Abstract:
A method of obtaining a test sample from a specimen using a lancet system includes engaging a lancet driver against a drive wing of a lancet system, the lancet system having a major portion of a lancet member slidably engaged within a lancet carrier and a sensor strip with a sample chamber attached to the lancet carrier, the lancet system having a lance connected to a first end of a lancet body of the lancet member wherein the lance is movable from a retracted position within the lancet carrier to an extended position outside the lancet carrier, the drive wing extending outwardly and transversely from the lancet body, the major portion of the lancet member having a sinuous portion with a distal end restricted from movement by the lancet carrier, the sinuous portion being non-compressible when initially disposed within the lancet carrier wherein the drive wing prevents the sinuous portion from being compressed, moving the drive wing with the lancet driver a predetermined distance causing the lancet tip to move from the retracted position to the extended position, and disengaging the lancet driver from the drive wing, the lance being automatically moved from the extended position to the retracted position.

Description:
[0001]    This application is a Divisional Application of Ser. No. 11/426,950, filed Jun. 28, 2006, which is a Continuation-in-Part Application of Ser. No. 10/899,345, filed on Jul. 26, 2004. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to testing body fluids. Particularly, the present invention relates to a lancet used for obtaining a sample of body fluid for testing. More particularly, the present invention relates to a lancet and test strip combination. Still more particularly, the present invention relates to a diagnostic system incorporating a lancet and test strip combination and an electronic meter. 
         [0004]    2. Description of the Prior Art 
         [0005]    The examination of blood samples in clinical diagnostics enables the early and reliable recognition of pathological states as well as a specific and well-founded monitoring of physical condition. Lancets and lancet devices enable blood sample collection especially for home monitoring by diabetics. 
         [0006]    A blood sugar level that is either too high or low can lead to adverse physical consequences for a diabetic. Personal blood sugar determination is important for diabetics to aid in controlling and maintaining blood sugar levels with the use of insulin and other medications. A lancet is used to pierce the skin (usually a finger) and produce a small blood sample. Lancing the skin is painful. For diabetics who are required to test their blood sugar level several times a day, lancing several times a day is a painful but necessary procedure. The blood sample is then placed on a test strip for analysis and the blood glucose level is read by a blood glucose meter. Various devices have been devised for lancing the skin of a user as well as combination devices that include lancets and analytical device. 
         [0007]    U.S. Pat. No. 6,620,112 (2003, Klitmose) discloses a disposable lancet combined with a reagent carrying strip which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact with the strip The reagent carrying strip is connected to the lancet, e.g. by molding. One end of the lancet is sharpened for piercing the skin. The strip is sheet-like and has a first side and a second side, which sides are both accessible for the user, such that the reagent carrying strip can be inserted into a blood glucose meter. A weakened tear line is provided at a connection between the lancet and an edge of the reagent carrying strip so that the reagent carrying strip may be easily disconnected from the lancet. 
         [0008]    U.S. Patent Application Publication No. US2003/0050573 (Kuhr et al.) discloses an analytical device containing a lancet comprising a lancet needle and a lancet body, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded, and an analytical test element which is permanently connected to the lancet body. In addition the invention concerns an analytical device containing a lancet comprising a lancet needle and lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of an elastic material, and an analytical test element which is permanently connected to the lancet body. 
         [0009]    U.S. Pat. No. 6,607,658 (2003, Heller et al.) discloses an analyte measurement device includes a sensor strip combined with a sample acquisition device to provide an integrated sampling and measurement device. The sample acquisition device includes a skin piercing member such as a lancet attached to a resilient deflectable strip which may be pushed to inject the lancet into a patient&#39;s skin to cause blood flow. The resilient strip is then released and the skin piercing member retracts. 
         [0010]    U.S. Patent Application Publication No. 2002/0130042 (Moerman et al.) discloses an apparatus having a meter unit, a lancet and an electrochemical sensor. The meter is reusable while the lancet and the electrochemical sensor are incorporated into assemblies intended for single use. The meter has a housing within which a lancet is engaged with a mechanism for moving the lancet, a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte, and a display operatively associated with a connector for displaying the amount of the analyte to the user. 
         [0011]    U.S. Patent Application Publication No. 2002/0082522 (Douglas et al.) discloses a device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from the body. The device includes a lancing needle, drive mechanism, kneading or vibration mechanism, optional suction system, and sample ejection mechanism. 
         [0012]    A disadvantage of the above prior art is that each of the lancets are rigid and rely solely on the spring action of a firing mechanism to retrieve the lancet after firing or, in the case of the Heller device, the specimen piercing speed of the lancet is uncontrolled and depends on the quickness of the user. Further, the prior art that provides for shallow depth penetration of the lancet generally includes a sophisticated system to knead the surrounding lanced area by ultrasonic action, piezo-electric or mechanical oscillation to stimulate the blood flow from the wound to draw the blood into a pumping system. It should also be noted that none of the prior art lancet sensor combination devices are currently available in the marketplace, which indicates that the prior art devices do not provide a reasonable, cost-effective, useful, and workable system for a lancet sensor combination test strip and meter. 
         [0013]    Currently available, prior art, blood glucose meters include those known as the Accu-Chek® Aviva system by Roche Diagnostics, the One-Touch® system by LifeScan, the Glucometer® DEX system by Bayer, the True Track® system by Home Diagnostics, and the Freestyle® system by Abbott. Although these meters advertise various advantages such as fast and reliable test results, small volume requirements and reduced pain systems, each of the currently available meters requires the use of a separate lancing device to obtain the blood sample from the patient. Some require the occasional use of a control reagent to calibrate the meter. All, however, require a patient to carry both the meter and the lancing device with the appropriate number of disposable test strips and lancets. None of these currently available meters, on the other hand, are capable of accepting a combination lancet sensor test strip or eliminating the need for a separate lancing device. 
         [0014]    Therefore, what is needed is a lancet assembly that has an inherent return action upon piercing a specimen. What is further needed is a lancet assembly that can incorporate an analytical test strip. What is also needed is a test strip diagnostic, handheld meter that is capable of driving a lancing device and electronically testing a blood sample. What is still needed is a diagnostic, handheld meter that is usable with a lancet sensor test strip combination. 
       SUMMARY OF THE INVENTION 
       [0015]    It is an object of the present invention to provide a lancet assembly that has an inherent return action upon piercing a specimen. It is another object of the present invention to provide a lancet assembly capable of incorporating an analytical test strip forming a disposable, integrated unit. It is a further object of the present invention to provide a diagnostic, handheld meter that is capable of driving a lancing device and electronically testing a blood sample. It is still another object of the present invention to provide a diagnostic, handheld meter that is usable with a lancet sensor test strip combination. It is yet another object of the present invention to provide a blood glucose diagnostic system that provides fast, reliable results and is virtually pain free when obtaining a blood sample. 
         [0016]    The present invention achieves these and other objectives by providing each of the following: a lancet assembly having at least a lancet, a lancet assembly having at least a lancet and an elongated carrier for holding the lancet; a lancet sensor combination test strip assembly; a diagnostic, handheld meter incorporating measuring circuitry and a lancing mechanism for use with a lancet sensor combination test strip assembly; and a portable glucose test system that includes a lancet sensor strip assembly and a diagnostic, handheld meter. 
