Integrated meter for analyzing biological samples

Analyte monitoring devices and methods therefore are provided. The devices integrate various functions of analyte monitoring, e.g., sample acquisition and testing.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to the field of medical diagnostic devices.

2. Discussion of the Art

The prevalence of diabetes is increasing markedly in the world. At this time, diagnosed diabetics represent about 3% of the population of the United States. It is believed that the actual number of diabetics in the United States is much higher. Diabetes can lead to numerous complications, such as, for example, retinopathy, nephropathy, and neuropathy.

The most important factor for reducing diabetes-associated complications is the maintenance of an appropriate level of glucose in the blood stream. The maintenance of the appropriate level of glucose in the blood stream may prevent and even reverse some of the effects of diabetes.

Analyte, e.g., glucose, monitoring devices known in the art have operated on the principle of taking blood from an individual by a variety of methods, such as by means of a needle or a lancet. The individual then coats a paper strip carrying reagents with the blood, and finally inserts the blood coated strip into a blood glucose meter for measurement of glucose concentration by optical or electrochemical techniques.

Medical devices of the prior art for monitoring the level of glucose in the blood stream have required that an individual have separately available a needle or a lancet for extracting blood from the individual, test strips carrying reagents for bringing about a chemical reaction with the glucose in the blood stream and generating an optical or electrochemical signal, and a blood glucose, meter for reading the results of the reaction, thereby indicating the level of glucose in the blood stream. The level of glucose, when measured by a glucose, meter, is read from the strip by an optical or electrochemical meter.

It is desired to simplify the systems, devices, and methods for determining the level of an analyte such as glucose in a body fluid such as blood. In particular, it is desired to integrate the operations of extracting a sample of blood by means of a needle or a lancet, applying the sample of blood to a reagent-bearing test strip, reading the result of a glucose, monitoring test, and discarding the used needle or lancet and test strip in a safe and efficient manner.

Certain patents describe devices that can perform steps of determining the concentration of glucose in the blood stream. For example, U.S. Pat. No. 5,632,410 discloses a sensor-dispensing instrument for handling a plurality of fluid sensors (i.e., test strips). However, this patent fails to include a lancing device for puncturing the skin of a patient in order to extract a sample of blood. U.S. Pat. No. 6,908,008 discloses an apparatus that includes a dispenser comprising a housing having a chamber; a means for retaining a plurality of test strips in a substantially moisture-proof, air-tight first position; and a means for opening the chamber and moving one of the plurality of test strips translationally from a first position inside of the chamber to a second position at least partially outside of the chamber, wherein the opening of the chamber and the moving of the one test strip is achieved by a single mechanical motion; and an electrochemical analyzing means for analyzing a biological fluid. However, like, U.S. Pat. No. 5,632,410, this patent fails to simplify the testing process, e.g., this patent fails to include a lancing device for puncturing the skin of a patient in order to extract a sample of blood.

In addition, U.S. Pat. No. 5,035,704 discloses a blood sampling mechanism including a test pad of a predetermined thickness set-off between opposite relatively closely spaced surfaces imparting a thin configuration to said test pad, said test pad carrying a dermis-piercing member having a pointed end, said pointed end being disposed inboard of said opposite surfaces, means for applying a force to said dermis-piercing member in a direction to move said pointed end beyond one of said opposite surfaces to pierce the dermis and thereby obtain a blood sample, means for testing the blood sample, means for defining a blood sampling station at which the blood sample is obtained, means for defining a blood testing station at which the blood sample is tested by said blood sample testing means, and means for conveying said test pad from said blood sampling station after the blood sample has been obtained to said blood testing station. The dermis-piercing member and test pad are, however, entirely separate components in this system (see also WO 03/082091).

U.S. Pat. No. 5,971,941 discloses a blood sampling apparatus for sampling blood from the skin of a patient for analysis. The apparatus includes a cartridge and a housing with a driver. The cartridge has a cartridge case, lancet, and a compartment associated with the cartridge case for receiving blood. The lancet is housed in the cartridge case and operatively connected thereto such that it is drivable to extend outside the cartridge case through a lancing opening for lancing the skin to yield blood. The housing has a driver for urging the lancet to extend outside the cartridge case. During lancing, the cartridge may be detachably held in the housing such that the cartridge can be disassociated from the driver after sampling blood. The U.S. Pat. No. 5,971,941 patent discloses that material around a lancet aperture in a cartridge case soaks up blood after lancing (see also U.S. Pat. No. 5,279,294). This does not bring the absorbent material to the center of the sample, and when only a small amount of blood is available such as is often the case in alternate site testing away from fingertips, then testing may be unreliable, may need to be repeated far too often, or may simply require testing at the fingertips. Application of sample fluid to a capillary end leading to reagent material involves careful manual alignment. A manual actuation step is also involves in getting the lancet to protrude from the cartridge.

WO 2004/041082 discloses a device for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature. The device comprises a cartridge having a plurality of cavities. The device may include a plurality of penetrating members each at least partially contained in the cavities of the cartridge wherein the penetrating members are slidably moved to extend outward from openings on the cartridge to penetrate tissue. The device may also include a plurality of analyte detecting members and a plurality of chambers. Each chamber may be associated with one of the cavities, the chambers positioned along an outer periphery of the cartridge, wherein at least one of the analyte detecting members forms a portion of one wall of one of the plurality of chambers.

SUMMARY OF THE INVENTION

It would be desirable to develop a medical diagnostic device that (1) stores and dispenses lancets and sensors as integrated STRIPLETS™, test elements having a body configured as a lancet at one and a test strip at the opposing end or having each coupled directly thereto, (2) forms an opening with the lancet in the skin of a patient to enable a sample of biological liquid to emerge from the patient, (3) reorients the STRIPLET™ for collecting the sample of biological liquid from the patient emerging from the opening in the skin by means of the test strip, (4) analyzes the sample of biological liquid to determine a characteristic of the biological liquid, and (5) ejects the used STRIPLET™ in a safe manner. It would also be desirable to develop a medical diagnostic device that is small in size, reliable to use, and provides accurate results, even when only a small volume of sample of biological liquid is collected.

An analyte monitoring apparatus is provided. An example is a glucose monitoring apparatus. The apparatus includes a housing with a user interface having one or more switches or a display or both. One or more analyte testing STRIPLETS™ are contained within a cartridge loaded within the housing.

A STRIPLET™ is an element which includes both a test strip portion and a lancet portion. A STRIPLET™ is also referred to herein as an analyte testing structure. These portions may be relatively opposed, e.g., extending about 180 degrees from each other, or extending at another angle from zero to 360 degrees. The lancet portion may couple to the test strip portion as a two-piece device, or each may couple with the ends of a central body as a three-piece device. Throughout the following description, the terms STRIPLET™ and test strip may be used interchangeably at times.

A lancing and testing port is defined in the housing for permitting a STRIPLET™ to contact a lancing site outside the housing. A set of mechanical components serve to load a STRIPLET™ for a lancing and testing process, advance the STRIPLET™ for lancing through the port at a lancing site proximate to the port, and reorient and advance the STRIPLET™ for testing at the lancing site also through the port. An analyzer determines an analyte level, e.g., a glucose level, of a body fluid, e.g., blood, applied to the test sensor from the lancing site.

The monitoring apparatuses are configured for analysis (e.g., concentration determination) of an analyte in a sample of body fluid, where in certain embodiments the apparatuses are configured to determine the concentration of an analyte in a small volume of sample, e.g., less than about 1 microliter, e.g., less than about 0.5 microliters, e.g., less than about 0.2 microliters, e.g., about 0.1 microliters or less. The monitoring apparatuses may be configured for analysis of an analyte in a volume of sample by, for example, coulometry, amperometry, and/or potentiometry. In certain embodiments, the monitoring apparatuses are configured for optical analysis of an analyte in a sample.

A cartridge that is coupled within a compartment of the housing may contain several STRIPLETS™. As used herein, the terms “cartridge”, “storing/dispensing assembly or sub-assembly”, “assembly for storing and dispensing test strips” mean a mechanism that is capable of both (a) storing a plurality of test strips in a magazine and (b) advancing the test strips, one at a time, from the magazine to a lancing/collecting assembly. The cartridge may include one or more guide rails or inserts for relative positioning within the housing with respect to the set of mechanical components. The guide rail has a stopping point which precisely locates the cartridge relative to the housing where the cartridge remains upon advancing the STRIPLET™ from the cartridge. A seal is provided at the cartridge's STRIPLET™-dispensing end for maintaining the STRIPLETS™ within the cartridge free from exposure to ambient air. The seal may be configured to be released temporarily to permit loading of a STRIPLET™ from the cartridge to within the apparatus for a lancing and testing process. The seal may be elastomeric and/or include a bellows. In this sense, a bellows may be understood as a container which is deformable in such a way as to alter its volume, or a portion of a container that includes a pleated or expansible part and/or a length or direction adjustable element, which may be tubular or connecting one plane; in collapsible devices or applications permitting good sealing. The cartridge may include a biasing member for providing the STRIPLETS™ at a loading end of the cartridge. One or more structural supports or inserts may be included within the cartridge for structural support of the STRIPLETS™ within the cartridge, and also for desiccating an interior of the cartridge to keep the STRIPLETS™ substantially free of moisture. The one or more inserts may include a hard plastic insert for providing the structural support and a desiccating plastic insert for providing the desiccating. Desiccants may also be provided separately.

The set of mechanical components includes a turret225including a STRIPLET™ slot299for holding the STRIPLET™ during reorientation which includes rotation of the STRIPLET™ . The STRIPLET™ slot may be coupled with a cam that oscillates, and in certain embodiments about a point of unstable equilibrium, although in a particular embodiment having a localized point of stability at or near its center or somewhere within its range of motion, between points corresponding to different orientations of the STRIPLET™ for lancing and testing.

The STRIPLETS™ may further include a lancet cap which covers the protruding lancet. A lancet cap mechanism or compartment may serve to remove the lancet cap, e.g., by grabbing it more tightly than it is being held covering the lancet, when the lancet cap is positioned into the compartment. The lancet cap compartment may provide a space and a frictional force for holding the lancet cap during a lancing and testing process, and may provide the lancet cap back to re-cover the lancet for safe ejection of a used STRIPLET™.

The set of mechanical components may include first and second primary component sets. The first primary component set includes a first set of gears within the housing, which, along with a cartridge housing and tub combination, a STRIPLET™ pusher, a STRIPLET™ track or chain, a rotatable turret225including STRIPLET™ slot299, and an ejection port in the housing, are respectively for unsealing the tub from the cartridge housing, advancing a STRIPLET™ to the turret, and ejecting the STRIPLET™ after testing. The second primary component set includes a second set of gears within the housing, which, along with a lever arm or blade and mating lancet cap contour, the turret, and a carriage which contains the turret, are respectively for arming/disarming (also referred to herein as uncapping/capping) the lancet by removing/replacing (uncapping/capping) the lancet cap over the lancet, flipping or reorienting the STRIPLET™ between lancing and testing, and performing both lancing and testing through the lancing and testing port when a user provides the lancing site proximate to the port. The primary component sets provide various sub-assemblies or subsets with associated componentry which perform these functions, where certain components contribute to more than one sub-assembly.

The arming/uncapping function includes removing the optional lancet cap which may involve the first primary component set in an embodiment wherein the pusher couples with the lancet cap and pulls both the lever arm and lancet cap away from the STRIPLET™ in a retreating motion. The disarming may include replacing the lancet cap for safe ejection of a used testing STRIPLET™ through a separate STRIPLET™ ejection port or through the same lancing and testing port. The pusher may contact and move the STRIPLET™ along the STRIPLET™ track until the STRIPLET™ is disposed within the turret, while both the lancing and the testing may occur by movement of the carriage relative to the rest the apparatus. The lancing and the testing may occur by same or similar movements of the carriage due to the reorienting of the STRIPLET™ by rotating the turret by 180 degrees, or by whatever angle at which the testing component and lancing component of the STRIPLET™ are relatively disposed. The reorienting of the STRIPLET™ may include rotating and/or flipping the STRIPLET™. A transmission system may be included for orienting a lancing/collecting assembly in a first position, whereby the lancet end of the STRIPLET™ can be used to form an opening in the skin of a patient, and in a second position, whereby the test sensor end of the STRIPLET™ can be used to collect a sample of biological liquid from the patient. As used herein, the expression “lancing/collecting assembly” or “lancing/sensing assembly” means a mechanism that is capable of both (a) forming an opening in the skin of a patient and (b) collecting a sample of biological liquid emerging from that opening.

An analyte, e.g., glucose, monitoring apparatus is further provided including a user interface coupled with a housing including one or more switches or a display or both. Multiple analyte, e.g., glucose, testing STRIPLETS™ include both a lancet and an analyte test sensor. A cartridge contains multiple STRIPLETS™ for loading into the housing within a cartridge compartment, wherein the cartridge includes at least one guide rail for relative positioning within the housing. The seal generally maintains the STRIPLETS™ within the cartridge free from exposure to ambient air, and is configured for releasing the seal temporarily to permit loading of a STRIPLET™ for a lancing and testing process. One or more lancing and testing ports are defined in the housing for permitting the STRIPLET™ to contact a lancing site outside the housing. A set of mechanical components load a STRIPLET™ for a lancing and testing process, advance the STRIPLET™ for lancing at a lancing site, and also advance the STRIPLET™ for testing at said lancing site, via the one or more lancing and testing ports. An analyzer determines an analyte, e.g., glucose, level of a body fluid applied to the test sensor from the lancing site.

The seal may be elastomeric and/or include a bellows. The guide rail may have a stopping point which precisely locates the cartridge relative to the housing. The cartridge may remain stationary relative to the housing due to the guide rail and stopping point when the seal is temporarily broken for loading the STRIPLET™. The cartridge may include a biasing member for urging the STRIPLETS™ to be loaded from the loading end of the cartridge. One or more structural supports and/or inserts within the cartridge may be for structural support of the STRIPLETS™ within the cartridge, and/or for desiccating an interior of the cartridge to keep the STRIPLETS™ substantially free of moisture. These may include a hard plastic insert for providing said structural support and a desiccating plastic insert for providing the desiccating.

A further analyte monitoring apparatus is provided with a housing having a user interface that includes one or more switches or a display or both. Multiple analyte testing STRIPLETS™ that include both a lancet and a test sensor are contained within a cartridge that is loaded into the housing within a cartridge compartment. One or more structural supports or inserts are provided within the cartridge for structural support of the STRIPLETS™ within the cartridge, and for desiccating an interior of the cartridge to keep the STRIPLETS™ substantially free of moisture. One or more lancing and testing ports are defined in the housing for permitting the STRIPLET™ to contact a lancing site outside the housing. A set of mechanical components automatically load the STRIPLET™ for a lancing and testing process, advance the STRIPLET™ for lancing and for testing at a lancing site upon reorienting via the one or more lancing and testing ports. An analyzer determines an analyte level, e.g., a glucose level, of a body fluid applied to the test sensor from the lancing site.

The one or more structural supports or inserts include a hard plastic insert for providing structural support and a desiccating plastic insert for providing desiccation. The cartridge may include one or more guide rails for relative positioning within the housing. The guide rail may have a stopping point which precisely locates the cartridge relative to the housing, such that the cartridge remains stationary relative to the housing when the seal is temporarily broken for loading a STRIPLET™ for lancing and testing. The seal generally maintains the STRIPLETS™ within the cartridge free from exposure to ambient air, and is configured for releasing temporarily to permit loading of a STRIPLET™ for a lancing and testing process. This apparatus can include other features described elsewhere hereinabove or below.

A further analyte monitoring apparatus is provided which includes many of the features already recited hereinabove. A set of mechanical components includes first and second subsets respectively including first and second sets of gears. The first subset, along with a lancet cap compartment, a STRIPLET™ track or chain and a rotatable slot, are respectively for arming/disarming the lancet, loading a STRIPLET™ for a lancing and testing process, and reorienting the STRIPLET™ between lancing and testing for performing both lancing and testing through a lancing and testing port when a user provides the lancing site proximate to the port. The second mechanical subset includes a second set of gears within the housing, which, along with a pusher, are for advancing the STRIPLET™ though the port to the lancing site for both lancing and testing upon reorienting.

Alone or in combination with one or more other features recited above and/or below herein, an assembly is also provided for storing and dispensing test strips, wherein each test strip includes a lancet-containing portion and a sensor-containing portion. The assembly includes an exterior cover, an interior housing, a platform for containing a biasing element, an insert for securing the biasing element, a test strip track for providing a guide path for an assembly for forming an opening in the skin of a patient and collecting a sample of biological liquid emerging from the skin of the patient, a biasing member for urging the test strips toward the test strip track, and an element for advancing a test strip from the assembly to the assembly for forming an opening in the skin of a patient and collecting a sample of biological liquid emerging from the skin of the patient.

The STRIPLETS™ are advanced, one at a time, to the assembly for forming an opening in the skin of a patient and collecting a sample of biological liquid emerging from the skin of the patient by a pushing element. A seal ensures a substantially moisture-tight, air-tight condition in the assembly for storing and dispensing a plurality of test strips. A bellows or elastomerically-composed seal ensures a substantially moisture-tight, air-tight condition in the assembly for storing and dispensing test strips. A door ensures a substantially moisture-tight, air-tight condition in the assembly for storing and dispensing test strips.

