Abstract:
A body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid. The body member, tissue penetrator, test strip holder and test strip are designed for a single use and for disposal as a unit without disassembly.

Description:
CLAIM OF PRIORITY 
     The instant application is a continuation of Kloepfer et al U.S. patent application Ser. No. 10/313,331, filed on 6 Dec. 2002; which, on 11 Jan. 2005 issued as U.S. Pat. No. 6,840,912; and claims priority to Kloepfer, Kloepfer and Roach, U.S. Provisional Patent Application No. 60/340,442 filed 7 Dec. 2001, both of which are hereby expressly incorporated by reference. 
    
    
     GOVERNMENT INTEREST STATEMENT 
     This invention was made with Government support under grant number R44 DK59219 from the National Institutes of Health. The Government has certain rights to this invention. 
    
    
     TECHNICAL FIELD OF THE INVENTION 
     The present invention relates to methods and devices for testing analysis fluids, and more particularly to a consolidated testing apparatus for use in performing analyses of one or more components of a fluid. Significant contemplated applications of the invention are in the biological sciences, especially diagnostic medicine. In this field, analysis fluids would primarily be bodily fluids, notably whole blood. 
     BACKGROUND OF THE INVENTION 
     A. Overview of Disease Conditions Warranting a Need for the Present Invention 
     Diabetes has been referred to as the “undiagnosed epidemic of the third millennium”. Some experts predict the number of diabetics world-wide to triple over the next 15 years to about 320 million. Self-monitoring of blood glucose (SMBG) is considered the quintessential prerequisite for diabetes management and treatment. As will be explained in more detail, most current SMBG systems, whether designed for patient or professional use, still have significant limitations. 
     Diabetes has reached alarming proportions in the western world and is growing at epidemic rates in countries other than the western world. Strategies for diagnosis and care are well developed (though still sub-optimal) in the western world, but marginal in developing countries. 
     The three major types of diabetes are type 1 (formerly insulin-dependent diabetes mellitus, IDDM, juvenile-onset), type 2 (formerly non-insulin-dependent diabetes mellitus, NIDDM, adult-onset), and gestational diabetes. About 130,000 children in the US have type 1 diabetes. Treatment for type 1 consists of insulin injections, diet and exercise. 
     In type 2 diabetes, treatment may include insulin, but preferably oral glucose lowering agents, diet, weight reduction and exercise. Approximately ninety percent (90%) of diabetics are type 2. 
     Powerful drivers for rising prevalence of diabetes and impaired glucose tolerance (IGT) in the US are growing minority populations, along with the graying, and the fattening of America. The yearly death toll from diabetes is one half million. Diabetics are predisposed to heart disease, peripheral vascular disease, stroke, retinopathy, kidney disease and neuropathy. The latter is associated with amputations, silent myocardial infarction and sudden death, and it accounts for over 300,000 hospitalizations each year. The number of annual hospital days is 6 million and emergency room visits close to 600,000. 
     Direct costs in 1992 were estimated at $39.1 billion for institutional and $6.2 billion for outpatient care. Today&#39;s total diabetes-related toll to the US economy (direct and indirect costs combined) is estimated to approach $150 billion. 
     As a true cure for diabetes remains elusive, tight glucose control will continue to be the sine-qua-non of diabetes combat strategies. The benefits of tight glucose control in curbing diabetes-related complications are now authoritatively documented. This evidence also suggests that a large portion of type 2 diabetics may benefit from tight glucose control and insulin. As worldwide knowledge about diabetes will be nurtured by the information age and media-assisted education, masses of undiagnosed diabetics who would benefit from tight glucose control will eventually be brought into the system. Since testing technology will also further mature, these megatrends will co-functionally establish an enormous market for SMBG in the future. 
     B. Discussion of Prior Art Products and Techniques 
     The mainstay of treatment for type 1 and many type 2 diabetics is SMBG in concert with responding self-administration of insulin to harmonize glucose levels. Current SMBG systems are typically comprised of a test strip-type, dry chemistry device; The test strip is insertable into a hand-held meter that contains a display that gives the user a read-out of results. Alternately, results can be obtained by comparing reaction colors to printed color charts. The combined 1998 world market for teststrips, meters and auxiliary products (lancets, sticking devices, swabs, etc.) was $3 billion and is now in excess of $4 billion, with $2 billion in the US alone. Long term growth projections for the market are 12-15% per annum. 
     Approximately two thirds (⅔) of the market is in teststrips. Examples of known test strip and meter systems are those sold by Beyer Diagnostics; Cascade Medical; LXN Corporation; LifeScan; MediSense; ReliOn; Roche Diagnostics; Terumo Corporation and TheraSense. 
     From a provider perspective, the main shortfall is that current systems are generally limited to the measurement of glucose. This is in drastic discord with the concept of diabetes as a multi-factorial metabolic syndrome. From a user point of view, there are still limitations in those features that consumers and users believe to be important, such as (1) minimal invasiveness; (2) speed of analysis and (3) ease of performance and minimal complexity (inconvenience) from primary and auxiliary product mixes. 
     The vast majority of current SMBG systems utilize more or less “invasive” technology as they require that finger tips be lanced to cause bleeding, which is the source of blood used in the test. Most current devices require the finger to be lanced to obtain blood samples in a range between 2 and 30 ml. Non-invasive and minimally invasive technologies (such as the one of the instant invention) have been under active development for years, but made it to market only on a very limited scale due to technical difficulties. 
     1. Invasive Systems. Several dry-chemistry technologies exist for testing of whole blood specimens. In most devices liquid reagents are applied onto solid support substrates by some impregnation or coating method. After solvent evaporation, the dry and therefore stable reagent is contained within a reactive zone or signal member (test field). As the blood sample makes contact with the reagents on a test strip, a chemical reaction is initiated with the analyte to be measured. 
     Both photometric and electro-sensimetric detection principles are in use for measuring compounds of interest in the reagent-reacted analyte on the test strip. Most systems employ reflectance photometry. In these meters, light of a wavelength absorbed by the colored reaction product is shined onto the surface of the test field and the reflected portion of the light is monitored. In contrast to conventional photometry where absorbance is measured from reduced light transmittance in the direction of the incident beam, reflectance is measured at locations angled away from incident light. As light of varying wavelengths is reflected in different directions, an informed choice must be made as to which incident and reflective angles to select for obtaining a signal that is most sensitively and most specifically related to concentration. 
