Patent Publication Number: US-8986223-B2

Title: Test media cassette for bodily fluid testing device

Description:
REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 12/840,352, filed Jul. 21, 2010. U.S. patent application Ser. No. 12/840,352 is a is a divisional of U.S. patent application Ser. No. 11/283,079, filed Nov. 18, 2005, now U.S. Pat. No. 7,785,272. The present application is also a continuation of U.S. patent application Ser. No. 12/848,282, filed Aug. 2, 2010. U.S. patent application Ser. No. 12/848,282 is a continuation of U.S. patent application Ser. No. 11/283,079. U.S. patent application Ser. No. 11/283,079 is a continuation of U.S. patent application Ser. No. 10/164,828 filed Jun. 7, 2002, now U.S. Pat. No. 6,988,996. U.S. patent application Ser. No. 10/164,828 claims the benefit of U.S. Provisional Patent Application No. 60/296,989, filed Jun. 8, 2001. All of the above-identified patent applications and patents are incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to bodily fluid sampling devices, and more specifically, but not exclusively, concerns a bodily fluid sampling device that incorporates a test media cassette that contains test media used to test bodily fluid. 
     General Fluid Testing 
     The acquisition and testing of bodily fluids is useful for many purposes, and continues to grow in importance for use in medical diagnosis and treatment, and in other diverse applications. In the medical field, it is desirable for lay operators to perform tests routinely, quickly and reproducibly outside of a laboratory setting, with rapid results and a readout of the resulting test information. Testing can be performed on various bodily fluids, and for certain applications is particularly related to the testing of blood and/or interstitial fluid. Such fluids can be tested for a variety of characteristics of the fluid, or analytes contained in the fluid, in order to identify a medical condition, determine therapeutic responses, assess the progress of treatment, and the like. 
     General Test Steps 
     The testing of bodily fluids basically involves the steps of obtaining the fluid sample, transferring the sample to a test device, conducting a test on the fluid sample, and displaying the results. These steps are generally performed by a plurality of separate instruments or devices. 
     Acquiring—Vascular 
     One method of acquiring the fluid sample involves inserting a hollow needle or syringe into a vein or artery in order to withdraw a blood sample. However, such direct vascular blood sampling can have several limitations, including pain, infection, and hematoma and other bleeding complications. In addition, direct vascular blood sampling is not suitable for repeating on a routine basis, can be extremely difficult and is not advised for patients to perform on themselves. 
     Acquiring—Incising 
     The other common technique for collecting a bodily fluid sample is to form an incision in the skin to bring the fluid to the skin surface. A lancet, knife or other cutting instrument is used to form the incision in the skin. The resulting blood or interstitial fluid specimen is then collected in a small tube or other container, or is placed directly in contact with a test strip. The fingertip is frequently used as the fluid source because it is highly vascularized and therefore produces a good quantity of blood. However, the fingertip also has a large concentration of nerve endings, and lancing the fingertip can therefore be painful. Alternate sampling sites, such as the palm of the hand, forearm, earlobe and the like, may be useful for sampling, and are less painful. However, they also produce lesser amounts of blood. These alternate sites therefore are generally appropriate for use only for test systems requiring relatively small amounts of fluid, or if steps are taken to facilitate the expression of the bodily fluid from the incision site. 
     Various methods and systems for incising the skin are known in the art. Exemplary lancing devices are shown, for example, in U.S. Pat. No. Re 35,803, issued to Lange, et al. on May 19, 1998; U.S. Pat. No. 4,924,879, issued to O&#39;Brien on May 15, 1990; U.S. Pat. No. 5,879,311, issued to Duchon et al. on Feb. 16, 1999; U.S. Pat. No. 5,857,983, issued to Douglas on Jan. 12, 1999; U.S. Pat. No. 6,183,489, issued to Douglas et al. on Feb. 6, 2001; U.S. Pat. No. 6,332,871, issued to Douglas et al. on Dec. 25, 2001; and U.S. Pat. No. 5,964,718, issued to Duchon et al. on Oct. 12, 1999. A representative commercial lancing device is the Accu-Chek Softclix lancet. 
     Expressing 
     Patients are frequently advised to urge fluid to the incision site, such as by applying pressure to the area surrounding the incision to milk or pump the fluid from the incision. Mechanical devices are also known to facilitate the expression of bodily fluid from an incision. Such devices are shown, for example, in U.S. Pat. No. 5,879,311, issued to Duchon et al. on Feb. 16, 1999; U.S. Pat. No. 5,857,983, issued to Douglas on Jan. 12, 1999; U.S. Pat. No. 6,183,489, issued to Douglas et al. on Feb. 6, 2001; U.S. Pat. No. 5,951,492, issued to Douglas et al. on Sep. 14, 1999; U.S. Pat. No. 5,951,493, issued to Douglas et al. on Sep. 14, 1999; U.S. Pat. No. 5,964,718, issued to Duchon et al. on Oct. 12, 1999; and U.S. Pat. No. 6,086,545, issued to Roe et al. on Jul. 11, 2000. A representative commercial product that promotes the expression of bodily fluid from an incision is the Amira AtLast blood glucose system. 