         [0017]    In one embodiment of the lancet of the lancet assembly, the lancet includes a lancet body, a lancet tip, a sinuous portion, and an anchor portion. Lancet body has a lancet tip end, a sinuous portion end, and a lancet slot. The lancet slot receives a lancet driver for driving the lancet tip and lancet body from a retracted position to an extended position. Lancet assembly may optionally include a lancet enclosure for receiving the lancet. 
         [0018]    The lancet enclosure is an elongated structure with a needle end and an anchor end, a surface with a recess for receiving the lancet, and a bottom with a lancet enclosure slot spaced from the needle end. In one embodiment, the recess has a narrower portion at the needle end through which the lancet tip is guided to the outside of the lancet enclosure. At the anchor end, there is configured a system to anchor one end of the lancet relative to the lancet enclosure. The lancet enclosure slot in the bottom is longer than the lancet slot to accommodate the extension of the lancet out of the lancet enclosure. The lancet enclosure also includes extended sides for receiving a cover or for direct attachment to a holder. The cover is in a layered relationship with the lancet. 
         [0019]    In another embodiment of the lancet enclosure, the recess has a first recess portion extending from the needle end, a bottom with a lancet enclosure slot spaced from the needle end, a second recess portion that is narrower than the first recess portion and which extends from the first recess portion opposite the needle end, and a third recess portion that is wider than the second recess portion and which extends from the second recess portion. Optionally, the lancet enclosure may have a plurality of first side openings and a plurality of second side openings to accommodate optional side tabs on the lancet that may be created during the manufacturing process. 
         [0020]    In either embodiment, the depth of the recess in the lancet enclosure is deeper than the thickness of the lancet so that the lancet body can freely move the lancet tip out of the needle end from a retracted position to an extended position and back to the retracted position. 
         [0021]    In another embodiment of the lancet of the lancet assembly, the lancet includes a lancet body, a lance extending from the lancet body on one end, a sinuous portion extending from the lancet body on an opposite end, and a drive wing extending outwardly from a side of the lancet body. The lance may be flat, round or any shape commonly used as a lancet for lancing the skin. The sinuous portion has a distal end with an anchor portion. The lancet body may optionally include a second drive wing extending outwardly from the side opposite of the first drive wing. 
         [0022]    The elongated carrier includes a lancet receiving recess, an open end that is also the needle end, a closed end, a first side, a second side, a first side opening, an optional second side opening, an anchor mechanism, and an assembly retaining mechanism. The first and second sides include supporting edges for supporting an optional lancet assembly cover or a sensor test strip. The assembly retaining mechanism is a plurality of tabs that can be bent over the recess or deformed to retain the lancet within the elongated carrier. The first side opening is elongated to allow the drive wing to extend outside of the elongated carrier in position to cooperate with a lancet driver. The elongated side opening allows the drive wing, lancet body and lance to slide between a retracted position and an extended position. The drive wing is initially positioned within the elongated side opening such that the drive wing prevents the sinuous portion of the lancet from being compressed when the lance is in an initial position disposed within the elongated carrier. The anchor mechanism engages the anchor portion of the lancet to prevent the distal end of the sinuous portion from moving when the drive wing is engaged to cause the lancet to slide to the extended position. The elongated carrier may optionally include side notches or slots near the closed end to enhance retention of the lancet assembly when inserted into a meter or lancing device. 
         [0023]    In one embodiment, the lancet carrier is made of metal and has a plurality of bendable tabs and an optional bottom groove. The metal elongated carrier is stamped, cut and bent to the desired shape. The optional bottom groove is formed by stamping and creates a rib along the outside surface of the bottom. The optional bottom groove/rib provides not only stability to the elongated carrier but also serves as a guide when inserting the lancet assembly into a meter/lancing device. In another embodiment, the lancet carrier is made of plastic that allows for molding/thermoforming the lancet carrier. 
         [0024]    In both lancet assembly embodiments, the elongated carrier may optionally include one or more wing guards that extend away from the side of the elongated carrier in the vicinity of the elongated side opening where the drive wing is located. The wing guard protects the drive wing of the lancet from being inadvertently hit when being handled by a user and/or inserted to a meter or lancing device. Furthermore, the depth of the recess in the lancet carrier is deeper than the thickness of the lancet so that the lancet body can freely move the lancet tip out of the needle end from a retracted position to an extended position and back to the retracted position. 
         [0025]    In another embodiment of the present invention, the lancet assembly may optionally include a test strip attached to the top side of the lancet carrier. The test strip typically includes a sample fluid entrance port, a sample chamber with at least one sensor and a sample vent hole. Electrical contacts are situated at the opposite end of the test strip for connecting to a meter. 
         [0026]    A lancet gun device may also be optionally included. The lancet gun device includes a housing, a lancet penetration gauge, a lancet assembly receiver for receiving a lancet, a lancet drive mechanism, an activating member, and a trigger. The lancet penetration gauge includes a plurality of recesses each having a different depth and is designed to cooperate with a lancet drive mechanism stop for regulating the penetration depth of the lancet tip. The housing includes rails having a first rail portion and a second rail portion offset from the first rail portion as well as a lancet driver slot configured to align with the lancet slot. 
         [0027]    In one embodiment of the lancet gun device, the lancet drive mechanism has a stop rod with a lancet penetration gauge disposed at one end of the lancet gun device. In another embodiment, the lancet drive mechanism has a stop on a portion of the lancet drive mechanism that is engaged with one of the rail portions. The lancet penetration gauge in this embodiment is located along the side of the lancet gun device adjacent to the rail where the stop is located. 
         [0028]    In still another embodiment, an optional diagnostic, handheld meter is included. The diagnostic, handheld meter has measuring circuitry, lancing driver assembly components and a test strip port incorporated into a meter housing. The measuring circuitry is preferably an electrochemical measuring circuit designed for using a particular electrochemical measuring method such as, for example, amperometric, coulometric, potentiometric, voltammetric, or other electrochemical techniques. A lancet sensor test strip socket is connected to the measuring circuitry to provide an electrical connection between the sensor strip and the measuring circuitry. The lancing driver assembly components include a lancet driver, a lancet trigger, a test strip receiver platform, and an optional lancing depth control. 
         [0029]    The lancet trigger is an asymmetrical trigger. The asymmetrical trigger includes a trigger body that is typically secured to the meter housing, a lancet driver piston release positioned near the base of the trigger body, and a user interface positioned on a trigger arm that extends outwardly from the top of the trigger body. The user interface is located along the central axis of the meter, which also coincides with the central axis of the disposable lancet sensor test strip. It is the asymmetrical design of the trigger relative to the trigger body that allows the user interface to be located along the central axis of the meter and test strip port providing the user with easy and comfortable access to the firing trigger regardless whether the user is right-handed or left-handed. Because of the user interface&#39;s position along the central axis of the meter and the test strip port, it makes the lancing procedure easy and comfortable for the user. No other prior art device has this structure. 
         [0030]    The test strip receiver platform supports the disposable lancet sensor test strip when it is inserted into the meter. The test strip receiver platform has two platform sides, a proximal end and a distal end. A portion of a first platform side at the proximal end is exposed at the test strip port. This makes it easy for the user to load and insert a disposable lancet sensor test strip. The distal end of the receiver platform includes a cross support with guide hooks on each end for cooperating with a charging member of the lancet driver. The first platform side includes a driver slot through which a lancet driver surface extends for engaging the drive wing of the lancet sensor test strip. The first platform side may also include a test strip guide groove when the test strip incorporates a mating guide rib. A second platform side slidingly supports a driver piston of the lancet driver. 
