Abstract:
A combined lancing and auxiliary device includes a lancing device with a lancing auxiliary device attached thereto. The lancing auxiliary device can be, for example, a compartment for securely and removably containing items associated or unassociated with lancing, a timer or personal digital assistant device for assisting in documentation, or an illumination device for illuminating a target site. The lancing auxiliary device can be permanently or removably attached to the lancing device.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The present invention relates, in general, to medical devices and, in particular, to lancing devices.  
         [0003]     2. Description of the Related Art  
         [0004]     Conventional lancing devices generally have a rigid housing, various operating mechanisms and a lancet that can be armed and launched so as to briefly protrude from one end of the lancing device. For example, conventional lancing devices can include a lancet that is mounted within a rigid housing such that the lancet is movable relative to the rigid housing along a longitudinal axis thereof. Typically, the lancet is spring loaded and launched, upon release of the spring, to penetrate (i.e., “lance”) a target site (e.g., a dermal tissue target site). A bodily fluid sample (e.g., a whole blood sample) can then be expressed from the penetrated target site for collection and analysis. Conventional lancing devices are described in U.S. Pat. No. 5,730,753 to Morita, U.S. Pat. No. 6,045,567 to Taylor et al., U.S. Pat. No. 6,071,250 to Douglas et al., U.S. Pat. No. 6,156,051 to Schraga, and U.S. Pat. No. 6,607,543 to Purcell et al., each of which is incorporated fully herein by reference.  
         [0005]     Conventional lancing devices typically require a user to arm the lancing device, urge the lancing device against a target site, and then press a button or other switch to manually activate the lancing device such that a lancet within the device is launched (also referred to as “fired”) towards the target site. The lancet then penetrates (e.g., lances) the target site, thereby creating an opening for the expression of a bodily fluid sample.  
         [0006]     Use of lancing devices can be inconvenient and cumbersome due to the multitude of items associated with lancing that must be carried (e.g., lancets, test strips, alcohol swabs, and pharmaceuticals) as well as the need to document results of analyses conducted on the bodily fluid samples produced with the lancing device.  
         [0007]     Still needed in the field, therefore, is a lancing device that that minimizes the inconvenience and cumbersomeness of carrying items associated with lancing. In addition, a lancing device that reduces the inconvenience of documentation is also desired.  
       SUMMARY OF THE INVENTION  
       [0008]     Combined lancing and auxiliary devices according to embodiments of the present invention minimize the inconvenience and cumbersomeness of carrying items associated with lancing. In addition, combined lancing and auxiliary devices according to embodiments of the present invention also reduce the inconvenience of documentation.  
         [0009]     A combined lancing and auxiliary devices according to an embodiment of the present invention includes a lancing device with a lancing auxiliary device attached thereto. The lancing auxiliary device can be, for example, a compartment for securely and removably containing items associated or unassociated with lancing, a timer or personal digital assistant device for assisting in documentation, an illumination device for illuminating a target site or any combination thereof. The lancing auxiliary device can be permanently or removably attached to the lancing device. Attachment and detachment of the lancing auxiliary device makes the combined lancing and auxiliary device longer or shorter, respectively, for better ergonomic fit to different sized hands.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]     A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings, of which:  
         [0011]      FIG. 1  is a perspective view of a compact lancing device according to an exemplary embodiment of the present invention;  
         [0012]      FIG. 2  is a perspective exploded view of the compact lancing device of  FIG. 1 ;  
         [0013]      FIG. 3  is a perspective exploded view of the lancet holder and trigger mechanism of the compact lancing device of  FIG. 1 ;  
         [0014]      FIGS. 4A and 4B  are perspective views of the lancet holder and trigger mechanism of the compact lancing device of  FIG. 1  in an armed position and in a triggered position, respectively (with dashed lines indicating features not visible in the view of FIGS.  4 A and  4 B);  
         [0015]      FIGS. 5A and 5B  are cross-sectional schematic views of the compact lancing device of  FIG. 1  set at maximum and minimum lancet needle penetration depths, respectively;  
         [0016]      FIG. 6  is a cut-away perspective view of the compact lancing device of  FIG. 1 ;  
         [0017]      FIGS. 7A through 7E  are simplified, schematic, cross-sectional views depicting the compact lancing device of  FIG. 1  during various stages of operation;  
         [0018]      FIG. 8  is a perspective view of a combined lancing and auxiliary device according to an embodiment of the present invention;  
         [0019]      FIG. 9  is partially cut away perspective view of the combined lancing and auxiliary device of  FIG. 8 ;  
         [0020]      FIG. 10  is a perspective view of a combined lancing and auxiliary device according to another embodiment of the present invention;  
         [0021]      FIG. 11  is a perspective view of a combined lancing and auxiliary device according to still another embodiment of the present invention; and  
         [0022]      FIG. 12  is a perspective view of a combined lancing and auxiliary device according to a further embodiment of the present invention.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]      FIGS. 1, 2 ,  3 ,  4 A,  4 B,  5 A,  5 B and  6  are various depictions a compact lancing device  100  according to an embodiment of the present invention. Compact lancing device  100  includes a housing  102 , end cap  104 , depth adjustment mechanism  106 , arming mechanism  108 , trigger mechanism  110 , and launching mechanism  112 .  
