WO2006065708A1

WO2006065708A1 - Mains-powered integrated-diagnostic instrument

Info

Publication number: WO2006065708A1
Application number: PCT/US2005/044817
Authority: WO
Inventors: John P. Creaven
Original assignee: Bayer Healthcare Llc
Priority date: 2004-12-13
Filing date: 2005-12-12
Publication date: 2006-06-22
Also published as: TW200633673A

Abstract

A integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid using a test sensor comprises a housing, a lancet mechanism, a user interface and at least one compartment. The housing forms at least one opening therethrough. The opening is adapted to hold a test sensor. The lancet mechanism includes a lancet holder and a lancet endcap. The lancet holder is adapted to hold a lancet. The lancet mechanism is manually operated or electronically operated. The user interface is adapted to communicate at least the analyte concentration. The integrated-diagnostic instrument is powered by mains-power supply.

Description

MAINS-POWERED INTEGRATED-DIAGNOSTIC INSTRUMENT

FIELD OF THE INVENTION¹.

[0001 J The present invention generally relates to an integrated-diagnostic instrument that is mains powered and, more particularly, to a mains-powered integrated diagnostic instrument that is used in determining an analyte (e.g., glucose) in a fluid (e.g., blood).

BACKGROUND OF THE INVENTION

[0002] 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, determining glucose in body fluids is important to diabetic individuals who must frequently check the glucose level in their body fluids to regulate the glucose intake in their diets. While the remainder of the disclosure herein will be directed towards determining glucose, it is to be understood that the present invention may be used for determining other analytes on selection of an appropriate enzyme.

[0003] 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 testing system, sensors are used to test a fluid such as a sample of blood.

[0004] Many individuals perform testing of their blood glucose at predominately a few locations. These locations are often their home or place of employment such as an office building. Many of these individuals who must test for glucose or other analytes are older individuals. Some of these older individuals have problems associated with being older such as poor memory, poor hand/finger coordination, and poor eyesight.

[0005] It would be desirable to have an integrated-diagnostic instrument that assists in addressing one or more of the above problems.

SUMMARY OF THE INVENTION

[0006] According to one embodiment, an integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid using a test sensor comprises a housing, a lancet mechanism, a user interface and at least one compartment. The housing forms at least one opening therethrough. The opening is adapted to hold a test sensor. The lancet mechanism includes a lancet holder and a lancet endcap. The lancet holder is adapted to hold a lancet. The lancet mechanism is manually operated or electronically operated. The user interface is adapted to communicate at least the analyte concentration. The integrated-diagnostic instrument is powered by mains-power supply.

[0007] According to one method, an integrated-diagnostic instrument is adapted to determine an analyte concentration of a fluid using a test sensor. The integrated-diagnostic instrument is provided and comprises a housing, a lancet mechanism, a user interface and at least one compartment. The housing forms at least one opening therethrough. The opening is adapted to hold a test sensor. The lancet mechanism includes a lancet holder and a lancet endcap. The lancet holder is adapted to hold a lancet. The lancet mechanism is manually operated or electronically operated. The user interface is adapted to communicate at least the analyte concentration. The integrated-diagnostic instrument is powered by mains-power supply. The integrated-diagnostic instrument is placed against a surface. The integrated- diagnostic instrument is secured against the surface.

[0008] According to another method, an integrated-diagnostic instrument is adapted to determine an analyte concentration of a fluid sample using a test sensor. The integrated- diagnostic instrument is provided and comprises a housing, a lancet mechanism, a user interface and at least one compartment. The housing forms at least one opening therethrough. The opening is adapted to hold a test sensor. The lancet mechanism includes a lancet holder and a lancet endcap. The lancet holder is adapted to hold a lancet. The lancet mechanism is either manually operated or electronically operated. The user interface is adapted to communicate at least the analyte concentration. The integrated-diagnostic instrument is powered by mains-power supply. The lancet endcap is removed from the lancet mechanism. The lancet is loaded into the lancet holder. The fluid sample is generated via the lancet and placed on the test sensor. The analyte concentration of the fluid sample is determined.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. Ia is a front perspective view of an integrated-diagnostic instrument according to one embodiment.