         [0031]    The lancet driver includes a piston driver, a driver charging member, a piston drive spring, a pair of piston return springs, and a pair of charging member return springs. The piston driver has a piston body with a lancet driver surface located near a drive wing end, a drive spring recess for receiving the piston drive spring and a pair of return spring arms that extend away from the driver body. As mentioned above, the driver piston is slidingly supported by the second platform side of the test strip receiver platform with the lancet driver surface extending through the driver slot to the first platform side for engaging with the drive wing of the test strip. The piston drive spring is secured on one end within the drive spring recess while the other end contacts a central portion of the cross support of the test strip receiver platform. The central portion of the cross support acts as a stop surface for the drive spring when the driver piston is loaded into the “armed” position. The proximal end of the driver piston has a driver piston holding surface that cooperates with the driver piston release of the lancet trigger to hold the driver piston in the “armed” position until released by the user. 
         [0032]    The driver charging member has a handle, a pair of parallel charging member rails that extend from the inside of the handle, charging member arms that extend perpendicularly from the inside of each of the charging member rails towards each other, a stop interface on one end of one of the charging member rails, and a pair of charging member return springs. Each of the charging member return springs connects on one end to the charging member rails and on the other end to the meter housing. Each of the charging member rails slidingly engages with one of the receiver platform side edges. The charging member arms also include a piston stop surface that is used to engage and arm the driver piston when the charging handle is pulled and to stop the sliding movement of driver piston when it is discharged from the armed position. 
         [0033]    The meter housing may optionally include a lancing depth control. The lancing depth control has a detent side and a depth gauge side. The detent side includes a plurality of tabs extending out of the surface of the detent side with spaces between each of the plurality of tabs for receiving the detent. The tabs are relatively rigid but sufficiently flexible to allow the tabs to deflect and ride over the detent when the lancing depth control is changed. The depth gauge side has a charging member interface surface that is a gradual recessing surface that cooperatively engages the stop interface of the driver charging member to set the depth of lance penetration. 
         [0034]    The portable glucose test system includes the handheld, portable meter capable of receiving a lancet sensor test strip, one or more disposable lancet sensor test strips, and an optional control solution. The handheld meter provides, in a single instrument, the dual functionality of driving a lance from the lancet sensor test strip to pierce a lancing site to obtain a sample and to perform the necessary electrochemical measurement steps to determine the concentration of glucose in the sample when it is added to the sample chamber of the sensor strip. No additional, separate lancing device is required to perform the lancing step. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0035]      FIG. 1  is a top view of the preferred embodiment of the present invention showing a lancet within a lancet enclosure. 
           [0036]      FIG. 2  is a top view of the lancet of the present invention shown in  FIG. 1 . 
           [0037]      FIG. 3  is a side view of the lancet of the present invention shown in  FIG. 2   
           [0038]      FIG. 3A  is an enlarged cross-sectional view of along line A-A′ in  FIG. 3 . 
           [0039]      FIGS. 4   a - 4   f  are enlarged perspective, front and side views of the lancet cutting edges representing the method of forming the unique structure of the lancet. 
           [0040]      FIG. 5  is a top view of the lancet enclosure of the embodiment shown in  FIG. 1 . 
           [0041]      FIG. 6  is a side view of the lancet enclosure of the present invention shown in  FIG. 5 . 
           [0042]      FIG. 7  is a perspective view of the lancet enclosure of the present invention shown in  FIG. 5 . 
           [0043]      FIG. 8  is a top view of the present invention showing the combination of a lancet, sensor strip and lancet enclosure where the lancet is in a retracted position. 
           [0044]      FIG. 9  is a top view of the present invention showing the combination of a lancet, sensor strip and lancet enclosure where the lancet is in an extended position. 
           [0045]      FIG. 10  is a side view of one embodiment of a lancet gun device showing a side mounted lancet penetration gauge. 
           [0046]      FIG. 11  is a side view of another embodiment of a lancet gun device showing a front mounted lancet penetration gauge. 
           [0047]      FIG. 12  is a cut-away perspective view of the lancet gun device shown in  FIG. 11 . 
           [0048]      FIG. 13  is a transparent perspective view of another embodiment of the present invention showing the lancet assembly. 
           [0049]      FIG. 14  is a top view of the present invention illustrated in  FIG. 13 . 
           [0050]      FIG. 15  is an enlarged top view of the lancet enclosure of the embodiment illustrated in  FIG. 13 . 
           [0051]      FIG. 16  is an enlarged side view of the lancet enclosure of the embodiment illustrated in  FIG. 15 . 
           [0052]      FIG. 17  is an enlarged top view of the lancet of the embodiment illustrated in  FIG. 13 . 
           [0053]      FIG. 18  is a perspective view of the embodiment of the present invention illustrated in  FIG. 13  showing a test strip affixed to the lancet assembly forming a disposable lancet-test strip combination. 
           [0054]      FIG. 19  is a side view of the embodiment illustrated in  FIG. 18 . 
           [0055]      FIG. 20  is a top view of another embodiment of the lancet assembly of the present invention. 
           [0056]      FIG. 21  is a perspective view of the lancet carrier of the embodiment shown in  FIG. 20 . 
           [0057]      FIGS. 22A and 22B  are top views of the lancet of the embodiment shown in  FIG. 20 . 
           [0058]      FIG. 23  is a perspective view of one embodiment of the present invention showing a lancet sensor test strip with dual drive wings. 
           [0059]      FIG. 24  is a perspective view of the embodiment shown in  FIG. 23  with a single drive wing. 
           [0060]      FIG. 25  is a perspective view of another embodiment of the lancet assembly of the present invention showing wing guards protecting the drive wings of the lancet. 
           [0061]      FIG. 26  is a perspective view of the elongated carrier of the lancet assembly in  FIG. 25 . 
           [0062]      FIG. 27  is an end view of the lancet assembly in  FIG. 26  showing the guide rib on the bottom of the elongated carrier. 
           [0063]      FIG. 28A  is a perspective view of another embodiment of the lancet carrier of the present invention. 
           [0064]      FIG. 28B  is a top view of the lancet carrier shown in  FIG. 28A . 
           [0065]      FIG. 28C  is a bottom perspective view of the embodiment in  FIG. 28A . 
           [0066]      FIG. 29  is a perspective view of one embodiment of the glucose measuring system of the present invention showing the portable meter with a disposable lancet sensor test strip inserted into the test strip port. 
           [0067]      FIG. 30  is a simplified, perspective view of the inside of the meter showing one embodiment of the lancing device components. 
           [0068]      FIG. 31A  is a perspective view of the lancet trigger of the embodiment in  FIG. 30 . 
           [0069]      FIG. 31B  is a perspective view of the test strip receiver platform of the embodiment in  FIG. 30 . 
           [0070]      FIG. 31C  is a perspective view of the lancet driver of the embodiment in  FIG. 30 . 
           [0071]      FIG. 31D  is a perspective view of the depth gauge control of the embodiment in  FIG. 30 . 
           [0072]      FIG. 32A  is a front, perspective view of one embodiment of the optional depth gauge control of the present invention. 
           [0073]      FIG. 32B  is a back, perspective view of the embodiment of the optional depth gauge control in  FIG. 32A . 
