Test strip with integrated lancet

(54) Title: TEST STRIP AND ANALYTICAL ANALYTIC METER AND TEST STRIP PRODUCTION METHOD WITH INTEGRATED LANCET.

(51) Int. Cl .: A61B 5/00; A61B 5/15 (30) Unionist Priority: 28/02/2007 US 11 / 711,621 (73) Holder (s): HOME DIAGNOSTICS, INC.

(72) Inventor (s): GARY NEEL; ALLAN JAVIER CABAN

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(74) Attorney (s): HUGO SILVA, ROSA &amp; MALDONADO-PROP. INT (86) International Application: PCT US2008054995 of 02/26/2008 (87) International Publication: WO

2008/106438 of 09/04/2008

1/16 “Test Strip and Analyte Meter of Analyte and

Test Strip Production Method with Integrated Lancet ”

Descriptive Report

This Order claims priority in US Patent Application No. 11 / 711,621, filed on February 28, 2007, the contents of which are incorporated herein by reference.

description

Technical Field

The present disclosure belongs to the field of diagnostic testing and, more particularly, to diagnostic testing systems using electronic analyte meters.

Background

Electronic testing systems are commonly used to measure or identify one or more analytes in a sample. These testing systems can be used to evaluate medical samples for diagnostic purposes and to test various non-medical samples. For example, medical diagnostic meters can provide information regarding the presence, quantity or concentration of various analytes in human or animal body fluids. In addition, diagnostic test meters can be used to monitor analytes or chemical parameters in non-medical samples, such as water, soil, sewage, sand, air, or any other appropriate sample.

Diagnostic test systems typically include both a test medium, such as a diagnostic test strip, and a test meter configured for use with the test medium. The appropriate test medium may include a combination of electrical, chemical, and / or optical components configured to provide a response indicative of the presence or concentration of an analyte to be measured. For example, some glucose test strips include electrochemical components, such as specific glucose enzymes, buffers and one or more electrodes. Specific glucose enzymes can cause a reaction between glucose in a sample and several chemicals in a test medium, thereby producing an electrical signal that can be measured with one or more electrodes. The test meter can then convert the electrical signal into a glucose test result. Such enzymes can include glucose dehydrogenase, glucose oxidase, etc.

Diagnostic test systems have improved significantly in recent years. For example, test meters have become smaller and faster and the amount of blood or other fluid needed to obtain accurate test results has decreased. However, while these improvements have made testing more convenient for patients, current systems have some disadvantages. For example, current systems and devices for monitoring blood glucose levels in diabetic patients require patients to carry at least three devices: a lancet, a glucometer and test strips; and the need to carry three separate items can be inconvenient and cumbersome. In addition, loading more components makes it easier to move around or lose a component. In addition, systems that employ separate lancets often include lancets that can be reused. However, reusing the same lancet is less hygienic than using a new disposable lancet each time. In addition, repeated use of the same lancet can cause the lancet to become amorphous over time and cause more pain to the patient with use.

While current methods and systems facilitate self-monitoring of analyte concentrations in blood or in a body fluid,

3/16 there is a need for additional resources and improvements, including systems with fewer components. The present invention is aimed at overcoming one or more deficiencies in the prior art of meters, lancets and test strips.

Summary of the invention

The present disclosure provides methods and systems for collecting blood from a patient using a lancet integrated into a test strip. In traditional systems, the various components of a blood collection system (ie, meter, test strip and lancet) are separate objects. However, the present disclosure provides integrated test strips having an integrated lancet, as well as methods for driving the integrated lancet within a test strip.

In one aspect of the present disclosure, the test strip is composed of at least one test strip substrate and has an elongated cavity extending over at least one of the substrates. The cavity is adapted to receive a lancet and the test strip has an opening through which the lancet can be used. The test strip also comprises a location where the patient's blood can be collected.