[0010] FIG. Ib is a front perspective view of the integrated-diagnostic instrument of FIG.

1 a after a lancet endcap has been removed and a test sensor has been placed in an opening.

[0011] FIG. 2 is a perspective view of the instrument of FIG. Ia without a built-in data management system is shown being mounted to a wall.

[0012] FIG. 3 is a top view of the instrument of FIG. Ia being mounted to a table or desk. [0013] FIG. 4a is a front view of a cartridge according to one embodiment. [0014] FIG. 4b is a side view of the cartridge of FIG. 4a.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0015] Referring to FIGS. Ia, Ib, an integrated-diagnostic instrument 10 is depicted according to one embodiment. The instrument is used to determine concentrations of analytes. Analytes that may be measured using the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin AiC, fructose, lactate, or bilirubin. The present invention is not limited, however, to these specific analytes and it is contemplated that other analyte concentrations may be determined. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine. One non-limiting example is determining the glucose concentration in a patient's blood or plasma. [0016] The integrated-diagnostic instrument 10 is powered by mains power supply. The mains power supply includes internally operated AC and/or DC power supplies. This is desirable because the instrument is not limited to electronic features that may be used therein. For example, electronic features such as electronic lancing require power that would be difficult to obtain over a desirable period of time using a power source such as a battery. Furthermore, having the instrument powered by mains power supply eliminates the need for replacing batteries. Thus, the instrument of the present invention is convenient, easy to use, and has desired features for the user.

[0017] The integrated-diagnostic instrument 10 comprises a housing 12, a lancet mechanism 14, a user interface 16, and at least one compartment 18. The housing 12 forms at least one test-sensor opening 20 therein. The opening 20 is adapted to hold a test sensor and assist in determining the analyte concentration of the fluid sample.

[0018] The housing 12 of the cartridge is typically made of a polymeric material. Non- limiting examples of polymeric materials include polycarbonate, ABS, nylon, polypropylene, or combinations thereof.

[0019] The lancet mechanism 14 includes a lancet holder 30 (see FIG. Ib) and a lancet endcap 32 (see FIG. Ia). The lancet holder 30 is adapted to hold a lancet 34 as shown, for example, in FIG. Ib. According to one embodiment, the lancet mechanism is manually operated. If the lancet mechanism is manually operated, the lancet mechanism according to one process is cocked by the user and then activated by pressing a button. For example, button 40 in FIGS. Ia, Ib may be used to activate the lancet 34 in a manually-operated lancet mechanism. It is further contemplated that the lancet may be activated by techniques other than pressing a button. For example, the lancet may be activated by a lever mechanism. It is further contemplated that the manually-operated lancet system may further include a mains- powered vacuum to assist in enhancing the fluid flow.

[0020] According to another embodiment, the lancet mechanism is electronically operated. According to another process, the lancet 34 may be activated by pressing the button 40. From a user's standpoint, the process of activating the lancet 34 is simplified when the lancet mechanism is electronically operated. It is contemplated that the electronically-operated lancet system may further include a mains-powered vacuum to assist in enhancing the fluid flow.

[0021] To communicate at least the analyte concentration to the user, the instrument 10 includes the user interface 16. One example of a user interface (a display) is depicted in FIGS. Ia, Ib. One example of a display that may be used in the instrument 10 is a liquid- crystal display. The liquid-crystal display typically shows information from the testing procedure and/or in response to signals input by a button set 42a, 42b on the instrument 10. For example, the button set 42a, 42b may be depressed to recall and view the results of prior testing procedures on the user interface 16.