         [0024]     As described in detail below, launching mechanism  112 , arming mechanism  108  and trigger mechanism  110  are operatively connected such that a target site (e.g., a user&#39;s skin target site) can be lanced with a lancet (for example, lancet L that includes lancet needle N) held within compact lancing device  100 . In this regard, launching mechanism  112  is configured for launching lancet L such that lancet needle N lances a target site, arming mechanism  108  is configured for arming lancing device  100  prior to firing the compact lancing device (i.e., prior to launching lancet L), and trigger mechanism  110  is configured to actuate the firing of compact lancing device  100 . Furthermore, depth adjustment mechanism  106  is configured for a user to select (i.e., predetermine) needle penetration depth into a target site.  
         [0025]     Compact lancing device  100  can be any suitable size but is typically sized to fit within the palm of a user&#39;s hand and has, therefore, a typical but non-limiting length in the range of 50 mm to 70 mm and a typical but non-limiting width in the range of about 10 mm to about 20 mm. Such a compact size is beneficial in that it requires less storage space and is less conspicuous than conventionally sized lancing devices.  
         [0026]     Housing  102  is generally cylindrical in shape and includes a proximal end  114 , a distal end  116 , a first surface  118 , an arming mechanism orifice  120 , a trigger mechanism orifice  122 , a window  124 , a second surface  126  and a gripping feature  128 . Housing  102  can be formed, for example, of rigid materials including, but not limited to, polycarbonate, polyester, polystyrene, polyamide, polyacetal, polyimide, polyketone, polyurethane, polybutyleneteraphthalate and combinations thereof. Housing  102  can also be formed of semi-rigid materials including, for example, polypropylene, high density polyethylene, polyurethane, ethylene propylene rubber, polymethylpentene and combinations thereof. If desired, housing  102  can be easily manufactured from two elongate pieces that are sonically welded or snap-fit together to create housing  102 .  
         [0027]     End cap  104  is detachably connected to distal end  116  of housing  102 . End cap  104  includes skin engaging surface  130  with opening  132  therein, collar engaging end  134  with raised features  136 , and indentations  138 .  
         [0028]     Depth adjustment mechanism  106  includes a collar  140  and a guide member  142 . Collar  140  includes a collar first end  144  with collar rim  146 , a collar second end  148 , depth setting indicators  150 , recesses  152  and internal spiral thread  154 . Furthermore, guide member  142  includes an aperture  156 , a cam surface  158 , a guide member groove  160  (labeled in  FIGS. 7A, 7B  and  7 C and described below) and outer protrusions  162 .  
         [0029]     Arming mechanism  108  includes a handle  164 , a first rim  166 , a second rim  168 , an internal groove  170  and an internal raised portion  172 . Trigger mechanism  110  includes a body  174 , a trigger button  176 , a spring element  178  and a latch rim  180 .  
         [0030]     Launching mechanism  112  includes a lancet holder  182 , a launch spring  184  (with launch spring first and second ends  186  and  188 , respectively), and a retraction spring  190 . Lancet holder  182  includes proximal end  192 , a distal end  194 , a first hollow portion  196 , a second hollow portion  198 , a first surface  200 , a second surface  202 , a space  204 , an outwardly expandable portion  206 , a slit  208 , a lip  210 , a cam surface  212 , a depression  214 , an internal surface  216 , and a projection  218  (with a projection end  220 ).  