A second aspect of the present disclosure includes an analyte meter to monitor a characteristic of a blood sample. The meter may include a trigger mechanism configured to extend a lancet through an opening of a test strip and to retract the lancet after it has pierced the patient's skin. The meter also includes a test strip interface to receive a test strip from which a blood sample can be collected. In addition, the meter includes a system for measuring the concentration of an analyte in a blood sample.

A third aspect of the present disclosure includes the integration of a test strip with a lancet. The method may include selecting a first test strip substrate material, followed by selecting a second test strip substrate material. Then, at least one elongated cavity is formed in at least one of the first or second test strip substrate material. Then, the lancet material is selected and cut into an elongated shape in order to fit into the elongated cavity formed in at least one of the substrate materials. Finally, the lancet is placed in the elongated cavity and the first and second substrate materials are joined together.

Brief Description of Drawings

The attached drawings, which are incorporated and constitute a part of this Descriptive Report, provide exemplary modalities of the invention and, together with the description, serve to explain the principles of the invention.

Figure 1 shows a perspective of an analyte meter, according to an exemplary embodiment of the disclosure.

Figure 2A illustrates a perspective of the test strip, according to an exemplary embodiment of the development.

Figure 2B illustrates a perspective of the test strip of Figure 2A, according to an exemplary embodiment of the disclosure.

Figure 2C illustrates the side view of the test strip of Figure 2A, according to an exemplary embodiment of the disclosure.

Figure 3 illustrates a perspective of a test meter including a drive mechanism, according to an exemplary embodiment of the disclosure.

Figure 4 illustrates a flowchart of a process for producing a test strip with an integrated lancet, according to an exemplary embodiment of the development.

Detailed Description of Drawings

Reference will now be made, in detail, to the exemplary modalities of this invention, examples of which are illustrated in the attached drawings. Whenever possible, the same reference numbers will be used throughout the drawings to refer to the same or similar parts.

The present disclosure provides a test strip having an integrated lancet. This test strip with integrated lancet can be used to collect a blood sample from a patient and then, in conjunction with an analyte meter, to measure the analyte content of the collected blood. In some embodiments, the test strip with an integrated lancet can be attached to an analyte meter configured to boost the lancet in order to pierce the patient's skin to collect a blood sample. In addition, in some embodiments, blood may be collected on the same test strip while still attached to the analyte meter, in order to detect or measure an analyte in the blood.

Figure 1 illustrates a perspective of an analyte meter 10, according to an exemplary embodiment of the disclosure. The analyte meter can be configured to measure or detect blood analytes and to display relevant information to the user. As shown in Figure 1, analyte meter 10 comprises several components, including a display system 12 and a test strip interface 14. Display system 12 can be configured to communicate test results to a user using visual and / or audio systems. In addition, the test strip interface 14 can be configured to join a test strip 16 (shown in Figures

6/16

2A-1C) for attaching the test strip to meter 10. In addition, interface 14 may include one or more electrodes 11, 13 configured to form an electrical connection to the attached test strip.

The analyte meter 10 can be used to detect or measure the concentration of one or more analytes. One or more analytes may include a variety of different substances, which can be found in biological samples, such as blood, urine, tears, semen, feces, gastric fluid, sweat, cerebrospinal fluid, saliva, vaginal fluids (including suspected amniotic fluid) , culture medium, and / or any other biological sample. In some embodiments, the biological sample may include blood and the analyte may include glucose.

As noted, Figure 1 also illustrates the test strip interface 14 having electrical meter components with one or more electrodes 11, 13. The test strip interface 14 can be configured to mate with the test strip 10 and one or more electrodes 11 13 on the test strip interface 14 can be configured to engage electrical components of the test strip, thus facilitating the measurement of electrical signals, that is, currents or voltages, which can be produced by an electrochemical reaction within a test strip test reaction site and can represent the concentration of an analyte within a collected sample . One or more electrodes 11, 13 can include a number of electrode types and configurations. For example, "one or more electrodes 11, 13" may include cathode 11 and anode 13, as well as one or more additional electrodes. The number and specific type of electrodes can be selected based on the desired test mode, the type of analyte meter being used and any other appropriate parameter. In addition, “one or more electrodes 11, 13” can include a number of shapes and configurations. For example, “one or more electrodes 11, 13” may include flat electrodes, interdigitated electrodes or any other appropriate electrode pattern. Besides that,