     Sampling 
     The acquisition of the produced bodily fluid, hereafter referred to as the “sampling” of the fluid, can take various forms. Once the fluid specimen comes to the skin surface at the incision, a sampling device is placed into contact with the fluid. Such devices may include, for example, systems in which a tube or test strip is either located adjacent the incision site prior to forming the incision, or is moved to the incision site shortly after the incision has been formed. A sampling tube may acquire the fluid by suction or by capillary action. Such sampling systems may include, for example, the systems shown in U.S. Pat. No. 6,048,352, issued to Douglas et al. on Apr. 11, 2000; U.S. Pat. No. 6,099,484, issued to Douglas et al. on Aug. 8, 2000; and U.S. Pat. No. 6,332,871, issued to Douglas et al. on Dec. 25, 2001. Examples of commercial sampling devices include the Roche Compact, Amira AtLast, Glucometer Elite and Therasense FreeStyle test strips. 
     Testing General 
     The bodily fluid sample may be analyzed for a variety of properties or components, as is well known in the art. For example, such analysis may be directed to hematocrit, blood glucose, coagulation, lead, iron, etc. Testing systems include such means as optical (e.g., reflectance, absorption, fluorescence, Raman, etc.), electrochemical, and magnetic means for analyzing the sampled fluid. Examples of such test systems include those in U.S. Pat. No. 5,824,491, issued to Priest et al. on Oct. 20, 1998; U.S. Pat. No. 5,962,215, issued to Douglas et al. on Oct. 5, 1999; and U.S. Pat. No. 5,776,719, issued to Douglas et al. on Jul. 7, 1998. 
     Typically, a test system takes advantage of a reaction between the bodily fluid to be tested and a reagent present in the test system. For example, an optical test strip will generally rely upon a color change, i.e., a change in the wavelength absorbed or reflected by dye formed by the reagent system used. See, e.g., U.S. Pat. Nos. 3,802,842; 4,061,468; and 4,490,465. 
     Blood Glucose 
     A common medical test is the measurement of blood glucose level. The glucose level can be determined directly by analysis of the blood, or indirectly by analysis of other fluids such as interstitial fluid. Diabetics are generally instructed to measure their blood glucose level several times a day, depending on the nature and severity of their diabetes. Based upon the observed pattern in the measured glucose levels, the patient and physician determine the appropriate level of insulin to be administered, also taking into account such issues as diet, exercise and other factors. 
     In testing for the presence of an analyte such as glucose in a bodily fluid, test systems are commonly used which take advantage of an oxidation/reduction reaction which occurs using an oxidase/peroxidase detection chemistry. The test reagent is exposed to a sample of the bodily fluid for a suitable period of time, and there is a color change if the analyte (glucose) is present. Typically, the intensity of this change is proportional to the concentration of analyte in the sample. The color of the reagent is then compared to a known standard which enables one to determine the amount of analyte present in the sample. This determination can be made, for example, by a visual check or by an instrument, such as a reflectance spectrophotometer at a selected wavelength, or a blood glucose meter. Electrochemical and other systems are also well known for testing bodily fluids for properties on constituents. 
     Testing Media 
     As mentioned above, diabetics typically have to monitor their blood glucose levels throughout the day so as to ensure that their blood glucose remains within an acceptable range. Some types sampling devices require the use of testing strips that contain media for absorbing and/or testing the bodily fluid, such as blood. After testing, the testing media contaminated with blood can be considered a biohazard and needs to be readily disposed in order to avoid other individuals from being exposed to the contaminated test strip. This can be especially inconvenient when the person is away from home, such as at restaurant. Moreover, the individual test strips can become easily mixed with other test strips having different expiration dates. The use of expired test strips may create false readings, which can result in improper treatment of the patient, such as improper insulin dosages for diabetics. 
     SUMMARY OF THE INVENTION 
     The present invention provides various systems and methods for sampling bodily fluid. The present invention encompasses a bodily fluid sampling device that incorporates a cassette containing test media. 
     In accordance with one aspect of the present invention, there is provided a bodily fluid sampling device for analyzing a bodily fluid. The sampling device includes a test media cassette that includes a test media tape adapted to collect the bodily fluid. The cassette includes a supply portion that stores an uncontaminated section of the test media tape, which is uncontaminated with the bodily fluid. A storage portion stores a contaminated section of the test media tape that is contaminated with the bodily fluid. An exposure portion is positioned between the supply portion and the storage portion. The exposure portion is adapted to expose a section of the test media tape to the bodily fluid. A sensor is positioned between the supply portion and the storage portion to sense at least one property of the bodily fluid collected on the test media tape at the exposure portion of the cassette. 