         [0031]     Having introduced various components of compact lancing device  100 , details of the interaction and functioning of such components will now be described with reference to  FIGS. 1 through 6 . A portion of arming mechanism  108  is visible to a user through arming member orifice  120  of housing  102  (see  FIGS. 1 and 6  in particular). Handle  164  of arming mechanism  108  protrudes through arming member orifice  120  near proximal end  114  of housing  102  and on housing first surface  118 . A user slides handle  164  to arm compact lancing device  100 .  
         [0032]     Trigger member  110  is accessible to a user through housing trigger member orifice  122  on housing first surface  118  (see, in particular,  FIGS. 1 and 6 ). Housing trigger member orifice  122  is in close proximity to, and on the same housing surface (i.e., housing first surface  118 ) as, housing arming member orifice  120  in order that a user can operate both trigger mechanism  110  and arming mechanism  108  using one hand.  
         [0033]     As depicted in  FIG. 1 , a lancing depth setting  150  (i.e., the numeral “6” in  FIG. 1 ) is visible to a user through housing window  124  near housing distal end  116  on housing first surface  118 . In addition, housing  102  includes a gripping feature  128  on second surface  126  of housing  102 . Second surface  126  and gripping feature  128  are in oppositional relationship to handle  164  and trigger button  176  such that a user can easily grip and operate compact landing device  100  with one hand.  
         [0034]     In the embodiment of  FIG. 1 , gripping feature  128  is an indentation in housing second surface  126 . However, once apprised of the present disclosure, those skilled in the art will recognize that gripping feature  128  can take any suitable form including, but not limited to, one or more protrusions or recesses on the surface of housing  102 .  
         [0035]     Lancet holder  182  is generally cylindrical in shape with first hollow portion  196  and second hollow portion  198  disposed at the proximal and distal ends  192  and  194 , respectively, of lancet holder  182  (see, for example,  FIG. 3 ). First hollow portion  196  extends into lancet holder  182  approximately a third of the distance from proximal end  192  to distal end  194 . Second hollow portion  198  extends into lancet holder  182  approximately a third of the distance from distal end  194  to proximal end  192 . Launch spring  184  is located at least partially within first hollow portion  196  and lancet L is removably retained at least partially within second hollow portion  198 .  
         [0036]     Space  204  of lancet holder  182  is approximately centrally located and bounded by first and second surfaces  200  and  202 , respectively. Distal end  194  includes a radially and outwardly expandable portion  206  with a slit  208  configured such that lancet L (e.g., a suitable commercially available lancet) can easily be inserted into and removed from lancet holder  182 .  
         [0037]     Proximal end  192  includes a lip  210  that engages with first rim  166  of arming mechanism  108  during latching of lancet holder  182 . Lip  210  further holds retraction spring  190  in surrounding relationship to lancet holder proximal end  192 . First surface  200  includes a cam surface  212  adjacent to a depression  214  for a spring element  178  of trigger mechanism  110  to cooperate with (e.g., to react against). Second surface  202  includes an elongate projection  218  that, along with cam surface  212  and depression  214 , function during arming and triggering operations, as will be described below.  
         [0038]     Launch spring  182  is configured to control movement of lancet holder  182 . Launch spring first end  186  engages an internal surface of housing proximal end  114  and launch spring second end  188  engages an internal surface  216  of lancet holder  182  (see  FIGS. 4A and 4B ). launch spring  184  typically applies a spring force to lancet holder  182  during launch of lancet L in the range of from about 0.25 pounds to 2 pounds and preferably from about 0.5 pounds to 1 pounds. In the embodiment of  FIG. 1 , retraction spring  190  is essentially concentric with launch spring  184 , thereby contributing to the compactness of compact lancing device  100 .  
         [0039]     Retraction spring  190  resides substantially within the circumferential space between arming mechanism  108  and lancet holder  182 . Retraction spring  190  pulls lancet holder  182  back after lancet needle N has been launched into a target site, dampens vibrations from lancet holder  182  during use of compact lancing device  100  and prevents lancet needle N from penetrating the target site a second time. Retraction spring  190  also returns arming mechanism  108  to a rest position after latching. One end of retraction spring  190  is also engaged by arming mechanism  108  during arming of compact lancing device  100 , as will be described below. Retraction spring  190  can be formed of any suitable material including plastic materials (such as polypropylene and polyester) metal materials or any combinations thereof.  