     Preferably, the photocurrent detector (photodiode) of the metering device is positioned at a location where unspecific scattering is minimal, and specific reflectance is maximized. However, since the two can usually not be completely spatially separated, pure signals are by definition unobtainable. 
     An advantage of photometric systems is that they measure color. Potentially, this enables both visual and instrumented signal recognition. Visual interpretation can serve as a confidence check for quantitative results provided by the meter. Importantly, in markets where meters are not readily available, glucose concentration can still be determined semi-quantitatively by a visual comparison of reaction colors on the test strip to standardized color charts. 
     Unfortunately, the important feature of visual backup is realized only in a minority of present systems. This limitation resides in the method by which cellular component of blood is separated from plasma. In older products plasma was separated by soak through methods into coated bibulous materials or reagent films. Cells were then manually removed from the site of blood application by either washing or wiping them away, potentially giving rise to significant operator-induced errors. 
     Several newer methods permit separation by means other than washing or wiping. The most frequently used methods are separation by porous glass fiber fleeces or membranes. In these matrices pore sizes are chosen so that cellular component is held back within the matrix, whereas plasma diffuses through the separating and into the detection layer. 
     2. Non-Invasive (NI) and Semi-Invasive Technology. The dream goal for the SMBG market of a completely non-invasive glucose monitoring technology, although pursued for over a decade, has so far proven elusive, despite perennial promises from companies in the industry. These failures have led to predictions that completely non-invasive optical technology (infrared or other) may not make it to market in any significant way, for both cost and technical reasons. It is also argued that this lack of success was predictable from early theoretical considerations of signal engineering. These considerations include the numerous and variable challenges of isolating a meaningful signal against a background of overpowering non-specific noise, such as noise from water. An authoritative recent review of NI glucose testing technology concludes that: “ . . . none of the NI experiments reviewed provides proof that the signal is related to actual blood glucose concentration. Clark error grid presentation shows performance that is not acceptable for home glucose meters.” 
     A promising alternative to non-invasive is “semi-invasive” or minimally invasive testing using interstitial fluid (IF). The only product currently marketed that employs this technology is Glucowatch™ from Cygnus, Inc. It uses electrically stimulated (reverse iontophoresis) glucose extraction from IF into a sensor-equipped sample pad. The product was recently approved by the FDA but only for supplementary (trend) testing. Reported problems with IF sampling are variations in skin thickness and permeability, changes in blood/IF equilibration, sweating, signal instability and skin irritation. Furthermore, the watch must be recalibrated every 12 hrs. which is done by invasive finger stick measurements. 
     In the future the SMBG market will increasingly be driven by consumer demand, managed care, and cost pressures from third party reimbursement companies. In this environment a market conversion from established and affordable invasive whole blood technology to unproven and costly non-invasive systems appears unlikely. However, it is expected that the market will migrate to invasive systems which minimize invasiveness and its associated pain. As such, the Applicant&#39;s minimally invasive and relatively less painful technology is believed by Applicants to better achieve the goals sought by the industry, and be well placed in the direction in which the market is heading. 
     C. The Present Invention Strives to Improve over the Known Prior Art 
     One development goal is to remove, or at least decrease the pain associated with finger sticks and reduce the complexity of test performance by reducing the number of separate components required to perform a blood test. 
     An inventive feature of the Applicant&#39;s invention is the consolidation of the test procedure components with the exception of the meter, into one single disposable test strip device. The product “clutter” of the prior art non-meter components including test strips, meters, lancets, lancet shooting devices, alcohol bottles or sealed swabs, multiple vials and bags requires the user to assemble and spread out a multitude of separate components on a flat surface such as a table or counter top, before testing can even begin. It is a perceived burden by users, and a deterrent for many diabetics to perform SMBG at all. The Applicants&#39; innovative concept of sweeping consolidation of a multitude of components into one single disposable of lancing site preparation, painless lancing (tiny sample, e.g. forearm), dosing and non-instrumented monitoring should reduce perceived inconvenience to the absolute minimum, making testing easier and widely accessible to the public. In instrument monitored versions, the monitor (meter) will comprise a second component. 
     The technology has four (4) contributive components: (1) unitization of lancing site preparation, lancing, dosing and testing; (2) direct (filter-less) absorption of blood plasma into polymer-based reagent films; (3) removal of cellular component by capillary force; and (4) visual recognition of designated glucose cut-points by the novel threshold assay (redox titration on a test strip) principle (in non-instrumented versions). In this mode of operation, only a single polymeric film with a thickness in the micrometer range (&lt;50 m dry film) is required for instant accommodation of both plasma acquisition and chemical analysis. Feasibility in theory and experiment for the candidate technological principles has been demonstrated by Applicants. 
     Elements of the consolidated testing device of the present invention are: (1) incorporation of a lancet into a test strip containing device at a side opposite to blood entry capillary with that side becoming the (currently separated) lancet/plastic support unit; (2) incorporation of an antiseptic cleaning swab into the lancet cap and (3) incorporation of a pressure cup into the lancet cap lid for focused acquisition of miniature blood specimens by enhancing blood flow from tissue site that, under normal conditions do not yield sufficient blood for testing purposes. 
     These steps eliminate product clutter by obviating separate vials, swabs, lancets, and lancing gun. Additionally, these steps help to synchronize purchasing of disposables which reduces frequent trips to a pharmacy. The consolidation of the testing components will also make testing faster, and less dependent on finding a suitable environment, such as a washroom, test surface, and/or disposal bin. As such, the Applicants consolidated device should be safer and more user friendly. 
     A third developmental goal of the consolidated testing apparatus of the present invention is the ultra-miniaturization of the sample size required to be taken from a patient in order to perform the test. Ultra-miniaturization of sample size is enabled by a proprietary thin film, capillary-augmented sample acquisition process which is described in more detail in Kloepfer et al., U.S. patent application Ser. No. 09/696,156, which was filed on 25 Oct. 2000, and contains a disclosure which is incorporated herein by reference. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention, a body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid. 