     Another aspect of the present invention concerns a test cassette for collecting a bodily fluid sample. The cassette includes a test media tape, which has a contaminated section that is contaminated with past samples of the bodily fluid and an uncontaminated section. The cassette includes a housing that has a supply portion in which the uncontaminated section of the test media tape is enclosed. The housing further includes a storage portion in which the contaminated section of the test media tape is enclosed. The housing defines an exposure opening along the test media tape at which the test media tape is exposed to the bodily fluid. A supply reel is disposed in the supply portion of the housing around which the uncontaminated section of the test media tape is wrapped. A storage reel is disposed in the storage portion of the housing around which the contaminated section of the test media tape is wrapped. 
     Other forms, embodiments, objects, features, advantages, benefits and aspects of the present invention shall become apparent from the detailed drawings and description contained herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a partial, cross-sectional view of a bodily fluid sampling device according to one embodiment of the present invention. 
         FIG. 2  is a cross-sectional view of a test cassette and sensor used in the  FIG. 1  sampling device. 
         FIG. 3  is a partial, side view of the  FIG. 2  cassette. 
         FIG. 4  is a cross-sectional view of the  FIG. 1  sampling device. 
         FIG. 5  is a front view of an indexing mechanism used in the  FIG. 1  sampling device. 
         FIG. 6  is a cross-sectional view of a test cassette according to another embodiment of the present invention. 
         FIG. 7  is a cross-sectional view of a bodily fluid sampling device according to another embodiment of the present invention. 
         FIG. 8  is a front view of test media used in the  FIG. 7  sampling device. 
         FIG. 9  is a side view of the  FIG. 8  test media. 
         FIG. 10  is a side view of the  FIG. 8  test media with a piercing device from the  FIG. 7  sampling device. 
         FIG. 11  is a cross-sectional view of a bodily fluid sampling device according to another embodiment of the present invention. 
         FIG. 12  is a diagrammatic view of a sensor system according to another embodiment of the present invention. 
         FIG. 13  is a cross-sectional view of a bodily fluid testing system according to another embodiment of the present invention. 
         FIG. 14  is a cross-sectional view of test media used in the  FIG. 13  sampling device. 
         FIG. 15  is an enlarged, cross-sectional view of a portion of the  FIG. 14  test media. 
     
    
    
     DESCRIPTION OF SELECTED EMBODIMENTS 
     For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the art that some of the features which are not relevant to the invention may not be shown for the sake of clarity. 
     The present invention concerns a bodily fluid sampling device that incorporates a test cassette. The cassette houses test media that is used to collect bodily fluid samples which are analyzed with a sensor in the sampling device. The test media in the cassette is indexed before or after each test so that successive tests can be performed without requiring disposal of the used test media. The test media can be indexed manually or automatically. In one aspect of the present invention, the test media includes a cover tape that protects the test media before testing. In another aspect, the test media defines one or more passageways through which a piercing device is able to pass through in order to pierce the skin of a user. The cassette, in another aspect of the present invention, is designed for use with a vacuum-style sampling device in which the bodily fluid sample is drawn to the test media by a vacuum. 
     A bodily fluid sampling device  30  according to one embodiment of the present invention is illustrated in  FIGS. 1-5 . As shown in  FIGS. 1 and 4 , the sampling device  30  includes a housing  32  with a piercing end portion  34  and an opposite, sampling end portion  36 . The piercing portion  34  of the housing  32  is slidable relative to the sampling portion  36 . As shown in  FIG. 4 , piercing portion  34  defines a piercing device cavity  38  with a piercing device opening  40 . In the piercing cavity  38 , a piercing device or member  42 , which is used for puncturing skin, is covered by the piercing portion  34  of the housing  32  to avoid accidental piercing of the skin. The piercing device  42  cuts an incision in the skin such that the bodily fluid, such as blood, pools on the surface of the skin. In one embodiment, the piercing device  42  includes a lancet suitable to puncture the cutaneous layer of the skin. As should be appreciated, other types of piercing devices  42  can also be used, such as needles and blades, to name a few. 
     As illustrated in  FIG. 4 , the piercing portion  34  of the housing  32  is slidably received on a slide member  44  that extends from the sampling portion  36  of the housing  32 . The piercing device  42  is removably coupled to the slide member  44 . A spring  46  on the slide member  44  biases the piercing portion  34  of the housing  32  away from the sampling portion  36 , and a stop member  48  on the slide member  44  prevents the piercing portion  34  from sliding off the slide member  44 . Normally, the piercing portion  34  of the housing  32  covers the piercing device  42 . Once the piercing portion  34  is pressed against the skin, the piercing portion  34  retracts towards the sampling portion  36  of the housing  32  to expose the piercing device  42  through opening  40 . In the illustrated embodiment, the piercing portion  34  of the housing  32  has a compression ring  50  around opening  40  in order to draw the bodily fluid to the surface of the skin. In one form, the compression ring  50  is clear so that the user can view the pooling of the bodily fluid. 