7/16 it will be understood that, although the revealed integrated test strip 16 and lancet 18 are described for use with an electrical test meter 10, any appropriate test system can be used. For example, suitable meters may include electrochemical systems, optical systems, electrochemical chemiluminescent systems, radioactive tests, and / or any other appropriate system in which an integrated test strip may be desirable.

Figure 2A illustrates a bottom view of a test strip 16, according to an exemplary embodiment of the development. As shown, test strip 16 includes an elongated cavity 17 configured to contain a lancet 18. Test strip 16 also includes an opening 20 at an end 54, through which a sharp end 41 of the lancet can advance and be retracted to pierce a patient's skin close to opening 20. Test strip 16 can be configured to join with a meter interface 14 at a second end 43 of test strip 16. The second end can also include one or more electrodes 27 (as shown in Figure 2B), which can form an electrical connection with the electrodes of meter 11, 13.

Test strip 16 may comprise a mechanism for adjusting the depth of lancet penetration 18. This can prevent lancet 18 from piercing the patient's skin too deeply, and allows deeper penetration for patients with thicker skin or less blood circulation. . The mechanism includes a projecting portion configured to fit a lever to physically prevent the lancet from projecting beyond a certain distance. The mechanism may alternatively include an adjustable cover by a sliding mechanism.

Figures 2B and 2C show test strip 16 with integrated lancet 18 attached to a drive mechanism 21 on the flow meter.

8/16 analyte 10. As previously mentioned, lancet 18 can advance through opening 20 at distal end 54 of test strip 16, in order to pierce a patient's skin near opening 20. For example, Figure 2B shows the sharp pointed end 41 of the lancet 18 pushed out of the test strip 16 by the drive mechanism 21. In addition, as shown in Figure 2C, the lancet 18 can be retracted onto the test strip 16 after perforating the patient's skin, thereby preventing further exposure of the sharp tip 41 to a patient.

The lancet 18 on the test strip 16 can be made of a biocompatible plastic or a biocompatible metal. Biocompatible plastic can include a number of types of suitable polymeric materials, including, but not limited to, thermosets, elastomers or other polymeric materials. In addition, suitable biocompatible metals can include, for example, stainless steel, titanium, etc. In addition, lancet 18 can also be formed of various composite materials.

Lancet 18 can be manufactured using a number of appropriate production processes. For example, the lancet can be manufactured using known metal processing techniques, such as casting or forging, or, for polymeric materials, any appropriate polymer processing system, including, for example, injection molding, can be used.

As mentioned earlier, the lancet 18 may have a sharp pointed end 41 which can be used to pierce a patient's skin in order to collect blood. The test strip 43 to be engaged with the analyte meter may include an orifice 40 for the coupling end 42. The coupling end 42 will be configured to engage the drive mechanism 21 with the analyte meter 10.

9/16

In some embodiments, the test strip 16 may include a membrane 37 that fluidly and seals the opening 20. The membrane 37 may help to hold the lancet 18 in the cavity 17 until the lancet 18 is needed for use. The membrane 37 can also prevent the lancet from being contaminated during storage. The membrane 37 can include a variety of suitable materials. For example, membrane 37 can include any appropriate polymer or composite material that can be pierced by lancet 18 when lancet 18 is driven by drive mechanism 21. Coating 37 can be impermeable or semi-impermeable to gas or liquid. For example, suitable materials include thin films of polymer, polyethylene, latex, etc.