           [0074]      FIG. 32C  is a frontal view of the embodiment of the optional depth gauge control shown in  FIG. 32A . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0075]    The preferred embodiment(s) of the present invention are illustrated in  FIGS. 1-32 .  FIG. 1  shows a lancet assembly  10  of the preferred embodiment of the present invention. Lancet assembly  10  includes a lancet enclosure  20  and a lancet  40 . Lancet enclosure  20  includes a recess  21  that is configured to receive and contain lancet  40  when lancet assembly  10  is in a static state. Lancet assembly  10  has a needle end  12  through which lancet  40  protrudes and retracts during use and an anchor end  14 . A separate lancet cover (not shown) or a test strip (discussed later) may optionally be included, but is not necessary, with the lancet enclosure  20 . Lancet enclosure  20  may be made of a plastic material such as, for example, polyvinyl chloride, polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate, cellulose propionate, cellulose acetate, cellulose acetate butyrate, polyester, acrylic, and polystyrene. 
         [0076]      FIG. 2  shows an enlarged top view of lancet  40 . Lancet  40  includes a lancet body  42 , a lancet tip  50 , a sinuous portion  55 , and an anchor portion  60 . Lancet body  42  has a lancet tip end  43 , a sinuous portion end  44 , and a slot  45 . Slot  45  is configured to align with slot  26  of lancet enclosure  20  but is shorter than slot  26 . This ensures sufficient clearance for a lancet driver to operate properly in conjunction with lancet assembly  10  during use. A lancet driver is inserted into slot  45  and drives lancet  40  to an extended position. 
         [0077]    Sinuous portion  55  is a continuous strand of material having a plurality of loops  57 . Sinuous portion  55  is connected on one end to lancet body  42  and to anchor portion  60 . Lancet  40  may optionally have one or more tabs  47 , which are the remnants of the connections between a plurality of lancets  40  formed during the manufacturing process. Lancet  40  is preferably made of a metal material such as, for example, stainless steel having a thickness of about 0.010 inches (0.254 mm). The thickness of lancet  40  must be thinner than the depth of recess  16  in lancet enclosure  20  to allow the protrusion and retraction of lancet tip  50 . Lancet  40  may also be made of other materials such as, for example, plastics having sufficient rigidity to act as a lancet tip  50  for piercing skin but be resilient enough to provide the spring-like action of the sinuous portion  55 . 
         [0078]      FIG. 3  shows a side view of lancet  40  illustrated in  FIG. 2 . As can be seen from  FIG. 3 , sinuous portion  55  is thinner than lancet body  42  and lancet tip  50 . Sinuous portion  55  is reduced in thickness to about 0.004 inches (0.102 mm). The reduction in thickness enhances the spring-like action of sinuous portion  55  in extending and retracting lancet tip  50  during use. The preferred method of reducing the thickness of sinuous portion  55  is by etching. Although it is illustrated that sinuous portion and anchor portion  60  are both etched to the same reduced thickness, it should be noted that anchor portion  60  may optionally not be etched since the thickness of anchor portion  60  has no bearing on the functionality of the sinuous portion  55 . 
         [0079]    During the etching process to reduce the thickness of sinuous portion  55 , a unique lancet tip design is created.  FIG. 3A  illustrates a cross-sectional view of lancet tip  50  taken along line A-A′ in  FIG. 3 . Lancet tip  50  has a concave recess  52  along opposite sides forming a plurality of cutting edges  53 . The formation of lancet tip  50  will now be explained. 
         [0080]    Turning now to  FIGS. 4   a - 4   f , there is illustrated lancet tip  50  after the etching process and the shaped tip after grinding/lapping. It should be noted that the process used in forming lancet tip  50  produces a unique needle tip with a minimum of nine cutting edges. Like most typical etching processes, a mask is applied to the object to be etched. Before subjecting lancet  50  to the etching process, lancet tip  50  is shaped into a needle point forming an included angle θ of about fifteen degrees (15°). 
         [0081]    In the present invention, an etching mask is applied to the bottom of lancet  40  while only a portion of the top of lancet  40  is masked. In the preferred embodiment, the top portion that includes the sinuous portion  55 , anchor portion  60 , and a portion of lancet body  42  at sinuous end  44  are not masked and neither are the sides and ends of lancet  40 . Lancet  40  is then exposed to the etching process for a predetermined time in order to obtain a thickness of the sinuous portion  55  of about 0.004 inches (0.102 mm). After etching, the mask is removed from lancet  40 . 
         [0082]    Turning now to  FIG. 4   a , there is illustrated a perspective view of lancet tip  50  with a portion of lancet body  42  as viewed from the bottom side of lancet  40 . The etching process produces a concave-shaped side  52 .  FIG. 4   b  shows a bottom view of lancet tip  50  formed with angled end  50   a  having an angle θ. Angled end  50   a  may be obtained by various methods known to those of ordinary skill in the art.  FIG. 4   c  illustrates a side view of lancet tip  50  with a concave shaped tip. To complete the formation of lancet tip  50 , lancet tip  50  is shaped to an acute angle σ on the bottom side. 
         [0083]      FIG. 4   d  illustrates a perspective view of a finished lancet tip  50  having angle σ formed on one side. As shown in  FIG. 4   d , a lancet tip  50  has a plurality of cutting edges  53 . For this embodiment, the total number of cutting edges is eleven as a result of the formation of concave sides caused by the etching process. The cutting edges include four side edges  53   a  of lancet tip  50 , the four edges  53   b  formed by the θ-angle, two edges  53   c  formed by the σ-angle, and the end edge  53   d .  FIG. 4   e  illustrates a bottom view of lancet tip  50  showing the relationship of the cutting edges.  FIG. 4   f  illustrates the angle σ of lancet tip  50 . Due to the size of lancet tip  50 , a lapping technique instead of grinding is the preferred method of forming angle σ. Angle σ is an angle of about seven and one-half degrees (7.5°). 
         [0084]    Turning now to  FIG. 5 , there is shown an enlarged top view of lancet enclosure  20  of the present invention. Lancet enclosure  20  has recess  21  having a lancet body recess portion  22  extending from a needle recess portion  23  at needle end  12 , a bottom  24  with a slot  26  spaced from needle end  12 , and an anchor structure  28  adjacent anchor end  14 . Optionally, anchor end  14  may include a tab extension recess  30  for receiving a manufacturing tab  47  of lancet  40 . In the preferred embodiment, anchor structure  28  is a protrusion extending away from lancet enclosure bottom  24  for anchoring lancet anchor portion  60 . Optionally, lancet enclosure  20  may have side wall extensions  32  and an anchor end wall  33  for receiving a cover or a sensor strip or for attaching to a lancet gun device. In addition, side wall extensions  32  may optionally include a plurality of lancet enclosure retaining tabs  34 .  FIG. 6  illustrates a side view of lancet enclosure  20 . The dashed lines indicate the recess bottom  24 , recess top surface  25 , and the side wall extension  32  and lancet enclosure retaining tabs  34 .  FIG. 7  illustrates a perspective view of lancet enclosure  20  and more clearly shows the recess bottom  24 , the recess top surface  25 , side wall extensions  32  with lancet enclosure retaining tabs  34 . Typically, the thickness of lancet enclosure  20  is about 0.018 inches (0.457 mm), not inclusive of side wall extensions  32  which are about 0.022 inches (0.559 mm). The depth of recess  21  is typically 0.012 inches (0.305 mm). 