     In the preferred embodiment of the present invention, the device also includes a cleansing member with a pressure inducing member. The cleansing member is carried by the body member for cleansing the tissue area to be penetrated by the tissues penetrator. The cleansing member includes an aperture, and, along with the penetrator, is disposed adjacent to the first end of the body portion. The penetrator is extendable through the aperture of the cleansing member, as the penetrator moves from its retracted position, to its axially extended position. Preferably, tissue penetrator includes an actuator for retaining the tissue penetrator in the retracted position releasing the tissue penetrator upon activation by the user, to move into the extended position. The tissue penetrator can include a depth adjustor for permitting the user to adjust the axial distance traveled by the tissue penetrator between its retracted and its extended position. 
     The pressure inducing member preferably comprises a cap member disposed adjacent to the first end of the body member. The cap member is hingedly coupled to the body member, and is movable between a closed position, wherein the cleansing member and the penetrator are covered by the cap member, in an open position. When the cap member is closed, it is disposed generally co-axially with the body member. The cap member includes a tissue engaging rim that defines an axially inwardly extending cavity. 
     One feature of the present invention is testing consolidation, i.e. unification of the various components needed to test blood into a single testing device. The Applicants believe that it is advantageous to keep the testing meter as a separate component, because to incorporate a testing meter into the remainder of the components (lancet, lancet gun, test strip and cleansing swab) would make the device too expensive to be disposable. Rather, the Applicants believe that cost-efficiencies and sanitary concerns are best addressed with a removable meter that is employed with a disposable testing device that includes the lancet, lancet gun, test strip and cleansing swab. 
     The Applicants believe that the consolidated testing device of the present invention will greatly reduce apprehension, inconvenience and fear and should receive a warm welcome from diabetics. A reduction in the fear factor is achieved by employing a retractable lancet, which is not seen by the user, thus lessening the “needle fear” caused by the sight of a traditional exposed lancet. 
     In one embodiment, the testing device has a removable and replaceable swab cap holding the cleaning fluid swab. Upon removal of the peel-off lid, the swab (cellulose or polypropylene sponge) protrudes outward because of interior pressure from material elasticity. The user cleans the intended lancing site, removes the lancet cap and lances the site by applying perpendicular pressure against the skin. He then recaps the lancet unit and turns the device 180 degrees, draws the sample into the reaction capillary, waits for removal of excess blood and monitors the result. 
     In another embodiment, the removable lancet cap has been replaced with a living hinge snap cap. In this embodiment the cleaning swab is enclosed within the snap cap. The exterior side of the snap cap features a dome shaped pressure cup for sample enlargement (when necessary), activated by pressing the cup against the lanced site. This pressure against the lanced site helps to enhance the flow of blood from the lanced site, thus ensuring a sufficient supply of blood to meet the quantity needs of the test strip and meter. 
     Another aspect of the consolidated testing device feature of the present invention is that it reduces the number of separate items that the user must handle from about six items to a single item. Current SMBG systems require at least half a dozen items to enable a user to perform a blood test. In addition to the meter, these items include a test strip, lancet, lancet shooting device, calibration strips, alcohol swab, bags, vials, and caps. These items must be removed from a common pouch, assembled and handled to perform a single, sterile test, and then repackaged. The proposed consolidated technology would require a person to handle only a single disposable, the test strip/lancet/swab/pressure cup unit (along with a meter), thereby reducing product clutter. Besides greatly facilitating ease and speed of performance, this unitization concept has the potential to streamline parts inventory control and save diabetics intermittent trips to the pharmacy every time they run out of a particular item. 
     The consolidation concept is particularly suited for alternate site testing (AST such as by withdrawing blood from the forearm, rather than a finger tip. AST is becoming increasingly popular because (1) pain from finger sticks is eliminated, and (2) available lancing surfaces are significantly increased. The amount of blood obtainable from a forearm stick is one magnitude less than what can be acquired from a finger stick. Because of this, many prior art blood test systems were unable to utilize AST, as insufficient amount of blood were obtained from these AST sites to satisfy the requirements of either or both of the test strip and meter. 
     Although Bayer and MediSense have introduced vacuum assisted devices that are useful for obtaining greater blood flow quantities from alternative sites, the Applicants have found that the application of a vacuum is unnecessary. Surprisingly, the Applicants have found that pressure applied around the lancing site will cause increased blood flows. One feature of the present invention is that a pressure inducing component such as a pressure cup is provided that increases blood flow at alternative stick sites, without the need for a vacuum assist 
     Through repeated experiments (at two different body sites) the Applicants have demonstrated that sample volumes can be increased 5-10 times when a pressure cup is applied as opposed to unassisted blood acquisition. In these studies we used one of the smallest lancets currently marketed, the Roche Softclix, at the lowest of its 11 depth settings=0.5). With unassisted lancing, blood volumes obtained were between 0 and 200 nanoliter. 
     In some sticks no blood was obtained at all. However, even in most of those “no-blood-obtained” cases, sufficient blood could be extracted when a cup was pressured against the sticking site. Such a pressure cup can be incorporated into the consolidated test device. 
     Several advanced designs of consolidated teststrips enhancing functionality and ergonomics are part of the present invention. Advantages of the advanced designs are: (1) elimination of one part (separate swab cap), streamlining production; (2) continuously adjustable depth penetration of lancet owing to a co-molded, eccentric cam lancet cap stop wall; (3) capacity for repeat lancing in the event of an insufficient sample volume; (4) provision of a pressure cup to enlarge sample volumes obtained from sticks &lt;300 nL; (5) the repositioned “living hinge” swab cap serves as a protective cover for the lancet, providing additional safety by preventing presence of used and exposed lancets in temporary and mass disposal, and (6) substantially improved user handling and ergonomics. 
     The entire consolidated test strip can be manufactured from three (3) injection molded parts joined together by two (2) snap-in connections, assembled with the punched foils that contain the test chemistry. 
