Abstract:
This invention generally relates to a method for producing an analytical system, and to a analytical system for detecting an analyte in a body fluid. The analytical system comprises a test element and a lancet which is movable relative to the test element and which is received on the test element. The lancet is connected to the test element via an elastomer spring.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is based on and claims priority to European Patent Application No. 06101434.6, filed Feb. 9, 2006, which is hereby incorporated by reference in its entirety. 
       TECHNICAL FIELD 
       [0002]    The invention generally relates to an analytical system, in particular a test strip for detection of analytes in body fluid, with a lancet for perforating the skin of the test subject. 
       BACKGROUND 
       [0003]    Test elements in the form of test strips for detection of analytes in blood have been state of the art for some time now. Test elements in test strip form are used particularly in the field of blood sugar measurement. Measurement of blood sugar levels by the patients themselves has led to continued development of test systems and of the test strips, mainly designed as test strips, used in said systems. The aims of this development were improved analysis, improved operating safety, a reduction in the volumes of blood that have to be taken from the patient, and simplified handling, particularly a reduction in the handling steps needed. 
         [0004]    To obtain the blood for carrying out the analysis by means of test elements designed as test strips, various designs of puncturing aids have been developed which are used to perforate the patient&#39;s skin and to allow emergence of the quantity of blood needed for the analysis. To improve handling, test elements have been proposed that permit a combination of puncturing and measuring devices. 
         [0005]    Prior art systems have disclosed a puncturing aid with a lancet system that is protected against reuse. 
         [0006]    The puncturing aid is used to create an opening in the skin and typically comprises a housing into which a lancet system can be inserted. The housing moreover comprises a retaining element which cooperates with a corresponding retaining element of the lancet system, so that the lancet system can be positioned in the housing at a defined location. The housing moreover comprises an opening from which a needle tip of at least one needle of the lancet system can emerge during a puncturing procedure. A drive mechanism for driving the at least one needle is provided, so that the needle can be transferred from a rest position to a puncturing position. The needle is connected to a needle body in such a way that the needle and a protection area of the needle body are movable relative to one another. In a first position, the protection area of the needle body at least partially surrounds the needle tip, whereas, in a second position, the needle and the protection area of the needle body are arranged relative to one another such that the needle tip is freed from the protection area of the needle body. The needle body moreover includes a blocking mechanism which is actuated through cooperation with the puncturing aid and changes the needle body so that, after the lancet system has been ejected from the puncturing aid, interaction between the retaining element of the puncturing aid and retaining element of the lancet system is prevented upon renewed insertion. 
         [0007]    According to know solution, the metal needle is secured on a plastic body and is fixedly connected to the plastic body. An area is formed on the plastic body for the purpose of coupling the lancet system to a drive ram, so that the needle can be moved along the axis in the direction of puncturing. The rear area of the plastic body is designed for coupling to the drive ram such that two arms, provided with projections, permit a form-fit connection of the plastic body to the puncturing aid. Therefore, producing a coupling between the lancet needle and the puncturing drive mechanism represents an additional outlay, both in terms of the lancet needle and in terms of the measurement appliance. 
         [0008]    The solutions known from the prior art, regarding a system composed of a combination of test element and puncturing aid, are all either associated with the disadvantage of having a large overall size or require a coupling to the measurement appliance, which, from the technical point of view, is an unsatisfactory situation. Therefore, there is a need to have a system is comprised of test element and puncturing aid that overcomes the disadvantages of prior art. 
       SUMMARY 
       [0009]    One of the objects of the invention is to make available a test element/puncturing aid system that has a simple structure and can be received in the measurement appliance without a coupling. 
         [0010]    According to one aspect of the invention on a substantially flat test element, a lancet or a needle is arranged and is connected movably to the test element via an elastic material. The test element comprises a capillary through which a blood sample, accessed after the skin has been punctured, is transported from the patient&#39;s skin to a measurement area contained in the test element. The opening of the capillary is located on the front edge of the test element in order to take up the blood sample from the patient&#39;s skin. 