In further embodiments, an apparatus is provided whereby a test strip or a lancet is applied through a testing or lancing port, followed by reorienting and ejection through an ejection port. According to one of these embodiments, an analyte monitoring apparatus includes a housing; a user interface coupled with the housing including one or more switches or a display or both; one or more analyte test strips; a testing port defined in the housing for permitting the strip to contact a testing site outside the housing; an ejection port separate from the testing port for disposing of the strip after testing; a set of mechanical components for loading a strip for a testing process, for advancing the strip for testing through said testing port at the testing site proximate to the port, for reorienting the strip after testing, and for ejecting the strip through the ejection port; and an analyzer for determining a glucose or other analyte level of a body fluid applied to the test strip from the lancing site.

A cartridge containing a plurality of strips may be received within a slot or internal compartment within the housing. A seal may generally maintain the strips within the cartridge free from exposure to ambient air, and may be configured for releasing the seal temporarily to permit loading of a strip for a testing process. The cartridge may have a structural support for the strips within the cartridge. The cartridge may include a desiccating member for keeping the strips substantially free of moisture. The set of mechanical components may include a strip turret for holding the strip at least during the reorienting which includes rotation of the strip in certain embodiments.

In another of these further embodiments, an analyte monitoring apparatus includes a housing; one or more lancets; a lancing port defined in the housing for permitting a lancet to contact a lancing site outside the housing; a separate ejection port for disposing of the lancet after testing; and a set of mechanical components for loading a lancet for a lancing process, for advancing the lancet for lancing through said lancing port at the lancing site proximate to the port, for reorienting the lancet after lancing, and for ejecting the lancet through the ejection port.

The apparatus may further include a user interface coupled with the housing including one or more switches or a display or both; one or more test strips; and an analyzer for determining an analyte level of a body fluid applied to the test strip from the lancing site. The apparatus may also include a cartridge contain a plurality of lancets received within a slot or interior compartment within the housing. The cartridge may include a structural support for the lancets within the cartridge. A set of mechanical components may include a lancet turret for holding the lancet at least during the reorienting which includes rotation of the lancet in certain embodiments.

Referring now to FIGS.1and2A-2C, the medical diagnostic device100,100ain accordance with certain embodiments includes a housing102,102a. The device100may have an end cap104, a tub106, and a protective cover108for the subsystems and assemblies located with the housing102, as in the embodiment ofFIG. 1. Within the housing102is located an assembly for storing and dispensing test strips110, a lancing/collecting assembly112, an assembly114for removing a protective cover from the tip of a lancet and re-attaching the protective cover to the tip of a used lancet, and an analyzer116. The end cap104has an opening117, through which a lancet can be projected for forming an opening in the skin of a patient, and through which a sensor can be projected for collecting a sample of biological liquid emerging from the opening in the skin of the patient.

An ejection port230is shown in the illustrations of a medical diagnostic apparatus in accordance with an alternative embodimentFIG. 1andFIG. 2A, while ejection port230ais shown in the illustration of the embodiment atFIG. 2B. Although either ejection port230,230amay also be used as a lancing and/or testing port, a separate lancing and testing port231is provided opening to the bottom ofFIGS. 2B and 2Cin accordance with an embodiment. In operation (which is described in moiré detail below with reference toFIGS. 7A-7P), the apparatus of an embodiment illustrated atFIGS. 2B-2Clances and tests through port231, by reorienting a STRIPLET™ within the housing102aafter lancing for testing through the same port231, and then retracting the STRIPLET™ into the housing after testing, rotating the STRIPLET™ 90 degrees, re-capping the lancet portion for safety, and ejecting the STRIPLET™ through ejection port230a.

As shown inFIGS. 3A-4D, the assembly for storing and dispensing test strips110,110aincludes a magazine118,118aincluding a plurality of test strips “TS”, each test strip comprising a lancet-containing portion and a sensor-containing portion. Test strips that are suitable for use with a medical diagnostic device in accordance with an embodiment are illustrated inFIGS. 26A-33, inclusive, and described in detail in the text accompanying those figures. The magazine118,118ahas an exterior cover120,120a. The purpose of the exterior cover120,120ais to maintain the test strips in a substantially moisture-tight, air-tight condition. Materials that are suitable for forming the exterior cover120,120ainclude rubber and other polymeric materials.

Inside the exterior cover120ofFIGS. 3A and 4Ais an interior cover122, which contains a desiccant. The purpose of the interior cover122is to provide a second barrier to maintain the test strips in a substantially moisture-tight, air-tight condition. Materials that are suitable for forming the interior cover122include polymeric materials impregnated with a desiccant, e.g., plastic impregnated with desiccant. The structure of the interior cover122is substantially congruent with the structure of the exterior cover120. The desiccant absorbs moisture that evades the exterior cover120. Inside the interior cover122is a platform124for containing a biasing element125, e.g., a constant force spring, for urging test strips toward the location in the magazine118from which test strips are fed to the lancing/collecting assembly112. Also inside the interior cover122is an insert126for securing the biasing element125. The platform124can be filled with a desiccant, in order to enhance moisture resistance of the test strips stored within the assembly110.

FIG. 3Billustrates a guide rail that moves within a guide track115(seeFIG. 6C) which is formed as part of the cartridge compartment123in the device100,100a. The coupling of the guide rail111and the guide track115permits the cartridge be positioned relative to the device100,100aand particularly the mechanical components contained therein which are configured to precisely load, advance and reorient STRIPLETS™ received from the cartridge. At the end of the guide rail111is a stopping point113. The stopping point meets with a complementary point within the guide track115at which point the cartridge110,110acannot be advanced deeper into the cartridge slot123. The walls of the cartridge slot123including the guide track115and the stopping point113precisely position the cartridge110,110arelative to the mechanical components of the medical diagnostic device100,100a.

In certain embodiments, the stopping point113and complementary point within the track just move apart when the tub T is sealed with the cartridge110, ensuring a good seal. The cartridge remains substantially stationary relative to the apparatus100,100awhen the tub T is moved away and unsealed from the cartridge to permit a STRIPLET™ to be loaded onto a segment of a track leading to turret225(seeFIGS. 6A and 7B, for example). By “substantially stationary”, a small movement actually occurs due to the loss of contact of the cartridge at the stopping point when the tub T is sealed, ensuring a good seal. The small movement of the cartridge occurs when the tub T is moved until the cartridge contacts the stopping point. This small movement may be a far smaller movement than the movement of the tub T to expose a STRIPLET™ to the guide track segment, which is why the cartridge is deemed to remain “substantially stationary” during the movement of the tub T.

The cartridge110ahas inserts or structural supports126aand126bin certain embodiments which are illustrated atFIGS. 4C and 4D. The insert126aofFIG. 4Cprovides structural support for the testing STRIPLETS™ that are stacked inside the housing cover120aof cartridge110a. The other insert126bofFIG. 4Dis made of a desiccating plastic. Insert126bmay provide some structural support or not, and element126bmay provide desiccation without being formed to also provide support, e.g., may be a coating on the wall or a small structure or series of small components interwoven with support126a, for example. Either or both of the “inserts”126aand126bmay actually be built-in, e.g., by being molded together with the cartridge body110,110a.

Referring back now toFIG. 4A, at least a segment of a test strip track128is disposed below the magazine118,118afor receiving the test strip from the magazine118,118aand for providing a segment of a guide path for a test strip when the test strip is being fed to the lancing/collecting assembly112. Some of the features shown inFIG. 4Amay be present in the embodiment ofFIG. 4Beven though they are not specifically shown inFIG. 4B. The test strip track128also abuts against a seal130attached to the bottom end of the magazine118,118a. The seal130surrounds the bottom end of the magazine118,118aand is typically made from a substantially air-impermeable, moisture-impermeable material, such as, for example, rubber or a polymeric material. The combination of the test strip track128and the seal130provides a substantially moisture-tight, air-tight seal for the magazine118,118a. A resilient biasing element132, e.g., a spring, is positioned exterior to and above the magazine118,118ain order to ensure that the magazine118,118acan maintain test strips in a substantially moisture-tight, air-tight condition.

Outside of the magazine118,118ais a mechanism134for feeding test strips to the lancing/collecting assembly112. This feeding mechanism134includes a cam or cam assembly136for lifting the magazine118,118a, whereby a gap is formed between the seal130at the bottom end of the magazine118,118aand the test strip track128. The feeding mechanism134further includes a mechanism138for advancing a test strip from the magazine118,118ato the lancing/collecting assembly112. The mechanism138for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112includes at least one flexible component140that translates a force applied from a first direction (e.g., vertically) to a force applied in a second direction (e.g., horizontally) to advance a test strip from the magazine118,118ato the lancing/collecting assembly112. Examples of the at least one flexible component140include, for example, a flexible strip or flexible strips of a material, e.g., metal or polymeric material, capable of extending around a corner, i.e., an angle of approximately 90°, or a flexible spring or flexible springs, e.g., formed of metal or a polymeric material, capable of extending around a corner, i.e., an angle of approximately 90°. In order to lift the magazine118,118aand advance a test strip out of the magazine118,118aand into the lancing/collecting assembly112, the medical diagnostic device100is equipped with a slide142to which is attached the at least one flexible component140, either directly, or indirectly by means of an intermediate connector. The slide142is positioned to move along a slot144in a wall of the housing102. The user moves the slide142in a direction that results in the cam or cam assembly136lifting the magazine118,118a. After the magazine118,118ais lifted to a sufficient extent, whereby the seal130separates from the test strip track128to temporarily break the substantially moisture-tight, air-tight seal formed by the test strip track128and the seal130, the at least one flexible component140pushes a test strip out of the magazine118,118aand into the lancing/collecting assembly112. In an alternative embodiment, the slide142can be eliminated and the aforementioned functions can be performed by a motor located within the housing102.

FIGS. 5A and 5Billustrate the operation of one alternative for the magazine118,118ain which test strips are stored and from which test strips are fed to the lancing/collecting assembly112. In this embodiment the magazine118,118ais mounted on a base146. The magazine118,118aremains immobile throughout the step of feeding a test strip to the lancing/collecting assembly112. The magazine118,118ais not lifted or lowered by a cam or cam assembly to unseal the magazine118,118a. An opening in the magazine118,118afrom which the test strips emerge when fed into the lancing/collecting assembly112is maintained in a sealed condition by a bellows150. The bellows150is attached to both the base146and a movable element152, which surrounds the bottom of the magazine118,118a. The movable element152is of such a shape and dimensions that the movable element152fits around the bottom of the magazine118,118ato bring about a substantially moisture-tight and air-tight seal of the magazine118,118a. The movable element152is biased to a position to maintain the substantially moisture-tight, air-tight seal of the magazine118,118a. Attached to the movable element152is a first post154, to which is attached one end156of a cord158. The cord158is typically made of a metallic material. The other end160of the cord158is attached to a second post162, which is attached to a slide164, which is used for advancing a test strip from the magazine118,118ato the lancing/collecting assembly112. Guide wheels166,168are attached to the base146for maintaining the cord158in a taut condition. When the slide164is in its starting position, the bellows150is fully extended, thereby maintaining the magazine118,118ain a sealed condition. Furthermore, a pin170projecting from the slide164orients a recess172in the periphery of the second post162so as to enable the bellows150to be maintained in the fully extended position. When the slide164is moved in a direction to advance a test strip from the magazine118to the lancing/collecting assembly112, the pin170projecting from the slide164orients of the recess172in the periphery of the second post162so as to cause the movable element152to descend and compress the bellows150, thereby enabling a gap to be formed between the movable element152and the bottom of the magazine118, thereby further enabling a mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112to advance a test strip through this gap and subsequently into the lancing/collecting assembly112. Movement of the slide164to its starting position raises the movable element152to a position whereby the bellows150is fully extended so as to maintain the magazine118in a substantially moisture-tight, air-tight condition.

FIGS. 5C and 5Dillustrate the operation of another alternative for the magazine118,118ain which test strips are stored and from which test strips are fed to the lancing/collecting assembly112. In this embodiment the magazine118,118ais mounted on a base180. The magazine118,118aremains immobile throughout the step of feeding a test strip to the lancing/collecting assembly112. The magazine118,118ais not lifted or lowered by a cam or cam assembly to unseal the magazine118,118a. An opening182in the magazine118,118afrom which a test strip emerges when fed into the lancing/collecting assembly112is maintained in a sealed condition, i.e., a substantially moisture-tight and air-tight condition, by a set of doors184and186. The door184is maintained in a closed position by a resilient biasing element188, e.g., a spring, which resiliently biases the door184to the closed position. The door186is maintained in a closed position by a resilient biasing element190, e.g., a spring, which resiliently biases the door186to the closed position. The resilient biasing elements188and190are extended to cause the doors184and186, respectively, to open, whereby a mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112can advance a test strip from the magazine118,118athrough the opening182to the lancing/collecting assembly112. The doors184and186are attached to the base180on which the magazine118,118ais mounted by hinges194,194aand196,196a, which enable the doors184and186to swing from a closed position to an open position, and vice-versa. The resilient biasing elements188and190are extended by a three-component assembly linked to a slide198, which is used to open the doors184and186to enable the advancement of a test strip from the magazine118,118ato the lancing/collecting assembly112. One component of the three-component assembly is a bi-directional rod200having a bi-directional slot202formed therein. The bi-directional slot202receives the pin170attached to the slide198. The pin170moves in a slot206, which restricts the movement of the pin204to a single direction. Attached to the bi-directional rod200is the second component of the three-component assembly, a rod208that extends in a direction substantially perpendicular to the lower end200aof the bi-directional rod200. The first end208aof the rod208is securely attached to the bi-directional rod200, and can only move when the bi-directional rod200moves. The third component of the three-component assembly is a rod210having a first end212pivotally connected to the second end208bof the rod208and a second end214having a T-shaped projection216thereon that exerts a negligible force upon the resilient biasing elements188and190when the slide198is in its uppermost, or starting, position. In order to cause the doors184and186to open so that a mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112can advance a test strip from the magazine118,118ato the lancing/collecting assembly112, the slide198is pushed in a direction to cause the pin170to move until it reaches a position “A”, at which point the bi-directional feature of the bi-directional rod200causes the second end208bof the rod208to move upwardly, which, in turn, causes the rod210to rise slightly, thereby causing the T-shaped projection216to raise an extension218aof the door184and an extension218bof the door186, which extends the resilient biasing elements188and190, respectively, thereby causing the doors184and186to open. When the doors184and186are open, the mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112causes a test strip to be fed from the magazine118,118ato the lancing/collecting assembly112. When the slide198returns to its starting position, the resilient biasing elements188and190retract, thereby causing the doors184and186to close, and, consequently restoring the substantially air-tight, moisture-tight seal between the doors184and186and the magazine118,118a.

For the latter two embodiments, the mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112can be similar to that shown and described for the first embodiment. In the three embodiments described herein, the mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112can be separate from the mechanism for unsealing of the magazine118,118aor the mechanism for advancing a test strip from the assembly for storing test strips and dispensing test strips110to the lancing/collecting assembly112can be integrated with the mechanism for unsealing of the magazine118,118a.

Because the lancet of the lancet-containing portion of the STRIPLET™ is furnished with a protective cover, the protective cover must be removed or displaced from the tip of the lancet before the lancet can be used to form an opening in the skin of the patient. Accordingly, the assembly114for removing a protective cover from the tip of a lancet and re-attaching the protective cover to the tip of a used lancet is located in a position whereby the assembly114can remove the protective cover from the tip of the lancet of the lancet-containing portion of the test strip prior to the lancing step and re-attach the protective cover to the tip of the lancet of the lancet-containing portion of the test strip prior to disposal of the test strip after the test strip has been used. As shown schematically inFIG. 23, the assembly114includes a strip of flexible metal comprising a cover-snagging portion220, a cover-storing portion222, and a cover-stopping portion297. The assembly114can be positioned between the magazine118,118aand the lancing/collecting assembly112. The assembly114is mounted to the tub106by one or more resilient biasing elements226and228, e.g., springs, which enable upward and downward movement of the assembly114. As a test strip is being advanced from the magazine118,118a, the test strip slides over the cover-stopping portion297and the cover-storing portion222until the protective cover is snagged by the cover-snagging portion220. As the test strip continues to advance to the lancing/collecting assembly, the lancet of the lancet-containing portion of the test strip is separated from the protective cover and the test strip enters the lancing/collecting assembly112. The protective cover is retained in the cover-storing portion220. At the completion of the testing procedure, the protective cover is re-attached to the tip of the lancet by moving the test strip toward the assembly114or by moving the assembly114toward the test strip, whereby the tip of the used lancet re-enters the protective cover. The protective cover is made from a material that can receive the sharp tip of a lancet. The cover-stopping portion297stops the protective cover from sliding during re-attachment of the protective cover to the tip of the lancet to facilitate the step of re-attachment. The resilient biasing elements226and228enable the assembly114to move upwardly and downwardly, as required, to remove the protective cover from the tip of the lancet or to re-attach the protective cover to the tip of the lancet. The cover-snagging portion220is moved downwardly by a compressing element229after the protective cover is re-attached to the tip of the lancet to allow the re-covered test strip to be ejected from the medical diagnostic device100. A pushing device can be used to push the re-covered test strip out of an ejection port230in the housing102.

Referring again to FIGS.1and2A-2C, a printed circuit board (PCB) assembly232for controlling the electromechanical components and the electronic components of the medical diagnostic device100,100ais positioned in the housing102,102a. At least one battery234is included in the housing102,102ato provide a source of power for at least one motor236that will drive the lancing/collecting assembly112and, optionally, to drive one or more additional functional components of the medical diagnostic device100, including, but not limited to, the assembly110,110afor advancing test strips from the magazine118,118ato the lancing/collecting assembly112, the system for arming the lancet, the system for triggering the lancet, and to provide power for the analyzer116for determining the parameter of the biological liquid to be measured, storing data collected, activating the display, and other features of the analyzer116. More than one motor can be employed for carrying out the various mechanical functions described herein. The medical diagnostic device100,100ahas a display238, typically a liquid crystal display, for showing the results of the determinations of analytes. The medical diagnostic device100,100atypically includes one or more flexible circuits for connecting the PCB assembly232to the analyzer116and connecting the PCB assembly232to the motor or motors. The medical diagnostic device100can also include flexible circuits to connect the PCB assembly232to one or more sensors to determine the status of the medical diagnostic device100,100a. The medical diagnostic device100,100aalso has various activation buttons240a,240b,240c, and240dfor actuation of various functions of the medical diagnostic device100,100a. The medical diagnostic device100,100acan also have an alphanumeric keypad for manual input of various parameters related to determination of analytes.

