Patent Abstract:
A lancet assembly has a lancet body with a needle end, a sinuous portion end, and a slot, a lancet tip connected to the needle end, a sinuous portion connected to the sinuous portion end, an anchor structure connected to the sinuous portion. The lancet assembly may also include a lancet enclosure having an elongated chamber with a needle end, an anchor end in communication with the elongated chamber opposite the needle end, and a lancet enclosure slot in communication with the elongated chamber and spaced from the needle end. The anchor end is configured to receive and hold the anchor structure in a substantially static position. The elongated chamber is sized to receive in sliding engagement the lancet tip, the lancet body where the lancet body slot is in communication with the lancet enclosure slot and the sinuous portion and to permit slidable movement of the lancet tip through the open end between a retracted position and an extended position.

Full Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     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.  
         [0003]     2. Description of the Prior Art  
         [0004]     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.  
         [0005]     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. 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.  
         [0006]     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 firs 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.  
         [0007]     U.S. Patent Application Publication No. U.S. 2003/0050573 (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.  
         [0008]     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.  
         [0009]     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.  
         [0010]     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.  
         [0011]     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 be mated to an analytical test strip.  
       SUMMARY OF THE INVENTION  
       [0012]     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 being mated to an analytical test strip forming a disposable integrated unit. It is a further object of the present invention to provide a lancet with a plurality of cutting edges.  
         [0013]     The present invention achieves these and other objectives by providing a lancet assembly having at least a lancet. 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.  
         [0014]     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.  
         [0015]     In another embodiment, 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.  
         [0016]     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.  
         [0017]     Additionally, a lancet and lancet enclosure assembly may optionally include a test strip attached the top side of the lancet enclosure. 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.  
         [0018]     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.  
         [0019]     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. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]      FIG. 1  is a top view of the preferred embodiment of the present invention showing a lancet within a lancet enclosure.  
         [0021]      FIG. 2  is a top view of the lancet of the present invention shown in  FIG. 1 .  
         [0022]      FIG. 3  is a side view of the lancet of the present invention shown in  FIG. 2   
         [0023]      FIG. 3A  is an enlarged cross-sectional view of along line A-A′ in  FIG. 3 .  
         [0024]      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.  
         [0025]      FIG. 5  is a top view of the lancet enclosure of the embodiment shown in  FIG. 1 .  
         [0026]      FIG. 6  is a side view of the lancet enclosure of the present invention shown in  FIG. 5 .  
         [0027]      FIG. 7  is a perspective view of the lancet enclosure of the present invention shown in  FIG. 5 .  
         [0028]      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.  
         [0029]      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.  
         [0030]      FIG. 10  is a side view of the preferred embodiment of a lancet gun device showing a side mounted lancet penetration gauge.  
         [0031]      FIG. 11  is a side view of another embodiment of a lancet gun device showing a front mounted lancet penetration gauge.  
         [0032]      FIG. 12  is a cut-away perspective view of the lancet gun device shown in  FIG. 11 .  
         [0033]      FIG. 13  is a transparent perspective view of another embodiment of the present invention showing the lancet assembly.  
         [0034]      FIG. 14  is a top view of the present invention illustrated in  FIG. 13 .  
         [0035]      FIG. 15  is an enlarged top view of the lancet enclosure of the embodiment illustrated in  FIG. 13 .  
         [0036]      FIG. 16  is an enlarged side view of the lancet enclosure of the embodiment illustrated in  FIG. 15 .  
         [0037]      FIG. 17  is an enlarged top view of the lancet of the embodiment illustrated in  FIG. 13 .  
         [0038]      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.  
         [0039]      FIG. 19  is a side view of the embodiment illustrated in  FIG. 18 . 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0040]     The preferred embodiments of the present invention are illustrated in  FIGS. 1-19 .  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.  
         [0041]      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.  
         [0042]     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 .  
         [0043]      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 .  
         [0044]     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.  
         [0045]     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 (150).  
         [0046]     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 .  
         [0047]     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  0 . 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.  
         [0048]      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°).  
         [0049]     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).  
         [0050]     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 .  
         [0051]     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 .  
         [0052]      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.  
         [0053]      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 .  
         [0054]      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 .  
         [0055]      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 .  
         [0056]     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).  
         [0057]      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.  
         [0058]     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 .  
         [0059]     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 .  
         [0060]     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.  
         [0061]     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.  
         [0062]     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 .  
         [0063]     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.  
         [0064]     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 .  
         [0065]     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.  
         [0066]     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.

Technology Classification (CPC): 0