[0022] The button set 42a, 42b is depressed to operate the electronics of the instrument 10. The instrument 10 typically includes a microprocessor or the like for processing and/or storing data generated during the testing procedure. It is contemplated that the number of buttons in the button set may be different than depicted in FIGS. Ia, Ib. The buttons may also be used to set and display date and time information, and to activate alarms that remind the user to conduct, for example, a blood glucose test according to a predetermined schedule. The buttons may also be used to activate certain calibration procedures for the instrument 10. It is desirable for the buttons 42a, 42b to be large to assist those individuals with poor hand/finger coordination and/or poor vision. For example, the buttons 42a, 42b may have a diameter of at least 0.5 inch. It is contemplated that the buttons may be shaped differently than shown in FIGS. Ia, Ib.

[0023] Some of the information that may be shown on the user interface include the following: a numerical display, an indication of the number of sensors remaining, an indication to load a cartridge or test sensor into the instrument, an apply blood indication, a temperature indication, results of prior testing procedures, or various combinations thereof. [0024] To assist in the readability of the user display 16, especially for those with poor vision, it is desirable to have a larger display. For example, the display typically has an area of at least 6 in² such as a 2 inch x 3 inch display. The display may even have an area of at least 12 in² such as a 3 inch x 4 inch display.

[0025] According to another embodiment, the user interface 16 may communicate in an audible manner instead of or in addition to the above discussed visual manner. Thus, the user interface may be designed to operate in audible and visual manners.

[0026] The instrument according to a further embodiment may include a programmable alarm 44 to alert the user to begin testing. The alarm 44 is programmed to sound at a predetermined schedule. An alarm is especially useful for those individuals who have poor memory as well as those individuals who get preoccupied and forget to test according to a predetermined schedule.

[0027] To enhance storage capabilities and ease to a user, the instrument 10 also includes the at least one compartment 18. The instrument desirably includes a plurality of compartments such as shown in FIGS. Ia, Ib with compartments 18a-d. The compartments 18a-d may be used to store items that are needed for use with the instrument 10. For example, in FIGS. Ia, Ib, the compartment 18a may contain unused lancets. The compartment 18b may contain individually used test sensors or a used cartridge that contains a plurality of used test sensors. The compartment 18c may store individually unused test sensors or an unused cartridge that contains a plurality of unused test sensors. The compartment 18d may be used to store other items such as a plurality of tissues for cleaning. [0028] It is contemplated that the compartments may be used to store other items such as a handheld lancet or cartridge-based lancets that are used in automatic operation. It is desirable for the instrument to have storage capabilities for all of the items used with the instrument such that the instrument can be a "one-stop" instrument to the user. [0029] The instrument 10 may include a built-in data management system 46 that is accessible to remote monitoring by, for example, a physician. Such a built-in data management system may be connected for remote monitoring by, for example, a telephone line 48 and a modem 50. [0030] The instrument 10 may also include a bar code reader that reads a bar code label on a disposable cartridge. The bar code reader can determine information such as the lot number and calibration numbers.

[0031] The integrated-diagnostic instrument 10 is designed to be secured in one location. For example, as shown in FIG. 2, the instrument 10 is placed against a surface (wall 80) and then secured or mounted on the surface. It is contemplated that the instrument may be secured to other surfaces such as table or desk (see, e.g., FIG. 3 with table or desk 90). By being secured or mounted to a surface, the testing procedure is made easier to the user by eliminating the requirement of holding the instrument or lancet mechanism during testing. The instrument is secured in a location where the individual tends to spend much of his or her time. For example, these locations are often their home or place of employment such as an office building. The instrument may be secured to a surface by mechanical fasteners such as screws, nails, or by adhesives. It is contemplated that the instrument 10 may be secured to such surfaces as wall 80 and table/desk 90 by other methods.

[0032] If electrochemical test sensors are used in the instrument 10, then one of the test sensors 60 (FIG. Ib) will be properly aligned with one or more electrical contacts. The testing end of the sensor 60 then receives, for example, a drop of blood to be tested, whereby the blood is analyzed by the electrochemical circuit. The results of the analysis are then displayed on the user interface 16 of the instrument 10. It is contemplated that other types of sensors may be used such as optical sensors.