     Additional objects, advantages and novel features of the invention are set forth in the description that follows, and will become apparent to those skilled in the art upon their viewing the drawings in connection with the following description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an exploded perspective view of the consolidated blood testing device of the present invention; 
         FIG. 2  is another exploded perspective view; 
         FIG. 3  is an assembled perspective view of the present invention; 
         FIG. 4  is another assembled perspective view of the present invention; 
         FIG. 5  is an exploded perspective view of a first alternate embodiment of the present invention; 
         FIG. 6  is another perspective view of the first alternate embodiment of the present invention; 
         FIG. 7   a  is a schematic flowchart illustrating the steps necessary to perform a blood test using the prior art; 
         FIG. 7   b  is a flowchart illustrating the steps necessary to perform a blood test using the testing device of the present invention; 
         FIG. 8  is a bottom view of the first alternate embodiment of the present invention; 
         FIG. 9  is a top view of the first alternate embodiment of the present invention; 
         FIG. 10  is a side view of the first alternate embodiment of the present invention; 
         FIG. 11  is a perspective view, illustrating the pressure cap of the present invention; 
         FIG. 12  is a perspective view, wherein the pressure cap in its open position, and the cleansing swab is exposed; 
         FIG. 13  is a perspective view, similar to  FIG. 12 , but with the cleansing swab removed to illustrate the cleansing swab receiving chamber; 
         FIG. 14  is a top view thereof showing the chemistry strip removed; 
         FIG. 15  is a bottom perspective view of a second alternate embodiment of the present invention; 
         FIG. 16  is a top perspective view of the perspective view of the second alternate embodiment of the present invention, with the dial cap removed; 
         FIG. 17  is a bottom perspective view thereof; 
         FIG. 18  is a top view of the present invention, similar to  FIG. 17  however with the dial member included and the lancet cap removed; 
         FIG. 19  is a top perspective view of the base member, including lancet of the second alternate embodiment; and 
         FIG. 20  is a perspective view, second alternate embodiment with the dial cap in place and the cleansing swab removed. 
     
    
    
     DETAILED DESCRIPTION 
     The first embodiment of the testing device  10  of the present invention is shown in  FIGS. 1-4  as including a body  12  that includes a first end body portion  14  that is attachable to and joinable with a second body portion  16  to form the assembled testing device  10 , as shown in  FIGS. 3 and 4 . The testing device  10  is generally pen-shaped, and includes a longitudinally extending axis A, which will be used as a reference point to describe the various surfaces and directional extent of the components of the testing device  10 . The first end body portion  14  includes a radially outwardly facing cylindrical surface  20  having a knurled or otherwise roughened gripping surface  22  for enhancing the user&#39;s ability to grip and control the device  10 . The first end body portion  14  also includes an arbitrarily designated proximal end  24  and a distal end  26 . A reduced diameter portion  28  is disposed adjacent the distal end  26 . The reduced diameter portion  28  is sized for interiorly receiving the proximal end of the second end body portion  16  within the generally hollow interior passageway  30  of the distal end  26 . The generally hollow interior passageway  30  is defined by a generally cylindrical interior surface  32 . 
     A bundt cake pan-shaped cleansing member receiver (not shown) is disposed within the interior of the proximal end  24  of the first end body portion  14 , and is sized and configured for receiving a toroidal-shaped absorbent cleansing member  36 , that preferably comprises an absorbent pad that absorbantly holds a disinfecting agent, such as a relatively non-volatile alcohol, or other disinfectant, such as those containing anti-microbial and anti-germ agents such as Nonoxyl-9. The cleansing member  36  has a radially extending, axially outwardly facing surface  38 , and a radially extending, axially inwardly facing surface  40 . 
     An axially extending central aperture  42  extends through the cleansing member  26  between the inwardly and outwardly facing surfaces  38 ,  40 , and is sized to be received by the axially extending hollow central finger (not shown) of the cleansing member receiver. As will be described in more detail below, the central aperture  42  and hollow finger of the cleansing member receiver are sized and positioned to permit lancet  50  to pass therethrough, so that when lancet  50  is in its fully extended position, the penetrating tip  81  of the lancet  50  will extend axially outwardly beyond the axially extending outwardly facing surface  38  of the cleansing member  36 . Of course, when the lancet  50  is in its retracted position, the penetrating tip  81  is disposed axially inwardly of the axially outwardly facing surface  38  of the cleansing member  36 , so that a person using the cleansing member  36  to disinfect and clean a body tissue area prior to penetration does not stick himself with the lancet  50 . 
     Cap member  54  is hingedly coupled to the first end body portion  14  by a snap-type living hinge member  56 . The cap member  54  is movable between an open position (as shown in the figures,) wherein the longitudinal axis of the cap member  54  is generally parallel to the longitudinal axis A of the testing device, and a closed position. In the closed position, the cap member  54  rotates 180 degrees about the pivot formed by hinge member  56 , and is disposed in a generally co-axial relationship with the proximal end of the first end body portion  14 . When in a closed position, end  60  of the cap member  54 , that is shown as being a proximal end in  FIG. 1 , becomes the distal end  60  of the cap member  54 , and the other end  62  of the cap member  54 , that is shown in  FIG. 1  (in the open position) as being the distal end, becomes the proximal end  52  of the cap member  54 . 
     The distal end  60  of cap  54  is designed to mate with the proximal end  24  of the first body portion  14 , when the snap-type living hinge  56  moves the cap member  54  to its closed position. Although, ideally the mating between the distal end  60  of the cap member  54  and the proximal end  24  is a sealing relationship of the type that prevents any disinfecting agent within the cleansing member  36  from evaporating, it is possible that some sort of covering will need to be placed over the axially outwardly facing surface  38  of the cleansing member  36  to prevent any volatile disinfectant absorbed within the cleansing member  36  from evaporating during the time period between when the device  10  is manufactured and when the device  10  is finally used by a patient. 
     As stated above, the living hinge members  56  are “snap-type” living hinge members that are designed to be spring-tensioned so that the cap  54  only finds a rest position when the cap  54  is either in its open position as shown in  FIG. 1 , or in its closed position wherein the cap  54  is disposed co-axially with the second body portion  14 . This snap-type spring arrangement of the living hinge  56  facilitates manipulation of the device by the user, because the opening of the cap  54  will cause it to snap into its fully open position, rather than to flop around within an arc of open positions. 