         [0011]    One or more measurement areas for detection of the analyte, and electrical contacts or optical windows for recording the detection reaction, are formed on one flat face of the test element. The measurement areas are applied to the test element, for example, in the form of a film coating of the corresponding face of the test element. On the other flat face of the test element, a puncturing aid in the form of a lancet or needle is attached. Instead of a needle with a round or circular cross section, it is also possible to use a puncturing aid that has a square or rectangular cross section. The lancet is oriented parallel to the longitudinal axis of the test element and is located approximately centrally in relation to the width of the test element. The end of the lancet directed towards the capillary is ground to a point, or is formed into a sharp tip in some other way, for example by laser cutting or an etching process. A wide variety of profiles can be used that are suitable for creating an opening in the skin. The rear end of the lancet, remote from the lancet tip, is blunt and has an end face. 
         [0012]    In yet, another aspect of the invention, the lancet integrated test system comprising a test element and a lancet. The lancet is movable relative to the test element and is connected to the test element by a connection composed of at least one cord of an elastic material. One end of the cord is secured centrally on the lancet, and the other end is secured on the two longitudinal sides of the test element. In addition to a cord-like connection of the lancet to the longitudinal sides of the test element, the connection between the lancet and the test element can also be configured as threads or as a number of strips situated between the longitudinal sides of the test element and the lancet, with is arranged centrally on a flat face of the test element. 
         [0013]    In yet another aspect of the invention, in the rest position, the sharp end of the lancet is located inside the contour of the test element. The rear, blunt end of the lancet can also lie inside the contour of the test element or can also extend beyond the contour of the test element. The length of the lancet is dimensioned such that it is shorter than the length of the test element. At the rear edge of the test element remote from the capillary opening, the test element is provided with a V-shaped or rectangular recess through which the puncturing drive mechanism of the measurement appliance contacts the rear end of the lancet and causes an advance movement of the lancet relative to the test element. 
         [0014]    The lancet is enclosed by a film pouch, at least in the area of the sharp tip. After sterilization, with β or γ rays, the film pouch ensures permanent sterility of the lancet tip during storage. The film pouch is fixedly connected to the outer edge of the test element, for example welded to it. Together with the film pouch, the elastic material is also connected to the test element. The connection of the film pouch to the test element is made following the sterilization. This ensures that the detection chemicals for detecting the analyte or analytes are not subjected to sterilization and their efficacy is not compromised. 
         [0015]    In yet another aspect of the invention, a test element can be handled manually, without any danger of accidentally touching the unused or used tip of the lancet and without any danger of inadvertent injury. The elastic connection between the test element and the lancet ensures that the tip of the lancet is drawn back into the contour of the test element after the puncture has been made, thereby ruling out any possibility of inadvertent injury. The connection in the form of an elastomer spring, made of a rubber elastic material, between the longitudinal sides of the test element and the lancet body represents a very simple mechanism for moving the lancet during use in a measurement appliance. If the lancet system proposed according to the invention is fitted in a measurement appliance, the latter can be produced without a coupling site, since the blunt end of the lancet simply has to be acted upon by the advance movement of a ram, for example of the puncturing drive mechanism arranged in the measurement appliance, as a result of which the lancet is pushed out from the contour of the test element, past the front edge of the latter, in order to carry out a puncturing movement counter to the action of the elastomer spring. On the measurement appliance, there is no need for a coupling to the lancet that is received movably on the test element. The elastomer spring functions more reliably and is less susceptible to failure than many mechanical couplings between the measurement appliance and the lancet. The work involved in forming a coupling on the lancet can also be avoided. 
         [0016]    In yet another aspect the lancet when penetrating the film pouch during the puncturing movement, the lancet received movably by the test element and enclosed by a film pouch loses less energy. Thus, a higher speed of puncturing is ensured, which reduces the patient&#39;s subjective experience of pain. 
         [0017]    Formed on the face of the test element directed away from the lancet is the aforementioned measurement area, to which a blood sample is transported from the skin of the patient by capillary forces after the puncture has been made. The analyte can be detected by optical means or by electrochemical means in the measurement area. The lancet system proposed is used for detection of clinical and chemical parameters or of coagulation parameters, for example glucose, lactate, electrolytes (e.g. Na + , K + , Ca ++ ), cholesterol or prothrombin, among other parameters. 