[0033] According to one process, a user removes the lancet endcap 32 from the lancet system of FIG. Ia to expose the lancet holder 30 as shown in FIG. Ib. The process of removing the lancet encap may be in response to the alarm 44 on the instrument 10 reminding the individual that testing is to begin. A lancet 34 is removed from, for example, the compartment 18a and loaded into the lancet holder 30.

[0034] A test sensor may then be removed from, for example, compartment 18c and then manually placed in the test-sensor opening 20. According to another process, a test sensor may be automatically advanced to the opening 20 by the user pressing a button. The instrument is generally turned on after the test sensor is placed into or advanced into the test- sensor opening 20. After the instrument is powered on, the testing is ready to begin. [0035] The user typically places her/his finger up to the lancet 34 to generate a whole blood sample. In one process, the user presses the button 40, which initiates the electronically operated lancet mechanism and lances the skin. In another process, the user cocks the lancet mechanism and then presses the button 40 to lance the skin. It is contemplated that a blood sample may be generated from other areas of the body. [0036] The user then removes his/her finger from the lancet mechanism and brings the test sensor and the whole blood sample into contact wherein the blood is generally drawn into the sensor by capillary action. After a minimum amount of blood is drawn into the test sensor, the testing is performed and the result is, for example, shown on the user interface 16 and stored in memory. The result of the testing may also be announced audibly by, for example, using a speaker 52 and stored in memory. It is contemplated that the instrument may include an eject mechanism 64 that is adapted to eject at least the lancet 34. [0037] The test sensors are typically provided with a capillary channel that extends from the front or testing end of the sensors to biosensing or reagent material disposed in the sensor. The biosensing or reagent material is designed to react with the desired analyte to be tested. When the testing end of the sensor is placed into fluid (e.g., blood that is accumulated on a person's finger after the finger has been pricked), a portion of the fluid is drawn into the capillary channel by capillary action. The fluid then chemically reacts with the reagent material in the sensor so that an electrical signal indicative of the blood glucose level being tested is supplied and subsequently transmitted to an electrical assembly. [0038] After the testing has been completed, the test sensor 60 may be removed by several methods from the instrument 10. In one embodiment, the instrument 10 may include an eject mechanism 62 that ejects the used test sensor from the instrument 10. Such an eject mechanism may automatically move the used test sensor to the compartment 18b. In such an embodiment, the test sensors are released forcefully, hi a further embodiment, the test sensor may also be removed manually from the instrument.

[0039] According to another embodiment, a disposable cartridge that contains a plurality of test sensors may be used. It is contemplated that many variations of disposable cartridges may be used. One example of a disposable cartridge that may be used in the instrument 10 is depicted in FIGS. 4a, 4b. The cartridge 110 of FIGS. 4a, 4b is a substantially moisture-proof and air-tight device. The disposable cartridge 110 of FIGS. 4a, 4b comprises a housing 112, a plurality of test sensors 114, a mechanical mechanism 116, and a plurality of moveable seals 118. The cartridge 110 is adapted to be disposable after each of the plurality of test sensors 114 has been used. After each of the plurality of test sensors 114 has been used, the cartridge 110 may be removed from the instrument 10 and replaced with a second identical cartridge that includes a plurality of unused test sensors. [0040] Referring to FIG. 4a, the housing 112 forms at least one opening 120 therethrough. The opening 120 is sealed at two locations using the plurality of moveable seals 118a,b. The moveable seals 118a,b prevent or inhibit air and moisture from entering into the interior of the cartridge 110 that contains the plurality of test sensors 114. The opening 120 has ends 120a, 120b and is sized to allow the plurality of test sensors 114 to move therethrough one at a time and eventually exit the cartridge 110. Specifically, the plurality of test sensors 114, one at a time, exits the cartridge 1 10 via the opening end 120a. [0041] The housing 112 of the cartridge 110 may be made of a variety of materials, but is typically made of polymeric material. Some examples of polymeric materials that may be used in forming the housing 112 include polycarbonate, ABS, nylon, polystyrene, polypropylene, or combinations thereof. Other additives may be added in forming the housing such as, for example, TEFLON® for lubrication or glass to provide strength. It is contemplated that other additives may be employed. The housing 112 may be formed by processes known to those skilled in the art including injection-molding processes. If injection-molding processes are used, the wall thicknesses are typically designed within normal ranges. It is contemplated that other processes may be used such as a molding process.