The medical diagnostic device100,100ahas a depth adjustment control242. A particularly useful depth adjustment control employs a knob that is rotated to control movement of the end cap104or a portion thereof so that the depth of penetration of the lancet of the lancet-containing portion of the test strip can be specified. In another embodiment, a series of caps of different sizes are affixed to the housing at the lancing and testing port to accommodate the different lancing depths that are preferred by different patients or users.

FIGS. 6A-6Dare front, back, side and opposite side views, respectively, of mechanical components of a medical diagnostic apparatus100,100a in accordance with an embodiment, whileFIG. 6Eis a perspective view of a rotatable turret225including a STRIPLET™ slot299for reorienting a testing STRIPLET™ within a medical diagnostic apparatus100,100ain accordance with an embodiment.

The apparatus shown functions substantially mechanically according to first and second mechanical subsets219and220, respectively, which includes first and second sets of gears221and222, in addition to various cams and levers. There is a cartridge slot defined down the center of the long dimension of the apparatus100a. A reorientation carriage224is shown including turret225that rotates according to the movement of a cam226that oscillates between points, for example around an unstable equilibrium or other mechanism for urging the rotation of the turret225for reorienting the STRIPLET™ between lancing and testing via port231and ejecting via port230a. In an embodiment, the turret225is rotated 90 degrees, from an original position that the turret225is in when the STRIPLET™ 1000a is loaded, prior to translation through the port231ofFIG. 6Bfor lancing, 180 degrees prior to translation through the port231for testing, and 90 degrees prior to ejection through port230aofFIG. 6B. Referring toFIG. 6E, the STRIPLET™ is oriented in a first direction when surfaces227aand227bmeet for lancing, and the STRIPLET™ is oriented in a second direction for testing, rotated approximately 180 degrees or another angle equal to the angular displacement of the lancet and reagent area of the STRIPLET™, or flipped relative to the first direction, when surfaces228aand228bmeet. When the STRIPLET™ is in the first direction, it is armed for lancing such that upon advancement through port231, a lancing site can be pierced. When the STRIPLET™ is reoriented as a result of the functioning of cam226, the STRIPLET™ is ready to be advanced through the port231in the new orientation, so that a test sensor this time extends to touch the bodily fluid exposed at the lancing site due to the lancing. In the position shown inFIG. 6E, a fresh STRIPLET™ may be loaded into the turret225from the cartridge, and a used STRIPLET™ may be discarded through ejection port230a.

A track229is shown inFIG. 6Balong which a pusher P, not shown but which may be a flexible piece such as a uniformly flexible plastic or a chain with a suitable end piece for contacting the STRIPLET™, seeFIGS. 7A-7P, moves to advance the STRIPLET™ into the turret225, or permit it to retreat into the housing110,110a. The pusher P may lead a chain drive, or a highly flexible uniform plastic and/or another flexible material such as a metal such as stainless steel. The pusher P and drive mechanism may itself be a single piece or multiple pieces like a chain drive. The flexible pusher mechanism, including the pusher P and the drive mechanism, may wind and unwind from a coil to advance when it unwinds and retreat when it winds.FIG. 6Fillustrates this feature. The unwinding coil may follow the track229to push the STRIPLET™ through port both when the STRIPLET™ is in a lancing orientation and when the STRIPLET™ is reoriented for testing.FIG. 6Fillustrates a Buehler KNO4 rotary drive system, which can be used to provide a linear drive mechanism for advancing a STRIPLET™. The system shown inFIG. 6Fincludes a DC gear motor (e.g., Mabuchi DC motor-3V DC) and solid height spring in coil form.

The pusher P may also simply extend along a long dimension of the housing and turn at a corner, with the help of a curved inner wall surface such that the track229is formed between an outer wall of the housing or a proximate attachment thereto and the curved inner wall surface. The pusher P may even bend around two or three corners of the housing, and may be condensed in various ways when it is in the retreated position so that it is long enough to extend sufficiently when advancing the STRIPLET™ and yet is maintained inside the housing out of the way of other components when retreated.

In operation, the pusher P moves along track229and meets with a loaded STRIPLET™ pushing it into the turret225. The STRIPLET™ is rotated 90 degrees and advanced through port231for lancing. The STRIPLET™ retreats some and is rotated or flipped by reorientation mechanism224, including cam226, as the STRIPLET™ remains within the slot229of turret slot225. The STRIPLET™ is reoriented by 180 degrees, or another angle equal to the angle between the lancet and testing area of the strip portion of the STRIPLET™, so that it can advanced again through the port230aso that test sensor end1002of the STRIPLET™ now exits port230a and bodily fluid, e.g., blood, is applied for testing a body analyte, e.g., glucose, level such as a blood glucose, or ketone or other analyte level. After testing, the STRIPLET™ is rotated 90 degrees or whatever the angle between the ejection port and the lancing and testing port relative to the rotational center of the turret or STRIPLET™, and is ejected through port231with lancet cap covering lancet for safety. The pusher P may be used a second time for assisting in the ejecting of the used and recapped STRIPLET™ 1000a.

FIG. 6Gillustrates an exemplary embodiment showing a side view with some transparencies of mechanical components of an integrated meter. A main gear602or drive gear602is shown partially transparent for illustration. Gear602is coupled with a cam which is not visible inFIG. 6G, but which controls cam follower604. A carriage C is shown including a turret225, and these components are further illustrated atFIGS. 7A-7Pand described below.FIG. 6Galso illustrates multiple photosensors PS that are used for monitoring various movements and status of a lancing and testing process performed with the integrated meter. Optical signals are received at photosensors PS, which may or may not also emit optical signals that are reflected back, for providing information to a microprocessor and/or other meter control circuitry.

FIGS. 6H-61illustrate front and back views of a main drive gear of an integrated meter according to an embodiment. The front of the main gear602includes a central ring-like portion that has a nub608, and a hook610and post612for a clock spring (not shown). When the nub608is at about the 7 o-clock position, nub608causes lever620to rotate clockwise releasing a disk gear630or cam gear630.

FIGS. 6J-6Killustrate front and back views of the disk gear630or cam gear630of an integrated meter according to an embodiment. The clock spring interfaces between the main gear602and the cam gear630. Two cam paths632and634are defined in the cam gear, one or either side.

FIGS. 6L-6Millustrates front and back views of cam follower604of an integrated meter according to an embodiment. Cam follower604includes pivots P1and P2which follow cam paths632and634.

FIGS. 7A-7Pillustrate an operational sequence of a medical diagnostic apparatus in accordance with an embodiment.FIG. 7Ashows the medical diagnostic apparatus of this embodiment. The turret225is shown with the positions of lancing and testing port231and ejection port230apointed out. Track229has a chain therein which is led by pusher P. The cartridge110ais closed with seal130in place sealed with a tub T. Seal130may utilize an o-ring type seal. Tub T includes centering element233, which centers a next STRIPLET™ for precision loading onto track229for permitting the STRIPLET™ and pusher P to be precisely relatively disposed. A blade B is also illustrated awaiting its time to move downwardly for uncapping a lancet of a STRIPLET™1000a.

FIG. 7Bshows the tub T moved down breaking the seal130with tub T to expose a STRIPLET™ 1000a. The STRIPLET™ 1000a is loaded from the cartridge110aonto track229guided by centering element233. The tub T may include a guide platform for positioning a STRIPLET™ while retreating from the cartridge110a. The STRIPLET™ may therefore be loaded with precision onto the guide track segment from which a pusher P matches a contour of the lancet end of the STRIPLET™ and advance the STRIPLET™ into the turret225.

FIG. 7Cshows the pusher P advanced to meet the STRIPLET™1000a. The tub T continues to be in the downward position while the track229is exposed.FIG. 7Dshows the pusher P after having pushed the STRIPLET™ 1000a into turret225. The strip end1002aof the STRIPLET™ 1000a is pushed through first, while the lancet end1004aof the STRIPLET™ 1000a is behind. AtFIG. 7E, a blade B or decapping lever moves down to engage the lancet cap1204a. A ridge on the lancet cap1204aallows a contour of the blade B to couple therewith. The chain retracts as shown inFIG. 7Frotating the blade B slightly to permit the lancet cap1204ato move rearward along with the chain and pusher P so that the lancet cap1204abecomes removed from the lancet end1004aof the STRIPLET™ 1000a which remains in position in the turret225.

Referring toFIG. 7G, now that the lancet cap1204ais removed and retracted fully from the STRIPLET™ 1000a, the turret225is rotated 90 degrees. This 90 degree rotation of the STRIPLET™ 1000a orients the STRIPLET™1000awith lancet1004afirst and strip1002abehind, for being advanced through port231for lancing.

FIG. 7Hillustrates a lancing position as the carriage C is moved relative to the rest of the meter apparatus for lancing. Alternatively, a mechanism for pushing only the STRIPLET™ downward or only a turret section of the carriage downward may be provided.

Referring toFIG. 7I, the carriage C is moved back upward after the lancing or piercing of the skin of a diabetic at a lancing site. The turret225is rotated 180 degrees preparing for sensing. Note that the strip end1002ais shown inFIG. 7Ipointing toward port231, while inFIGS. 7G and 7H, the lancet end1004awas pointing toward port231.

FIG. 7Jillustrates how the carriage C is again moved downward this time for permitting body fluid appearing at the lancing site to be applied to the strip1002a. Note that the lancet cap1204a, blade B, and pusher P each remain in position while the lancing and testing occurs. The pusher P is overlapped with the cap1204a, such that the blade holds both the cap1204aand pusher P in place.

FIG. 7Kshows the carriage C moved back upward, and the turret225having been rotated 90 degrees from when the body fluid was being applied to the strip1002a. Now atFIG. 7L, the pusher P pushers the cap1204aback onto the lancet end1004a.

The STRIPLET™ may protrude from the housing when loaded into the turret225. The port231and230amay be configured with a slot or may be two ends of a same cavity that curves around the two sides of the housing shown. In this way, the carriage C. advances the STRIPLET™ for lancing and testing, and the turret225may remain translationally fixed relative to the carriage C. The turret225may alternatively move to expose either end of the STRIPLET™ through either port. In another embodiment, the carriage C does not move, while the turret225translates to expose the ends of the STRIPLET™ in turn through port231.

FIG. 7Mshows the uncapping lever or blade B moved back up disengaging from the lancet cap1204aand pusher P.FIG. 7Nshows the ejecting of the STRIPLET™ 1000a. The pusher P is shown after having advanced to push the STRIPLET™ 1000a through port230a.

AtFIG. 7O, the pusher P is retracted back to the start position on the track229that it was in atFIG. 7A. Now the pusher P is out of the way of the tub T, which can move back up as shown atFIG. 7Pand meet again with seal130to protect the STRIPLETS™ from ambient air and moisture until a next testing is to be performed.

Referring now toFIGS. 8-12, inclusive, the lancing/collecting assembly112includes a frame250having two upright members252and254and a horizontal member256. The upright member252has an inner face258and an outer face260. The upright member254has an inner face262and an outer face264. The inner face258and the outer face260are bounded by a top edge266a, a bottom edge266b, and two side edges266cand266d. The inner face262and the outer face264are bounded by a top edge268a, a bottom edge268b, and two side edges268cand268d. The inner face258has a track270and the inner face262has a track272for guiding the movement of a cam follower274. The inner faces258and262of the upright members252and254, respectively, of the frame250face one another. The horizontal member256of the frame250has a top edge276a, a bottom edge276b, two side edges276c,276d, and two faces276e,276f. One of the faces276eof the transverse member256of the frame250faces one of the upright members252of the frame250and the other face276fof the horizontal member256of the frame250faces the other of the upright members254of the frame250.

Referring now toFIGS. 11,13, and15-22, inclusive, the lancing/collecting assembly112includes a cradle280. The purpose of the cradle280is to hold a test strip during both the lancing step and the sample collecting step, which are carried out by the medical diagnostic device100. Another purpose of the cradle280is to orient a test strip during the lancing step and the sample collecting step so that the lancet of the lancet-containing portion of the test strip can form an opening in the skin of the patient during the lancing step and the sensor of the sensor-containing portion of the test strip can collect the sample of biological liquid emerging from the opening in the skin of the patient during the sample collecting step. In the embodiment shown inFIGS. 1-22, inclusive, the cradle280also holds the test strip during the analyzing step. The cradle280includes two upright members282and284and a transverse member286. The transverse member286of the cradle280connects the two upright members282and284of the cradle280. The upright member282of the cradle280has a slot288formed therein, and the upright member284of the cradle280has a slot290formed therein. The slots288and290receive an L-shaped element292and294, respectively, formed on a carrier296. The L-shaped element292has a foot292aand a leg292b. The L-shaped element294has a foot294aand a leg294b. The foot292aof the L-shaped element292and the foot294aof the L-shaped element294are capable of sliding in the slots288and290, respectively, of the cradle280during the lancing step and the sample collecting step so that the lancet of the lancet-containing portion of the test strip can form an opening in the skin of the patient during the lancing step and the sensor of the sensor-containing portion of the test strip can collect the sample of biological liquid emerging from the opening in the skin of the patient during the collecting step. The sliding motion of the foot292aand the foot294ais brought about by the movement of the cam follower274during the lancing step and during the sample collecting step. The upright member282of the cradle280further contains a track298formed therein, and the upright member284of the cradle280further contains a track300formed therein, each of which tracks298and300is of a size suitable for holding a test strip during the lancing and collecting functions of the medical diagnostic device, and in the embodiment shown inFIGS. 1-22, inclusive, the analyzing function.

The function of the carrier296is to house the electrical components and electronic components for completing a circuit when the test strip has received a sample of biological liquid from the patient.FIGS. 19-22, inclusive, shows how the carrier296receives and holds a test strip. The carrier296, which is shown as a six-sided element, has a first L-shaped element292formed in one side296aand a second L-shaped element294formed in an opposing side296b, which L-shaped elements292and294are received by the slots288and290, respectively, in the cradle280. The leg292bof the L-shaped element292and has a pin292c, which pin292cfits into and rotates in an aperture of the cam follower274. Similarly, the leg294bof the L-shaped element294and has a pin294c, which pin294cfits into and rotates in an aperture of the cam follower274. The electrical and electronic components of the carrier296, and the types of analyses that can be performed by the carrier296are described in detail in U.S. Pat. Nos. 6,299,757 and 6,616,819, the entireties of which are incorporated herein by reference.

Referring now toFIGS. 8-22, inclusive, the lancing/collecting assembly112includes a transmission system, including gears for (1) enabling operation of components required for a lancing operation for forming an opening in the skin of a patient, (2) collecting the sample of biological liquid emerging from the opening in the skin of the patient formed by the lancing operation, and (3) positioning a test strip during the analyzing operation. It should be noted that other configurations of gears, racks, can be used in place of the configuration shown inFIGS. 8-22, inclusive. It should be noted that transmission systems that utilize components other than gears can be used. The transmission system of the lancing/collecting assembly comprising the gears shown inFIGS. 8-22, inclusive, can be replaced in whole or in part by subsystems involving one or more racks and one or more pinions. Two important features of the medical diagnostic device100are that movement of the cam follower274can be effected in two directions, the directions being separated by approximately 180°, and that the cradle280or equivalent be capable of being rotated approximately 180° from a first position to a second position, the first position and the second position being separated by approximately 180°. As used herein, the expression “approximately 180°” means an angle ranging from about 160° to 200°, such as angles equal to or close to 180°.

Devices for mechanical transmission of power, or “mechanisms”, constitute the basic units from which all kinds of devices are built. Every mechanism consists of individual elements whose movements in relation to one another are “positive”, i.e., the motion of one element produces an accurately determinable and definable motion of every individual point of the other elements of that mechanism. Numerous combinations and modifications are possible, but only certain basic types of mechanisms will be noted here:(1) Screw mechanism: When a screw spindle is rotated, the element attached to the nut will move in the longitudinal direction of the screw.Conversely, if the nut is rotatably mounted in the frame of the mechanism and driven, the screw spindle will move longitudinally.(2) Linkage or crank mechanism: The characteristic element is the crank, which is rotatably mounted on a frame and is usually so designed that it can perform complete revolutions. Its motion is transmitted through the coupler (or connecting rod) to the lever (or rocker arm), likewise rotatably mounted, but not performing complete revolutions. Alternatively, instead of being connected to a lever, the coupler may be attached to a sliding element, e.g., a piston.(3) Pulley mechanism: Connection between pulleys on their respective shafts is effected by flexible elements (belts, ropes).(4) Ratchet mechanism: This serves to arrest a motion or to produce an intermittent rotation in the driven element. The pawl allows the ratchet wheel to rotate in one direction only, preventing rotation in the opposite direction by engaging the specially shaped teeth on the wheel.(5) Gear mechanism: This type of mechanism, which is used extensively herein, transmits rotary motion from one shaft to another, usually in conjunction with a change in rotational speed and torque. In a gear mechanism of the usual type, the transmission is effected by the meshing of gear teeth, but in a friction-gear mechanism, this positive drive is replaced by frictional contact of wheels or rollers.(6) Cam mechanism: This type of mechanism, which is used extensively herein, involves a cam mounted on a frame. The cam is driven and thereby moves a follower, which performs a desired predetermined motion depending on the shape of the cam.
Further information relating to the foregoing mechanisms can be found in The Way Things Work, Volume 2, Simon and Schuster (New York: 1971), pages 198-217, incorporated herein by reference.

