The present invention generally relates to a process of making electrodes for test sensors. More specifically, the process is directed to making electrodes for test sensors, in which the test sensors are adapted to be used in instruments or meters that determine the concentration of an analyte (e.g., glucose) in a fluid.
The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example, lactate, cholesterol and bilirubin should be monitored in certain individuals. In particular, it is important that diabetic individuals frequently check the glucose level in their body fluids to regulate the glucose intake in their diets. The results of such tests can be used to determine what, if any, insulin or other medication needs to be administered. In one type of blood-glucose testing system, sensors are used to test a sample of blood.
A test sensor contains biosensing or reagent material that reacts with blood glucose. The testing end of the sensor is adapted to be placed into the fluid being tested, for example, blood that has accumulated on a person's finger after the finger has been pricked. The fluid is drawn into a capillary channel that extends in the sensor from the testing end to the reagent material by capillary action so that a sufficient amount of fluid to be tested is drawn into the sensor. The fluid then chemically reacts with the reagent material in the sensor resulting in an electrical signal indicative of the glucose level in the fluid being tested. This signal is supplied to the meter via contact areas located near the rear or contact end of the sensor and becomes the measured output.
One method of currently forming electrodes and leads on a test sensor is by laminating a substrate with a metal foil followed by a subtractive cutting/ablation process to define the electrodes and leads. Another method currently being used includes sputtering a metal onto the substrate and subsequently removing the metal by a subtractive cutting/ablation process to define the electrodes and leads. These existing processes tend to be more costly than necessary because a portion of the metallic material is removed from the substrate and, thus, is not present in finalized test sensor. Additionally, these existing metallic deposition processes themselves can be costly.
It would be desirable to provide a method for forming the electrodes and leads on the test sensor that is more cost-effective than existing processes.
According to one method, a plurality of electrodes is formed on a test sensor. The test sensor assists in determining the concentration of an analyte. A substrate is provided. At least one aperture is formed through the substrate. Catalytic ink or catalytic polymeric solution is applied in a pattern on two sides of the substrate. The catalytic ink or catalytic polymeric solution assists in defining the plurality of electrodes on the test sensor. After applying the catalytic ink or catalytic polymeric solution, the substrate is electrolessly plated to form the plurality of the electrodes of the substrate. The plurality of electrodes assists in determining the concentration of the analyte.
According to another method, a plurality of electrodes is formed on a test sensor. The test sensor assists in determining the concentration of an analyte. A substrate is provided. A plurality of apertures is formed through the substrate. Catalytic ink or catalytic polymeric solution is applied in a pattern on two sides of the substrate. The catalytic ink or catalytic polymeric solution assists in defining the plurality of electrodes on the test sensor. After applying the catalytic ink or catalytic polymeric solution, the substrate is electrolessly plated with a conductive metal to form the plurality of the electrodes of the substrate. The plurality of electrodes assists in determining the concentration of the analyte. An enzyme is applied to the substrate.
a is a top view of a substrate with a plurality of apertures formed therein according to one embodiment.
b is a bottom view of the substrate of
a is the top view of the substrate of
b is the bottom view of the substrate of
c is an enlarged cross-sectional side view generally taken along line 6c-6c in
a is the top view of the substrate of
b is the bottom view of
c is an enlarged cross-sectional side view generally taken along line 7c-7c in
a is a top view of the substrate of
b is a cross-sectional view taken generally along line 9b-9b of
c is a cross-sectional view taken generally along line 9c-9c of
a is a top view of the substrate of
b is a cross-sectional view taken generally along line 10b-10b of
c is a cross-sectional view taken generally along line 10c-10c of
a is a top view of the substrate with a plurality of electrodes formed thereon according to one embodiment.
b is a bottom view of the substrate of
The present invention is directed to a method of forming a test sensor. The test sensors to be formed by the method are adapted to be used in, for example, an instrument or meter 10 such as shown in
The sensor package 12 of
In one embodiment, the plurality of test sensors 22 includes an appropriately selected enzyme to react with the desired analyte or analytes to be tested. An enzyme that may be used to react with glucose is glucose oxidase. It is contemplated that other enzymes may be used such as glucose dehydrogenase. It is contemplated that other test sensors may be used.