     The proximal end  62  of the cap member includes a pressure cup  64  that is defined by a circumferential pressure inducing lip  66 , and a cup-shaped interior  68 . As will be described in more detail below, placement of the circumferential pressure exerting lip  66  on a tissue area that surrounds a tissue site that has been penetrated by the tissue penetrator, along with the application of a moderate amount of axially directed force, has been surprisingly found by the Applicants to induce a flow of blood out of the penetrated site to enhance the volume of blood that is obtained from the penetrated site. This feature has the advantage of enabling the testing device to obtain a sufficient quantity of blood from testing sites, such as the forearm, that formerly were unuseable by blood test strips because they normally did not bleed sufficiently to yield enough blood to enable the user to perform a blood test. In the prior art, this inability to obtain a sufficient quantity of blood required the user to obtain blood samples from sticks made on the user&#39;s fingertips, as the finger tips yielded sufficient blood. 
     An axially movable tissue penetrator  72 , that is movable between the retracted position, and an extended position includes a needle-like tissue penetrating lancet  50 , that is fixedly coupled to an axially movable mounting carriage  78 . It will be noted that the mounting carriage  78  and the lancet  50  are coupled to the first end of a portion  16 . However, when the device  10  is assembled, as shown in  FIGS. 3 and 4 , the carriage  78  and lancet  50  are interiorly received within the hollow interior  30  of the first end portion  14 , so that the penetrating tip  81  of the lancet  50  is disposed adjacent to the proximal end  24  of the first end body portion  14 . 
     As alluded to above, the lancet  50  normally resides in its retracted position where the penetrating tip  81  is disposed axially inwardly of the axially outer facing surface  38  of the cleansing member  36 , so that when the user employs the cleansing member  36  to cleans his finger, he does not stick himself with the tip  81  of the lancet  50 . The lancet  50  is also movable into an extended position, wherein it is moved axially outwardly, under the force of a biasing member, such as spring  82  so that the penetrating tip  81  extends axially outwardly beyond the axially outer facing surface  38  of the cleansing member  36 , to prick the tissue site to cause bleeding therefrom. 
     One end  76  of the lancet  50  is coupled to a mounting collar on the carriage  78 , that couples the lancet  50  to the carriage  78 . Lancet  50  can be fixedly coupled to the movable carriage  78 , and the carriage  78  can be designed to move axially, to cause the axial movement of the lancet  50 . Alternatively, the carriage  78  can be fixedly positioned, and the lancet  50  be designed to be axially moveable relative to the carriage  78 . 
     Spring  82  is provided for biasing the lancet  50  to move in an axially outward direction, to engage tissue. A trigger member  84  is provided for maintaining the lancet  50  in its retracted position, until the user actuates the trigger  84 , that permits the spring  82  to move the lancet  50  to move axially outwardly, to thereby prick a tissue surface. Although a single spring  82  is shown in the figures for biasing the lancet  50  to move axially outwardly, a dual-acting spring arrangement can be designed that enables the lancet  50 , upon actuation of trigger  84  to move axially outwardly to engage a tissue surface, with a second spring being provided to move the lancet  50  axially inwardly to retract it after the tissue poke is made. 
     A depth gauge  86 , including a camming surface for facilitating axial movement (not shown) is provided for enabling the user to adjust the extent of axial movement of the lancet  50 , that permits the user to adjust the depth to which the penetrating tip  81  of the lancet  50  penetrates the tissue surface of the user. As will be appreciated, some users would prefer that the lancet  50  penetrate more deeply, to ensure a better blood flow and supply, whereas others would prefer that the lancet  50  make a more shallow penetration of the tissue, that would likely be less painful. The depth gauge  86  includes pointer  88  that is reconcilable with a gauging surface (surface  28 ) for maintaining one or more numerical indicators, such as numerical indicator  89  ( FIG. 4 ) that provides an indication to the user of the relative depth to which the lancet  50  will penetrate. A gripping surface  92  is provided for permitting the user to rotate the cylindrical gauging wheel that contains gripping surface  92  on pointer  88  (or alternately, to rotate first end body portion  14 ) to permit the user to vary the insertion depth of the lancet  50 . 
     The second end body portion  16  also includes a test strip component  94  that is disposed generally at the distal end  96  of the second end body portion. 
     The test strip component  94  is disposed at the distal end of the second end body portion  16 , and includes four primary components, a test strip  98 , a test strip holder  100 , a test strip retainer  102 , and a living hinge mechanism  104  for hingedly coupling the test strip holder  100  to the retainer  102 . Test strip retainer  102  is movable between an open position (as shown in the figures) and a closed position (see, e.g.,  FIGS. 8-10 ). When the test strip retainer  102  is in its closed position, the test strip  98  is sandwiched between the test strip retainer  102  and the test strip holder  100  to maintain the test strip  98  in its appropriate position on the device  10 . 
     The test strip  98  is preferably a capillary containing test strip of the type described in Kloepfer, Kloepfer and Roach patent application Ser. No. 09/696,156, that is also assigned to the Assignee of the instant invention. Although the disclosure relating to the test strip of the &#39;156 application is incorporated herein by reference, and need not be repeated further here, the test strip  98  is designed to separate the colored (primarily hemoglobin) components of the blood from the clear, primarily plain components of the blood, to provide a generally clear analyte fluid, that can then be reacted with reagents contained on the test strip to form either a calorimetric or non-colorimetric reaction product that can then be analyzed either visually, or through the use of a meter (not shown). 
     The test strip  98  includes a collection component that comprises an inlet, a collection capillary structure to draw the fluid of interest into the collection component via the inlet exerting capillary forces upon the fluid applied to the inlet. The device also includes a film that is operable to collect the correct analyte from the fluid as the fluid is drawn over the film. A wicking component is provided that is coupled to the collection component, and is structured to draw the fluid over the film and into the wicking component. The wicking component exerts sufficient capillary force on the analyte fluid to effectively sweep the film free of particulate matter (e.g. hemoglobin) of the fluid, without filtration or other mechanical removal devices. The functional components described above of the test strip are incorporated into test strip  98 . 