     Referring to  FIG. 1 , the bodily fluid sampling device  30  includes a sampling system  52  for sampling and testing the drawn bodily fluid. As shown, the sampling system  52  includes a test cassette  54  and a sensor  56 . In one embodiment, the sensor  56  is an optical sensor that includes a light source and a detector for determining the amount of light reflected from the collected sample. It should be appreciated, however, that other types of sensors  56  can be used to monitor analyte levels in bodily fluid. For example, the sensor  56  can include an electrical type sensor that measures the electrical and/or electrochemical properties of the sample. The sampling portion  36  of the housing  32  defines a bodily fluid acquisition opening  58  through which the bodily fluid is supplied to the cassette  54 . In one embodiment, the cassette  54  is removably coupled to the sampling device  30  such that the cassette  54  can be replaced with a new one. A pivotal cover  60  is pivotally mounted to the housing  32 . The cover  60  can be opened to allow disposal and replacement of the cassette  54 . 
     As shown in greater detail in  FIGS. 2 and 3 , the cassette  54  has an outer casing  62  that encloses test media  64 . In the illustrated embodiment, the test media  64  is in the form of a continuous strip or tape. As will be appreciated, the test media  64  can be further segmented into discrete test sections. The casing  62  of the cassette  54  defines an unexposed test media supply portion  66 , which stores unused test media  64 , and an exposed test media storage portion  68 , which stores used test media  64 . Connecting together the unexposed  66  and exposed  68  media portions, an exposure/testing portion  70  is configured to allow the bodily fluid to be collected and tested on the test media  64 . As shown, the testing portion  70  has outboard sidewall  72  and an opposite, inboard sidewall  74 . On the outboard sidewall  72  of the cassette  54 , the casing  62  defines an exposure opening  76  at which the test media  64  is exposed to the bodily fluid. Opposite the exposure opening  76 , the inboard sidewall  74  of the casing  62  defines a test opening  78  at which the sensor  56  is able to analyze the bodily fluid collected on the test media  64 . In the illustrated embodiment, the exposure  76  and test  78  openings are aligned with another. In other embodiments, openings  76  and  78  can be instead offset from one another. For instance, the testing opening  78  can be located closer towards the exposed media storage portion  68 , as compared to exposure opening  76 . 
     In the unexposed media storage portion  66  of the cassette  54 , a supply reel  80  is rotatably mounted, and unused test media  64  is wrapped around the supply reel  80 . Similarly, the exposed media storage portion  68  has a take-up reel  82  rotatably mounted inside. Test media  64  that has been exposed to the bodily fluid at the exposure opening  76  is wrapped around the take-up reel  82 . It should be appreciated that in other embodiments, one or both of the reels  80 ,  82  can be omitted from the cassette  54 . Both reels  80  and  82  define drive cavities  84  that can be engaged with drive members  86  in the sampling end portion  36  of the sampling device  30  ( FIG. 4 ). As shown in  FIGS. 2 and 4 , the drive cavities  84  have notches  88  that mate with flanges  90  on the drive members  86  such that the drive members  86  are able to rotate the reels  80  and  82 . To ensure that the used test media  54  is not removed from the exposed media storage portion  68  of the cassette  54 , the take-up reel  82  has a geared portion  92  that engages a biased, cassette pawl  94  that permits the take-up reel  82  to rotate in only one direction. This ensures that the test media  64  can only be fed into exposed media storage portion  68  and not removed. 
     As shown in  FIGS. 4 and 5 , the sampling device  30  further incorporates an advancement or indexing device  96  that advances the test media  64  in the cassette  54  such that fresh test media  54  is available every time a bodily fluid sample is taken. In the illustrated embodiment, a mechanical type advancement device  96  is used to advance the test media  64 . However, it should be appreciated that an electrical or a combination electro-mechanical type advancement device  96  may also be used. In  FIG. 4 , the advancement device  96  includes a rack member  98  that is attached to the piercing portion  34  of the housing  32 . The rack member  98  extends from the piercing portion  34  and terminates proximal to take-up drive member  100 . The take-up drive member  100  is constructed to engage and rotate the take-up reel  82  in the cassette  54 . The rack member  98  has rack teeth  102  that engage take-up drive teeth  104  on the take-up drive member  100 . To ensure that the take-up drive member  100  only rotates in one direction, the advancement device  96  has an advancement pawl  106  attached to the housing  32  and biased against the take-up drive teeth  104 . As shown in  FIG. 5 , both teeth  102  and  104  are angled in such a manner to only firmly engage one another when rotating the take-up drive member  100  in a counter-clockwise fashion (from the perspective of  FIG. 5 ). In the illustrated embodiment, only the take-up drive member  100  is powered, while supply drive member  108  is able to freely rotate. In other embodiments, both drive members  100  and  108  may be powered individually or together. For instance, when an electro-mechanical type advancement device  96  is used, both drive members  100  and  108  can be individually powered by separate electric motors. 