[0042] As shown in FIGS. 4a, 4b, the plurality of test sensors 114 is stacked in the housing 1 12. The plurality of test sensors 114 is adapted to assist in testing at least one analyte. As discussed above, one of the analytes that may be tested is glucose from, for example, a whole blood sample. In one embodiment, the plurality of test sensors 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. An example of a test sensor 114 is disclosed in U.S. Patent No. 6,531 ,040 assigned to Bayer Corporation. It is contemplated that other test sensors may be used in the disposable cartridge 110.

[0043] The plurality of test sensors 114 may vary in number than shown in FIGS. 4a, 4b so as to address the needs of different users. Typically, the stacked test sensors contain from about 10 to about 50 sensors and, more specifically, contain from about 25 to about 40 sensors. Because of limited shelf- and use-life of the test sensors, it is envisioned that a user who tests infrequently would likely desire a cartridge having less test sensors as opposed to a user who tests more frequently.

[0044] To urge the stacked test sensors 114 upwardly (in the direction of arrow A in FIGS. 4a, 4b), the mechanical mechanism 116 is used according to one embodiment. The mechanical mechanism 116 assists in positioning one of the plurality of test sensors for , eventual ejection from the cartridge 110 via opening end 120a. The mechanical mechanism is any device that can urge pressure on the stacked test sensors 114 so as to position one of the plurality of test sensors for ejection. For example, the mechanical mechanism 116 depicted in FIGS. 4a, 4b is a spring.

[0045] To assist in guiding the mechanical mechanism 116 upwardly (in the direction of arrow A in FIGS. 4a, 4b), the housing 112 has been formed with a plurality of prongs or extensions 124. The optional prongs or extensions 124 assist in guiding the mechanical mechanism 116 in a generally upwardly direction, thus making movement of the plurality of test sensors in the direction of arrow A easier.

[0046] To assist in protecting the reagent(s) in the test sensors 114, desirable packaging material and/or desiccant material may be used. It is contemplated that desiccant material may be added in the interior of the removable packaging to assist in maintaining an appropriate humidity level therein. If the reagent in the test sensors is not humidity sensitive, then there is little or no need to include much, if any, desiccant. The removable packaging with or without the desiccant material assists in increasing the shelf- and use-life of the test sensors. The removable packaging is to be removed before the cartridge 110 is placed into the instrument.

[0047] Desiccant material 126 is desirably added to the disposable cartridge 110 to assist in maintaining an appropriate humidity level within the interior of the housing 112 that contains the test sensors 114. Specifically, some moisture may enter the interior of the housing 112 whenever a sensor is pushed out from the disposable cartridge, but such moisture is desirably absorbed by the desiccant so as to protect the reagent in the test sensors from degradation. By maintaining an appropriate humidity level, reagent material in the test sensors is protected. The amount of desiccant material 126 should be sufficient to obtain the desired shelf-life (the time period before any of the plurality of test sensors are used). More specifically, the shelf-life typically refers to the time period before the cartridge 110 is removed from the packaging material, if used. The amount of desiccant material 126 should also be sufficient to obtain the desired use-life (the time period after first use of one of the plurality of test sensors). More specifically, the use-life typically refers to the time period after the cartridge 110 is removed from the packaging material, if used. [0048] Examples of desiccant that may be used include commercially available desiccants. The desiccant may be in the form of several shapes including balls, tablets, granular, or paper. For example, the desiccant may be molecular sieve spheres or thick desiccant paper. The desiccant may be placed within the interior of the housing 112. The desiccant may be molded into an interior surface of the housing 112 of the cartridge so as to absorb moisture within the same. One non-limiting example of desiccant material may be purchased from Multisorb of Buffalo, New York in the form of, for example, molecular sieve beads.