         [0085]    Turning now to  FIG. 8 , there is illustrated an integrated lancet-test strip combination  100  that includes a test strip  110  attached to lancet assembly  10 . Test strip  110  includes a sample fluid entrance port  112  (not shown), a sample chamber  114  (not shown) containing at least one sensor and a sample vent hole  120 . Electrical contacts  130  are situated at the opposite end adjacent anchor end  14 . Test strip  110  is preferably fixed to lancet assembly  10  forming an integrated lancet-test strip combination  100 . Test strip  110  acts as a cover to recess  21  of lancet assembly  10  enclosing lancet  40  within lancet enclosure  20 .  FIG. 9  illustrates the integrated lancet-test strip combination embodiment of  FIG. 8  where the lancet  40  is in an extended position with lancet needle  50  outside of lancet enclosure  20 . 
         [0086]    Lancet  40  requires the use of a lancet drive mechanism in order to drive the lancet tip  50  into its destination. One embodiment of such a driving mechanism is illustrated in  FIG. 10 .  FIG. 10  shows a side view of a lancet gun device  200 . Lancet gun device  200  includes a housing  202 , a lancet penetration gauge  204 , a lancet assembly receiver  206  for receiving lancet-test strip combination  100 , a lancet drive mechanism  220 , an activating member  240 , and a trigger  208 . Lancet penetration gauge  204  includes a plurality of recesses  205  each having a different depth that are configured to cooperate with a stop  218  of the lancet drive mechanism  220  for regulating the penetration depth of lancet tip  50 . Housing  202  includes rails  212  having a first rail portion  214  and a second rail portion  216  offset from the first rail portion  214  as well as a receiver slot  201  (not shown) configured to align with the lancet enclosure slot  26 . To set the penetration depth, lancet penetration gauge  204  is turned to align the selected recess  205  that corresponds to the depth of penetration of the lancet tip  50  desired with the position of stop  218  on second rail portion  216 . 
         [0087]      FIG. 11  shows another embodiment of lancet gun device  200  with an alternate configuration for the lancet penetration gauge. The same reference numerals are used to reference the same components. The alternate configuration for the lancet penetration gauge includes a penetration gauge wheel  203  having a plurality of gauge recesses  206 . The depth of each one of the plurality of gauge recesses  206  differs and corresponds to the distance the drive mechanism  220  will drive lancet tip  50  forward. 
         [0088]      FIG. 12  shows a cutaway view of the lancet gun device  200  illustrated in  FIG. 11 . Lancet drive mechanism  220  includes a drive mechanism body  222 , drive mechanism guides  228 , a drive mechanism stop rod  226 , a lancet driver  224 , and spring plate  230 . Drive mechanism guides  228  cooperate with housing rails  212  to guide the movement of drive mechanism body  222 . Lancet driver  224  engages lancet slot  45  through housing slot  201  and lancet enclosure slot  26  to drive the lancet tip  50  out of the lancet assembly  10  and into the skin. The depth of lancet penetration is determined by the cooperation between the stop rod  226  and the selected recess  206  of penetration gauge  203  chosen. Spring plate  230  slides along activating member  240  between a return spring  242  and a drive spring  244 . In the preferred embodiment in  FIG. 10 , stop  218  is configured on the side of at least one of the drive mechanism guides  28  that corresponds with the positioning of depth penetration gauge  204 . 
         [0089]      FIG. 13  shows another embodiment of the present invention. Lancet assembly  300  includes a lancet enclosure  320  and a lancet  340 . Lancet enclosure  320  includes a recessed portion  316  that is configured to receive and contain lancet  340  when lancet assembly  300  is in a static state. Lancet assembly  300  has a needle end  312  through which lancet  340  protrudes and retracts during use and an anchor end  314 . A separate lancet cover (not shown) or a test strip (discussed later) may optionally be included, but is not necessary, with the lancet enclosure  320 . 
         [0090]      FIG. 14  shows a top view of lancet assembly  300  during a dynamic state when lancet  340  is protruding out of open end  312  of lancet assembly  300 . It should be understood that lancet  340  may be disposable and lancet enclosure  320  may be reusable or may be a part of the lancet gun device used with lancet  340 . 
         [0091]    Turning now to  FIG. 15 , there is shown an enlarged top view of lancet enclosure  320  of the present invention. Lancet enclosure  320  has recess portion  316  having a first recess portion  322  extending from needle end  312 , a bottom  324  with a slot  326  spaced from needle end  312 , a second recess portion  328  that is narrower than first recess portion  322  and which extends from first recess portion  322 , and a third recess portion  330  that is wider than second recess portion  328  and which extends from second recess portion  328 . Optionally, lancet enclosure  320  may have a plurality of first side openings  332  and a plurality of second side openings  334  to accommodate optional side tabs on lancet  340  that may be created during the manufacturing process.  FIG. 16  is a side view of lancet enclosure  320  in  FIG. 15  taken along arrows  16 ′ and  16 ″. First side opening  332  and second side opening  334  are more clearly depicted as being portions of lancet enclosure  320  where sections of the wall of recess  316  are absent. Typically, the thickness of lancet enclosure  320  is about 0.018 inches (0.457 mm). The depth of recess  316  is typically 0.012 inches (0.305 mm). 
         [0092]      FIG. 17  shows an enlarged top view of lancet  340 . Lancet  340  includes a lancet body  342 , a lancet tip  350 , a sinuous portion  355 , and an anchor portion  360 . Lancet body  342  has a lancet tip end  343 , a sinuous portion end  344 , and a slot  345 . Slot  345  is configured to align with slot  326  of lancet enclosure  320  but is shorter than slot  326 . This ensures sufficient clearance for a lancet driver to operate properly in conjunction with lancet assembly  300  during use. The lancet driver is inserted into slot  345  and drives lancet  340  to an extended position. 
         [0093]    Optionally along each side  346  of lancet body  342  are located one or more lancet body protrusions  347 . Lancet body protrusions  347  are optionally included to reduce the friction that arises between the sides  346  of lancet body  342  and the side walls of recess  316  during use of lancet  340 . Sinuous portion  355  has a zigzag shape with a sinuous neck extension  357 . Sinuous portion  355  is connected on one end to lancet body  342  and to anchor portion  360  by way of sinuous neck extension  357 . Lancet  340  is preferably made of a metal material such as, for example, stainless steel having a thickness of about 0.010 inches (0.254 mm). The thickness of lancet  340  must be thinner than the depth of recess  316  in lancet enclosure  320  to allow the protrusion and retraction of lancet tip  350 . Lancet  340  may also be made of other materials such as, for example, plastics having sufficient rigidity to act as a lancet tip  350  for piercing skin but be resilient enough to provide the spring-like action of the sinuous portion  355 . 
         [0094]    When assembled, lancet tip  350 , lancet body  342  and sinuous portion  355  reside within first recess portion  322  of lancet enclosure  320 . Sinuous neck extension  357  resides in second recess portion  328  and anchor portion  360  resides in third recess portion  330 . Because second recess portion  328  is narrower than either first and third recess portions  322  and  330 , respectively, third recess portion  330  holds anchor portion  360  during use as the rest of lancet  340  extends out of and retracts back into lancet enclosure  320 . 