         [0018]    These and other features and advantages of the present invention will be more fully understood from the following detailed description of the invention taken together with the accompanying claims. It is noted that the scope of the claims is definitely by the recitations therein and not by the specific discussion of the features and advantages set forth in the present description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    The followings detailed description of the embodiments of the present invention can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which: 
           [0020]      FIG. 1  shows a front face of the analytical system proposed according to the invention, comprising a lancet received elastically on a test element, 
           [0021]      FIG. 2  shows the rear face of the system according to the view in  FIG. 1 , 
           [0022]      FIG. 3   a  shows a cross section through the layered structure of the system according to the cross-sectional profile IIIa-IIIa in  FIG. 1  at about half way along its length, 
           [0023]      FIG. 3   b  shows a cross section through the layered structure of the system according to the cross-sectional profile IIIb-IIIb in  FIG. 2 , near the front end, 
           [0024]      FIG. 4  shows a view of the sterile protective band of film, with the pilot holes permitting orientation, 
           [0025]      FIG. 5  shows the support band with pilot holes on both sides, 
           [0026]      FIG. 6  shows an alternative embodiment of the lancet, 
           [0027]      FIG. 6   a  shows a cross section through the alternative embodiment of the lancet according to  FIG. 6 , and 
           [0028]      FIG. 7  shows a continuous band of lancets. 
       
    
    
       [0029]    Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help improve understanding of the embodiment(s) of the present invention. 
         [0030]    In order that the invention may be more readily understood, reference is made to the following examples, which are intended to illustrate the invention, but not limit the scope thereof. 
       DETAILED DESCRIPTION 
       [0031]    The following description of the preferred embodiment is merely exemplary in nature and is in no way intended to limit the invention or its application or uses. 
         [0032]    The term lancet system or the analytical system, as used below, is to be understood as a combination of a test element  14  with a puncturing aid which is mounted movably thereon and which is designed as a lancet. The test element  14  can be a test strip which is substantially flat and is configured in such a way that it can be inserted into a measurement appliance for determining an analyte in a human or animal body fluid. The lancet  26  can be a needle of circular cross section or a material having a square or rectangular cross section which is provided with a sharp tip or a sharp cutting edge in order to create an opening in the skin of the patient. 
         [0033]    Measurement appliance is to be understood hereinafter as meaning one that receives the lancet system and displays the analysis results of the body fluid analysis carried out in a measurement area of the lancet system. 
         [0034]    Measurement area is to be understood below as meaning the area of the lancet system within which the collected human body fluid is determined by reagents, to give one example, applied to the test element of the lancet system. Within the measurement area, the measurement can take place by electrochemical means and also optically. 
         [0035]    Film pouch is understood below as a plastic film, sealed on all four edges, and in which there is no connection between the two plies of plastic film, or in which the twin ply is formed by folding at one edge. To form the film pouch, the two plies of the plastic film are connected fixedly to one another, at the remaining three edges. 
         [0036]    Rest position is understood below as that position of the lancet or needle on the test element in which the needle or lancet remains without the effect of external forces. The elastic material is relaxed in the rest position. 
         [0037]    Cuttings are understood as recesses in the area of the elastomer spring which are formed by shaping during formation of the elastic band in the liquid or partially liquid state of the elastomer material. 
         [0038]      FIG. 1  shows the front face of the lancet system proposed according to the invention, comprising a test element with a lancet mounted elastically thereon. 
         [0039]    It will be seen from the view of the front face  12  of a lancet system  10  that a test element  14  has a surface  24  which is delimited by a front edge  16 , a rear edge  18 , a first longitudinal side  20  and a second longitudinal side  22 . Along the first longitudinal side  20 , the rear edge  18  and the second longitudinal side  22 , a peripheral edge  56  extends about the surface  24  of the test element  14 . The peripheral edge  56  comprises a first widened area  42  on the first longitudinal side  20  and the second longitudinal side  22  of the test element  14 , and a second widened area  44  on the second longitudinal side  22 . These widened areas  42  and  44  each represent a spring abutment  40  for an elastomer spring  36 . 