         [0040]     Arming mechanism  108  is generally hollow and elongate and is disposed in surrounding relation to lancet holder  182 . Internal raised portion  172  of arming mechanism  108  engages one end of retraction spring  190  during arming of compact lancing device  100 , as will be described below.  
         [0041]     Lancet holder projection  218  is adapted to slidably move within internal groove  170  (see  FIG. 2 ). Internal groove  170  engages lancet holder projection  218 . Internal groove  170 , therefore, limits relative rotational motion of lancet holder  182  upon actuation of compact lancing device  100 , thereby reducing vibration and pain felt by the user. Internal groove  170  and guide member groove  160  are aligned to one another such that both internal groove  170  and guide member groove  160  can engage projection  218  simultaneously.  
         [0042]     Trigger mechanism  110  is generally internally elongate, ring-shaped and disposed in a surrounding relationship to lancet holder  182 . Trigger mechanism  110  can move laterally but not longitudinally relative to housing  102 .  
         [0043]     Spring element  178  projects into body  174  of trigger mechanism  110 . Spring element  178  engages cam surface  212  when compact lancing device  100  is armed (see  FIG. 3B ) and slidably engages depression  157  when lancet  132  is fired as lancet holder  140  moves toward housing distal end  106  (see  FIG. 4A ). In both the armed and fired position of lancet holder  182 , spring element  178  is at a minimal load while retaining an armed or loaded position, but is momentarily loaded to a greater extent when trigger button  176  is pressed to unlatch lancet holder  182 . Therefore, the typical load on spring element  178  is low (i.e., less than 20 grams) even when lancing compact lancing device  100  is armed, thus improving the durability of compact lancing device  100 . Trigger mechanism  110  can be formed (e.g., molded) in one piece, thus reducing the number of parts and simplifying the manufacture of compact lancing device  100 .  
         [0044]     When compact lancing device  100  is armed, trigger member latch rim  180  engages projection end  220  of lancet projection  218  and trigger button  176  moves laterally to a triggering position (as depicted in  FIG. 4A ). When lancet L is fired (i.e., when trigger button  176  is depressed), latch rim  180  slides over lancet projection  218 , allowing lancet holder  182  to move toward housing distal end  116  (see  FIG. 4B ). Arming and triggering of compact lancing device  100  are described in more detail below with respect to  FIGS. 7A through 7E .  
         [0045]     Adjustment mechanism  106  enables a user to predetermine a depth of needle penetration into a target site. End cap  104  includes opening  132  for lancet needle N to pass through and a plurality of indentations  138  such that a user can grip end cap  104  and rotate, tip or pull the end cap away from housing  103  when replacing lancets. End cap  104  can be formed of any suitable material including, but not limited to, elastomeric materials such as rubber, latex or silicone such that when end cap  104  is removed, end cap  104  can optionally deform inward and grab onto lancet L, thereby allowing lancet L to be removed along with end cap  104 .  
         [0046]     Collar engaging end  134  of end cap  104  is configured to mate with collar first end  144 . Collar engaging end  134  includes a plurality of raised features  136  for engaging with a plurality complimentary recesses  152  of collar  140 . Raised features  136  and complimentary recesses  152  provide for detent-based retention of end cap  104 , yet facilitate easy removal of end cap  104  by, for example, i.e., tipping to one side or pulling off.  
         [0047]     Collar  140  includes an internal spiral thread  154  that engages a complimentary cam surface  158  (which is essentially an external spiral thread cam surface) on guide member  142 , an rim  146  on first end  144 , and a second end  148 . Collar  140  is sidably moveable relative to housing  102  and guide member  142  and has a generally hollow cylindrical shape.  
         [0048]     Guide member  142  includes an aperture  156  through which trigger member  110  is inserted such that trigger member  110  is nested therein. Guide member  142  further includes a groove  160  (see  FIG. 7A-7C ) that cooperates with lancet holder projection  218 . Guide member groove  160  beneficially limits rotational motion of lancet holder  182  during firing of lancet L, thus reducing vibration and pain felt by the user.  