         [0095]    Sinuous portion  355  provides a spring-like characteristic to the lancet body  342 . As lancet body  342  is extended during the skin-piercing dynamic action of lancet  340 , the sinuous portion  355  provides the resiliency needed to extend lancet tip  350  out of lancet enclosure  320  during use without breaking and to retract lancet tip  350  back into recess  316  of lancet enclosure  320 . In this way, a user is protected from lancet tip  350  before and after use. 
         [0096]    It should be noted that this embodiment of lancet  340  also includes lancet tabs  365 . Lancet tabs  365  are the connecting material that connects one lancet  340  to another lancet  340  during mass production of lancet assembly  300 . It is less expensive to leave tabs  365  on lancet  340  than to remove them. If tabs  65  are not removed, then lancet enclosure  320  requires side openings  332  and  334  in order to accommodate tabs  365  during assembly and use of lancet assembly  300 . However, it should be understood by those skilled in the art that if tabs  365  are removed or if lancet  320  is made as an individual piece, then side openings  332  and  334  are also not required and may be optionally included or not. 
         [0097]    Turning now to  FIG. 18 , there is illustrated an integrated lancet-test strip combination  400  that includes lancet assembly  300  attached to a test strip  410 . Test strip  410  includes a sample fluid entrance port  412 , a sample chamber  414  (not shown) containing at least one sensor and a sample vent hole  420 . Electrical contacts  430  are situated at the opposite end adjacent anchor end  314 . Test strip  410  is preferably fixed to lancet assembly  300  forming an integrated lancet-test strip combination  400 . Test strip  410  acts as a cover to recess  316  of lancet assembly  300  enclosing lancet  340  within lancet enclosure  320 .  FIG. 19  illustrates a side view of lancet-test strip combination  400 . Sample chamber  314  is shown as a series of dashed lines between sample fluid entrance port  412  and sample vent hole  420 . 
         [0098]    To operate the lancet gun device  200 , a lancet assembly  10  is loaded into lancet receiver  206 . The depth of penetration of the lancet tip  50  is selected by rotating penetration gauge  204  to the desired setting. Activating member  240  is pulled away from housing  202  causing the drive spring  244  to compress while return spring  242  on activating member  240  pushes against spring plate  230  sliding lancet drive mechanism  220  into a loaded position arming trigger  208 . Trigger  208  has catch  210  that holds lancet drive mechanism  220  in the loaded state until trigger  208  is fired. After arming the lancet gun device  200 , activating member  240  is released and returns to its original position by return spring  242  while lancet drive mechanism  220  remains in the loaded position. As trigger  208  releases lancet drive mechanism  220 , drive spring  244  quickly expands pushing against spring plate  230  driving lancet drive mechanism  220  at a relative high rate of speed. 
         [0099]    As lancet drive mechanism  220  is released, rails  212  guide lancet drive mechanism  220  along a path that causes lancet driver  224  of drive mechanism  220  to move up through housing slot  201 , lancet enclosure slot  26  and into lancet slot  45  to engage lancet body  42 . As lancet drive mechanism  220  continues along the rails  212  moving from first rail portion  214  to second rail portion  216 , lancet driver  224  drives lancet tip  50  towards its intended target. Lancet tip  50  penetrates the target to a predetermined depth as stop  218  engages the pre-selected recess  205  on penetration gauge  204 . The return force of the impact of stop  218  against the end of recess  205  along with the spring-like action of the sinuous portion  55 , which was stretched by the lancet driver  224  during the discharge of drive spring  244 , causes the lancet tip  50  and lancet body  42  to return to its released, steady-state position. While returning to a steady-state position, lancet driver  224  retracts from lancet  40  disengaging with lancet, lancet enclosure and housing slots  45 ,  26  and  201 , respectively, aided by return spring  242 , which was compressed by spring plate  230  during discharge of drive spring  244 . 
         [0100]    It should be noted that lancet gun device  200  may be configured to accept only a disposable lancet  40 , a lancet assembly  10 , a lancet assembly  10  with a cover, or a lancet-test strip combination  100 . The preferred embodiment as disclosed contemplates the use of a lancet-test strip combination for ease of use, reduced costs and increased dependability and reliability. 
         [0101]      FIG. 20  shows a lancet assembly  1000  of the preferred embodiment of the present invention. Lancet assembly  1000  includes a lancet carrier  1020  and a lancet  1040 . Lancet carrier  1020  includes a recess  1021  that is configured to receive and contain lancet  1040  when lancet assembly  1000  is in a static state. Lancet assembly  1000  has a needle end  1012  through which lancet  1040  protrudes and retracts during use and an anchor end  1014 . Lancet  1040  has a first drive wing  1045  and a second drive wing  1046  that extend out the side of lancet carrier  1020  through side openings  1023   a  and  1024   a , respectively. It is noted that the position of first drive wing  1045  within the opening  1023   a , which extends out the opening  1023   a  when in the static state or the initial position, is such that the spring portion or sinuous portion  1055  cannot be compressed. A separate lancet cover (not shown) or a test strip (discussed later) may optionally be included, but is not necessary, with the lancet carrier  1020 . Lancet carrier  1020  may be made of metal or a plastic material such as, for example, polyvinyl chloride, polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate, cellulose propionate, cellulose acetate, cellulose acetate butyrate, polyester, acrylic, and polystyrene. Lancet cover  1001 , which is represented by dashed lines, is not part of the invention but is used only to maintain the sterility of the lance  1040  until it is used. 
         [0102]      FIG. 21  shows one embodiment of lancet carrier  1020 . In this embodiment, lancet carrier  1020  is preferably made of sheet metal, which allows lancet carrier  1020  to be stamped, cut and bent. Lancet carrier  1020  has recess  1021 , a bottom  1022 , a first side  1023 , a second side  1024 , a closed end  1025 , an open end  1027 , a first side opening  1023   a , an optional second side opening  1024   a , an anchor member  1026 , and an assembly retaining mechanism  1028 . First side  1023  and second side  1024  have supporting edges  1023   b ,  1024   b , respectively, for supporting a lancet assembly cover or a sensor test strip when either one is used as part of the assembly. Assembly retaining mechanism  1028  are elongated tabs that are bent over recess  1021  to retain lancet  1040  and optional cover or test strip (not shown) when incorporated in the assembly. First side opening  1023   a  and optional second side opening  1024   a  are positioned to allow the outward extension of first drive wing  1045  and optional second drive wing  1046  through first side opening  1023   a  and optional second side opening  1024   a , respectively, when lancet  1040  is assembled in lancet carrier  1020 . 
         [0103]      FIGS. 22A and 22B  show an enlarged top view of lancet  1040 . Lancet  1040  includes a lancet body  1042 , a lance  1050 , a sinuous portion  1055 , and an anchor portion  1060  located at a sinuous portion distal end  1056 . Lancet body  1042  has a lance end  1043 , a sinuous portion end  1044 , a first drive wing  1045 , and an optional second drive wing  1046 . First drive wing  1045  and optional second drive wing  1046  extend outwardly from a first side  1042   a  and second side  1042   b , respectively, of lancet body  1042 . Lance  1050  may be integrally made with lancet body  1042  or may be a separate component that is fixedly attached to lancet body  1042 . A lancet driver (discussed later) cooperates with first drive wing  1045  and optional second drive wing  1046  to drive lancet  1040  to an extended position. Lancet cover  1001  is shown in  FIG. 22B  connected to lancet body  1042  to protect lance  1050  and maintain its sterility, and disconnected from lance body  1042  in  FIG. 22A  to expose lance  1050  for use. 