Referring now toFIGS. 8-22, inclusive, a motor gear310is attached to a gear shaft312from the motor314. The motor gear314drives an idler gear316. The combination of motor gear310and idler gear316drives a first drive gear320, which is attached to a second drive gear322. As shown inFIGS. 8-22, inclusive, the first drive gear320is circular and has a greater diameter than the second drive gear322. The second drive gear322is capable of driving both a gear324for rotating the cradle280and a gear326for rotating an index cam328. The first drive gear320has teeth surrounding the entire periphery thereof. The second drive gear322is a sector gear, and contains teeth on only a portion of the periphery thereof. The first driven gear324is included for rotating the cradle280. The second driven gear326is included for rotating the index cam328. Both the first driven gear324and the second driven gear326have teeth surrounding the entire periphery thereof. The first driven gear324has a locking pin332projecting from the major surface thereof that faces the first drive gear320. Similarly, the second driven gear326has a locking pin334projecting from the major surface thereof that faces the first drive gear320. The locking pins332and334perform a variety of locking functions during the operation of the lancing/collecting assembly112. The first drive gear320has a slot320aformed therein for retaining the locking pins332and334during the operation of the lancing/collecting assembly112.FIGS. 25A-25J, inclusive, show and TABLE 1 describes the positions of the locking pins332and334during one cycle of the medical diagnostic device100.

A lancing gear336is included for arming and firing a lancing cam338. A gearbox340is also shown. The gearbox340contains those components that enable the second drive gear322to switch from driving the first driven gear324, i.e., the gear for rotating the cradle280, to driving the second driven gear326, i.e., the gear for rotating the index cam328. The gearbox340also contains those components that enable the drive gears to reverse their direction of rotation.

The lancing cam338is shown as having major surfaces that are circular in shape. The lancing cam338has an inner face342and an outer face344. The inner face342contains a cylindrical element346formed thereon in such a manner that a circular path348is formed between the cylindrical element346and the peripheral edge350of the lancing cam338. A pin352formed on a projection354on the cam follower274travels along this circular path348in order to enable the cam follower274to move in the direction desired for the particular operation being undertaken. Further projecting from the cylindrical element346of the inner face342is a substantially cylindrical projection358having a recess360formed in the periphery thereof. The purpose of the cylindrical projection358is to support one end of an axle362that traverses the distance between the lancing cam338and the index cam328.

The purpose of the recess360in the cylindrical projection358is to receive a lock364to prevent the force of gravity from drawing the lancing cam338and the index cam328downwardly when the lancing cam338and the index cam328are not being operated. The lock364includes a hook portion366, a resilient biasing element-retaining portion368, and a cam-supporting portion370. A resilient biasing element372, e.g., a spring, one end of which is secured to the resilient biasing element-retaining portion368and the other end of which is secured to the frame250, biases the lock364to the locked position. The lock364is released to enable movement of the lancing cam338and the index cam328merely by causing either the lancing cam338or the index cam328to be rotated a few degrees. The force generated by such rotation is sufficient to overcome the biasing force of the resilient biasing element372.

The peripheral edge350of the lancing cam338has a portion382cut out to enable the pin352formed on the projection354of the cam follower274to enter the circular path348surrounding the cylindrical element346on the inner face342of the lancing cam338. The lancing cam338has a lancing camshaft384projecting from the outer face386of the lancing cam338. The lancing camshaft384is positioned eccentrically with respect to the outer face386of the lancing cam338. Positioned on the lancing camshaft384is a torsion spring388, which has the function of storing sufficient energy to enable the lancet of the lancet-containing portion of the test strip to be fired with sufficient force to form an opening in the skin of the patient. Located on the lancing camshaft384, but facing the outer face264of the upright member254of the frame250is a ring390having a pin392projecting from the peripheral surface thereof. Adjacent to the ring390is a spring winder394, which is permanently attached to the lancing gear336. The spring winder394is cylindrical in shape and has an element396projecting from the periphery thereof. A pin398for contacting the pin392projecting from ring390projects from the end of the element396. Upon rotation of the lancing gear336by a lancing rack400, the lancing gear336drives the spring winder394, whereby the element396brings about rotation of the ring390by means of rotating the pin392projecting from the periphery of the ring390. After the ring390is rotated approximately 340-360°, a locking tab402on the face344of the lancing cam338abuts a locking tab404positioned on a trigger406, thereby arming the medical diagnostic device100. The teeth of the lancing gear336are capable of meshing with the teeth of the lancing rack400.

In order to trigger the medical diagnostic device100so that the lancet of the lancet-containing portion of the test strip can form an opening in the skin of the patient and can subsequently be retracted from the opening so formed, the user merely actuates the trigger406, such as, for example, by pushing a button, whereby the locking tab404disengages from the locking tab402, and the energy stored in the torsion spring388causes the lancet of the lancet-containing portion of the test strip to be fired and subsequently retracted. Attached to one end of the lancing rack400is a lance return spring408. During the lancing step, as the lancing rack400drives the lancing gear336, the lance return spring408is expanded. The energy stored in the expanded lance return spring408is sufficient to enable retraction of the lancet of the lancet-containing portion of the test strip.

As described earlier with respect to the interaction between the cradle280, the carrier296, the L-shaped elements292and294, the lancet-containing portion of the test strip, and the sensor-containing portion of the test strip, the lancet of the lancet-containing portion of the test strip is moved toward the skin of the patient to form an opening in the skin of the patient by means of movement of the cam follower274, which causes the foot292aof the L-shaped element292and the foot294aof the L-shaped element294, both of which are attached to the carrier296, to slide in the slots288and290, respectively, of the cradle280. In the lancing step, the cam follower274is driven by the lancing cam338.

The lancing cam338engages a pin352on the cam follower274when the cradle280is in either of two vertical positions (the position required for lancing the skin of a patient and the position required for collecting a sample of biological liquid from the patient). Because these positions are 180° apart, there are two engagement surfaces on opposite ends of the cradle280. The sliding of the L-shaped elements292and294of the carrier296in slots288and290of the cradle280produces the required motions for forming an opening in the skin of the patient and collecting a sample of biological liquid from the opening formed in the skin of the patient.

The index cam328is shown as having major surfaces that are circular in shape. The index cam328has an inner face410and an outer face412. The inner face410contains a cylindrical element414formed thereon in such a manner that a circular path416is formed between the cylindrical element414and the peripheral edge418of the index cam328. A pin420formed on a projection422on the cam follower274travels along this circular path416in order to enable the cam follower274to move in the direction desired for the particular operation being undertaken. Further projecting from the cylindrical element414of the inner face410is a substantially cylindrical projection424having a recess426formed in the periphery thereof. The purpose of this cylindrical projection424is to support one end of an axle362that traverses the distance between the lancing cam338and the index cam328. The index cam328has an index camshaft428. The index camshaft428is positioned eccentrically with respect to the outer face412of the index cam328.

After an opening is formed in the skin of the patient during the lancing step, and after the lancet-containing portion of the test strip is retracted, the test strip is oriented so that the sensor-containing portion of the test strip can collect a sample of biological liquid emerging from the opening in the skin of the patient. In the embodiment of the lancing/collecting assembly112shown herein, the mechanical transmission system orients the test strip by rotating the cradle280approximately 180° so that the sensor-containing portion of the test strip faces the opening in the skin of the patient. The mechanical transmission system then causes the index cam328to advance the test strip to the opening in the skin of the patient through the opening117in the end cap104. Unlike the lancing step, no arming step or trigger step is required. However, the test strip moves in the same manner as it did during the lancing step, namely, the mechanical transmission system causes the index cam328to move the cam follower274, which in turn causes the L-shaped elements292and294to slide in the slots288and290in the cradle280, thereby enabling the sensor of the sensor-containing portion of the test strip to contact the sample of biological liquid emerging from the opening in the skin of the patient. The sensor of the sensor-containing portion of the test strip receives a sufficient quantity of the sample to carry out a determination of the analyte. In the embodiment of the lancing/collecting assembly112shown herein, the carrier296is designed to carry out the determination of the analyte. During the assay or after the completion of the assay, the cradle280is rotated 90° by the mechanical transmission system to position the test strip for re-attaching the protective cover to the used lancet of the lancet-containing portion of the test strip, removing the used test strip from the lancing/collecting assembly112, and disposing of the used test strip through an ejection port230in the housing102.

The cam follower274is a substantially U-shaped element having two upright members430and432that are connected by a transverse member434. The upright member430has an aperture436into which the pin292cprojecting from the leg292bof the L-shaped element292on the carrier296is received. The upright member432has an aperture442into which the pin294cprojecting from the leg294bof the L-shaped element294on the carrier296is received. The upright member430of the cam follower274is disposed between the upright member448of an L-shaped projection450of the cradle280and the upright member282of the cradle280. Similarly, the upright member432of the cam follower274is disposed between the upright member454of an L-shaped projection456of the cradle280and the upright member284of the cradle280. Rotation of the pins292cand294cin the apertures436and442, respectively, make it possible for the lancing/collecting assembly112to achieve all of the positions required to carry out the operations needed to (a) receive a test strip from the assembly for storing and dispensing test strips110, (b) form an opening in the skin of the patient, (c) collect a sample of biological liquid emerging from the skin of the patient, and (d) remove the test strip form the lancing/collecting assembly112.

As shown inFIG. 17, the projection422on the cam follower274is flexible and the projection354on the cam follower274is rigid. The flexible projection422is in the shape of the letter U. However, such a shape is merely a matter of choice and other shapes can be selected. For example, the projecting element can be diamond-shaped. The flexibility of the projection422enables the test strip to comply with the opening formed in the skin of the patient to facilitate collection of the sample of biological liquid. The rigid projection354is adjacent to the flexible projection422. The lack of flexibility of the projection354enables the motion of the lancet of the lancet-containing portion of the test strip to be fixed, thereby allowing uniform puncturing of the skin of the patient during the lancing step. A nose portion354aprojecting from the projection354receives one end of the resilient biasing element372, which locks the lancing cam338and the index cam328when these cams are not in operation.

The medical diagnostic device100can also include a mechanism for ejecting used test strips from the cradle280. This mechanism can be operated by employing a user-actuated pushing assembly or a motor-actuated pushing assembly to push a used test strip out of the cradle280and out of the ejection port230of the housing102.

To operate the lancing/collecting assembly, a motor can be used to apply a rotating drive input. Alternatively, any rotating drive source could be used, e.g., manual input by the user.

The lancing/collecting assembly112can be armed by actuating a slide460positioned in a slot in a side of the housing102. The slide460is connected to the lancing rack400by means of a connector. In order to arm the lancet of the lancet-containing portion of the lancing/collecting assembly, the user need only move the slide460in the appropriate direction until the locking tab404on the trigger406abuts the locking tab402on the lancing cam338. In an alternative embodiment, the slide460can be replaced by a motor capable of driving the lancing rack400in the appropriate direction.

The trigger406of the lancing/collecting assembly112can be actuated by a push-button462positioned at the proximal end of an elongated element464that carries the locking tab404, as shown inFIG. 24.

In order to make effective use of the medical diagnostic device described above, a novel testing and lancing element, i.e., a STRIPLET™, was developed. As shown inFIGS. 26A-26B, STRIPLET™ 1000, 1000a has a sensor-containing portion1002,1002aand a lancet-containing portion1004,1004a. Referring specifically toFIGS. 26A-26B, an integrated lancet and testing STRIPLET™ 1000, 1000a is provided for measuring a body analyte, e.g., glucose, level in a diabetes care regimen. A lancet body1202,1202aincludes a test strip receiving end1036,1036aand a lancet end. A lancet1200is coupled with and protruding from the lancet end and secured by a lancet cap1204,1204a. A test strip1002,1002ais coupled to the test strip receiving end1036,1036aof the lancet body1202,1202ahaving multiple electrodes and assay chemistry for testing an analyte, e.g., glucose, level of an applied body fluid. The test strip1002,1002aand lancet1200are relatively disposed at different ends of the STRIPLET™ 1000, 1000a for providing both lancing and application of body fluid at a lancing site by reorienting and advancing the STRIPLET™ 1000, 1000a within the meter after lancing to contact a sample receiving portion of the test strip precisely at the lancing site.

The reorienting may include rotating the STRIPLET™ 1000, 1000a when the lancing site remains approximately at the predetermined location relative to the meter for application of body fluid to the sample receiving portion of the test strip1002,1002a. The test strip1002,1002aand lancet1200may be symmetrically disposed at opposite ends of the lancet body1202,1202a. The reorienting may include rotating and/or flipping the STRIPLET™ 1000, 1000a when the lancing site remains approximately at the predetermined location relative to the meter for application of body fluid to the sample receiving portion1010aof the test strip1002,1002a.

The lancet body1202,1202amay include a pair of relatively disposed recesses1028a,1028bfor respectively positioning the test strip via a spring-loaded ball and detent mechanism (not shown) for lancing and application of body fluid at a same lancing/testing site. The recesses1028a,1028bmay be trapezoidally-shaped, as inFIG. 26B.

The lancet cap1204aofFIG. 26Bincludes two elastomeric arms1029, although there may be one or more than two, that couple with defined cutouts in the lancet body1202afor snapping the cap1204ainto and out of mating relationship with the lancet body1202aby respective application of sufficient coupling and separation force.

Referring for a moment toFIG. 26C, a STRIPLET™ 1000 is shown including a lancet body1202, test strip1002coupled with the lancet body1202, and a lancet cap1204aprotecting a lancet1200which is also coupled to the lancet body1202. The pusher P ofFIGS. 7A-7Pis shown coupled with the STRIPLET™ 1000. The pusher P has a U-shape inFIG. 26C, and may have any of a variety of shapes that fit somewhat snugly such as to overlap the lancet cap1204aat least through the plane of a mating contour1201of the lancet cap1204a. Although not shown inFIG. 26C, the pusher may have a corresponding contour to the mating contour1201of the lancet cap1204a. When the blade B ofFIGS. 7A-7Pis disposed in mating relation with the mating contour1201of the lancet cap1204a, the pusher P is also coupled, via its own corresponding contour or sufficient friction, with the blade B and/or with the lancet cap1204a. This permits a retreating motion of the pusher P to bring the lancet cap1204awith it away from the lancet body1202of the STRIPLET™ 1000 for arming the lancet1200while the STRIPLET™ 1000 is disposed in the turret225shown inFIGS. 7A-7P. Although not shown, a chain or other flexible component may be attached to the pusher P for advancing and retreating the pusher P, e.g., as illustrated in one example atFIG. 6F.

The lancet body1202,1202aand test strip1002,1002aofFIGS. 26A,26B or see specificallyFIG. 31, may include at least two teeth1136,1138that fit corresponding slots1122,1124for coupling the lancet body1202,1202aand test strip1002,1002a,1102together, and the lancet body1202,1202ahas the teeth and the test strip1002,1002a,1102has the corresponding slots1122,1124.

The test strip1002,1002a,1102may include a base1006and a cover1008as illustrated atFIG. 28. The base1006may have a layer of electrically conductive material applied to one major surface thereof1006a, while the cover1008may have a working electrode and a trigger electrode applied to one major surface1008bthereof. The base1006may be adhered to the cover1008by a layer of electrically conductive adhesive and/or a layer of non-conductive adhesive1020,1026. The sensor-containing portion may include a sample flow channel, and a working electrode and a trigger electrode may be positioned in the flow channel. The cover1008may include at least one electrical passageway running from an inner face to an outer face and/or a slot formed therein to attach the sensor-containing portion to a tab in the lancet-containing body. The base may include an opening formed therein to attach the sensor-containing portion to a tab in the lancet-containing body.

The base1006or the cover1008has a recess1010,1010a,1012formed in an edge thereof that forms the sample receiving portion of the test strip. The recess1010,1010a,1012may have a hydrophilic material applied thereto. The lancet1200may be positioned approximately 180° from the recess1010,1010a,1012. Electrical contact pads may be on one major surface of the cover1006and/or base1008. The cover1006may include a layer of electrically conductive or semiconductive material, such as carbon. The trigger electrode may include carbon.

In one embodiment, the sensor-containing portion1002includes a base1006and a cover1008. As shown inFIGS. 26-29B, inclusive, both the base1006and the cover1008are substantially rectangular in shape, although other shapes may be used. In this substantially rectangular embodiment, the base1006has two major surfaces1006a,1006band four edges1006c,1006d,1006e, and1006f(seeFIG. 28). The cover1008has two major surfaces1008a,1008band four edges1008c,1008d,1008e, and1008f. The base1006has a recess1010formed in one edge thereof, and the cover1008has a recess1012formed in one edge thereof. The surfaces of these recesses1010and1012bear a hydrophilic material in order to enable the sample of biological liquid to have greater affinity for the recesses1010and1012than if the recesses were not bearing a hydrophilic material. The base1006and the cover1008may be made from an electrically non-conducting material, e.g., an insulating material that is not capable of carrying substantial electric charge or current. Examples of materials usable include polyesters, polyethylene (both high density and low density), polyethylene terephthalate, polycarbonate, vinyls, and the like. The material may be treated with a primer or other such coating to improve the adhesion of the electrodes thereon. In certain embodiments, the base and/or cover is made from a hydrophobic polymeric material, e.g., “MELINEX” polymer, or the like.