     Referring again to  FIG. 1 , the bodily fluid sampling device  30  further includes a test indicator  110 , a display  112 , at least one control button  114 , and a grip portion  116 . In the illustrated embodiment, the grip portion  116  has ridges that help ensure the user has a firm grip on the sampling device  30 . The test indicator  110  can either indicate the number of tests performed or the number of tests remaining on the current cassette  54 . The housing  32  has an indicator window  118  through which the indicator  110  can be viewed. The display  112  is operatively coupled to the sensor  56  and displays readings from the sensor  56 . The button  114  is used to control and enter information into the bodily fluid sampling device  30 . In the illustrated embodiment, the indicator  110  and the display  112  are separate components. However, it should be appreciated that the indicator  110  can be incorporated into the display  112  to form a single unit. 
     A detailed view of a test indicator assembly  120 , which moves the indicator  110 , according to one embodiment of the present invention is illustrated in  FIG. 5 . As shown, the take-up drive member  100  has a gear  122  that engages an intermediate gear  124 . The intermediate gear  124  engages an indicator gear  126  that is attached to the indicator  110 . The indicator  110  has numbering  128 , or other types of characters, that indicates the number of samples taken with the cassette  54  or the number of tests remaining on the cassette  54 . As the take-up drive member  100  is rotated by the rack member  98 , the intermediate gear  124  rotates, which in turn rotates the indicator. Although in the illustrated embodiment of the test indicator assembly  120  is mechanically driven, it should be appreciated that the indicator  110  can be operated in other manners, such as electronically. 
     In operation, the user presses opening  40  of the piercing portion  34  against the skin. The piercing portion  34  of the housing  32  retracts towards the sampling portion  36  exposing the piercing device  42  so as to pierce the skin. As the piercing portion  34  retracts, the rack member  98  rotates the take-up drive  100  in order to advance the test media  64  in the cassette  54  such that unused test media  64  is available for testing. Once the user creates a bodily fluid sample with the piercing device  42 , the user places opening  58  over the bodily fluid sample. A portion of the bodily fluid sample travels via direct or capillary action to the unused test media  64  exposed at exposure opening  76  of the cassette  54 . When a portion of the bodily fluid sample deposits on the test media  64 , the sensor  56  determines the amount of analyte material in the sample. The readings from the sensor  56  are shown on the display  112 . During the next test, the cassette  54  is indexed in response to pressing the sampling device  30  against the skin so as to move the contaminated portion of the test media  64  into the storage portion  68  of the cassette  54 . As should be appreciated, the sampling device  30  can be instead configured to advance the test media  64  after the bodily fluid sample has been collected or analyzed. 
     As should be appreciated, the cassette  54  allows a user to perform a number of tests without replacing the test media  64 . Once the test media  64  has been completely used, the contaminated test media  64  in the cassette  54  can be safely discarded. In one embodiment, the cassette  54  allows the user to perform a number of tests within a range from about five (5) tests to about five-hundred (500) tests. In another embodiment, the cassette  54  is adapted to perform five (5) to fifty (50) tests before being replaced, and in a further embodiment, the cassette  54  is designed to perform around twenty-five (25) tests. With the above described configuration, the cassette  54  according to the present invention minimizes the amount of biohazard material generated after each test because a test strip does not have to be discarded after each test. Further, since test strips do not have to be individually inserted and removed during each test, the ease of use and convenience is improved with the cassette  54  according to the present invention. Moreover, the cassette  54  obviates the need for the user to carry a vile containing the test strips. 
     A cassette  54   a  according to another embodiment of the present invention is illustrated in  FIG. 6 . As shown, the cassette  54   a  has an outer cover  60   a  with an unexposed media supply portion  66   a , an exposed media storage portion  68   a , and an exposure/testing portion  70   a . The exposed portion  68   a  of the cover  60   a  houses a take-up reel  82   a , while the unexposed portion  66   a  houses a supply reel  80   a . The test media  64   a  extends between and is wrapped around both the supply reel  80   a  and the take-up reel  82   a . In the illustrated embodiment, the test media  64   a  has a cover tape  130  that covers a test tape  132 . The cover tape  130  provides an airtight seal over the test tape  132  in order to preserve test chemicals on the test tape  132  while the sampling device  30  is not in use. As illustrated, the cassette  54   a  further includes a peel tab  134 , a cover reel  136  and guides  138  to guide the test media  64   a  between reels  80   a  and  82   a . The peel tab  134  along with the cover reel  136  are configured to peel the cover tape  130  from the test tape  132 . To synchronize rotation of the supply reel  80   a  and the cover reel  136 , the supply reel  80   a  and the cover reel  136  respectively have a supply gear  140  and a cover gear  142  that are intermeshed with one another. In another embodiment, the rotation of the cover reel  136  is synchronized with the take-up reel  82   a.    