         [0104]    Turning now to  FIG. 23 , there is illustrated a lancet sensor assembly  1000 . Lancet sensor assembly  1000  includes a lancet carrier  1120 , a lancet  1140  with a first drive wing  1145  extending outwardly from a first side opening  1123   a  and a second drive wing  1146  extending outwardly from a second side opening  1124   a , and a disposable sensor strip  1060 . Disposable sensor strip  1060  has an electrical contact end  1062  over closed end  1125  and a sample receiving end  1064  over open end  1027 .  FIG. 24  illustrates another embodiment of lancet sensor assembly  1000  but without the optional second drive wing  1146 . The remaining features are identical. 
         [0105]      FIG. 25  illustrates another embodiment of lancet sensor assembly  1000 . Like the previously described embodiments, lancet sensor assembly  1000  includes a lancet carrier  1120 ′, a lancet  1140  and a sensor strip  1060  combined in a single use, disposable unit. Lancet carrier  1120 ′ includes all of the features of lancet carrier  1020  but with an additional feature. Lancet carrier  1120 ′ includes a first wing guard  1129  and an optional second wing guard  1130 . First wing guard  1129  extends over first drive wing  1145 . Retaining assembly mechanism includes tabs  1128  behind first wing guard  1129  and optional second wing guard  1130  and front tabs  1128 ′ in front of first wing guard  1129  and optional second wing guard  1130 . Tabs  1128  and  1128 ′ are bent at about 90 degrees to the side walls  1123 ,  1124  to secure sensor strip  1060  against supporting edges  1123   b ,  1124   b . First wing guard  1129  protects first drive wing  1145  from being engaged or hit inadvertently when lancet sensor assembly  1000  is being handled or inserted into a meter. Optional second wing guard  1130  protects optional second drive wing  1146 . 
         [0106]      FIG. 26  illustrates an enlarged perspective view of lancet carrier  1120 ′ to more clearly illustrate the features of lancet carrier  1120 ′. As can be seen from  FIG. 26 , lancet carrier  1120 ′ includes another optional feature. The optional feature is a bottom groove  1122   a  in bottom  1122  that also creates a bottom rib  1122   b  along the outside surface  1122   c  of bottom  1122 . Bottom groove  1122   a  acts as a carrier stiffener in the metal embodiment while bottom rib  1122   b  also provides a guiding means when the lancet sensor assembly  1000  is loaded into a handheld meter. 
         [0107]      FIG. 27  is a front end view of lancet sensor assembly  1000 . Wing guards  1129  and  1130  wrap around the drive wings  1145 ,  1146  to protect the drive wings from being hit inadvertently when handled or inserted into a meter. Bottom rib  1122   b  is also shown. It should be understood that bottom rib  1122   b  does not have to be located along the central axis of lancet carrier  1120 ′ in order to obtain the benefits disclosed above. 
         [0108]    Turning now to  FIGS. 28A ,  28 B and  28 C, there is illustrated another embodiment of the lancet carrier. In this embodiment, lancet carrier  1220  is preferably made of a plastic, thermoform material that can be easily molded. Like its metal counterpart, lancet carrier  1220  includes a bottom  1222 , a first side  1223 , a second side  1224 , a closed end  1225 , an open end  1227 , a first side opening  1223   a , an optional second side opening  1224   a , an anchor member  1226  located near closed end  1225 , and an assembly retaining mechanism  1228 . Assembly retaining mechanism  1228  are preferably a plurality of deformable tabs that are deformed to retain the test strip/cover and lancet of the assembly. First side  1223  and second side  1224  have supporting edges  1223   b ,  1224   b , respectively, for supporting a lancet assembly cover or a sensor test strip. Lancet carrier  1220  also includes optional first wing guard  1229  and optional second wing guard  1230 . Bottom  1222  may include optional bottom groove  1222   a . In this embodiment, optional side notches  1231  are included near closed end  1225  to provide additional retention means for retaining the lancet sensor assembly when inserted into the meter. It should be understood that optional first and second wing guards  1229 ,  1230  may be any length and do not need to “wrap around” the drive wings. Wing guards  1229 ,  1230  need only extend over the drive wings sufficient to prevent the drive wings from being inadvertently hit by the user or the meter when being inserted.  FIG. 28B  illustrates a top view of lancet carrier  1220  with the above described features. 
         [0109]      FIG. 28C  is a bottom, perspective view of lancet carrier  1220 . Lancet  1220  has optional bottom rib  1222   b  for use as a guiding means when inserting the lancet sensor assembly into a meter. Wing guards  1229 ,  1230  include wing driver channels  1229   b ,  1230   b  when optional wing guard side walls  1229   a ,  1230   a  are included. Wing driver channels  1229   b ,  1230   b  are formed between wing guard side walls  1229   a ,  1230   a  and first and second sides  1223 ,  1224 . Drive wings  1145 ,  1146  are shown with dashed lines to provide their relative position when lancet  1040  is assembled into lancet carrier  1220 . Wing driver channels  1229   b ,  1230   b  can also be used as guiding means when inserting the lancet sensor assembly into a meter. 
         [0110]    Turning now to  FIG. 29 , there is illustrated a blood glucose test system  1500 . Test system  1500  includes a lancet sensor strip assembly  1510  and a handheld, portable, electrochemical measuring instrument/meter  1520 . Lancet sensor strip assembly  1510  is similar to the previously described strip assemblies. Portable meter  1520  includes a meter housing  1522  with a housing body  1522   a  and a housing cover  1522   b , a test strip socket  1524 , an electronic measuring circuit (not shown), a lancet driver charging system handle  1662 , a display  1526 , a plurality of meter measurement controls  1528 , a lancet trigger  1610 , and an optional lancing depth control  1620 . Meter  1520  is typically battery powered for portability. 
         [0111]      FIG. 30  is an enlarged, simplified, perspective view of the inside of meter  1520  with the housing cover  1522   b  removed showing only the unique lancet driver assembly components  1600  within housing body  1522   a  for clarity. Lancet driver assembly components  1600  include the lancet trigger  1610 , the optional lancing depth control  1620 , a test strip receiver platform  1630 , and a lancet driver  1640 . 
         [0112]      FIGS. 31A-D  show each of the lancet driver assembly components  1600  separated for clarity.  FIG. 31A  is a perspective view of lancet trigger  1610 . Lancet trigger  1610  is an asymmetrical trigger having a trigger body  1611 , a drive piston release  1612  positioned near the base of trigger body  1611 , and a user interface  1614  positioned on a trigger arm extension  1616  that extends outwardly from the top of trigger body  1611 . When assembled, user interface  1614  is located along the central axis of the meter  1520 , which coincides with the central axis of lancet sensor strip assembly  1510 . 
         [0113]      FIG. 31B  is a perspective view of test strip receiver platform  1630 . Test strip receiver platform  1630  has a first platform side  1632 , a second platform side  1634 , a platform proximal end  1636 , and a platform distal end  1638 . First platform side  1632  includes a test strip support surface  1632   a  beginning at platform proximal end  1636  for a pre-determined distance toward platform distal end  1638 . Test strip support surface  1632   a  includes an optional guide groove  1632   b  configured for receiving optional bottom rib  1022   b  or  1222   b  of lancet carrier  1020 ,  1200 , respectively. Platform proximal end  1636  is supported at test strip port  1524  of meter  1520  by a pair of proximal end legs  1636   a . Distal platform end  1638  includes a cross support  1638   a  with a guide hook  1639  on each end. Test receiver platform  1630  also includes at least one driver slot  1633  parallel to the guide groove  1632   b  and an elongated guide surface  1635  for sliding cooperation with driver charging member  1660 . 