The base1006bears a layer of electrically conductive material1014on the major surface thereof facing the cover1008. Conductive material that may be used include gold, carbon, platinum, ruthenium dioxide, palladium, and conductive epoxies, such as, for example, ECCOCOAT CT5079-3 Carbon-Filled Conductive Epoxy Coating (available from W. R. Grace Company, Woburn, Mass.), Ag/AgCl, Ag/AgBr, as well as other materials known to those skilled in the art. For example, the embodiment ofFIG. 6Amay include Ag/AgCl. This electrically conductive material functions as a dual-purpose reference/counter electrode. The major surface of the cover1008facing the base1006bears a layer of electrically conductive material1016in a first area, which layer of electrically conductive material constitutes a working electrode, and a layer of electrically conductive material1018in a second area, which layer of electrically conductive material constitutes a trigger electrode. The major surface of the cover1008facing the base1006also bears a layer of non-conductive adhesive1020in a first area and layer of non-conductive adhesive1022in a second area to bond the cover1008to the base1006. The layers of non-conductive adhesive1020,1022also function to space the cover1008from the base1006so that a channel1024running along the center of the sensor-containing portion1002of the test strip1000is formed. A layer of electrically conductive adhesive1026enables the transfer of signal from the major surface1006aof the base1006to the major surface1008bof the cover1008. The layer of electrically conductive adhesive1026can be made from a pressure-sensitive adhesive doped with an electrically conductive material, e.g., carbon. The layer of electrically conductive adhesive1026may be any suitable thickness, e.g., 0.002 inch.

At least one electrical passageway1028enables the transfer of signal from the major surface1008bof the cover1008to the major surface1008aof the cover1008. An electrical passageway is a passageway formed in the cover1008. The at least one electrical passageway1028is filled with electrically conductive material, such as, for example, carbon. The benefit resulting from the use of one or more electrical passageways is that all of the contact pads1029a,1029b,1029cof the sensor-containing portion1002of the test strip1000can be positioned on one major surface of the cover1008of the test strip1000.

While not critical, it is advantageous that the dimensions of the sensor-containing portion1002of the test strip1000be as small as possible in order to reduce the size of the assembly110and reduce the volume of sample required to carry out a test. Typical dimensions of the base1006and cover1008are approximately 6 mm×6 mm x<2 mm. Typical dimensions of the electrodes and typical dimensions of a sample flow channel1024are described in U.S. Pat. Nos. 6,229,757 and 6,616,819, incorporated herein by reference. When the sample of biological liquid is introduced at the hydrophilic recesses1010,1012, the liquid is easily drawn up into the channel1024, along which the liquid flows by means of capillary attraction. The major surface1008aof the cover1008not facing the base1006has electrical contact pads1029a,1029b,1029cexposed, which electrical contact pads1029a,1029b,1029care in contact with the contact leads1030a,1030b,1030c,1030dof the carrier296, as shown inFIG. 29C. The cover1008also has two recesses1032,1034in the edges perpendicular to the edge having the sample uptake recess1012. The function of these recesses1032,1034in the sides is to securely attach the sensor-containing portion1002of the test strip1000to the lancet-containing portion1004of the test strip1000, which holds the lancet in place. As shown inFIG. 26, the tabs1036and1038project downwardly from the lancet-containing portion1004of the test strip1000toward the recesses1032,1034in the edges of the sensor-containing portion1002of the test strip1000.

A meter or other electrical device may use an electrical connector, which is configured to couple with and contact the contact pads at the end of a sensor. The meter may include a potentiostat or other component to provide a potential and/or current for the electrodes of the sensor. If configured for optical analysis, at least one light source may be provided, including componentry for measuring a property of the light as it impinges the sample, e.g., reflectance, absorbance, etc. The meter also typically includes a processor (e.g., a microprocessor or hardware) for determining the concentration of an analyte from the signals from the sensor. The meter also includes a display or port for coupling a display to the sensor. The display displays the signals from the sensor and/or results determined for the signals from the sensor including, for example, the concentration of an analyte, and/or the exceeding of a threshold of the concentration of an analyte (including, for example, hypo- or hyperglycemia). Furthermore, the meter may be configured to indicate to the user, via, for example, an audible, visual, or other sensory-stimulating alarm, when the level of the analyte is at or near a threshold level. For example, an alarm system may be included. For example, if glucose, is monitored then an alarm may be used to alert the user to a hypoglycemic or hyperglycemic glucose level and/or to impending hypoglycemia or hyperglycemia. The electrical connector employs contact leads that provide electrical connection between the sensor and the meter. The leads have proximal ends to physically contact the contact pads and distal ends to connect to any attached meter. The end of the sensor that has the contact pads can be slid into or mated with the electrical connector by placing the sensor into a slide area, which provides a support for and retains the sensor. It is important that the contact leads of the electrical connector make electrical contact with the correct pads of the sensor so that the working electrode and counter electrode(s) are correctly coupled to the meter. In certain embodiment of the medical diagnostic device100described herein, the carrier296substantially performs the aforementioned functions of the meter that is described in U.S. Pat. No. 6,616,819.

In another embodiment, the sensor-containing portion1002′ includes a base1006′ and a cover1008′. As shown inFIGS. 30A-30C, inclusive, both the base1006′ and the cover1008′ are substantially rectangular in shape, but other shapes may be employed. In this embodiment, the base1006′ has two major surfaces1006a′,1006b′ and four edges1006c′,1006d′,1006e′, and1006f′. The cover1008′ in this embodiment has two major surfaces1008a′,1008b′ and four edges1008c′,1008d′,1008e′, and1008f′. The base1006′ has a recess1010′ formed in one edge thereof, and the cover1008′ has a recess1012′ formed in one edge thereof. The surfaces of these recesses1010′ and1012′ bear a hydrophilic material in order to enable the sample of biological liquid to have greater affinity for the recesses10100′,1012′ than if the recesses were not bearing a hydrophilic material.

The base1006′ bears a layer of electrically conductive material1014′ (for example, Ag/AgCl) on the major surface thereof facing the cover layer1008′. This electrically conductive material functions as a dual purpose reference/counter electrode. The major surface of the cover1008′ facing the base1006′ bears a layer of electrically conductive material1016′ in a first area, which layer of electrically conductive material constitutes a working electrode, and a layer of electrically conductive material1018′ in a second area, which layer of electrically conductive material constitutes a trigger electrode. The major surface of the cover1008′ facing the base1006′ also bears a layer of non-conductive adhesive1020′ in a first area and layer of non-conductive adhesive1022′ in a second area to bond the cover1008′ to the base1006′. The layers of non-conductive adhesive1020′,1022′ also function to space the cover1008′ from the base1006′ so that a channel1024′ running along the center of the sensor-portion1002′ of the test strip1000′ is formed. A layer of conductive adhesive1026′ enables the transfer of signal from the major surface1006a′ of the base1006′ to the major surface1008b′ of the cover1008′. The layer of electrically conductive adhesive1026′ can be made from a pressure-sensitive adhesive doped with an electrically conductive material, e.g., carbon. The layer of electrically conductive adhesive1026′ typically has a thickness of about 0.002 inch.

At least one electrical passageway1028′ enables the transfer of signal from the major surface1008b′ of the cover1008′ to the major surface1008a′ of the cover1008′. An electrical passageway1028′ is a passageway formed in the cover1008′. The at least one electrical passageway1028′ is filled with electrically conductive material, such as, for example, carbon. The benefit resulting from the use of one or more electrical passageways is that all of the contacts of the sensor-containing portion of the test strip can be positioned on one major surface of the cover of the test strip. The electrical passageways1028′ are identical to or substantially similar to the electrical passageways1028previously described and shown inFIG. 28.

While not critical, it is advantageous that the dimensions of the sensor-containing portion1002′ of the test strip1000′ be as small as possible in order to in order to reduce the size of the magazine118and reduce the volume of sample required to carry out a test. Typical dimensions of the base1006′ and cover1008′ are about 6 mm×6 mm x<2 mm. Typical dimensions of the electrodes and typical dimensions of channels1024′ that may be used are described in U.S. Pat. Nos. 6,229,757 and 6,616,819, incorporated herein by reference. When the sample of biological liquid is introduced at the sample receiving area, e.g., hydrophilic recesses1010′ and 1012′, if present, the sample is easily drawn up into the channel1024′, along which the sample flows by means of capillary attraction. The major surface of the cover1008′ not facing the base1006′ has electrical contact pads1029a′,1029b′,1029c′ exposed, which electrical contact pads1029a′,1029b′,1029c′ are in contact with the contact leads1030a,1030b,1030c,1030dof the carrier296, as shown inFIG. 30C. The base1006′ also has two openings1032′,1034′ formed therein on either side of one leg of the L-shaped electrode1014′. The function of these openings1032′,1034′ is to securely attach the sensor-containing portion1002′ of the test strip1000′ to the lancet-containing portion, which holds the lancet in place. When the sensor-containing portion of the test strip has recesses in the sides of the cover, as shown inFIGS. 26 and 29A, the tabs of the lancet-containing portion of the test strip project downwardly, in the manner of the tabs of the lancet-containing portion shown inFIG. 26. When the sensor-containing portion of the test strip has openings in the base, as shown inFIGS. 30B,31, and32, the tabs of the lancet-containing portion of the test strip project upwardly, in the manner of the tabs of the lancet-containing portion shown inFIG. 31. The test strip1000′ of this embodiment can employ the same carrier296that can be used with the embodiment of the test strip1000previously described and the same type of meter as described in U.S. Pat. No. 6,616,819.

In still another embodiment, as shown inFIGS. 31-33, inclusive, a test strip1100includes a sensor-containing portion1102and a lancet-containing portion1104. The sensor-containing portion1102includes a base1106and a cover1108. The base1106is substantially rectangular in shape and has two major surfaces1106a,1106band four edges1106c,1106d,1106e, and1106f. The base1106has a recess1110formed in one edge thereof. The surface of this recess1110bears a hydrophilic material in order to enable the sample of biological liquid to have greater affinity for the recess1110than if the recess were not bearing a hydrophilic material.

On one major surface of the base1106is a layer of electrically conductive material1112in a first area and a layer of electrically conductive material1114in a second area. The first area constitutes the working electrode and the second area constitutes the trigger electrode. The cover1108is separated from the base1106by layers1116,1118of non-conductive adhesive applied to the base1106and cover1108in such a manner that a channel1120forming a sample flow path is created. This channel1120runs along the center of the sensor-portion1102of the test strip1100. The cover1108is made of an electrically conductive material (such as, for example, vinyl having an electrically conductive material, e.g., Ag/AgCl, thereon) and functions as a dual purpose reference/counter electrode. When a sample of biological liquid is introduced at the hydrophilic recess1110, the sample is easily drawn up into the channel1116, along which the sample flows by means of capillary attraction. Portions of the electrically conductive material of the base1106function as electrical contact pads. The base1106has two openings1122,1124formed therein on either side of the cover1108. The function of these openings1122,1124is to securely attach the sensor-containing portion1102of the test strip1100to the lancet-containing portion1104, which holds the lancet in place. This embodiment does not require a conductive adhesive or electrical passageways to carry out determination of analytes.

The test strip1100of this embodiment can employ the same carrier296that can be used with the embodiments of the test strips1000,1000′ previously described and the same type of meter as described in U.S. Pat. No. 6,616,819, which is incorporated by reference.

Below a sample application well or zone of a test strip may be a wicking membrane that is striped with various reagents to create various reagent, capture and/or eluate zones. A hemolysis reagent zone may be positioned below a sample application zone. The hemolysis reagent zone may include a hemolysis reagent that is striped, such as absorbed, confined, or immobilized, on a wicking membrane of the test strip. A small amount of hemolysis reagent, such as about 1 to about 2 or about 3 microliters, for example, is sufficient for striping the wicking membrane such that the hemolysis reagent zone is sufficiently confined on the test strip. Any reagent or combination of reagents suitable for hemolysis, and the consequent liberation of hemoglobin, can be used. By way of example, an ionic detergent, such as sodium dodecyl sulfate (SDS), a non-ionic detergent, such as a octylphenol ethylene oxide condensate or octoxynol-9 or t-octylphenoxypolyethoxy-ethanol, sold under the name, Triton X-100, and commercially available from Sigma Chemical or Sigma-Aldrich Co., or a hypotonic solution, may be used as a hemolysis reagent.

A glycated hemoglogin capture zone may be disposed downstream relative to the hemolysis zone. By way of example, any chemical reagent comprising at least one boron ligand, such as phenyl boronate or other boron affinity chemistry used in the above-referenced Glycosal test, or such as m-aminophenylboronic acid, such as that of a gel that is immobilized on cross-linked, beaded agarose, any antibody, such as anti-HbA1c antibody available from a number of sources, any immunoassay reagent, any chemical reagent including at least one binding ligand, such a boronic acid involving boron binding ligands, and the like, and any combination thereof, that is suitable for the binding of glycated hemoglobin to the capture zone222, such as via covalent bonds, for example, or the capture of glycated hemoglobin in capture zone222, may be used. A hemolysis layer/zone and a glycated hemoglobin capture zone can be integrated to form an integrated reagent zone.

A lancet1200can be integrated directly into the sensor-containing portion1002,1002′,1102of the test strip. Alternatively, the sensor-containing portion1002,1002′,1102of the test strip can be attached to the lancet-containing portion of the test strip. The medical diagnostic device100can have an alignment feature to ensure that movement, e.g., rotation, of the test strip during use does not result in misalignment of the sample application zone of the test strip. The alignment feature can be provided by springs associated with the carrier296.

The lancet-containing portion1004shown inFIG. 26can be used with, or can be modified to be used with, any of the sensor-containing portions1002,1002′, and1102described herein. For example, the tabs for connecting the lancet-containing portion to the sensor-containing portion can be modified to project upwardly to enable the lancet-containing portion to be used with a sensor-containing portion having openings in the base, rather than recesses in the sides of the base and the cover. It should be noted that other embodiments of the lancet-containing portion can be used with any of the sensor-containing portions1002,1002′, and1102described herein. As shown inFIG. 26, the lancet-containing portion1004is shown as having a lancet-containing body1202. The lancet1200is held in the lancet-containing body1202. The lancet-containing body1202can be attached to the sensor-containing portion1002by tabs1036,1038or can be attached to the sensor-containing portion1002′,1102by tabs1136,1138. When the sensor-containing portion of the test strip has recesses in the sides of the cover, as shown inFIGS. 26 and 29A, the tabs1036,1038of the lancet-containing portion of the test strip project downwardly, in the manner of the tabs of the lancet-containing portion shown inFIG. 26. When the sensor-containing portion of the test strip has openings in the base, as shown inFIGS. 30B,31, and32, the tabs1136,1138of the lancet-containing portion of the test strip project upwardly, in the manner of the tabs of the lancet-containing portion shown inFIG. 31. Any suitable dimensions of the lancet-containing body may be employed, and in certain embodiments the lancet-containing body1202of the lancet-containing portion1004is 10 mm×8 mm×1.5 mm. Typical dimensions of the protective cover1204for the lancet1200are 3 mm×1.4 mm. Typical dimensions of the needle for forming the lancet1200are 28 to 30 gauge, 10 mm total length, 3.5 mm exposed length.

A lancet1200for puncturing the skin to obtain a sample of biological liquid includes a sharp metal component (needle) that is maintained in a sterile condition until the moment of use. In addition, an ideal lancet1200is disposable with minimum possibility of an injury subsequent to the initial use. The lancet1200includes a substantially cylindrical needle having a sharp end and an opposing end which may be a blunt end. The tip1200aof the lancet1200, i.e., the sharp end, has a protective cover1204that ensures sterility of the lancet1200. The protective cover1204is also designed to be re-attached to the tip1200aof the lancet1200for safe disposal. The blunt end can be embedded into the lancet-containing body1202by insert molding or adhesive. In one embodiment, the lancet-containing body1202includes a polymeric material molded into a substantially rectangular shape.

The tip1200aof the lancet1200and as much of the lancet1200as is expected to puncture the skin of the patient can embedded in the protective cover1204, e.g., a polymeric plug, which may be an elastomeric plug, e.g., thermoplastic elastomeric, silicone, plug. In this configuration, ionizing radiation can be used to sterilize the lancet1200and the elastomer will prevent subsequent contamination. Embedding the piercing portion (tip)1200aof the lancet1200in a soft material does not damage the delicate tip1200aof the lancet1200but forms a tight seal that allows for sterilization (such as by irradiation) and the preservation of that sterile condition. Such a protective cover1204can be removed from the piercing portion of the lancet1200either by pulling the protective cover1204off the tip1200aof the lancet1200or by fully piercing the protective cover1204and allowing the protective cover1204to cover a more proximal part of the lancet1200.

The nature of the thermoplastic elastomer (TPE) eliminates the necessity of relocating the tip1200aof the used lancet1200precisely into the hole originally occupied by the tip1200aof the unused lancet1200. Relocation of the tip1200aof the lancet1200at any position in the thermoplastic elastomeric protective cover1204is sufficient to prevent the tip1200aof the lancet1200from being exposed after the test strip is ejected from the medical diagnostic device100.

Thermoplastic elastomers (TPE) are easily processed rubbery materials. They can be easily formed in various shapes. If a sharp lancet1200is embedded into a piece of thermoplastic elastomer, and then irradiated by either gamma radiation or electron beam radiation of sufficient energy, the lancet1200is rendered sterile, and because the thermoplastic elastomer forms a tight seal, the lancet1200remains sterile for a relatively long period of time.