Referring still to
The plurality of test sensors may be stored in, for example, a cartridge such as shown in
The present invention is directed to the formation of the test sensors. According to one method, a substrate is provided. The substrate forms at least one aperture therethrough. An electroless plating catalyst solution is applied in a pattern on two sides of the substrate. The electroless plating catalyst solution assists in defining the plurality of electrodes and leads on the test sensor. After applying the electroless plating catalyst solution, the substrate is electrolessly plated by an autocatalytic or immersion plating process to form the plurality of the electrodes and leads on the substrate. The plurality of electrodes and leads assist in determining the concentration of the analyte.
The inventive process for forming the test sensors is a process that allows production of the finished plurality of electrodes in a single pass. The single pass avoids between-pass tolerances and associated increase in size and sample volume that happens with multi-pass screen-printing processes. This process thus minimizes registration errors that can occur. The present process is desirably a single-pass process that minimizes any registration errors between a lid and base.
The substrate to be used in the process of forming the test sensors with the plurality of electrodes and leads may be comprised from a variety of materials. The substrate is typically made of insulated material. For example, the substrate may be formed from a polymeric material. Non-limiting examples of polymeric materials that may be used in forming the substrate include polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthlate (PET), polyether ether ketone (PEEK), polyether sulphone (PES), polycarbonate, or combinations thereof.
The substrate includes at least one aperture formed therethrough. It is desirable for the substrate to form a plurality of apertures, which in one embodiment may be referred to as via apertures. One non-limiting example of a substrate is shown in
The plurality of apertures may also be of different shapes and sizes than the generally circular shaped plurality of apertures 102a-d of
Referring to
The catalytic ink or catalytic polymeric solution 110a-c is applied in a desired pattern that will eventually form the plurality of electrodes and leads. Specifically, in
In one embodiment, the catalytic ink or catalytic polymeric solution 110, 112 applied to the substrate 100 is an ink-jet printable catalytic polymeric solution. The catalytic ink or catalytic polymeric solution adapted to be electrolessly plated may be applied to the substrate by a variety of methods such as screen printing, gravure printing, and ink-jet printing. The catalytic ink or catalytic polymeric solution includes a thermoset or thermoplastic polymer to allow the production of a catalytic film adhered to the substrate. This film is now capable of being electrolessly plated.
According to one method, after the catalytic ink or catalytic polymeric solution is applied, it is dried or cured. One example of a drying or curing process that may be used is curing by ultraviolet light. The drying process may include drying or curing by applying thermal heat. The catalytic ink or catalytic polymeric solution has catalytic properties to allow electroless plating.
After the catalytic ink or catalytic polymeric solution has been applied to the substrate and dried in the process, the substrate is electrolessly plated. Electroless plating uses a redox reaction to deposit conductive metal on the substrate without using an electric current. The conductive metal is generally placed on the predefined pattern of the resulting catalytic film that has been applied to the substrate. Thus, the conductive metal is deposited over the dried or cured catalytic film that includes the electroless plating catalyst.
As shown in
The conductive metal located in the plurality of apertures 102a-d establishes the electrical connection between the working electrode 140b and its lead 140d. It is desirable to have a substrate that forms a plurality of apertures in case one of the apertures does not establish an electrical connection.
Non-limiting examples of conductive metals that may be used in electroless plating include copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof. For example, a palladium/nickel combination may be used as the conductive metal or a cobalt alloy may be used as the conductive metal. It is contemplated that other metallic materials and alloys of the same may be used in the electroless plating process. It is contemplated that the test sensor may be made from a combination of metals such that a less expensive layer (e.g., nickel or copper) may be plated first and then an enzyme catalyzible metal (e.g., gold, platinum, palladium or rhodium) may be added later. The thickness of the conductive metallic material may vary, but generally is from about 1 to about 100μ inches and, more typically, from about 5 to about 50μ inches.
The electroless plating process typically involved reducing a complex metal in an aqueous solution. The substrate may be electrolessly plated by an autocatalytic or immersion plating process. The aqueous solution typically includes a mild or strong reducing agent that varies by the metal or the bath. One reducing agent that may be used in electroless plating is sodium hypophosphite (NaH2PO2). It is contemplated that other reducing agents may be used in electroless plating. The aqueous solution may be located in a container, which is referred to as an electroless plating bath. Thus, in one process, the substrate 100 proceeds through an electroless plating bath containing the conductive metal that forms the plurality of electrodes and leads.