[0049] The seals 118a,b are adapted to move from closed positions (shown in FIG. 4a) to open positions. In a closed position, the plurality of seals 118a,b seals the interior of the housing 112 containing the test sensors 114. In such a closed position, the plurality of seals 118a,b provides a substantially moisture-proof and a substantially air-tight cartridge. The plurality of seals 118a,b is desirably designed to prevent or inhibit moisture from entering via either opening ends 120a,b and effecting the plurality of test sensors 114 for at least the shelf- life and use-life of the plurality of sensors. When the moveable seal 118a is in an open position, the test sensors 114, one at a time, can be moved through the opening 120 so as to eventually exit via the opening end 120a. [0050] Alternative Embodiment A

An integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid sample using a test sensor, the instrument comprising: a housing forming at least one opening therethrough, the opening being adapted to hold a test sensor; a lancet mechanism including a lancet holder and a lancet endcap, the lancet holder being adapted to hold a lancet, the lancet mechanism being manually operated or electronically operated; and a user interface being adapted to communicate at least the analyte concentration; at least one compartment, wherein the integrated-diagnostic instrument is powered by mains-power supply. [0051] Alternative Embodiment B

The instrument according to embodiment A wherein the lancet mechanism is manually operated. [0052] Alternative Embodiment C

The instrument according to embodiment A wherein the lancet mechanism is electronically operated. [0053] Alternative Embodiment D

The instrument according to embodiment A wherein the lancet mechanism further includes a vacuum to assist in enhancing the fluid flow. [0054] Alternative Embodiment E

The instrument according to embodiment A wherein the user interface is a visual display. [0055] Alternative Embodiment F

The instrument according to embodiment E wherein the visual display has an area of at least 6 in². [0056] Alternative Embodiment G

The instrument according to embodiment F wherein the visual display has an area of at least 12 in². [0057] Alternative Embodiment H

The instrument according to embodiment A wherein the user interface communicates the analyte concentration in an audible manner. [0058] Alternative Embodiment I

The instrument according to embodiment A further including a programmable alarm to alert the user to test at predetermined intervals. [0059] Alternative Embodiment J

The instrument according to embodiment A further including a modem. [0060] Alternative Embodiment K

The instrument according to embodiment A wherein the at least one compartment is a plurality of compartments. [0061] Alternative Embodiment L

The instrument according to embodiment A wherein the analyte is glucose. [0062] Alternative Embodiment M

The instrument according to embodiment A wherein the fluid sample is a blood sample. [0063] Alternative Embodiment N

The instrument according to embodiment A wherein the analyte is glucose and the fluid sample is a blood sample. [0064] Alternative Embodiment O

The instrument according to embodiment A wherein the instrument further includes an eject mechanism that is adapted to eject the test sensor. [0065] Alternative Embodiment P

The instrument according to embodiment A wherein the instrument further includes an eject mechanism that is adapted to eject the lancet. [0066] Alternative Process Q

A method of installing an integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid using a test sensor, the method comprising the acts of: providing the integrated-diagnostic instrument comprising a housing, a lancet mechanism, a user interface and at least one compartment, the housing forming at least one opening therethrough, the opening being adapted to hold a test sensor, the lancet mechanism including a lancet holder and a lancet endcap, the lancet holder being adapted to hold a lancet, the lancet mechanism being either manually operated or electronically operated, the user interface being adapted to communicate at least the analyte concentration, the integrated- diagnostic instrument being powered by mains-power supply; placing the integrated-diagnostic instrument against a surface; and securing the integrated-diagnostic instrument against the surface. [0067] Alternative Process R

The method of process Q wherein the surface is a wall. [0068] Alternative Process S

The method of process Q wherein the surface is a desk. [0069] Alternative Process T

The method of process Q wherein the surface is a table. [0070] Alternative Process U