         [0114]      FIG. 31C  is a perspective view of lancet driver  1640 . Lancet driver  1640  includes a driver piston  1642  and a driver charging member  1660 . Driver piston  1642  has a piston body  1643  with a drive wing end  1644  having at least one lancet driver surface  1645 , a drive spring recess  1646 , a pair of return spring arms  1648  extending away from and perpendicular to driver body  1643 , a piston drive spring  1647 , and a pair of piston return springs  1649 . Driver piston  1642  is positioned adjacent second platform side  1634  with lancet driver surface  1645  extending through driver slot  1633  of test strip receiver platform  1630  for engagement with drive wing  1145  of lancet  1040 . Driver piston  1642  also includes a driver piston holding surface  1652  that cooperates with driver piston release  1612  to hold driver piston  1642  in an “armed” position. Drive spring recess  1646  secures piston drive spring  1647  on one end and the other end of piston drive spring  1647  contacts a central portion of cross support  1638   a  of test receiver platform  1630 . A piston return spring  1649  is positioned on each side of piston body  1643  between proximal end legs  1636   a  of test strip platform  1630  and the return spring arms  1648 . Each return spring arm  1648  includes a charging contact stop surface  1650 . 
         [0115]    Driver charging member  1660  has a charging system handle  1662 , a pair of parallel, charging member rails  1664  extending from the inside of handle  1662 , charging member arms  1666  located distally from charging member handle  1662  and extending perpendicularly from the inside of each charging member rail  1664  towards each other, a stop interface  1669  on an end of one of the charging member arms  1666 , and a pair of charging member return springs  1670 . Each of the charging member return springs  1670  connects on one end to a charging member arm spring receiver  1665  located on the outside of the charging member arm  1666  and on the other end to the inside of meter housing  1520 . Charging member rails  1664  slidingly support the guide hooks  1639  of test strip platform  1630 . Each charging member arm  1666  has a test strip platform rail  1667  that slidingly engages with one of the platform side edges  1635 . Charging member arm  1666  also includes a piston stop surface  1668  that is used to arm drive piston  1642  by engaging against charging contact stop surface  1650 . Piston stop surface  1668  also stops the sliding movement of drive piston  1642  when the armed lancet driver  1640  is discharged.  FIG. 31D  is a perspective view of optional lancing depth control  1620 . Lancing depth control  1620  is more fully illustrated in  FIGS. 32A , B and C. 
         [0116]      FIG. 32A  illustrates a perspective view of lancing depth control  1620 . Lancing depth control  1620  is considered optional since the lancet driver could be made for a single lancing depth. Lancing depth control  1620  includes a detent side  1622  and a depth gauge side  1628 . The preferred shape of lancing depth control  1620  is a wheel having an outer peripheral surface  1626 . Outer peripheral surface  1626  may include indicia  1627  to indicate relative depth of penetration of the lance. Detent side  1622  includes a plurality of extending tabs  1624 . 
         [0117]      FIG. 32B  shows depth gauge side  1628  with a charging member interface surface  1629 . Charging member interface surface  1629  is a gradually, recessing, circumferential surface that has a variable distance between the interface surface  1629  and the back surface  1628   a  of lancing depth control  1620 . Charging member interface surface  1629  cooperatively engages with stop interface  1669  of driver charging member  1660  to set the lancing depth for lance  1050 . 
         [0118]      FIG. 32C  is a front view of lancing depth control  1620 . Extending tabs  1624  are space along the detent side  1622  to coincide with a pre-determined lancing depth for lance  1050 . The tab spaces  1625  are important for engaging a detent  1621  to temporarily lock the position of lancing depth control  1620 . Detent  1621  may be a separate structure or may be integrally formed on the inside of meter housing  1520 . Extending tabs  1624  are relatively rigid but have sufficient flexibility to allow the tabs to ride over detent  1621  when lancing depth control  1620  is re-positioned for a different lancing depth. Extending tabs  1624  return to their original position when detent  1621  enters a tab space  1625  to temporarily set and temporarily lock the lancing depth control  1620  to the desired lancing depth. 
         [0119]    To determine the blood glucose level of a user, blood glucose test system  1500  requires a lancet sensor strip assembly  1510  and the handheld meter  1520 . To make the measurement, lancing depth control  1620  is set to the preferred lancing depth. The charging handle  1662  is pulled away from meter housing  1520 . This action causes the piston stop surface  1668  of the charging member arms  1666  to engage charging contact stop surface  1650  of driver piston  1642  pulling driver piston  1642  toward an “armed” position and causing the piston drive spring  1647  to compress against cross support  1638   a  of test receiver platform  1630 . As driver piston  1642  is pulled toward cross support  1638   a , driver piston holding surface  1652  engages drive piston release  1612  of lancet trigger  1610  to hold driver piston  1642  in the “armed” position. When the charging handle  1662  is released after arming the driver piston  1642 , the charging member return springs  1670  returns the charging handle  1662  to its original position with the stop interface  1669  resting against the charging member interface surface  1629  of lancing depth control  1620 . 
         [0120]    A lancet sensor test strip  1510  is inserted into test strip port  1524  of meter  1520  and the protective lancet cover  1001  is pulled away from the test strip. It should be noted that “arming” the driver piston  1642  may be performed after the lancet sensor test strip  1510  is inserted into test strip port  1524 . The end of lancet sensor test strip  1510  is placed against the user&#39;s skin where the lancing is to be performed. Once in position, the user simply pushes the lancet trigger  1610  releasing the driver piston  1642 . As the driver piston  1642  moves, lancet driver surface  1645  engages drive wings  1145 ,  1146  causing the lance  1050  to extend out of lancet carrier  1020  piercing the user&#39;s skin. Driver piston  1642  stops when charging contact stop surface  1650  hits piston stop surface  1668  of charging member  1660 . Piston return springs  1649  cause piston driver  1642  to return to its discharged/resting position. Once drive wings  1145 ,  1146  are released, the spring action of sinuous portion  1055  causes lance  1050  to retract back into lancet carrier  1020 . 
         [0121]    The user then removes the meter and strip from the wound site and massages or “milks” the wound site to generate sufficient sample for testing. The penetration depths of lance  1050  are purposely selected for pain-free lancing. Because the penetration depth of lance  1050  is so shallow, massaging or “milking” the wound site is necessary to obtain sufficient sample for testing. Once a sufficiently sized blood droplet appears, the meter and strip are returned to the wound site to allow the sample to enter the sample chamber of the sensor test strip. The meter then electrochemically determines the concentration of glucose in the blood from the blood sample. Once the measurement is complete, the disposable lancet sensor strip  1510  is removed from meter  1520 . 
         [0122]    It should be understood that the blood glucose test system  1500  may be configured to use anyone of the electrochemical methods used for determining the concentration of glucose in a sample. For example, these methods include amperometric, coulometric, potentiometric, voltammetric, and other electrochemical techniques. 
         [0123]    Although the preferred embodiments of the present invention have been described herein, the above description is merely illustrative. Further modification of the invention herein disclosed will occur to those skilled in the respective arts and all such modifications are deemed to be within the scope of the invention as defined by the appended claims.