If the protective cover1204made is made of thermoplastic elastomer, and the thermoplastic elastomer is at least partially enveloped by a more rigid material, the protective cover1204acts more like a rigid body, but keeps the desired features of the thermoplastic elastomer. Configurations of this design might include the lamination of thermoplastic elastomer between thin layers of rigid plastic or metal or the coextrusion of thermoplastic elastomer with a more rigid polymer. The cross-section of such a coextruded profile can be circular, rectangular, or any other shape that renders it useful. Such a combination of thermoplastic elastomer and rigid material can be provided with features such that the combination is allowed to slide proximally on the shaft of the lancet1200, eventually exposing the tip1200aof the lancet1200for lancing. After the lancet1200is used, the subassembly can be slid distally and the connection between the protective cover1204and the lancet1200changed such that the protective cover1204cannot return to a position that exposes the tip1200aof the lancet1200.

It should be noted that all of the embodiments of the test strip shown herein are characterized by having the tip1200aof the lancet1200of the lancet-containing portion1004of the test strip located 180° from the uptake recess of the sensor-containing portion1002,1002′,1102of the test strip. Such positioning renders the test strips suitable for use with the medical diagnostic device.

The test strips and the magazines118containing a plurality of test strips can be made by the following process: To prepare the lancet-containing portion1004of a test strip, unfinished lancets are provided. These unfinished lancets are ground and cut to 10 mm. The ground, cut lancets1200are then molded into a plastic body1202to form the lancet-containing portion1004of the test strip. To prepare the sensor-containing portion1002,1002′,1102of the test strip, the electrodes are printed onto the backing or cover, the appropriate reagents (discuss these) are coated over the electrodes, and the cards of sensor-containing portions1002,1002′,1102are singulated to form individual sensor-containing portions1002,1002′,1102. The individual sensor-containing portions1002,1002′,1102are combined with the lancet-containing portions1004to form completed test strips. Pluralities of test strips are then loaded into magazines118.

The sensors described herein may be configured for analysis of an analyte in a small volume of sample by, for example, coulometry, amperometry, and/or potentiometry. The sensors may also be configured for optical analysis. The sensors may be configures to determine analyte concentration in about 1 μL or less of sample, e.g., 0.5 μL or less of sample e.g., 0.25 μL or less of sample e.g., 0.1 μL or less of sample. The chemistry of the sensors generally includes an electron transfer agent that facilitates the transfer of electrons to or from the analyte. One example of a suitable electron transfer agent is an enzyme which catalyzes a reaction of the analyte. For example, glucose, oxidase or glucose, dehydrogenase, such as pyrroloquinoline quinone glucose, dehydrogenase (PQQ), may be used when the analyte is glucose. Other enzymes may be used for other analytes. Additionally to or alternatively to the electron transfer agent, may be a redox mediator. Certain embodiments use a redox mediator that is a transition metal compound or complex. Examples of suitable transition metal compounds or complexes include osmium, ruthenium, iron, and cobalt compounds or complexes. In these complexes, the transition metal is coordinatively bound to one or more ligands, which are typically mono-, di-, tri-, or tetradentate. The redox mediator may be a polymeric redox mediator or a redox polymer (i.e., a polymer having one or more redox species). Examples of suitable redox mediators and redox polymers are disclosed in U.S. Pat. Nos. 6,338,790; 6,229,757; 6,605,200 and 6,605,201, which are incorporated by reference.

The sensor also includes a sample chamber to hold the sample in electrolytic contact with the working electrode. In certain embodiments, the sample chamber may be sized to contain no more than about 1 μL of sample, e.g., no more than about 0.5 μL, e.g., no more than about 0.25 μL, e.g., no more than about 0.1 μL of sample.

The magazines118can be prepared by first molding the desiccants into platforms. Resilient biasing elements and the platforms are then assembled into the housings of the magazines. The magazines are then packed and shipped.

Embodiments for operating the medical diagnostic device100to dispense a test strip, form an opening in the skin of a patient to obtain a sample of biological liquid, collect a sample of biological liquid from the patient, analyze the sample of biological liquid collected from the patient, and dispose of the used test strip will now be described.FIG. 34also depicts the operational steps in a flow chart. In most places above and below herein, the reference numerals ending with “a” are left off for convenience, although most reference numerals having a corresponding numeral ending in “a” is intended to have the corresponding numeral there, and such are hereby incorporated there.

Referring now toFIGS. 1-7, the assembly110for storing and dispensing a plurality of STRIPLETS™ is inserted into the housing102of the medical diagnostic device100. The housing has a door through which the assembly110can be introduced to the proper position in the interior of the housing102. The door is on the side of the housing102opposite the display238. The door can be mounted by means of at least one hinge or can be mounted by a snap-fit feature.

For the sake of simplification, the STRIPLET™ will be the test strip shown inFIGS. 26A-B. Other test strips described can be used in place of the STRIPLET™ shown inFIG. 26A-26B. Each STRIPLET™ 1000, 1000a in the assembly110has a lancet-containing portion and a sensor-containing portion1002. The lancet-containing portion1004of the STRIPLET™ 1000 has a protective cover1204to render the tip1200aof the lancet1200sterile and prevent the tip1200aof the lancet1200from causing an unwanted puncture. The sensor-containing portion1002of the STRIPLET™ 1000 emerges first from the magazine118. In order to feed a STRIPLET™ 1000 from the magazine118to the cradle280of the lancing/collecting assembly112, the lowermost STRIPLET™ 1000 in the assembly110is fed from the assembly110to the cradle280of the lancing/collecting assembly112.

In order to advance a STRIPLET™ 1000 from the magazine118to the cradle280of the lancing/collecting assembly112, the user causes the slide142to move in the required direction. Movement of the slide142alone, or in combination with another feature, enables the magazine118to become unsealed, so that a test strip1000can be removed from the magazine118. When the magazine118is unsealed, the mechanism for advancing a STRIPLET™ 1000 from the assembly for storing and dispensing test strips1000to the lancing/collecting assembly112advances a STRIPLET™ 1000 into the cradle280of the lancing/collecting assembly112and positions the STRIPLET™ 1000 so that proper lancing, collecting of sample of biological liquid, and analyzing of the collected sample can be carried out. Prior to the lancing step, the protective cover1204of the lancet1200is removed, either before the STRIPLET™ 1000 is positioned in the cradle280or after the STRIPLET™ 1000 is positioned in the cradle280. The assembly114for removing a protective cover1204from the tip1200aof a lancet1200and re-attaching the protective cover1204to the tip1200aof a used lancet1200retains the protective cover1204for subsequent re-attachment to the tip1200aof the lancet1200of the lancet-containing portion1004of the STRIPLET™ 1000 after the lancing step, the collecting step, and the analyzing step are completed.

After STRIPLET™ 1000 has been fed into the cradle280, the medical diagnostic device100causes the STRIPLET™ 1000 to be oriented in such a manner that the lancet1200may be introduced into the skin of a patient. In many embodiments, such an orientation step is carried out by a motor. In these embodiments, the PCB assembly232can be programmed so that orientation is carried out accurately and reliably. Such an orientation step is carried out by having the transmission system rotate the cradle280of the lancing/collecting assembly112about 90° (clockwise or counterclockwise), so that the tip1200aof the lancet1200faces the opening in the end cap104, so that when the medical diagnostic device100is placed against the skin of the patient, the tip1200aof the lancet1200will be facing the skin of the patient.

Then, the lancing/collecting assembly112is armed. Movement of the slide460causes a sufficient amount of energy for lancing and retracting to be stored in the torsion spring388. Appropriate movement of the slide460causes the locking tab402to abut the locking tab404to arm the lancing/collecting assembly112. In an alternative embodiment, the lancing/collecting assembly112can be armed by means of a motor, thereby eliminating the need for the slide460.

After the lancing/collecting assembly112is armed, the medical diagnostic device100is placed against the skin of the patient in such a manner that the opening in the end cap104overlies the position where the patient desires to puncture the skin. When the patient is ready to trigger the lancet1200, the patient actuates the trigger406, to disengage the locking tab402from the locking tab404, thereby allowing the carrier296to traverse the slots288and290in the cradle280and move rapidly toward the skin of the patient, whereby the lancet1200in the lancet-containing portion1004of the STRIPLET™ 1000 causes an opening to be formed in the skin of the patient. Immediately after the opening is formed in the skin of the patient, the carrier296is retracted by the action of the lancing cam338, whereupon the lancet1200of the lancet-containing portion1004of the STRIPLET™ 1000 moves away from the skin of the patient. Meanwhile, the sample of biological liquid is caused to emerge from the opening formed in the skin of the patient

The medical diagnostic device100then causes the STRIPLET™ 1000 to be oriented in such a manner that the sensor-containing portion1002of the STRIPLET™ 1000 can be placed in contact with the sample of biological liquid emerging from the opening in the skin of the patient. For this step, the cradle280is rotated 180° so that the sensor-containing portion1002of the STRIPLET™ 1000 directly overlies the biological liquid.

The medical diagnostic device100then enables the index cam338to move the cam follower274so that the carrier296can traverse the slots288and290to move toward the opening in the skin of the patient so that the sensor-containing portion1002of the STRIPLET™ 1000 is able to collect biological liquid emerging from the opening in the skin of the patient. The carrier296and the movements thereof can be designed so that the carrier296can move toward and away from the skin in such a manner that a suitable quantity of biological liquid is collected. The flexibility of the flexible component422of the cam follower274assists in obtaining a sample of biological liquid from the opening in the skin of the patient.

The sample of biological liquid enters the sample application zone of the sensor-containing portion1002of the test strip1000, i.e., the recesses1010,1012formed in an edge of the test strip1000. The sample of biological liquid travels along the sample flow channel1024to the area where the reagents are disposed. The appropriate reaction occurs, thereby activating the electronics and bringing about a reading of the concentration of the analyte, which reading is shown in the display. If insufficient quantity of the sample of biological liquid is drawn in the initial lancing step, the user can actuate a retesting procedure before actuating the analyzing step, whereby the test is aborted so that the user can re-arm the lancing mechanism and begin again.

The sensor-containing portion1002of the test strip1000collects a sufficient quantity of sample of biological liquid to allow analysis of the sample of biological liquid. After a sufficient amount of sample of biological liquid is collected, the carrier296, the electrical components of which are in electrical contact with the contacts of the sensor-containing portion1002of the test strip1000, measures the quantity of analyte in the sample by means of an electrochemical analyzer. By this process, the sample of biological liquid is analyzed to determine at least one characteristic of the sample of biological liquid.

After the sample of biological liquid is analyzed, the protective cover1204is re-attached to the tip1200aof the lancet1200of the lancet-containing portion1004of the test strip1000. After the protective cover1204is re-attached, the re-covered test strip1000is ejected from the port230in the housing102.

FIG. 34is a flow chart that illustrates various steps of a method in accordance with several embodiments. As shown inFIG. 34, there are five basic components of the method. Component0involves advancing the test strip from the magazine118into the cradle280, removing the protective cover1204from the lancet1200, and rotating the cradle280to position the lancet1200for entering the skin of the patient. It should be noted that the protective cover1204could be removed from the lancet1200prior to rotating the cradle280into position for lancing. Component1involves arming and triggering the lancet1200. Component2involves indexing the test strip so that the sensor portion of the test strip can obtain blood from the opening formed in the skin in Component1. Component3involves collecting blood from the opening formed in the skin in Component1. Component4involves reattaching the protective cover1204to the lancet1200and ejecting the used test strip from the medical diagnostic device100.

FIG. 35AthroughFIG. 35M, inclusive, illustrate in schematic form one way of carrying out a method according to embodiments herein. For the sake of simplification, the test strip will be the test strip shown inFIG. 26. Other test strips described can be used in place of the test strip shown inFIG. 26.FIG. 35Ashows a test strip1000in the magazine118.FIG. 35Bshows the test strip1000advanced from the magazine118and inserted into the lancing/collecting assembly112, which is represented schematically by two parallel upright elements, each element having a slot formed therein.FIG. 35Cshows the protective cover1204being removed from the lancet1200of the test strip1000. It should be noted that the protective cover1204could be removed before the test strip1000is inserted into the lancing/collecting assembly112.FIG. 35Dshows the test strip1000rotated 90° so that the lancet1200is in position for lancing the skin of the patient.FIG. 35Eshows that the lancet1200has entered the skin of the patient.FIG. 35Fshows that the lancet1200has been retracted from the skin of the patient.FIG. 35Gshows that the test strip1000is being rotated 180° so that the sensor-containing portion1002can collect biological liquid emerging from the opening formed in the skin of the patient.FIG. 35Hshows that the sensor-containing portion1002of the test strip1000is ready to be indexed so that the sensor-containing portion1002can collect biological liquid emerging from the opening formed in the skin of the patient.FIG. 35Ishows the sensor-containing portion1002of the test strip1000contacting the biological liquid emerging from the skin of the patient.FIG. 35Jshows that the test strip1000is being rotated 90° so that the test strip1000will come into the proper in position for being ejected from the medical diagnostic device.FIG. 35Kshows the test strip1000in position for ejection from the medical diagnostic device100.FIG. 35Lshows the protective cover1204being reattached to the lancet1200.FIG. 35Mshows the test strip1000being ejected from the medical diagnostic device100.

FIGS. 36-40and the accompanying description are directed to another “point and shoot” medical diagnostic device1300of the present invention which has certain components and functions similar to many of those of the previously described device. By point and shoot, it is meant that a user places the meter on the skin location chosen for fluid/blood extraction, and is merely required to push a button to activate the device and then simply wait for the meter to make the measurement and report blood glucose level.

The following description first provides a discussion of the top-level componentry of device1300followed by a more detailed description of the various sub-assemblies of the device and how they interface with a STRIPLET™ cartridge, such as cartridge1450described below with respect toFIGS. 39A and 39B.

FIGS. 36A-36Fprovide various views of the top-level componentry of diagnostic device1300. The exterior of device1300includes front and back housings1302,1304and battery compartment/cartridge door1306. The collective housing contains a primary component assembly1328of mechanical and electronic components, including but not limited to various components for directly interfacing with the STRIPLET™ cartridge (not shown), gears and motors for moving and orienting the STRIPLETS™ to various operative positions, and various printed circuit boards having circuitry for storing electronic data and running software programs for controlling and operating the device and measuring the target analyte in the extracted bodily fluid.

Front housing1302frames a display1308, a navigation keypad1310and a trigger button1314which enable a user to interface with and operate the device. Back housing1304frames various apertures including aperture1316afor receiving a cartridge door release latch1316, a STRIPLET™ ejection slot1318, an electronic communications port1326by which an on-board microprocessor (not shown) is accessed for programming, software download and off-board control, and a recessed aperture1324afor receiving a thumb wheel1324for adjusting the depth of expression cap1312, here in the form of a contoured finger pad and described in greater detail below. Back housing1304also provides an electrical switch1320to disable or “lock” the meter against accidental button pushes when not in active use. Cartridge door1306opens to an interior compartment of the device in which a replaceable STRIPLET™ cartridge (not shown) resides and is mechanically and electronically nested within primary component assembly1328. As shown inFIGS. 36E and 36F, the door structure contains a spring-loaded piston1315which resides within the rectangular frame1317. A coil spring1319biases piston1325which in turn, when door1306is closed on the cartridge, biases the cartridge downward, either against a tub (described in greater detail below) to create a hermetic seal at the cartridge's STRIPLET-disposing end or against stops within assembly1328or cavity1345when the tub is in a lowered position. The spring loaded piston1315simultaneously serves as the electrical contact interface to the cartridge. Housed within door1306under cover1321are batteries1323which provide power to the electronics and electronic motors which operate the device.

The top end of the collective device housing provides expression cap1312for engaging with a finger or other lancing site on the user's body to facilitate the expression of bodily fluid, e.g., blood, from the skin. A small aperture1330resides within expression cap1312through which STRIPLETS™ are advanced and retracted for their lancing and sampling functions. The expression cap resides within and is carried by a frame structure1322which mates with the STRIPLET™ dispensing end of the STRIPLET™ cartridge, and is mechanically coupled to thumb wheel1324. Rotating thumb wheel1324adjusts the vertical height of expression cap1312relative to the STRIPLET™ when in a lancing position. As the lancing stroke of the STRIPLET™ is fixed, adjusting the relative height of the expression pad adjusts the location of the skin surface relative to the lance stroke allowing variable lancing depths to accommodate, for example, blood extraction at different sites on the body which may require varying lancing depths.

Prior to further describing the details of the internal mechanisms of component assembly1328and the various sub-assemblies therein, the basic functions of the STRIPLET™ cartridge are identified, and an exemplary STRIPLET™ cartridge1450suitable for use with the medical diagnostic device ofFIGS. 37A-37Cis described with respect toFIGS. 39A and 39B.

As discussed at least in part above, the basic functions of the STRIPLET™ cartridges of the present invention include: (a) providing a hermetically sealed container which protects STRIPLETS™ contained within from moisture; (b) positioning the contained STRIPLETS™ relative to the STRIPLET™ manipulating mechanism within the device; (c) guiding individual STRIPLETS™ sequentially into a position in which they are fed into the device's STRIPLET™ manipulating mechanisms; (d) spring loading each STRIPLET™ as it is moved within the device mechanisms; (e) containing structural members made of desiccant material which perform the integrated function of protecting STRIPLETS™ from moisture as well as guiding the STRIPLETS™; (f) containing locking features which prevent the STRIPLETS™ from accidental ejection due to shock or vibration loading; (g) interfacing with the device to ensure that the STRIPLETS are correctly oriented for feeding into the manipulating mechanisms; (h) interfacing with reference surfaces within the device to establish a datum plane for STRIPLET™ motion; and (i) containing an on-board active means, sometimes referred to as a “smart chip”, for communicating data to the device, including but not limited to STRIPLET™ serial and batch numbers, calibration information, date and time of manufacture, expiration date, and the number of unused STRIPLETS™ remaining in the cartridge.