     The shape of test strip  98  is dictated largely by its need to incorporate the above-discussed functional components, while fitting into the test strip holder  100  and test strip retainer  102 , while still being insertable into an appropriate glucose meter so that the glucose meter can “read” the reaction product analyte that is drawn from the body fluid (e.g. blood) that is placed on the collection component of the test strip  98 . The test strip  98  includes a proximal end  108  and a fluid sample receiving distal end  110 . Generally, blood placed on a test strip flows from the distal end  110  toward the proximal end  108 . 
     Test strip  98  includes finger receiving apertures  112  that are designed for receiving an upstanding finger  130 , whose purpose is to fixedly position the test strip  98  on the test strip holder  100  and receiver  102 . A pair of radially extending tabs  114  are formed on the test strip  98  to also help to fixedly position the test strip  98  on the test strip holder  100  and receiver  102 . 
     The test strip  98  includes a body fluid receiving upper surface  116  having a separating portion and a capillary containing portion, a wicking component portion, and a reagent impregnated portion, as taught by the above Kloepfer, Kloepfer and Roach patents. Generally, only one side of the test strip  108  needs to be treated with the functional components, as blood is generally only placed one side  116  of the test strip  98 . 
     The test strip holder  100  includes a generally planar base for receiving test strip  98  and a set of upstanding perimetral side walls  124  for capturing the test strip  98 , and maintaining it on the holder  100  in a snug relationship. The test strip holder  100  also includes a concave distal surface  128  that facilitates the introduction of blood to the test strip  98 , and a strip retaining upstanding finger  130 , that may be movable between a strip  98  engaging position and strip  98  releasing position. A pair of ramping surfaces  142  are formed on the frontal distal surface of the upstanding side walls  126  to facilitate the lifting of the test strip  98  by an appropriately designed glucose meter (not shown). 
     The test strip retainer  102  is designed to matingly engage with the test strip holder  100 , for retaining the test strip  98  by securing the test strip  98  on the test strip component  94  of the blood testing device  10 . The test strip retainer  102  is movable between an open position, such as shown in  FIGS. 1-4 , and that permits the test strip  98  to be inserted onto and/or removed from its engagement with the test strip holder  100 ; and a closed position (see, e.g.  FIG. 8 ) wherein the test strip retainer  102  frictionally engages the test strip holder  100 , so that the test strip retainer  102  is positionaly secured onto the test strip holder  100 , to positionaly secure and retain the test strip  98  onto the test strip component  94 . When so engaged, the test strip  98  is sandwiched between the planar base  124  of the test strip holder  100 , and test strip retainer  102 . 
     The test strip retainer  102  includes upstanding walls  136  for engaging the upper surface  116  of the test strip  98 . The test strip retainer  102  is hingedly coupled to the test strip holder  100  by a living hinge  104 , and includes a generally perimetral strip engaging retaining wall set  134  that is designed to be disposed above the upper surface  116  of the test strip  98 . 
     The distal portion of the test strip retainer  102  includes a concave cut-out portion  138  for facilitating the introduction of blood onto the test strip of the upper surface  116  of the test strip  98 . A pair of complimentary ramping surfaces  139  are formed on the distal end of the retainer  102 , and are provided for facilitating engagement of the testing strip component  94  with an appropriate glucose meter. The primary purpose of the ramping strip surfaces  132 ,  139  is to permit a mechanism (not shown) within the glucose meter to lift the strip  98  as it is inserted into the meter for better fitting of the strip by the meter. 
     Another feature of the strip is the sufficient sample indication window  141 . This allows the meter to interrogate the strip in the reservoir to insure sufficient sample has been applied prior to giving a test result. 
     As is best shown in  FIG. 3 , the retainer  102  includes four upstanding studs  137  that are sized and positioned for being received into four complimentary apertures  140  that are formed on the test strip holder  100 . When the studs  137  are inserted into the apertures  140 , the studs  137  fixedly engage the apertures  140  to maintain the retainer  102  in a secure frictional engagement with the holder  100 . 
     Your attention is now directed to  FIG. 7   b , that comprises a flow chart describing the manner in which the test strip device  10  is used. 
     First, the test strip device  10  is removed from its packaging. When packaged, the cap  54  is placed in its co-axial relationship with the second end  14  of the testing device  10 , so as to create a seal against the cleansing member  36 , that helps to prevent the cleansing member  36  from drying out. 
     When the device  10  is removed from its packaging, the cap  54  is opened, and moved from its co-axial position (see, e.g.  FIG. 14 ) to its parallel axis position, as shown in  FIGS. 1-4 . The user then employs the cleansing pad  36  to wipe the cleansing pad on an area of body tissue that the user desires to have penetrated by the lancet  50  in order to remove a blood sample. After the area around the testing site is wiped with the cleansing pad  36 , the testing site is lanced with the user actuating trigger mechanism  94 , to permit the spring  82  to move the lancet  50  axially, so that the penetrating tip  81  of the lancet  50  penetrates the skin, to thereby allow blood to flow from the puncture site. The depth to which the lancet  50  will insert itself into the skin is governed by the setting established by the user through the use of the depth gauge  86 . 
     After the site is lanced, cap  54  is then moved back into its co-axial position, primarily to help reduce the likelihood that the user will re-stick himself with the lancet  50 . As described above, the lancet  50  can be designed with a two-way biasing mechanism so that the lancet  50 , after it is moved axially to engage the skin, will fall into the influence of a counter-spring to withdraw the lancet back below the axially outwardly facing surface  38  of the cleansing member  36 , to reduce the likelihood of such unintentional “sticks”. 
     From a functional perspective, an important reason to close the swab cap  54  is that it enables the user to employ the pressure cup  64  to enhance the flow of blood from the penetrated test site. Although it is likely that the pressure cup  64  would not be needed in all circumstances, such as those circumstances where the site that is lanced is a fingertip, the pressure cup  64  is especially useful when the lanced site is a relatively slower bleeding site such as a forearm. 
     The circumferential lid  66  of the pressure cup  64  is then placed around the lanced site, and axially directed pressure is exerted against the body tissue. This causes additional quantities of blood to flow out of the lanced site. This finding was most surprising to Applicants, as enhanced blood flow was achieved by the Applicants, without the need to resort to vacuum-assisted removal as in some prior art. 