Figure 2B illustrates the perspective of the test strip of Figure 2A, according to an exemplary embodiment of the disclosure. As shown, strip 16 may include a test reaction site 22 configured to receive a blood sample collected after piercing the patient's skin with lancet 18. Test site 22 may include one or more substances configured to react with one or more analytes. For example, test reaction site 22 may include one or more enzymes configured to react with an analyte, such as glucose. In addition, the test reaction site 22 may include other additives, including salts, buffers, enzyme stabilizers, electrochemical mediators, color indicators and / or other chemicals necessary to facilitate the production of an appropriate test reaction.

Test reaction site 22 can be shaped and sized to contain certain substances necessary to react with an analyte to be tested. For example, test reaction site 22 may include a well configured to contain a certain volume of sample. In addition, test reaction site 22 may include several configurations that can facilitate sample acquisition, placement

10/16 adequate sample or fluid flow required.

In addition, test strip 16 can include one or more electrodes 27. These electrodes 27 can be configured to engage the corresponding electrodes on an analyte test meter to form an electrical connection with test meter 10, thereby allowing for a reaction that occurs at test site 22 to be correlated with a blood analyte concentration.

It should be noted that, although the test strip 16 is shown as a rectangular shaped strip, the test strip 16 can include a variety of appropriate shapes and sizes, provided that the test strip 16 can include an elongated cavity 17 and the lancet 18. For example, the test strip 16 can be in the form of tapes, tabs, discs or any other suitable shape. In addition, as noted above, test strip 16 can also be configured for use with a variety of appropriate test modalities, including electrochemical tests, photochemical tests, electrochemical chemiluminescent tests, and / or any other appropriate test mode.

Figure 2C illustrates a side view of the test strip of Figure 2A, according to an exemplary embodiment of the disclosure. As shown, test strip 16 has a first test strip substrate 24 and a second test strip substrate 26 that form the bottom or top portions of test strip 16. In some embodiments, the substrates of the test strip test 24, 26 can be formed separately and then linked together. For example, substrates 24, 26 can be bonded together using glue, epoxy, or mechanical bonds (for example, pins, clips, etc.). In addition, in some embodiments, test strip substrates 24, 26 can be welded, cauterized, or bonded to each other using any other appropriate thermal, mechanical or chemical methods.

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Test strip substrates 24, 26 can be produced from a variety of appropriate types of material. For example, in some embodiments, test strip substrates 24, 26 may include plastics, metals, ceramics, and / or composite materials. Substrates 24, 26 can be selected based on a variety of factors, including, for example, cost, processing, sterilization feasibility, mechanical properties and effects on enzymes, mediators or other chemicals necessary to produce the appropriate reaction. In addition, suitable substrates can include a single layer material or a multilayer material.

In some embodiments, the analyte test meter 10 of the present disclosure may include a drive mechanism 21 configured to advance the lancet 18 through opening 20 in the test strip 16 in order to pierce the patient's skin. Figure 3 illustrates a perspective of an exemplary embodiment of a test meter 10 with a drive mechanism 21. As shown, the drive mechanism 21 can include a spring 19 configured to quickly push the lancet 18 into and out of the opening 20. The spring 19 can include a variety of appropriate spring types, including buckling columns, compression springs nested, tapered springs, variable pitch springs, snap rings, double twist springs, wire shapes, limited displacement extension springs, interlaced wire springs, etc. In addition, the spring can be produced from any number of metals, plastics or composite materials.

In addition, even though, as shown, the drive mechanism 21 is a spring-loaded drive mechanism, any appropriate drive mechanism can be used. For example, as shown, the drive mechanism 21 can alternatively or additionally include a motor, such as a motor

12/16 electric which can control the movement of the spring 19 or directly engage the lancet 18. In addition, other suitable actuation mechanisms may include a solenoid or other linear actuator, which can advance and collect appropriate materials having certain magnetic properties.

Test strip 16 with the revealed integrated lancet 18 can be produced using a number of appropriate manufacturing processes. For example, Figure 4 illustrates a flow chart of a method for making a test strip with an integrated lancet 18, according to an exemplary embodiment of the disclosure. As shown in Step 30, the first and second substrate materials 24, 26 are selected first. As noted above, these substrate materials can be selected from a variety of different plastics, polymers, metals, ceramics or composite materials. Then, as shown in Step 31, a lancet 18 can be produced with a sharp distal end 41 and a proximal end 42 configured to engage a meter drive system.