Referring now toFIGS. 39A and 39B, an exemplary STRIPLET™ cartridge1450usable with medical diagnostic device1300is described. Cartridge1450includes a cartridge body or vial1452, often referred to as a STRIPLET™ magazine, containing a plurality of STRIPLETS™ and parallel guide rails or inserts1454which maintain the orientation of the STRIPLETS™ for feeding to the device. The STRIPLETS™ are retained within cartridge1450by opposing spring-loaded forces from the top and bottom ends of the cartridge. When door1306of device1300is closed on the nested cartridge, a constant-force spring mechanism (i.e., piston1325which is biased by coil spring1319inFIG. 36F) biases the cartridge and continuously forces the STRIPLETS™ toward the dispensing end of the cartridge. The distal ends of guide rails1454have spring-loaded, inwardly extending end features or protrusions1456(best viewed inFIG. 39B) which provide the cartridge “floor” and apply an upward force on the STRIPLETS™ prior to being fed from the cartridge. The end features1456are configured so that an advance chain and associated STRIPLET™ pusher of the meter, described in greater detail below, enter from one side of cartridge body1452, engage with the cap that covers the lancing end of each STRIPLET™, and then push a single STRIPLET™ out of the cartridge while the remaining stacked STRIPLETS™ are retained within the cartridge. Structures1456each provide a triangular-shaped depression or “shark tooth” feature1458which mates with a corresponding indentation on respective sides of the interfaced STRIPLET™. This mating engagement protects the STRIPLET™ from being knocked out of the cartridge should the cartridge be dropped or jarred. “Shark teeth”1458are configured to flex outwardly, or perpendicular to the direction of STRIPLET™ advance, to release the interfaced STRIPLET™ as it is pushed out of the cartridge.

The primary component assembly1328and the various sub-assemblies therein and the manner in which they interface with the STRIPLET™ cartridge are now described in greater detail with respect toFIGS. 37A-37E, which provide perspective, side and exploded views, respectively, of assembly1328, and with respect toFIGS. 38A-38F, which provide various exploded views of the sub-assembly components therein. In the description that follows, the individual components within assembly1328are identified and their interconnecting structures briefly described, followed by a more expansive description of the various sub-assemblies formed by the components and of their respective functions. It should be noted that some of the components have overlapping functions and contribute to the functioning of more than one sub-assembly.

Assembly1328includes three structural frames or walls, front chassis1340, rear chassis1342and gear retaining plate1344, which hold a plurality of functional or moveable components between them. As best illustrated inFIGS. 37A and 38A, front and rear chasses1340,1342define an internal cavity1345for receiving a STRIPLET™ cartridge (not shown) and further house between them various components which retain the STRIPLET™ cartridge and/or directly handle and move the individual STRIPLETS™ from the STRIPLET™ cartridge.

These components include an advance chain1346positioned within opposing guides or tracks1350a,1350bextending from opposing walls of front and rear chasses1340,1342, respectively. Best viewed inFIG. 37C, advance chain1346has a distal end piece1346aconfigured for engaging the bottommost STRIPLET™ within a STRIPLET™ cartridge. An involute sprocket1348is configured to engage with chain1346to advance and retract it within tracks1350a,1350b. Positioned just below the bottom end of the STRIPLET™ cartridge (not shown) is a tub1352consisting of a flat, continuous surface which, when pressed against the cartridge's elastomeric seal, as described above with respect to cartridge110(seeFIG. 4A), provides a hermetic seal, thereby protecting the STRIPLETS™ from environmental humidity. A rotary lever arm lift1354positioned under and coupled to tub1352also extends between the two chassis. Activation of lever arm1354lifts and applies a force at the geometric center of the bottom of tub1352thereby lifting it perpendicular to the cartridge seal perimeter through a distance equal to at least one STRIPLET™ thickness and with such force as to compress the cartridge's elastomeric seal to provided hermetic sealing of the STRIPLET™ magazine. Reversal of this motion releases the seal against the cartridge. When a STRIPLET-loaded cartridge is inserted into the meter and the cartridge door closed, the cartridge inserts1454pass into clearance grooves (not shown) within the tub1352. Even in the dropped or unsealed position, the tub surface is higher than the top of the retaining “shark teeth”1458within protrusions1456of the cartridge insert rails1454, so that the STRIPLETS™ may slide out of the cartridge. When the tub1352is lifted to seal the cartridge, the inserts1454simply pass deeper into the tub clearance grooves. Thus, once the cartridge is inserted into the meter and the cartridge door closed, the “shark teeth” are no longer engaged with the STRIPLETS™.

As illustrated inFIGS. 38C and 38D, positioned adjacent a side seam of the front and rear chassis1340,1342when joined is another lever arm1358. Lever arm1358functions to pull the lancet cap off of the STRIPLET™ lancet immediately prior to its use and to push the lancet cap back onto the STRIPLET™ lancet immediately after its use. As best illustrated inFIG. 38C, a spring1360is connected between a top portion of lever arm1358and a side wall of the conjoined chasses to bias the uncapping lever down against the cap of the next-to-be-used STRIPLET™ (not shown) thereby locking the lever end into a depression within the STRIPLET™ cap so that the cap may be pulled off and pushed onto the lancet. Positioned in front of uncap lever arm1358, as shown inFIG. 38D, is a carriage assembly1362slidable mounted on a guide rail1382. Carriage1362carries, orients and moves the STRIPLET™ through the various motions required to extract body fluid and sense the targeted analyte. At a distal end of the carriage is a turret1364which has a rotating slot for receiving and retaining a STRIPLET™. Now referring to the components retained between rear chassis1342and a gear retention plate1344, there are provided two electric motors1356a,1356b, each of which operates a plurality of gears to carry out all of the steps during the point and shoot operation of the device. The first motor1356adrives the gears responsible for lifting the tub and sealing the cartridge, advancing the STRIPLETS™ from the cartridge into the turret, in part, uncapping the STRIPLETS™ prior to use, in part, recapping the STRIPLETS™ after use, and ejecting the STRIPLETS™ out of the turret. The second motor1356bdrives the gears responsible for, in part in and conjunction with the gears driven by first motor1356a, uncapping the STRIPLETS™, moving the STRIPLETS™ to perform the lancing function, orienting the STRIPLETS™ from a lancing position to a sensing position, and, in part, recapping the STRIPLETS™. These gears and their operation in each of the aforementioned functions are now described in greater detail. Each of the motors has electro-optical encoders integrated within it to determine the position and speed of the respective meter components which it drives. Additionally, a plurality of sensors is provided throughout the internal components of the meter, particularly along the path traversed by a STRIPLET™, to sense the physical position, both linear and rotational, of moving components critical to proper advancement and movement of the STRIPLETS™. The combination of motor encoding with sensor positioning in a closed loop control system ensures that the STRIPLETS™ are accurately advanced and manipulated to perform the various meter functions.

As best illustrated inFIG. 38B, the sub-assembly of gears and associated components involved in lifting the tub and, thus, sealing the cartridge, include an output pinion gear1376driven by motor1356a, which in turn drives a larger follower tub lift gear1366rotatably mounted on an axial mount or shaft1368extending from back plate1342, a tub lift follower arm1370having a fixed end rotatably coupled to tub lift arm1354and a movable end coupled to a roller bearing1372which sits and is movable within grooved face cam1366aof tub lift gear1366. The cam may alternately be configured as a disk edge cam. As the movable end of the follower arm1370moves within cam1366a, it rotates the fixed end of the follower arm, thereby rotating shaft1368which in turn lifts (closed position) or drops (open position) the tub, depending on the direction in which the follower arm is traveling within the grooved cam. In the lifted or closed position, the tub surface engages against the cartridge's seal and moves against the opposing force imposed by the spring loaded piston1315within the closed cartridge door1306. When the tub is in the dropped or opened position, the spring force imposed by piston1315holds the cartridge body against datum stops (not shown) within the cartridge cavity1345, precisely positioning the bottommost STRIPLET™ for feeding with respect to the apparatus. In this position, there is no seal, allowing a single STRIPLET™ to be fed from the cartridge into the apparatus. The movement of tub1352is constrained to vertical linear movement by the frictional engagement between its vertical side walls and the internal structure of the conjoined chasses. Alternately, the tub may be guided in a linear fashion by pins, shafts or other sliding elements. While the lifting of the tub and sealing of the cartridge has been described as operating in an automatic manner, these functions may be accomplished by manual action of the user applied to a system of gears and levers as described above. In an alternate embodiment, the tub may be fixed with respect to the device and the cartridge may be movable relative to the tub. Additionally, a system of one or more sensors within the device may be used to detect whether or not the tub is fully lifted and the seal fully engaged.

The sub-assembly of gears and associated components involved in advancing the STRIPLET™ out of the cartridge into turret1364and out of the turret through exit slot1318is also driven by first electric motor1356a. The advancing components include articulated chain1346which is linearly driven by a sprocket1348to various points within chain guides1350a,1350bof front chassis1340. In alternate embodiments, chain1346may be a continuous, yet bendable strip of a material such as plastic or metal or a composite of both, or may be a combination of rigid transverse elements connected axially by one or more continuous flexible connectors. The final link1346ain chain1346serves as a pusher mechanism to push, guide and fix the bottommost STRIPLET™ at various locations within the assembly1328. Sprocket1348is rotatably driven by a sprocket drive gear1374which, in turn, is driven by output pinion gear1376of motor1356awhich drives the larger idler or follower gear1366containing the tub lift cam1366a. Because actuation of the advance prime mover1356acauses idler/follower gear1366to rotate, which simultaneously lowers tub1352and drives the articulated chain1346forward, the two operations are synchronized such that the pusher1346adoes not enter the cartridge's footprint until tub1352is in its fully dropped position. Likewise, during chain retraction, the aforementioned mechanical synchronization causes the chain pusher1346ato retract completely past the cartridge's footprint before the tub lifts to seal against the cartridge. Further, as chain drive sprocket1348rotates, chain1346is driven forward or backward collinearly with the STRIPLET™. The STRIPLET™ may be advanced with its sensing end leading and its capped lancing end interfacing with the chain pusher, or visa versa.

The constant-force spring (see, e.g.,125inFIG. 4A) inside cartridge1450forces the STRIPLETS™ down against the tub1352which in turn forces the tub down against precision stops1355a,1355bat the distal end of internal cavity1345, establishing a datum slide plane for the STRIPLET™. The mechanical stops are configured so that when both the cartridge and the tub are against their respective stops, there is an opening so as to allow one and only one STRIPLET™ to be removed from beneath the cartridge footprint. When the tub “opens”, it is mechanically removed from contact with the cartridge seal. At the same time, the pusher pushes a STRIPLET™ from the open end of the cartridge to the open tub, thereby transferring the STRIPLET™ advancement to assembly1328. When the device has completed an analyte measurement cycle, pusher1346ais retracted from beneath the cartridge footprint and the cartridge is re-sealed by the tub to prevent moisture degradation of the unused STRIPLETS™. A system of one or more sensors may be provided along the travel path of STRIPLET™ advancement to facilitate moving a STRIPLET™ through precise linear distances. Pusher1346amay also serve as a sensor flag to precisely indicate STRIPLET™ position.

The sub-assembly of gears and associated components for uncapping or arming lancet end of the STRIPLET™ is best illustrated inFIGS. 38C-38E. The uncapping sub-assembly includes, among other components, the second motor1356band the STRIPLET™ feeding/advance subsystem described in the preceding paragraph which is used to pull the lancet cap off and push the lancet cap back on the STRIPLET™ lancet. The uncapping sub-assembly also includes uncap lever1358which, as described above, moves up and down in a direction perpendicular to STRIPLET™ advance and, when in contact with the lancet cap (not shown), locks the cap to the chain pusher1346a. The uncap lever1358may also swing about a pivot1362such that the non-pivoted tip may move forward and backward in the direction parallel to STRIPLET™ advance. An extension spring1360biases the end of the uncap lever1358down against the STRIPLET™ cap thereby locking the non-pivoting end of the uncap lever into a depression in the STRIPLET™ cap such that the cap may be pulled off and pushed on to the STRIPLET™ lancet. The output pinion gear1386of motor1356bdrives an idler gear1388which in turn drives a larger main gear1390which in turn moves an uncap lever lift follower arm1384which lifts the uncap lever1358against the downward force of uncap lever spring1360. Arm1384is actuated by a dual-purpose cam1392which facilitates both the uncapping/capping actions and the lancing/collecting functions of the device. As best illustrated inFIG. 37E, showing enlarged views of front and back sides1392a,1392b, respectively, of cam1392, the front side1392aof cam1392provides an uncap cam1389which guides uncap lever lift follower arm1384during the uncapping portion of the point and shoot cycle. An uncap lever lift arm slider1378communicates with uncap lever1358and uncap lever lift arm1384in such a way as to transfer lifting motion to uncap lever1358when the uncap lever is swung forward, but leaving it in the down position if the uncap lever is swung back (cap removed). More particularly, a compression spring1380(FIG. 38F) holds uncap slider1378down such that uncap follower arm1384is always in contact with uncap cam1389. This serves as a clutch, lifting or not lifting the uncap lever1358depending on whether the lancet cap is being removed or replaced. This functionality allows the user to perform the function of re-lancing the user's skin with the same lancet should the first try not draw sufficient blood.

The gears and associated components which provide the lancing/collecting (or sensing) sub-assembly, some of which provide functionality to other sub-assemblies, are best illustrated inFIGS. 37D,37E,38E-38G and40A-40F. A second motor1356b, by way of its output pinion gear1386, drives idler gear1388which in turn drives main gear1390, one revolution of which defines the complete reorienting, lancing, sensing (collecting) and uncap cycle of the apparatus. Cam1392, described in part above with respect to the uncapping/capping sub-assembly, is concentrically aligned with, rotates on a common axis with, and is coupled to the main gear1390by means of a flat torsion spring or clock spring1394, which is used to power cam1392through the lancing stroke when released from its wound position. At the start of a lancing segment, the cam rotates counterclockwise (as viewed inFIGS. 37C and 37F) in concert with the main gear because of a constant torsional preload (established during the device's assembly) in the clock spring1394which tends to pull the two rotating disks together.

As shown inFIG. 37E, the grooved face on the front side1392aof cam1392provides a lancing/sensing cam1391which interacts with a lancing/sensing cam follower1400having a free end1401aand an opposite end1401bcoupled to carriage assembly1362(seeFIG. 40A). Centrally disposed between ends1401a,1401bis pin1401cwhich resides within groove1391of cam1392. Because the cam groove1391width is only slightly larger than cam follower1400, the radial location of the groove determines the vertical position of the follower arm tip1410b. A protrusion1406within groove1391defines the starting position of a lancing-collecting/sensing cycle with carriage assembly1362biased in the “home” position, as shown inFIG. 40A, by a light-weight coil spring1405attached to the apparatus chassis. Spring1405places a continuous downward force, e.g., of about 2 ounces, on carriage1362. As cam1392rotates in a counter-clockwise direction from the starting position, as viewed fromFIGS. 40A-40F, pin1401cof cam follower1400traverses within groove1391and the cam follower is pivoted about end1401b. The force placed on carriage1362by cam1392is greater than the bias placed on it by sensing spring1405, causing the carriage to be cam-driven and moving it linearly in a vertical direction transversely to the surface of the user's skin.

Rotation of main gear1390rotates cam1392to a first pre-determined angle, as shown inFIG. 40B. At this first pre-determined angle, the lancing cam latch1396(seeFIG. 37F), biased downward by a torsion spring1398, biases cam latch1396in the clockwise direction which then catches protrusion1393on the lancing cam1392and prevents the lancing cam from further rotation. However, since the main gear is connected to the lancing cam only through the clock spring1394, it continues to rotate and, in the process, increases the clock spring torsion. This wind-up segment traverses about 45 degrees of the main gear's rotation. At the end of the wind-up segment, the main gear knock-off dog1397is positioned underneath the cam latch1396, forcing it in the counterclockwise direction until protrusion1393is no longer captured. At this point, clock spring1394is fully wound and cam1392is free to rotate. The wound up clock spring energy is thus released and cam1392races to catch up with main gear1390. After 45 degrees of very fast, accelerating motion, lancing cam stop1395hits a mating surface1399(seeFIG. 37F) on main gear1390. When the clock spring1394is released, the potential energy created in it effects a quick, downward stroke by carriage assembly1362, as illustrated inFIG. 40C, orienting and moving the STRIPLET™ through the motion required to substantially painlessly lance the skin and extract body fluid. It is noted that, if cam1392were directly driven by motor1356bas the main gear1390is, the lancing stroke would be positive but relatively slow, and thus, very painful for the user. As clock spring1394unwinds, the upward bias placed on carriage assembly1362by coil spring1405drives it back upwards, as illustrated inFIG. 40D. Meanwhile, the continued rotation of main gear1390to a second pre-determined angle causes a dog or knock-off cam1397on the rotating main gear1390, as shown inFIG. 37D, to contact the spring loaded lancing cam latch1396and move in the counterclockwise direction, knocking it off of the lancing cam latch catch1393on lancing cam1392. This action, in turn, knocks lancing cam1392off the main gear, thereby causing the lancing cam1392to quickly rotate in the clockwise direction to “catch up” with the main gear1390, at which point the cam and main gear slowly rotate in tandem again to a third pre-determined angle to commence the sensing phase of the device. At this point, pin1401con follower arm1400is moved to a cut-away portion1406within groove1391, as shown inFIG. 40E, thereby “disengaging” carriage1362from being driven by cam1392. Meanwhile, the STRIPLET-loaded turret1364is reoriented by the reorienting sub-assembly, discussed below, with respect to the carriage1364. The cut-away places cam1391in a neutral position relative to carriage1362and, as such, the movement of carriage1362is effected solely by the light bias of coil spring1405, being moved slowly downward, as illustrated inFIG. 40F. The sensing end of the STRIPLET™ is thus gently moved against the user's skin at the lancing sight, thereby collecting the body fluid. Motor1356b, which drives lancing cam1392, may be stopped when carriage1392is fully extended downward to ensure sufficient fluid is collected by the STRIPLET™ for analysis. As the lancing cam1392continues to rotate, lancing follower arm1400is driven back up to the neutral position with the STRIPLET™ now fully contained within the primary assembly1328and oriented to engage with electronic contacts within the meter. Thus, carriage1362is cam-driven to effect a fast, positive stroke during the lancing segment/phase, and then spring-driven to effect a slow, gentle stroke during the collecting/sensing segment. The analyte concentration within the body fluid collected by the STRIPLET™ is then detected by the meter electronics and the resulting data displayed for the user.