The method of process Q wherein the lancet mechanism is manually operated. [0071] Alternative Process V

The method of process Q wherein the lancet mechanism is electronically operated. [0072] Alternative Process W

The method of process Q wherein the lancet mechanism further includes a vacuum to assist in enhancing the fluid flow. [0073] Alternative Process X

The method of process Q wherein the user interface is a visual display, the visual display has an area of at least 6 in². [0074] Alternative Process Y

The method of process Q wherein the user interface communicates the analyte concentration in an audible manner. [0075] Alternative Process Z

The method of process Q wherein the integrated-diagnostic instrument further includes a programmable alarm to alert the user to test at predetermined intervals. [0076] Alternative Process AA

The method of process Q wherein the at least one compartment is a plurality of compartments. [0077] Alternative Process BB

The method of process Q wherein the fluid sample is a blood sample. [0078] Alternative Process CC

The method of process Q wherein the analyte is glucose and the fluid sample is a blood sample. [0079] Alternative Process DD

A method of using an integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid sample using a test sensor, the method comprising the acts of: providing the integrated-diagnostic instrument comprising a housing, a lancet mechanism, a user interface and at least one compartment, the housing forming at least one opening therethrough, the opening being adapted to hold a test sensor, the lancet mechanism including a lancet holder and a lancet endcap, the lancet holder being adapted to hold a lancet, the lancet mechanism being either manually operated or electronically operated, the user interface being adapted to communicate at least the analyte concentration, the integrated- diagnostic instrument being powered by mains-power supply; removing the lancet endcap from the lancet mechanism; loading the lancet into the lancet holder; generating the fluid sample via the lancet; placing the fluid sample on the test sensor; and determining the analyte concentration of the fluid sample. [0080] Alternative Process EE

The method of process DD wherein the lancet mechanism is manually operated. [0081] Alternative Process FF

The method of process DD wherein the lancet mechanism is electronically operated. [0082] Alternative Process GG

The method of process DD wherein the lancet mechanism further includes a vacuum to assist in enhancing the fluid flow. [0083] Alternative Process HH

The method of process DD wherein the user interface is a visual display, the visual display has an area of at least 6 in². [0084] Alternative Process II

The method of process DD further including communicating the analyte concentration in an audible manner via the user interface. [0085] Alternative Process JJ

The method of process DD wherein the integrated-diagnostic instrument further includes a programmable alarm to alert the user to test at predetermined intervals. [0086] Alternative Process KK

The method of process DD wherein the integrated-diagnostic instrument further includes a modem. [0087] Alternative Process LL

The method of process DD wherein the at least one compartment is a plurality of compartments. [0088] Alternative Process MM

The method of process DD wherein the analyte is glucose and the fluid sample is a blood sample. [0089] Alternative Process NN

The method of process DD further including ejecting the test sensor. [0090] While the invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Claims

CLAIMS:

1. An integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid sample using a test sensor, the instrument comprising: a housing forming at least one opening therethrough, the opening being adapted to hold a test sensor; a lancet mechanism including a lancet holder and a lancet endcap, the lancet holder being adapted to hold a lancet, the lancet mechanism being manually operated or electronically operated; and a user interface being adapted to communicate at least the analyte concentration; at least one compartment, wherein the integrated-diagnostic instrument is powered by mains-power supply.

2. The instrument according to claim 1, wherein the lancet mechanism is manually operated.

3. The instrument according to claim 1, wherein the lancet mechanism is electronically operated.

4. The instrument according to claim 1, wherein the lancet mechanism further includes a vacuum to assist in enhancing the fluid flow.

5. The instrument according to claim 1, wherein the user interface is a visual display.

6. The instrument according to claim 5, wherein the visual display has an area of at least 6 in².

7. The instrument according to claim 6, wherein the visual display has an area of at least 12 in².

8. The instrument according to claim 1, wherein the user interface communicates the analyte concentration in an audible manner.