Then, as shown in Step 32, a cavity 17 can be formed on one or more substrates 24, 26. The cavity 17 can be formed using a number of appropriate production processes. For example, cavity 17 can be etched using a laser cutter or water jets. Cavity 17 can also be formed using a chemical that chemically reacts with at least one of the test strip substrates 24, 26 to remove a selected portion of the substrate, thereby forming a cavity in the substrate. In addition, the cavity 17 can also be formed using a saw or other cutting tool to cut a cavity of at least one of the test strip substrates 24, 26. Any appropriate method can be selected, as long as the cavity has a size and shape configured to contain the lancet 17 and allow the

13/16 lancet is moved in and out of opening 20 to pierce the patient's skin.

Then, as shown in Step 33, the lancet 18 is placed in the cavity 17, and the cavity 17 can be fluidly sealed with a membrane 37, as shown in Step 34. After sealing the opening 20 with the membrane 37, the lancet 18 and / or the substrate 26 in which the lancet is contained can be sterilized. The lancet 18 can be sterilized before the test strip is complete, or, alternatively, the lancet 18 can be sterilized before sealing the opening 20 or before placing it into cavity 17, as long as the final product is hygienic enough to patient use. The lancet can be sterilized after being placed on the first or second substrate material together with the first or second substrate. In addition, in some embodiments, the entire test strip 16, including both test strip substrates 24, 26, can be sterilized in one step after the first and second substrates 24, 26 are bonded together. In this case, the sterilization process can be carried out before applying selected enzymes or mediators, or using a process that will not damage the enzymes or mediators. The lancet can be sterilized using a number of different sterilization techniques, including, for example, autoclaving, radiation, ethylene oxide and ethyl alcohol.

The test strip of the present disclosure is simple to use. First, a person will engage the test strip 16 with the meter interface 14 to hold the strip in place and form a connection between the electrical components and the test strip lancet and the meter drive system. Then, the user will place his or her through the opening 20 of the test strip and activate the lancet using the meter to pierce the skin and obtain a blood sample. Blood will be collected at the sample 22 reaction site, and the blood

14/16 analyte 10 will then analyze the blood for analyte concentration and display the results on display unit 12.

A feature of the present test strip with integrated lancet is the consolidation of the test components in a single disposable test strip device 16. The consolidated test strip and the meter with drive system provide a more convenient and user friendly system , with fewer components. Having a lancet 18 incorporated into a test strip 16 ensures that the patient will use a single lancet 18 only once before discarding it. This method allows the patient to use a sterile lancet 18 whenever he or she needs to obtain a blood sample. Using an 18 lancet only once also reduces the pain the patient may experience, as he or she will always use a new, sharp lancet, rather than reusing the same lancet, which may have become amorphous over time.

Other modalities of the invention will be evident to those skilled in the art from the consideration of the Description and Practice of the invention disclosed in this document. It is intended that the Descriptive Report and the examples are considered only as examples, with a true scope and spirit of the invention being indicated by the following Claims.

List of Elements

Title: Test Strip with Integrated Lancet electrode analyte meter

15/16 electrode test system interface test strip engine test strip cavity lancet spring opening to the sharp end of the lancet local test reaction drive mechanism first test strip substrate second test strip substrate test strip electrodes test step of selecting the first and second substrates step of forming a lancet step of forming a cavity in one or more substrates step of placing the lancet in the cavity sealing step of the cavity lancet sterilization step step of connecting two substrates to each other with the lancet in the cavity

16/16 coating the lancet opening with thin film opening for the lancet seam end sharp end (distal lancet end) lancet seam end (proximal lancet end) second end of the test strip first end of the test strip “Test Strip and Analyte Meter of Analyte and

Test Strip Production Method with Integrated Lancet ”