thus defining a unique third resistive path of a fourth contact pad 316 through the third resistive element 312 and at least a portion of the first resistive element 300 for the first contact pad 302. A single fourth resistive path is also defined from the fourth contact pad 316 through the third resistive element 312 and at least a portion of the first resistive element 300 to the second contact pad 304. In this way, up to twelve can be defined (12) states by the third and fourth unique resistive paths depending on which connector 314a-314l is placed in the closed state. The number of connectors 314a-314l associated with the third resistive element 312 dictates how many states can be defined on the test strip 50. In other ways, resistive elements, contact pads, and additional connectors could be placed on the test strips to encode additional information. on the test strips.
Referring to Figs. 5a-g 10
<img file="MX356609B_D0044.tif" />
An overview of a representative process is determined that enables meter 10 to measure the concentration of an analyte in a biological fluid.
The process begins by inserting a test strip 50 (step 340) into meter 10. In this way, meter 10 is configured to automatically turn on once a test strip 50 is inserted into meter 10. In this At this point, meter 10 is configured to measure the conductivity of base resistance network 104 to determine at least one attribute associated with test strip 50, which is represented in step 342. In one form, meter 10 is configured to apply a predetermined voltage across the secondary resistive element contact pad 103 and one of the contact pads 110, 112 (depending on whether the first or second single resistive path is being queried ) and then measures the resulting current flow to calculate the resistance and determine the state of test strip 50 (for example one of States 1-7). As determined above, the state of test strip 50 is determined as a function of a first resistance value that is associated with any one of the first or second unique resistive path that defines the secondary resistive element.
100 .
<img file="MX356609B_D0045.tif" />
MEXICAN INSTITUTE OF PRGFISDAD
INDUSTRIAL
<img file="MX356609B_D0046.tif" />
In other ways, meter 10 is also configured to determine a second resistance value associated with primary resistive element 102. In this way, meter 10 is configured to apply a predetermined voltage across contact pads 110, 112 of the primary resistive element and then measure the resulting current flow and calculate the resistance respectively. Meter 10 then calculates a ratio of the first resistance value (i.e., the resistance associated with the selected single resistive path) and the second resistance value (i.e., the resistance associated with the primary resistive element 102) and then correlates this proportion to an attribute of test strip 50 such as by a lookup table pre-stored in meter memory 10. As determined above, in one way the attribute that meter 10 determines during this process correlates with a gradient and intersection of the algorithm for the particular batch of test strips 50.
Once meter 10 determines the attribute, meter 10 is configured to automatically use the information related to the attribute, which is represented in step 344. For example, in one mode meter 10 is instructed to perform a particular type of specific test for test strip 50 that has been inserted; or the meter 10 calibrates the meter according to information r
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX356609B_D0047.tif" />
Pre-stored calibration kit for test strip batch. The meter 10 is configured as a function of the attribute that is determined in step 342. Thus, in the calibration mode, depending on the determined state of the test strip 50, the meter 10 includes algorithm gradients stored in memory allowing meter 10 to be adjusted for the particular type of test strip 50 that has been inserted into meter 10. This allows meter 10 to provide more accurate results without requiring the user to interact with meter 10 during the testing process.
After meter 10 is configured in accordance with the encoded attribute information, the measurement sequence is ready to be initiated such as urging the user to apply blood, for example, to test strip 50, which is depicted in the step 346. Once blood has been applied to test strip 50, meter 10 then begins the blood glucose measurement cycle depicted in step 348. After the meter 10 performs the blood glucose measurement cycle, the meter is configured to display the results on screen 16 (step 350). It should be appreciated that this illustrative example is only a basic example and that meter 10 is configured to do many other tasks as well. By i; · -<sup>λ</sup> ·\
IMP
MEXICAN INSTITUTE /
OF THE TROPIEÜAD í>. !
INDUSTRIAL · * <; · - *. .:> -<sup>to</sup>> · · For example, meter 10 can be configured to store test results in memory so that the user can view test results from the past.
As used herein, the term separate should be broadly constructed to mean remove or destroy, which may be done for example by cutting, abrasion, or vaporization. In one form, at least a portion of the connectors 120a-120g is separated by a laser, which may be a diode-pumped solid state laser or a fiber laser. In an illustrative way, the diode-pumped solid-state laser is a 355-nanometer diode-pumped solid-state laser and the fiber laser is a 1090-nanometer fiber laser.
The illustrated embodiments of the secondary resistive element 100 show that seven states are possible depending on which of the connectors 120a-120g are left closed. It will be well understood by those skilled in the art that the number of states can increase or decrease
2.0 as desired or necessary by adding or removing connectors 120 from the design for base resistance network 104, with a corresponding increase or decrease in the number of predetermined connection points 122.