         [0049]     Guide member  142  is held stationary relative to lancet holder  182  by attaching guide member  142  to the inner surface of housing  102  via outer protrusions  162  that mate with recesses (not shown) on the inner surface of housing  102 . However, any attachment means known to those skilled in the art can be used to secure guide member  142  to housing  102  including, but not limited to a pin, a screw, and ultrasonic welding.  
         [0050]     Rotation of end cap  104  adjusts the depth of needle penetration. When end cap  104  is rotated, raised features  136  engage with collar recesses  152  via a spline interface methodology. This causes collar internal spiral threads  154  to engage guide member cam surface  158 , thereby moving end cap  104  away from or toward housing  102  and changing the distance needle N penetrates into a target site. In this regard,  FIGS. 5A and 5B  show cross-sectional views of lancing device  100  set at maximum and minimum needle penetration depth, respectively.  
         [0051]     Arming mechanism  108 , trigger mechanism  110 , lancet holder  182 , collar  140 , and guide member  142  can, for example, be formed of rigid materials including, but not limited to, polycarbonate, polyester, polystyrene, polyamide, polyacetal, polyimide, polyketone, polyurethane polybutyleneteraphthalate or combinations thereof. Arming mechanism  108 , trigger mechanism  110 , lancet holder  182 , collar  140 , and guide member  142  can optionally contain lubricating additives including, for example, Teflon or graphite to reduce friction (and resulting vibration) therebetween.  
         [0052]     All mechanisms of compact lancing device  100  cooperate with a close fit, thereby minimizing vibration during firing of lancet L. In addition, the interface between lancet holder lip  210  and arming mechanism first rim  166  can include materials that dampen sound and vibration (e.g., rubber or elastomeric materials). Such a sound/vibration dampening material interface can be formed, for example, as an additional component (e.g., a layer of sound/vibration dampening material) disposed between lip  210  and first rim  166  or by forming lip  210  and/or first rim  166  either partially or completely of a sound and/or vibration dampening material. Use of tight tolerances (such as tight tolerances in the range of 0.0005 inches to 0.003 inches) and sound/vibration dampening materials may reduce the perception of pain by the device user.  
         [0053]     Referring to  FIGS. 7A through 7E , the operation of compact lancing device  100  (depicted in simplified cross-section in  FIG. 7A ) will be described. In compact lancing device  100 , trigger mechanism  110  and arming mechanism  108  are located on the same side of the compact lancing device such that arming and triggering can be performed with one hand.  
         [0054]     Compact lancing device  100  is armed by moving arming mechanism  108  toward proximal end  114  of housing  102  such that one end of retraction spring  190  is engaged by internal raised portion  172  of arming mechanism  108  and the other end of retraction spring  190  with lip  210  of lancet holder  182  (see  FIG. 7B ). When first rim  166  contacts lip  210 , lancet holder  182  starts to move towards proximal end  114 . As retraction spring  190  is thus engaged, lancet holder  182  moves toward housing proximal end  114  and spring element  178  of trigger mechanism  110  engages cam surface  212  on lancet holder  182 . Furthermore, trigger member latch rim  180  engages projection end  220  of a lancet holder projection  218  and trigger mechanism  110  moves laterally relative to housing  102  such that trigger button  176  is raised above (or alternatively level with) first surface  118  of the housing  102 , thus giving the user a visual and tactical indication of when compact lancing device  100  is armed (see  FIG. 7B ).  
         [0055]     When arming mechanism  108  is released, both arming mechanism  108  and the end of retraction spring  190  in contact with first rim  166  move back to their original positions (see  FIG. 7C ). Arming of compact lancing device  100  can also be achieved by an axial force exerted on lancet holder  182  by an act of inserting a lancet into lancet holder  182 .  
         [0056]     Next, end cap engaging surface  130  is contacted with a target site. Subsequently, the engaging surface is urged towards the target site, thereby creating a bulge B in the target site (see  FIG. 7D , where the arrow indicates the direction of urging).  