     When sufficient blood has been bled out of the user, the blood sample is then loaded on to the distal end  110  of the test strip  98 . After a short interval necessary for the blood on the test strip to complete its journey through the capillary and wicking components of the test strip  98 , the distal end of the test strip component  94  is inserted into an appropriately sized and configured glucose meter. Typically, it requires the glucose meter approximately 5 to 10 seconds in order to perform its necessary analysis of the analyte fluid contained on upper surface  116  of the test strip  98 . After the glucose meter has performed its test, the user can then observe the results of the test or the display of the glucose meter, which is typically either a liquid crystal display, or light emitting diode display. After the results are observed, the testing device  10  is removed from the glucose meter, and disposed of appropriately. A visual back-up system can be used prior to disposing of the strip if the user has any doubts about the accuracy of the result (i.e. user feels bad but the result is in the acceptable range). 
     It is believed by the Applicants that the entire testing procedure utilizing the strip of the present invention should require only about 25 seconds of the user&#39;s time. The reader is invited to compare the number of steps using the test device of the present invention with the significantly greater number of steps required for conventional testing, which is set forth in  FIG. 7   a . It is believed by the Applicants that the consolidation of the various components upon a single testing device  10  that is accomplished with the present invention saves the user considerable amounts of time, due largely to significantly fewer number of steps required to perform testing, and the significantly fewer number of components that must be manipulated by the user. By comparison, the Applicants believe that a person using the prior art testing devices will require somewhere between 2 and 3 minutes to completely perform the task, which compares rather unfavorably to the estimated 25 seconds required by the device of the present invention. 
     The first alternate embodiment of the testing device  210  of the present invention is generally similar to testing device  10  in the manner it functions, but slightly different in its construction, and is shown in  FIGS. 5-14  as including a body  212  that includes a first end body portion  214  that is attachable to and joinable with a second end body portion  216  via a central portion  217  to form the assembled testing device  210 , as shown in  FIGS. 8-14 . The testing device  210  is also generally pen-shaped, and includes a longitudinally extending axis A. The first end body portion  214  includes a radially outwardly facing cylindrical surface  220  having a knurled or otherwise roughened gripping surface  222  for enhancing the user&#39;s ability to grip and control the device  210 . The first end body portion  214  also includes a proximal end  224  and a distal end  226 . A reduced diameter portion  228  is disposed adjacent the distal end  226 . The reduced diameter portion  228  is sized for interiorly receiving the proximal end of the central body portion  217  within the generally hollow interior passageway of the distal end. The generally hollow interior passageway is defined by a generally cylindrical interior surface  232 . 
     A bundt cake-shaped cleansing member receiver  223  ( FIG. 13 ) having a hollow central finger  225  is disposed within the interior of the proximal end  224  of the first end body portion  214 , and is sized and configured for receiving a toroidal-shaped absorbent cleansing member  236 , that is identical to cleansing pad  36 . As will be described in more detail below, the central aperture and hollow finger of the cleansing member receiver are sized and positioned to permit lancet  250  ( FIG. 6 ) to pass therethrough, so that when lancet  250  is in its fully extended position, the penetrating tip  281  of the lancet  250  will extend axially outwardly beyond the axially extending outwardly facing surface of the cleansing member. Of course, when the lancet  250  is in its retracted position, the penetrating tip is disposed axially inwardly of the axially outwardly facing surface of the cleansing member  236 , so that a person using the cleansing member  236  to disinfect and clean a body tissue area prior to penetration does not stick himself with the lancet  250  while wiping down the tissue area. 
     Cap member  254  is identical to cap  54  and hingedly coupled to the second end body portion  214  by a snap-type living hinge member. The cap member  254  is movable between an open position (as shown in the figures,) wherein the longitudinal axis of the cap member  254  is generally parallel to the longitudinal axis A of the testing device, in a closed position as shown in  FIGS. 8-14 . 
     The distal end of the cap  254  is designed to mate with the proximal end of the first body portion  214 , when the snap-type living hinge moves the cap member  254  to its closed position. 
     The living hinge members  256  are “snap-type” living hinge members that are designed to be spring-tensioned so that the cap  254  only finds a rest position when the cap  254  is in its open position as shown in  FIG. 5 , or in its closed position wherein the cap is disposed co-axially with the second body portion  214 , as shown in  FIGS. 8-14 . 
     The proximal end of the cap member includes a pressure cup  264  that is defined by a circumferential pressure inducing lip  266 , and a cup-shaped interior. As with device  10 , the placement of the circumferential pressure extending lip  266  on a tissue area that surrounds a tissue site that has been penetrated by the tissue penetrator, along with the application of the moderate amount of axially directed force, has been surprisingly found by the Applicants to induce a flow of blood out of the penetrated site to enhance the volume of blood that is obtained from the penetrated site. 
     An axially movable tissue penetrator  272 , that is movable between the retracted position, and an extended position includes a needle-like tissue penetrating lancet  250 , that is fixedly coupled to an axially movable mounting carriage  278 . It will be noted that the mounting carriage  278  and the lancet  250  are coupled to the first end of a portion  216 , but is separated from the central portion  217  unlike testing device  10 . Nonetheless, when the device  210  is assembled, as shown in  FIGS. 8-14 , the carriage  278  and lancet  250  are interiorly received within the hollow interior of the first end portion  214 , so that the penetrating tip  281  of the lancet  250  is disposed adjacent to the proximal end  224  of the first end body portion  214 . The lancet  250  is movable between a retracted position wherein the penetrating tip  281  is disposed axially inwardly of the axially outer facing surface of the cleansing member  236 , so that when the user uses the cleansing member  236  to cleans his finger, he does not stick himself with the tip  281  of the lancet  250 . The lancet  250  is also movable into an extended position, wherein it is moved axially outwardly, under the force of a biasing member, such as spring  282  so that the penetrating tip  281  extends axially outwardly beyond the axially outer facing surface of the cleansing member  236 , to prick tissue site to cause bleeding therefrom. 
     One end  276  of the lancet  250  is coupled to a mounting collar on the carriage  278 , that couples the lancet  250  to the carriage  278 . 
     Lancet  250  can be fixedly coupled to the movable carriage  278 , and the carriage  278  can be designed to move axially, to cause the axial movement of the lancet  250 . Alternatively, the carriage  278  can be fixedly positioned, and the lancet  250  be designed to be axially moveable relative to the carriage  278 . 