Although the embodiments of the invention have been described using specific terms, such
<img file="MX356609B_D0048.tif" />
'N-m' / X, or MEXICAN ' <sup>AND</sup> '-A «”' SDAO • NDUÍJkíAL
<img file="MX356609B_D0049.tif" />
Description is for illustrative purposes only, and it is understood that changes and variations obvious to one skilled in the art will be considered within the scope of the following claims and their equivalents.
<td>It is noted that</td><td>in relation to this date,</td><td>the</td>
<td>best method known for the</td><td>applicant to carry</td><td>the</td>
<td>practice the said invention,</td><td>is the one that is clear from</td><td>the</td>
present description of the invention.
IΜ ΡI
MEXICAN INSTITUTE, 'ú' -%, of PROPERTY V<sup>1</sup>—
INDUSTRIAL
Contents35
66 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25 Sheet 26 Sheet 27 Sheet 28 Sheet 29 Sheet 30 Sheet 31 Sheet 32 Sheet 33 Sheet 34 Sheet 35 Sheet 36 Sheet 37 Sheet 38 Sheet 39 Sheet 40 Sheet 41 Sheet 42 Sheet 43 Sheet 44 Sheet 45 Sheet 46 Sheet 47 Sheet 48 Sheet 49 Sheet 50 Sheet 51 Sheet 52 Sheet 53 Sheet 54 Sheet 55 Sheet 56 Sheet 57 Sheet 58 Sheet 59 Sheet 60 Sheet 61 Sheet 62 Sheet 63 Sheet 64 Sheet 65 Sheet 66
46 members in 10 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 13194031 | United States of America | – | |
| 201113194031 | United States of America | A | |
| 2012003131 | European Patent Office (EPO) | W |
Members46
| Document | Office | Kind | |
|---|---|---|---|
| US2013027064A1 | United States of America | A1 | |
| CA2838759A1 | Canada | A1 | |
| WO2013017218A1 | World Intellectual Property Organization (WIPO) | A1 | |
| MX2014000832A | Mexico | A | |
| KR20140042887A | Republic of Korea | A | |
| CN103733056A | China | A | |
| EP2737306A1 | European Patent Office (EPO) | A1 | |
| JP2014521943A | Japan | A | |
| US8888973B2 | United States of America | B2 | |
| US2015076010A1 | United States of America | A1 | |
| KR20150132599A | Republic of Korea | A | |
| US2015362455A1 | United States of America | A1 | |
| US9267911B2 | United States of America | B2 | |
| KR101622529B1 | Republic of Korea | B1 | |
| KR20160060151A | Republic of Korea | A | |
| KR101632123B1 | Republic of Korea | B1 | |
| KR101656650B1 | Republic of Korea | B1 | |
| CN103733056B | China | B | |
| CA2992283A1 | Canada | A1 | |
| WO2017039976A1 | World Intellectual Property Organization (WIPO) | A1 | |
| JP6158805B2 | Japan | B2 | |
| MX349766B | Mexico | B | |
| CN107064257A | China | A | |
| US9754708B2 | United States of America | B2 | |
| JP2017181523A | Japan | A | |
| CA2838759C | Canada | C | |
| CN107923864A | China | A | |
| KR20180039075A | Republic of Korea | A | |
| MX356609BThis record | Mexico | B | |
| EP3335035A1 | European Patent Office (EPO) | A1 | |
| JP2018523129A | Japan | A | |
| JP6473776B2 | Japan | B2 | |
| EP3335035A4 | European Patent Office (EPO) | A4 | |
| CN107064257B | China | B | |
| CN107923864B | China | B | |
| JP6772249B2 | Japan | B2 | |
| EP2737306B1 | European Patent Office (EPO) | B1 | |
| PL2737306T3 | Poland | T3 | |
| EP4141433A1 | European Patent Office (EPO) | A1 | |
| CA2992283C | Canada | C | |
| ES2935572T3 | Spain | T3 | |
| KR102601322B1 | Republic of Korea | B1 | |
| EP3335035B1 | European Patent Office (EPO) | B1 | |
| EP3335035C0 | European Patent Office (EPO) | C0 | |
| ES3000674T3 | Spain | T3 | |
| PL3335035T3 | Poland | T3 |
Numbers
- Publication
- 356609
- Application
- 2017007746
Titles2
- Spanish
- BIOSENSORES CODIFICADOS Y METODOS PARA SU ELABORACION Y USO.
- English
- ENCODED BIOSENSORS AND METHODS OF MANUFACTURE AND USE THEREOF.
Classification
- CPC, 3
- G01N27/327
- G01N27/3272
- G01N33/48771
- IPC, 2
- G01N27 327
- G01N33 487