         [0057]     When trigger mechanism  110  is triggered (e.g., trigger button  176  is pressed in a lateral direction relative to housing  102 ), latch rim  180  is disengaged from projection end  220  of lancet holder  182 , thereby allowing projection  218  to slide over latch rim  180  and lancet holder  182  to move toward end cap  104  (see  FIG. 7E ). Simultaneously, spring element  178  disengages from lancet holder cam surface  212  and then engages with depression  214  in the surface of lancet holder  182  and moves toward housing distal end  116  (see  FIG. 7E ). Launch spring  184  exerts a force on lancet holder internal surface  216  causing lancet holder  182  to move longitudinally toward bulge B (i.e., to be fired or launched toward bulge B) such that bulge B is lanced with the lancet needle N.  
         [0058]     As described above, trigger mechanism  110  has a role in both the arming and triggering of compact lancing device  100 , thereby eliminating the need and expense of separate components to perform these functions.  
         [0059]      FIGS. 8 and 9  depicts a combined lancing and auxiliary device  300  according to an embodiment of the present invention. Combined lancing and auxiliary device  300  includes lancing device  302  (e.g., compact lancing device  100  of  FIG. 1 ) and a lancing auxiliary device, namely a storage compartment  304 , attached thereto. Storage compartment  304  is configured to receive and removably retain items (not shown) related to the use of lancing device  302 . Items related to lancing device  302  that can be removably retained in storage compartment  304  include, but are not limited to, lancets, test strips, pharmaceuticals and alcohol swabs. Storage compartment  304  is optionally configured to receive and removably retain items (not shown) unrelated to the use of lancing device  302 . Items unrelated to lancing device  302  that can be removably retained in storage compartment  304  include, but are not limited to, coins, pills and medications.  
         [0060]     For illustrative purposes only in  FIGS. 8 and 9 , lancing device  302  of combined lancing and auxiliary device  300  is illustrated as compact lancing device  100  of  FIG. 1 . However, once apprised of the current invention, those skilled in the art will recognize that lancing device  302  of combined lancing and auxiliary device  300  can be any suitable lancing device.  
         [0061]     Storage compartment  304  is generally elongate and cylindrical in shape and includes a proximal end  310 , a distal end  312 , a body  314  and a cavity  316  (see  FIG. 9 ) for storing items related to the use of lancing device  302 . Storage compartment  304  can be removably attached to lancing device  302  by, for example, slide mounting, snap fitting or screw fitting techniques. Compartment proximal end  310  can also be fixedly (i.e., permanently) attached to housing  302  by, for example welding or molding techniques.  
         [0062]     Distal end  312  of compartment  304  includes a cap  318  and an opening  320  (see  FIG. 9 ) for inserting and removing items from compartment  304 . Cap  318  retains and protects items contained in compartment  304  from possible contamination or damage due to exposure to humidity or light. Cap  318  can be attached to compartment distal end  312  by, for example, a snap-type fit (with or without a hinge connection) or a screw fit.  
         [0063]      FIG. 10  depicts a combined lancing and auxiliary device  400  according to another embodiment of the present invention. Combined lancing and auxiliary device  300  includes lancing device  402  (e.g., compact lancing device  100  of  FIG. 1 ) and a lancing auxiliary device, namely an illumination device  404 , attached thereto. In this embodiment, illumination device  404  includes an illuminating means  406  (e.g., a flashlight) for illuminating a target site and a sliding switch  408  for adjusting the intensity of illuminating means  406 .  
         [0064]      FIG. 11  depicts a combined lancing and auxiliary device  500  according to yet another embodiment of the present invention. Combined lancing and auxiliary device  500  includes lancing device  502  (e.g., compact lancing device  100  of  FIG. 1 ) and a lancing auxiliary device, namely a timing and sound recording device  504 , attached thereto.  
         [0065]      FIG. 12  depicts a combined lancing and auxiliary device  600  according to yet another embodiment of the present invention. Combined lancing and auxiliary device  600  includes lancing device  602  (e.g., compact lancing device  100  of  FIG. 1 ) and a lancing auxiliary device, namely a personal digital assistant device  604 , attached thereto. It is envisioned that personal digital assistant device  604  can be used to aid in the management of a medical condition (e.g., diabetes) by, for example, storing glucose testing results, carbohydrate counting, calculating insulin dosage based on food consumed or recording the date and time of testing. Personal digital assistant device  604  can be either removably or permanently attached to lancing device  602 .  
         [0066]     It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that structures within the scope of these claims and their equivalents be covered thereby.