The substrate is removed from the bath and is dried to form the plurality of electrodes, leads and electrical connections. Specifically, the conductive metal located in the plurality of apertures establishes the electrical connection between the sides of the substrate. This is illustrated, for example, in
The electrodes, leads and electrical connections are dried and then a reagent layer is applied. For example, as shown in
Referring to
In another embodiment, a spacer and lid are added to the substrate to form a test sensor. Referring to
It is also contemplated in another embodiment that the electrode lead of one of the electrodes may be entirely located on a first side of the substrate while the electrode lead of another electrode may be entirely located on a second side of the substrate. For example, referring to
A method of forming a plurality of electrodes on a test sensor, the test sensor assisting in determining the concentration of an analyte, the method comprising the acts of:
providing a substrate;
forming at least one aperture through the substrate;
applying a catalytic ink or catalytic polymeric solution in a pattern on two sides of the substrate, the catalytic ink or catalytic polymeric solution assisting in defining the plurality of electrodes on the test sensor; and
after applying the catalytic ink or catalytic polymeric solution, electroless plating of the substrate to form the plurality of the electrodes of the substrate, the plurality of electrodes assisting in determining the concentration of the analyte.
The method of process A wherein the substrate is a polymeric material.
The method of process B wherein the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthlate (PET), polyether ether ketone (PEEK), polyether sulphone (PES), polycarbonate, or combinations thereof.
The method of process A wherein the electroless plating uses a conductive metal being copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof.
The method of process D wherein the thickness of the conductive metallic material is from about 1 to about 100μ inches.
The method of process E wherein the thickness of the conductive metallic material is from 5 to about 50μ inches.
The method of process A wherein the catalytic ink or catalytic polymeric solution is applied onto the substrate by ink-jet printing.
The method of process A wherein the catalytic ink or catalytic polymeric solution is applied onto the substrate by screen printing.
The method of process A wherein the catalytic ink or catalytic polymeric solution is applied onto the substrate by gravure printing.
The method of process A further including drying or curing the catalytic ink or catalytic polymeric solution.
The method of process A wherein the at least one aperture is a plurality of apertures.
The method of process K wherein the plurality of apertures is formed by a laser prior to defining the plurality of electrodes on the substrate.
The method of process K wherein the plurality of apertures is formed by punching prior to defining the plurality of electrodes on the substrate.
The method of process A further including the act of attaching a lid to the substrate.
The method of process A further including the acts of providing a lid, attaching a spacer to the substrate, the spacer being located between the lid and the substrate.
The method of process A further applying an enzyme to the substrate.
The method of process P wherein the enzyme is glucose oxidase or glucose dehydrogenase.
A method of forming a plurality of electrodes on a test sensor, the test sensor assisting in determining the concentration of an analyte, the method comprising the acts of:
providing a substrate;
forming a plurality of apertures through the substrate;
applying a catalytic ink or catalytic polymeric solution in a pattern on two sides of the substrate, the catalytic ink or catalytic polymeric solution assisting in defining the plurality of electrodes on the test sensor;
after applying the catalytic ink or catalytic polymeric solution, electroless plating of the substrate with a conductive metal to form the plurality of the electrodes of the substrate, the plurality of electrodes assisting in determining the concentration of the analyte; and
further applying an enzyme to the substrate.
The method of process R wherein the substrate is a polymeric material.
The method of process R wherein the electroless plating uses a conductive metal being copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof.
The method of process R wherein the catalytic ink or catalytic polymeric solution is applied onto the substrate by screen printing.
The method of process R wherein the catalytic ink or catalytic polymeric solution is applied onto the substrate by gravure printing.
The method of process R wherein the catalytic ink or catalytic polymeric solution is applied onto the substrate by ink-jet printing.
The method of process R wherein the at least one aperture is a plurality of apertures.
The method of process X wherein the plurality of apertures is formed by a laser prior to defining the plurality of electrodes on the substrate.
The method of process X wherein the plurality of apertures is formed by punching prior to defining the plurality of electrodes on the substrate.
The method of process R further including drying or curing the catalytic ink or catalytic polymeric solution.
The method of process R further including the act of attaching a lid to the substrate.
The method of process R further including the acts of providing a lid, attaching a spacer to the substrate, the spacer being located between the lid and the substrate.
The method of process R wherein the enzyme is glucose oxidase or glucose dehydrogenase.
While the present invention has been described with reference to one or more particular embodiments, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present invention. Each of these embodiments, and obvious variations thereof, is contemplated as falling within the spirit and scope of the invention as defined by the appended claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US06/48876 | 12/21/2006 | WO | 00 | 6/11/2008 |
Number | Date | Country | |
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60754146 | Dec 2005 | US |