     During use, as the take-up reel  82   a  is indexed by the sampling device  30 , both the supply reel  80   a  and the cover reel  136  are rotated in unison through gears  140  and  142 . As the cover reel  136  rotates, the tension formed on the cover tape  130  between the cover reel  136  and the peel tab  134  causes the cover tape  130  to be pulled from the test tape  132  at the peel tab  134 . The peeled cover tape  130  is wrapped around and stored on the cover reel  136 . After the cover tape  130  is removed, the test tape  132  is exposed to the bodily fluid sample at an exposure opening  76   a  formed in the cover  60   a . The now exposed test tape  132  can be tested at testing opening  78   a  that is incorporated into the exposure opening  76   a . During the next index of the cassette  54   a , the used test tape  132  is wrapped around and stored on the take-up reel  82   a.    
     A bodily fluid sampling device  144  according to another embodiment of the present invention is illustrated in  FIG. 7 . The sampling device  144  includes a cassette  54   b  and a pivot arm  146  with a pivot end  148  pivotally mounted to the cassette  54   b . Opposite the pivot end  148 , at free end  150 , the pivot arm  146  is coupled to piercing device  42 . A spring  152  mounted between the cassette  54   b  and the pivot arm  146  biases the free end  150  of the pivot arm  146  to move towards the cassette  54   b  in the direction indicated by arrow A in  FIG. 7 . A release mechanism  154  is coupled to the free end  150  of the pivot arm  146  in order to bias the piercing device  42  away from the cassette  54   b . The cassette  54   b  includes a supply reel  80 , a take-up reel  82  and a test media  64   b  extending between and wrapped around both reels  80 ,  82 . As illustrated, housing  156  of the sampling device  144  defines a sample opening  158  through which the bodily fluid sample is collected. The test media  64   b  of the cassette  54  is positioned over the sample opening  158  between the opening  158  and the piercing device  42 . 
     As shown in further detail in  FIGS. 8 ,  9  and  10 , the test media  64   b  in this embodiment includes a number of test pads  160  spaced apart from one another along the test media  64   b . In one embodiment, the test pads  160  contain chemicals reactive to specific constituents contained in the bodily fluid. In one form, the test pad  160  includes a chemistry pad available in an AT LAST™ Blood Glucose System available from Amira Medical located in Scotts Valley, Calif. In another embodiment, the bodily fluid sample is collected on the test pad  160  for electrical and/or optical analysis. Over each test pad  160 , the test media  64   b  has a blister pack  162  that is used to draw the bodily fluid through capillary action onto the test pad  160 . During indexing of the test media  64   b , a capillary opening  163  ( FIG. 8 ), such as a slit or hole, is cut or pierced into the blister pack  162  by a cutting device, such as razor, in the fluid sampling device  144 . In the illustrated embodiment, the opening  163  is in the form of a slit. The capillary slit  163  is used to draw the bodily fluid into the blister pack  162  through capillary action. In the illustrated embodiment the blister pack  162  has a circular shape that fits inside the rectangularly shaped test pad  160  such that portions of the test pad  160  extend past the blister pack  164 . In one form, the blister pack  164  is a plastic film covering the test pad  160  and attached to the test media  64   b  through an adhesive and/or heat sealing. Moreover, in one embodiment, the test media  64   b  is transparent or semitransparent to allow optical analysis of the bodily fluid. As illustrated in  FIGS. 9 and 10  each blister pack  162  has a convex surface  164  that aids in drawing the fluid up to the test pad  160  through the slit  163  via capillary action. To be near the skin in order to collect bodily fluid, both the test pad  160  and the blister pack  162  are positioned on the outboard side  170  of the test media  64   b . In another embodiment, the blister pack  162  is omitted such that the bodily fluid directly contacts the test pad  160  during collection of the bodily fluid. Between each test pad  160 , the test media  64   b  defines a piercing device hole or throughway  166 . The piercing device throughway  166  extends from inboard side  168  to outboard side  170  of the test media  64   b . The throughway  166  is sized such that the piercing device  42  is able to extend through the test media  64   b  in order to pierce the skin. In another embodiment, the test media  64   b  is designed to be pierced by the piercing device  42  such that the throughway  166  is not required. 