The purpose of the reorienting sub-assembly is to orient the STRIPLET™ with respect to carriage1392in three or more distinct orientations to prepare the STRIPLET™ for lancing, fluid collection/analyte sensing and ejection from the device. Reorientation of the STRIPLET™ may include flipping/rotating the STRIPLET™ about its longitudinal axis and/or transversely to its longitudinal axis. The gears and associated components which provide the reorienting sub-assembly, some of which provide functionality to other subsystems of the apparatus, are best illustrated inFIGS. 37D,38E-38G andFIGS. 41A-41C.

Second motor1356bwhich, by way of its output pinion gear1386, drives idler gear1388which, in turn, drives main gear1390which, in turn, by means of a face groove cam track1387, rotates a broom gear1402consisting of a cam follower pin1402a(residing within track1387) and a partial toothed gear segment1402b. Gear segment1402bcommunicates with a male Geneva gear1404which, in turn, drives a female Geneva gear1407(shown partially in phantom from behind the male Geneva gear inFIGS. 41A-41C) by way of two pins1404a,1404bon the male gear1404which are matingly received within corresponding grooves1407a,1407bwithin the female gear. The female Geneva gear1407is directly affixed to an end of the turret1364such that rotation of that gear causes the turret to rotate into three discrete functional positions, thereby flipping the STRIPLET™ about the transverse axis of carriage1362.

Various stages in the reorientation of STRIPLET™ are described in greater detail with reference toFIGS. 41A-41C. In general, main gear1390rotates counterclockwise with follower pin1402amoving in an arc defined by the distance from the pin center to the broom gear axis of rotation, and thus, moving up and down relative to main gear1390. As follower pin1402amoves downward relative to main gear1390, the toothed segment1402bof broom gear1402moves counterclockwise relative to the broom gear axis of rotation. Conversely, as follower pin1402amoves upward relative to main gear1390, the toothed segment1402brotates clockwise relative to the broom gear axis of rotation1402c. In the orientation shown inFIG. 37D, as well as inFIG. 41A, follower pin1402a, situated within cam groove1387, is positioned midway between its innermost and outermost radial positions, i.e., in the neutral or load position, at which point the STRIPLET™ is advanced into the turret (not shown). As main gear1390rotates counterclockwise approximately ⅛ of a rotation (e.g., to approximately 44 degrees in one embodiment) from the home position, broom gear follower pin1402ais guided at a constant radius with no radial motion. As shown inFIG. 41B, upon further counterclockwise rotation of main gear1390, from about ⅛ to about ⅕ of a rotation (e.g., to approximately 72 degrees in the one embodiment), cam track groove1387and broom gear follower pin1402atransition radially inward causing broom gear1402to rotate clockwise about its fixed axis of rotation1402c. Meanwhile, gear mesh1402bbetween broom gear1402and male Geneva1404causes the latter to rotate about ¼ turn (e.g., to approximately 90 degrees in the one embodiment) counterclockwise about its axis which, in turn, causes female Geneva gear1407to rotate approximately ¼ turn or 90 degrees clockwise about its axis, thereby causing the turret (not shown) to rotate clockwise approximately ¼ turn or 90 degrees to position the lancing end of the STRIPLET™ downward in the lancing position. As main gear1390continues to rotate counterclockwise, as shown inFIG. 41Cfrom about ⅕ to about ⅖ of a rotation (e.g., to approximately 154 degrees in the one embodiment), broom gear follower pin1402ais guided at a constant radius without any radial motion. Upon further counterclockwise rotation of main gear1390to about ⅗ of a rotation (e.g., to approximately 209 degrees in the one embodiment), cam track groove1387and broom gear follower pin1402atransition radially outward causing broom gear1402to rotate counterclockwise about its fixed axis of rotation. This reverses the motion described above and results in the counterclockwise rotation of female Geneva gear1407of about ½ turn or 180 degrees, thereby rotating the turret (not shown) a further ¼ turn or 90 degrees or so in the clockwise direction to position the sensing end of the STRIPLET™ downward in the sensing position (i.e., the lancing end of the STRIPLET™ is now pointing upward). As main gear1390continues to rotate counterclockwise to about ¾ of a rotation (e.g., to approximately 274 degrees in the one embodiment), broom gear follower pin1402ais guided at a constant radius without any radial motion. From about ¾ to about ⅘ of a rotation (e.g., to approximately 302 degrees in the one embodiment) of main gear1390in the counterclockwise direction, cam track groove1387and broom gear follower pin1402atransition radially inward to the medial position, as inFIG. 41A, causing broom gear1402to rotate clockwise about its fixed axis of rotation. This, again, reverses the previous motion and rotates female Geneva gear1407clockwise about ¼ turn or 90 degrees, thereby rotating the turret (not shown) about ¼ turn or 90 degrees, placing the STRIPLET™ in the neutral position once again. The turret remains in this neutral position as the main gear1390completes one full rotation cycle (i.e., 360 degrees) and until the point and shoot cycle of the device is once again initiated by the user.

The cap adjustment sub-assembly is described with reference toFIG. 36D. The effective depth of lancet penetration into the skin of the user is controlled by adjusting the vertical position of expression cap1312. The lancet penetrates deeper into the subject's skin as the cap1312is moved up toward the meter structure, and penetrates less as the cap1312is moved away from the meter. The cap is securely fixed into a sliding frame1322constrained by features in rear outer housing1324and front outer housing1302at one end, and by gear retaining plate1344and adjustment knob1324at the other end, which allow it only to move vertically up and down. Frame1322is actuated by a cam groove1324bin adjustment knob1324communicating to lift pin1332attached to frame1322. Adjustment knob1324is constrained to rotate within feature1329fabricated into plate1327. Additional features within plate1327result in a detented action such that the knob remains in one of several pre-determined angular positions, thereby resulting in a similar number of vertical frame positions, thereby determining a similar number of lancing depth settings. These settings are indicated to the user by numbers on knob1324and visible though opening or window1324cin front outer housing1302.

As mentioned previously, the subject devices perform the aforementioned functions in a single “point and shoot” cycle based on the integrated workings of the above-described sub-assemblies. Certain of the primary activities performed by the collective assembly are as follows: The first motor1356aruns so as to drop (open) the tub1352, thereby breaking the hermetic seal around the bottom end of the STRIPLET™ cartridge and providing an exit path for a single STRIPLET™. The first motor1356aadvances the chain1346such that its pusher segment1346ainterfaces with the bottommost STRIPLET™, pushing it out into turret1364where it is secured into place therein by a detent. The second motor1356bdrives the uncap lever arm1358to engage the cap of the fed STRIPLET™ and locks the cap to the chain1346. Second motor1356bthen runs in reverse so as to pull the protective lancet cap off the STRIPLET™, exposing the lancet. Motor1356b, again, runs in the forward direction so as to rotate the STRIPLET™ such that the lancing end is pointing down towards the skin surface, and continues to run so as to wind up clock spring1394. Upon being fully wound, the clock spring is released, in turn, driving the lancet end of the STRIPLET™ downward at a high rate of speed to lance the patient's skin and extract bodily fluid, i.e., blood, and then is immediately retracted. Motor1356bcontinues to rotate the STRIPLET™ 180 degrees such that the sensing/testing end points toward the lancing site with the now-extracted body fluid, and then gently and more slowly moves the sensing end of the STRIPLET™ against the exposed fluid, pausing for fluid collection to take place. Use of the clock spring allows the lancing action to be performed at a much faster rate of speed as opposed to the slower rate at which the sensing action is performed. As such, the former action minimizes pain to the patient and the latter allows a sufficient amount body fluid, e.g., blood, to be drawn onto the sensing portion of the STRIPLET™. The motor continues so as to rotate the STRIPLET™ back to its original position, i.e., the position it was in when it was advanced to turret1364. First motor1356athen pushes the cap back over the used lancet end of the STRIPLET™. Second motor1356bcontinues so as to lift the uncap lever1358, unlocking the cap from the advance chain. First motor1356acontinues to push the used, recapped STRIPLET™ through STRIPLET™ ejection port1318, and then retracts chain1346so as to appose pusher1346awith the next or bottommost STRIPLET™ within the cartridge while, at the same time, lifting tub1352to seal against the cartridge.

In an alternative embodiment, a medical diagnostic device is provided that carries out the functions of:(a) storing a plurality of lancets and sensors;(b) feeding a plurality of lancets and sensors to a system that employs a lancet to form an opening in the skin of a patient and then employs the sensor to collect a sample of biological liquid that emerges from the opening formed in the skin;(c) forming an opening in the skin of the patient by means of the lancet;(d) collecting the sample of biological liquid emerging from the opening formed in the skin of the patient by means of the sensor;(e) analyzing the sample of biological liquid collected by the sensor; and(f) ejecting the used lancet and the used sensor in a safe manner.

In a further embodiment, a test strip includes a lancet-containing portion and a sensor-containing portion. During the time that the test strip is stored in the medical diagnostic device, a protective cover encloses the lancet of the lancet-containing portion. The medical diagnostic device is capable of removing the protective cover to enable the lancet to form an opening in the skin of the patient and is further capable of re-attaching the protective cover onto the lancet to enable the medical diagnostic device to eject the used test strip in a safe manner.

In another embodiment, a lancing/collecting assembly receives a test strip that includes both a lancet-containing portion and a sensor-containing portion. By means of various operations, the lancing/collecting assembly is configured to (a) orient the lancet-containing portion of the test strip in such a manner that the lancet of the lancet-containing portion of the test strip can be advanced toward a lancing and testing site on the skin of the patient in order to form an opening therein, (b) arm the lancet of the lancet-containing portion of the test strip, (c) trigger the armed lancet of the lancet-containing portion of the test strip so that the lancet forms an opening in the skin of the patient at the lancing and testing site, (d) orient the sensor-containing portion of the test strip in such a manner that the sensor-containing portion of the test strip can be advanced toward the opening formed in the skin of the patient to collect a sample of biological liquid emerging from the opening in the skin of the patient at the lancing and testing site which remains proximate to a lancing and testing port of an analyte, e.g., glucose, monitoring apparatus; and (e) advance the sensor of the sensor-containing portion of the test strip so that sufficient quantity of the sample of biological liquid can be collected for analysis to determine a parameter of the biological liquid, e.g., a body analyte, e.g., glucose, level.

The lancing/collecting assembly may also incorporate an analyzer that is capable of analyzing the sample of biological liquid collected from the opening in the skin of the patient.

In another embodiment, a storing/dispensing assembly is provided for a plurality of test strips, each of which includes a lancet-containing portion and a sensor-containing portion.

In a further embodiment, a method for using a medical diagnostic device includes:(a) feeding one of multiple test strips, each of the test strips having a lancet-containing portion and a sensor-containing portion, to a lancing/collecting assembly that employs a lancet of the lancet-containing portion to form an opening in the skin of a patient, and then employs a sensor of the sensor-containing portion to collect a sample of biological liquid that emerges from the opening formed in the skin;(b) forming an opening in the skin of the patient by means of a lancet in the lancet-containing portion;(c) collecting a sample of biological liquid emerging from the opening formed in the skin of the patient by means of the sensor of the sensor-containing portion;(d) analyzing the sample of biological liquid collected by the sensor of the sensor-containing portion; and(e) ejecting the used test strip in a safe manner.

The medical diagnostic device of this embodiment can perform a plurality of diagnostic tests, e.g., 25 tests, before the device requires refilling with test strips. The medical diagnostic device can perform the functions of storing and dispensing test strips, lancing the skin of a patient, collecting a sample of biological liquid, analyzing the sample of biological liquid collected, and disposing of used test strips. In the case of collection of an inadequate quantity of sample, the medical diagnostic device enables re-lancing.

In accordance with another embodiment, the medical diagnostic device requires only a small volume of sample to carry out a complete test, e.g., 0.3 microliter (see, e.g., U.S. Pat. Nos. 7,058,437, 6,618,934, 6,591,125 and 6,551,494, which are hereby incorporated by reference).

The test strip combines a lancet and a sensor in a single small unit. After the skin of the patient is pierced and a sample of biological liquid, e.g., blood, appears, the test strip is moved into position for collecting a sample of the liquid, and the liquid enters the sample application zone of the sensor-containing portion of the test strip without manipulation of the test strip by the user.

Further features and advantages include the small, readily portable and storable size of the integrated meter. The integrated meter is small enough to be handheld, and easily handled by a self-care diabetic. In some embodiments, the meter is less than 5″ tall, less than 3″ wide, and less than 1.5″ deep. In some of these embodiments, the meter is less than 4″ tall and in one embodiment, just under 3.5″ tall. In some embodiments, the meter is less than 2.6″ wide, such as between approximately 2.5″ and 2.6″ wide, and just under 1.5″ deep. The meter may be rectangular, or one or both sides may be contoured concave or convex, as may the top and/or bottom, and the front and back faces.

In some embodiments, the meter may be plugged in, but is also powered by a battery which is located substantially opposite to where the STRIPLETS™ are accessed, i.e., disposed oppositely in at least one dimension of the meter. The battery may be provided in a compartment at the top and back of the meter, which is opposite the STRIPLET™ access near the front and bottom of the meter, i.e., disposed oppositely in at least two dimensions. In some embodiments, the STRIPLET™ is exposed from lancing and testing and ejection at one side of the meter, while the battery compartment is at the other side, i.e., disposed opposite the STRIPLET™ access in all three dimensions.

The STRIPLET™ is also small in size. Generally the STRIPLET™ is less than 2 mm×less than 1 mm×less than 0.3 mm, and in some embodiments, less than 1.5 mm×less than 0.75 mm×less than 0.2 mm, e.g., approximately 1 mm×0.5 mm×0.1 mm.

The meter and STRIPLET™ are advantageously ideal for alternative site testing, i.e., away from the fingertips, where smaller amount of blood are available than at the fingertips, such as less than 1 microliter, and even less than 0.5 microliters, or less than 0.3 microliters, or less than 0.2 microliters, or even 0.1 microliters (100 nanoliters). See for example U.S. Pat. No. 6,284,125 which describes this feature in more detail and in incorporated by reference.

The system includes, in some embodiments, calibration one or more schemes. A calibration module, whether it be a bar code, a RFID tag, a label, or otherwise may be located on a STRIPLET™ and/or on a STRIPLET™ container. U.S. application Ser. No. 11/350,398, which is assigned to the same assignee and incorporated by reference, provides further examples. There may be contact pads that may be shorted together or kept apart during the test strip manufacturing process in order to communicate a calibration code to the meter. There may be a set of contact pads and a varying resistance between the two pads where the resistance is changed during the manufacturing process of the test strip to communicate a calibration code to the meter. There may be an electrical memory that is readable and writable by the meter, which communicates a calibration code to the meter. A calibrator can carry other information such as STRIPLET™ expiration and/or a STRIPLET™ number count down.

In addition, a data processing terminal may include a personal computer, a portable computer such as a laptop or a handheld device (e.g., personal digital assistants (PDAs)), and the like, each of which may be configured for data communication with the integrated meter, or a receiver associated therewith, via a wired or a wireless connection. Such data processing terminal may be connected to a data network for storing, retrieving and updating data corresponding to a detected analyte level of a user.

The data processing terminal may include an infusion device such as an insulin infusion pump or the like, which may be configured to administer insulin to patients, and which may be configured to communicate with the integrated meter for receiving, among others, the measured analyte level and/or transmitting insulin dose values or other information relating to a diabetes care or other health care regimen. Alternatively, a receiver unit may be especially provided for receiving communications from the integrated meter, and may be configured to integrate an infusion device therein or otherwise communicate therewith. The receiver unit may be configured to administer insulin therapy to patients, for example, for administering and modifying basal profiles, as well as for determining appropriate boluses for administration based on, among others, the detected analyte levels received from the integrated meter.

Additionally, the integrated meter may be configured for bi-directional wireless communication, or may be configured in a network of devices that communication via a network hub. The integrated meter may be configured to communicate (that is, transmit data and/or receive data) from multiple devices via a wired or wireless communication link. The communication link may include one or more of an RF communication protocol, an infrared communication protocol, a Bluetooth enabled communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol which provides secure, wireless communication of several units (for example, per HIPPA requirements) while avoiding potential data collision and interference.

The present invention is not limited to the embodiments described above herein, which may be amended or modified without departing from the scope of the present invention as set forth in the appended claims, and structural and functional equivalents thereof. The Background section is incorporated by reference into the detailed description as disclosing alternative embodiments.

In methods that may be performed according to embodiments herein and that may have been described above and/or claimed below, the operations have been described in selected typographical sequences. However, the sequences have been selected and so ordered for typographical convenience and are not intended to imply any particular order for performing the operations.