9. The instrument according to claim 1, further including a programmable alarm to alert the user to test at predetermined intervals.

10. The instrument according to claim 1, further including a modem.

11. The instrument according to claim 1, wherein the at least one compartment is a plurality of compartments.

12. The instrument according to claim 1, wherein the analyte is glucose.

13. The instrument according to claim 1, wherein the fluid sample is a blood sample.

14. The instrument according to claim 1, wherein the analyte is glucose and the fluid sample is a blood sample.

15. The instrument according to claim 1, wherein the instrument further includes an eject mechanism that is adapted to eject the test sensor.

16. The instrument according to claim 1, wherein the instrument further includes an eject mechanism that is adapted to eject the lancet.

17. A method of installing an integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid using a test sensor, the method comprising the acts of: providing the integrated-diagnostic instrument comprising a housing, a lancet mechanism, a user interface and at least one compartment, the housing forming at least one opening therethrough, the opening being adapted to hold a test sensor, the lancet mechanism including a lancet holder and a lancet endcap, the lancet holder being adapted to hold a lancet, the lancet mechanism being either manually operated or electronically operated, the user interface being adapted to communicate at least the analyte concentration, the integrated-diagnostic instrument being powered by mains-power supply; placing the integrated-diagnostic instrument against a surface; and securing the integrated-diagnostic instrument against the surface.

18. The method of claim 17, wherein the surface is a wall.

19. The method of claim 17, wherein the surface is a desk.

20. The method of claim 17, wherein the surface is a table.

21. The method of claim 17, wherein the lancet mechanism is manually operated.

22. The method of claim 17, wherein the lancet mechanism is electronically operated.

23. The method of claim 17, wherein the lancet mechanism further includes a vacuum to assist in enhancing the fluid flow.

24. The method of claim 17, wherein the user interface is a visual display, the visual display has an area of at least 6 in².

25. The method of claim 17, wherein the user interface communicates the analyte concentration in an audible manner.

26. The method of claim 17, wherein the integrated-diagnostic instrument further includes a programmable alarm to alert the user to test at predetermined intervals.

27. The method of claim 17, wherein the at least one compartment is a plurality of compartments.

28. The method of claim 17, wherein the fluid sample is a blood sample.

29. The method of claim 17, wherein the analyte is glucose and the fluid sample is a blood sample.

30. A method of using an integrated-diagnostic instrument adapted to determine an analyte concentration of a fluid sample using a test sensor, the method comprising the acts of: providing the integrated-diagnostic instrument comprising a housing, a lancet mechanism, a user interface and at least one compartment, the housing forming at least one opening therethrough, the opening being adapted to hold a test sensor, the lancet mechanism including a lancet holder and a lancet endcap, the lancet holder being adapted to hold a lancet, the lancet mechanism being either manually operated or electronically operated, the user interface being adapted to communicate at least the analyte concentration, the integrated-diagnostic instrument being powered by mains-power supply; removing the lancet endcap from the lancet mechanism; loading the lancet into the lancet holder; generating the fluid sample via the lancet; placing the fluid sample on the test sensor; and determining the analyte concentration of the fluid sample.

31. The method of claim 30, wherein the lancet mechanism is manually operated.

32. The method of claim 30, wherein the lancet mechanism is electronically operated.

33. The method of claim 30, wherein the lancet mechanism further includes a vacuum to assist in enhancing the fluid flow.

34. The method of claim 30, wherein the user interface is a visual display, the visual display has an area of at least 6 in².

35. The method of claim 30, further including communicating the analyte concentration in an audible manner via the user interface.

36. The method of claim 30, wherein the integrated-diagnostic instrument further includes a programmable alarm to alert the user to test at predetermined intervals,

37. The method of claim 30, wherein the integrated-diagnostic instrument further includes a modem.

38. The method of claim 30, wherein the at least one compartment is a plurality of compartments.

39. The method of claim 30, wherein the analyte is glucose and the fluid sample is a blood sample.

40. The method of claim 30, further including ejecting the test sensor.