     During testing, the user places sample opening  158  of the sampling device  144  against his or her skin  172  ( FIGS. 7 and 10 ). Next, the user disengages the release  154  such that the piercing device  42  on the pivotal arm  146  moves toward the test media  64   b . As the pivot arm  146  rotates, the piercing device  42  extends through the throughway  166  and pierces the skin  172  ( FIG. 10 ). After piercing the skin  172 , the piercing device  42  retracts away from the skin  172  and out of the throughway  166 . In one embodiment, the piercing device  42  is retracted through recoil of a firing spring that is used to initially advance the piercing device  42  to lance the skin  172 . At the site where the skin  172  was pierced, the bodily fluid collects and is drawn up by the slit  163  in the blister pack  162  to the test pad  160  via capillary action. To store used test media  64   b  on the take-up reel  82 , the test media  64   b  in the cassette  54   b  can be advanced mechanically or manually before or after a test is performed. In one embodiment, the test media  64   b  in the cassette automatically advances when the pivot arm  146  swings toward the cassette  54   b . In another embodiment, the test media  64   b  is advanced manually after the sample has been collected and tested. 
     A bodily fluid sampling device  174  according to another embodiment of the present invention is illustrated in  FIG. 11 . The sampling device  174  has a piercing device  42  coupled to a pivot arm  146  that is pivotally coupled to a trigger mechanism  176 . Both the pivot arm  146  and the trigger mechanism  176  of the sampling device  174  are pivotally coupled to a housing  178 . The housing  178  defines a sample opening  158 . The pivot arm  146  and the piercing device  42  are positioned within the housing  178  such that the piercing device  42  is able to swing through the opening  158  and pierce the skin. The sampling device  174  further includes a cassette-sensor assembly  180  pivotally mounted to the housing  178  through a swing arm  182 . As shown, the cassette-sensor assembly  180  includes a cassette  54  and a sensor  56 . The sensor  56  is mounted proximal to and in a fixed relationship with the cassette  54  through mounting arms  184 . The swing arm  182  of the cassette-sensor assembly  180  can be moved by a number ways. In one embodiment, the swing arm  182  is actuated through a mechanical linkage with the trigger mechanism  176 , and in another embodiment, the swing arm  182  is moved by an electric motor. 
     To take and test a bodily fluid sample, the user presses the sample opening  158  against the skin of the user. The user then cocks the trigger mechanism  176  and releases the trigger mechanism  176  in order to swing the piercing device  42  through the sample opening  158  to pierce the skin of the user. Afterwards, the piercing device  42  retracts back into the housing  178  as a sample of the bodily fluid, such as blood, collects on the skin. In one form, the piercing device  42  is retracted by the recoil of a firing spring that is initially used to lance the skin. To collect and test the bodily fluid sample, the swing arm  182  swings the cassette sensor assembly  180  over the opening  158 . After the sample is deposited on the test media  64  in the cassette  54 , the sensor  56  analyzes the collected sample. In one form, the sensor  56  is an optical type sensor that analyzes the optical properties of the sample. In another form, the sensor  56  analyzes the electrical properties of the sample. 
     As mentioned above, the sensor  56  can analyze the bodily fluid sample by using a number of techniques. In one embodiment, the sensor  56  analyzes the electrochemical properties of the sample. In another embodiment that is illustrated in  FIG. 12 , the sensor  56  includes an optical sensor system  186  that remotely detects the optical properties of the sampled bodily fluid. The optical sensor system  186  includes a remotely located light source/detector  188 , which can be located inside or outside of the bodily fluid sampling device. The light source/detector  188  employs components suitable for emitting light and for determining the amount and/or frequency of reflected light. By way of nonlimiting example, the light source/detector  188  can include a light emitting diode (LED), a photodiode and the like. With such a construction, the optical sensor system  186  according to the present invention allows for more compact sampling device and cassette designs. As shown, a pair of fiber optic cables  190  are coupled to the light source/detector  188 . The fiber optic cables  190  include a transmission cable  192  and a detection cable  194 . The fiber optic cables  190  extend from the light source/detector  188  to a test area  196  that is proximal the test media  64 . In the test area  196 , the transmission cable  192  is coupled to an emitter  198  that is adapted to emit light, and the detection cable  194  is coupled to a detector  200  that is adapted to receive light. 
     During testing, after the bodily fluid sample has been placed on the test media  64 , the light source/detector  188  emits light from the emitter  198  via transmission cable  192 . The light emitted from the emitter  198  is reflected off the bodily fluid sample on the test media  64 , and the reflected light is detected by the light source/detector  188  via the detector  200 . The light/source detector  188  analyzes the amount and/or frequency of the light reflected from the bodily fluid sample in order to determine the amount of analyte in the sample. As used herein and in conventional fashion, reference to analysis of the bodily fluid also includes analysis of the results of a reaction of a selected reagent with the bodily fluid. 