     Spring  282  is provided for biasing the lancet  250  to move in an axially outward direction, to engage tissue. A trigger member  284  is provided for maintaining the lancet  250  in its retracted position, until the user actuates the trigger  284 , that releases the spring  282  to permit the lancet  250  to move axially outwardly, to thereby prick a tissue surface. 
     A depth gauge  286 , including a camming surface for facilitating axial movement (not shown) is provided as a part of central portion  215  for enabling the user to adjust the extent of axial movement of the lancet  250 , that permits the user to adjust the depth to which the penetrating tip  281  of the lancet  250  penetrates the tissue surface of the user. The depth gauge  286  includes pointer  288  ( FIG. 9 ) that is reconcilable with numerical indicators  289  ( FIG. 4 ) that provides an indication to the user of the relative depth to which the lancet  250  will penetrate. A gripping surface  292  is provided for permitting the user to rotate the cylindrical gauging wheel. 
     The second end body portion  216  also includes the test strip component  294  that is disposed generally at the distal end  296  of the second end body portion. The test strip component  294 , test strip  298 , receiver  300  and retainer  302  are virtually identical to test strip component  94 , and does not need to be described again herein. 
     Testing device  210  also operates virtually identically to testing device  10 , thereby eliminating the need to re-describe its method of operation. 
     The second alternate embodiment of the testing device  410  of the present invention is generally similar to testing device  10  insofar as it performs all of the functions of testing device  10 . As is shown in  FIGS. 15-20 , device  210  utilizes a body  412  that includes a longitudinally extending second end body portion  416  that is attachable to and joinable with a lancet  450 , cleansing member, and suction cap  454  containing end body portion  414  via a generally disk-shaped central portion  417 . The testing device  410  includes a first, test strip component axis B, and a second lancet axis C, that is disposed at an outer angle to the test strip component axis B. The first end body portion  414  includes a radially outwardly facing ovaloid surface  420 , a proximal end  424  and a distal end  426 . A pair of support braces  425  help to securely connect the first end body portion  414  to the central portion  417 . 
     An ovaloid-shaped cleansing member receiver  423  ( FIG. 17 ) having a hollow central finger  429  is disposed within the interior of the proximal end  424  of the first end body portion  414 , and is sized and configured for receiving a toroidal-shaped absorbent cleansing member  36 . As will be described in more detail below, the central aperture and hollow finger of the cleansing member receiver are sized and positioned to permit lancet  450  ( FIG. 18 ) to pass therethrough, so that when lancet  450  is in its fully extended position, the penetrating tip  481  of the lancet  450  will extend axially outwardly beyond the axially extending outwardly facing surface of the cleansing member. Of course, when the lancet  450  is in its retracted position, the penetrating tip  481  is disposed axially inwardly of the axially outwardly facing surface of the cleansing member, so that a person using the cleansing member to disinfect and clean a body tissue area prior to penetration does not stick himself with the lancet  450  while wiping down the tissue area. 
     Cap member  454  is ovaloid in cross section, and is hingedly coupled to the second end body portion  414  by a snap-type living hinge member  456 . The cap member  454  is movable between an open position (as shown in  FIGS. 15-17  and  20 ) wherein the longitudinal axis of the cap member  454  is generally parallel to the longitudinal axis C of the lancet  450 , and a closed position wherein the cap member  454  is disposed generally co-axially with the lancet  450 . 
     The distal end of the cap  454  is designed to mate with the proximal end of the first body portion  414 , when the snap-type living hinge moves the cap member  454  to its closed position. 
     The living hinge members  456  are “snap-type” living hinge members that are designed to be spring-tensioned so that the cap  454  only finds a rest position when the cap  454  is in its open position as shown in  FIG. 5 , or in its closed position wherein the cap is disposed co-axially with the second body portion  414 . 
     The proximal end of the cap member  454  includes a pressure cup  464  that is defined by a circumferential pressure inducing lip  466 , and a cup-shaped interior. As with device  10 , the placement of the circumferential pressure extending lip on a tissue area that surrounds a tissue site that has been penetrated by the tissue penetrator  481 , along with the application of the moderate amount of axially directed force, has been surprisingly found by the Applicants to induce a flow of blood out of the penetrated site to enhance the volume of blood that is obtained from the penetrated site. 
     An axially movable tissue penetrator  472  ( FIG. 19 ), that is movable between the retracted position, and an extended position includes a needle-like tissue penetrating lancet  450 , that is coupled to a mounting member  478  The lancet  450  is movable between a retracted position wherein the penetrating tip  481  is disposed axially inwardly of the axially outer facing surface of the cleansing member so that when the user uses the cleansing member to cleans his finger (or forearm or other sticking site), he does not stick himself with the tip  481  of the lancet  450 . The lancet  450  is also movable into an extended position, wherein it is moved axially outwardly, under the force of a biasing member, so that the penetrating tip  481  extends axially outwardly beyond the axially outer facing surface of the cleansing member, to prick the tissue site to cause bleeding therefrom. 
     A depth gauge  486 , including a camming surface for facilitating axial movement (not shown) is provided as a part of central portion  415  for enabling the user to adjust the extent of axial movement of the lancet  450 , that permits the user to adjust the depth to which the penetrating tip  481  of the lancet  450  penetrates the tissue surface of the user. The depth gauge  486  includes pointer  488  ( FIG. 15 ) that is reconcilable with numerical indicators  489  that provides an indication to the user of the relative depth to which the lancet  450  will penetrate. A gripping edge  492  is provided for permitting the user to rotate the disk-shaped gauging wheel  479 . 
     The second end body portion  416  also includes the test strip component  494  that is disposed generally at the distal end  496  of the second end body portion. The test strip component  494 , test strip  498 , receiver  500  and retainer  502  are virtually identical to test strip component  94 , and do not need to be described again herein. Testing device  410  also operates virtually identically to testing device  10 , thereby eliminating the need to re-describe its method of operation. 
     Although the invention has been described with reference to the currently perceived best mode of practicing the invention, it will be appreciated by those skilled in the art the variation and modifications exist which are encompassed within the spirit of the invention.