     A bodily fluid testing system  202  that can be integrated into a sampling device according to the present invention is illustrated in  FIG. 13 . The testing system  202  includes a vacuum assembly  204 , a piercing assembly  206 , a sensor  56 , and test media  64   c . In the illustrated embodiment, the test media  64   c  is not housed in a cassette case. Rather, the test media  64   c  is wrapped around and extends between supply reel  80  and take-up reel  82 . It should be appreciated that the test media  64   c  can be encased in a cassette case. As shown, the test media  64   c  has an inboard side  208  and an opposite, outboard side  210 . The vacuum assembly  204 , the piercing assembly  206  and the sensor  56  are positioned along the test media  64   c  between the supply reel  80  and the take-up reel  82 . In particular, both the vacuum assembly  204  and the sensor  56  are positioned on the inboard side  208 , with the sensor  56  positioned between the take-up reel  82  and the vacuum assembly  204 . The piercing assembly  206  is disposed opposite the vacuum assembly  204  on the outboard side  210  of the test media  64   c.    
     The vacuum assembly  204  is adapted to generate a vacuum in order to draw a bodily fluid sample onto and/or into the test media  64   c . The vacuum assembly  204  can include, but is not limited to, a pre-charge vacuum device, an electromagnetic diaphragm vacuum device and/or a mechanical vacuum device, to name a few. In the illustrated embodiment, the vacuum assembly  204  has a body  212  that defines a vacuum cavity  214 . Near the test media  64   c , the body  212  defines a vacuum port  216  that opens into the vacuum cavity  214 . A piston  218  is slidably received in the vacuum cavity  214 . Solenoids  220  are used to actuate the piston  218  in order to form a vacuum in the vacuum cavity  214 . 
     As shown in  FIG. 13 , the piercing assembly  206  includes a piercing device  42   a , a holder  222 , which holds the piercing device  42   a , and a protective cover  224 . In the illustrated embodiment, the piercing device  42   a  has a distal tip  226  adapted to pierce the skin of the user and a proximal tip  228 . As depicted in  FIG. 15 , the piercing device  42   a  defines a cavity  227  that extends from the distal tip  226  to the proximal tip  228 . The cavity  227  transports bodily fluid from the user to the test media  64   c . Referring again to  FIG. 13 , the protective cover  224  covers the distal tip  226  of the piercing device  42   a  so as to prevent a person from being accidentally cut with the piercing device  42   a . The holder  222  includes a coil spring  230  wrapped around the piercing device  42   a  such that the piercing device  42   a  is able to be removed and replaced with another piercing device  42   a . As shown, the holder  222  has a hollow, inner holder member  232  that is surrounded by an outer holder member  234 . The piercing device  42   a  along with the coil spring  230  are received inside the inner holder member  232 . To prevent over-penetration of the proximal tip  228  of the piercing device  42   a  into the test media  64   c  during testing, the inner holder member  232  has a stop ridge  236  that engages the piercing device  42   a . The holder  222  further includes a collapsible, biasing member  238  that normally biases the piercing device  42   a  away from the test media  64   c . When the holder  222  is pressed against the skin during piercing, the biasing member  238  collapses such that the proximal tip  228  of the piercing device  42   a  is able to pierce the test media  64   c.    
     As illustrated in  FIGS. 14 and 15 , the test media  64   c  has a number of testing sections  240  that are adapted to collect separate bodily fluid samples. Each testing section  240  has a test pad  242  positioned between a seal membrane  244  and a vacuum passageway  246  that is defined in the test media  64   c . In one embodiment, the test pad  242  is embedded with chemicals that are reactive with specific bodily fluid constituents for testing purposes. In another embodiment, the test pad  242  is adapted to collect and absorb the bodily fluid sample for analysis by the sensor  56 . On the outboard side  210  of the test media  64   c , the seal membrane  244  seals over the test membrane  242 . On the inboard side  208 , the vacuum passageway  246  is adapted to align with the vacuum port  216  of the vacuum assembly  204  such that the vacuum assembly  204  is able to form a vacuum (an area of low pressure) in the vacuum passageway  246  and around the test pad  242 . The seal  244  is made of suitable material that allows the vacuum to be maintained around the test pad  242 , while at the same time being able to be punctured by the piercing device  42   a  ( FIG. 15 ). The seal  244  may be formed from various types of sealing materials, such as rubber and/or silicone, to name a few. 
     As mentioned above, to test a bodily fluid sample, the user presses the holder  222  against the skin in order to pierce the skin with the piercing device  42   a . As piercing device  42   a  pierces the skin, the biasing member  238  collapses to allow the proximal tip  228  to puncture the test media  64   c . As shown in  FIG. 15 , the seal  244  is punctured by and seals around the proximal tip  228 . The vacuum assembly  204  forms a vacuum in the vacuum passageway in order to draw the bodily fluid sample onto the test pad  242 . Once the sample is collected on the test pad  242 , the holder  22  is removed from the skin and the vacuum assembly  204  ceases operation. The test pad  242  is then indexed proximal to the sensor  56  for analysis. 
     While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.