         [0040]    A lancet  26  is arranged centrally on the surface  24  of the test element  14 . In the embodiment shown in  FIG. 1 , the lancet  26  is designed as a needle and accordingly has a circular cross section. Instead of a needle-shaped lancet  26 , it is of course also possible to design the lancet  26  with other than needle-like geometries (see the alternative embodiments shown in FIGS.  6  and  6 . 1 ). 
         [0041]    The lancet  26  comprises a lancet tip  28 , which is sharpened to a point. The lancet tip  28  can be provided with a ground surface, which can be provided in a wide variety of geometries so that, upon insertion of the lancet tip  28  into the skin of the test subject, a skin opening is created that allows a body fluid to emerge. The lancet  26  moreover comprises a lancet body  32 . At the end remote from the lancet tip  28 , the lancet body  32  has a blunt end  30 . The blunt end  30  can be designed, for example, simply as a flat surface. The lancet body  32  of the lancet  26  is enclosed at about the middle by a plastic sheath  34 . 
         [0042]    An elastomer spring  36  extends between the plastic sheath  34  of the lancet body  32  and the spring abutments  40  formed at the first widened area  42  and at the second widened area  44 . The elastomer spring  36  has at least one elastomer cord  38  on both sides of the lancet  26 . The areas of the elastomer spring  36  extending between the plastic sheath  34  of the lancet body  32  and the spring abutments  40  can be cord-like, thread-like or strip-shaped. The elastomer spring  36  is formed by punches, incisions or cuttings  46  being made in a hot-melt elastomer (e.g. Geniomer produced by Wacker, Burghausen, or Pellethane produced by Dow Plastics). The individual cords  38  are formed by the punches, incisions or cuttings  46  in an area of the hot-melt elastomer in which the latter has a reduced thickness of, for example, at most 200 μm. It will be seen from the view in  FIG. 1  that the elastomer spring  36  shown there has two individual cords  38  on both sides of the plastic sheath  34  of the lancet body  32 , which individual cords  38  elastically connect the plastic sheath  34  of the lancet body  26  to the first widened area  42  and to the second widened area  44  of the peripheral edge  56 . 
         [0043]    In the area of the rear edge  18  of the lancet system  10 , a recess contour  48  is formed in which upon insertion of the lancet system  10  into a measurement appliance the peripheral edge  56  at the rear edge  18  and the surface  24  of the test element  14  can be optionally incised in order to expose the blunt end  30  of the lancet  26 . Although the recess contour  48  in the view according to  FIG. 1  is rectangular it may also be semicircular or V-shaped. However, the incising of the lancet system  10  along the recess contour  48  in the area of the rear edge  18  of the lancet system  10  is not absolutely necessary. The separation of the material of the lancet system  10  along the recess contour  48  can take place during insertion of the lancet system  10  into a measurement appliance, can be done manually, or can be completely omitted. 
         [0044]    The lancet system  10  shown from the front in  FIG. 1  comprises a sterile protective band of film which forms a film pouch  50  and encloses the lancet  26  and the elastomer spring  36 . The undersides  82  of the film pouch  50  is fixedly connected, for example welded, to the test element  14 , along the peripheral edge  56  thereof. The film pouch  50  is folded along the front edge  16  of the lancet system  10 ; a fold lying in front of the lancet tip  28  is designated by reference number  54 . The top face  62  of the film pouch  50  is fixedly connected, along the peripheral edge  56  to the underside  82 . In the region of the widened areas  42  and  44 , the top face  52  of the film pouch  50  is fixedly connected to the top face of the widened areas  42  and  44 , and the underside  82  of the film pouch  50  is fixedly connected to the underside of the widened areas  42 ,  44 . Narrow edges  42   a,    42   b,    44   a  and  44   b  of the widened areas  42 ,  44  are flattened and merge in a gas-tight and germ-proof manner into the connection between the top face  52  and underside  82  of the film pouch  50 . 
         [0045]    The view according to  FIG. 2  is a plan view of the rear face of the lancet system according to the invention shown from the front in  FIG. 1 . 
         [0046]    It will be seen from the view in  FIG. 2  that a film with an electrode structure  96  is applied to a rear face  60  of the lancet system  10 . The film with electrode structure  96  is preferably a film which is made of an electrically conductive material, for example gold, and in which conductor tracks  71  extend between a measurement area  64  on the rear face  60  of the test element  14  and connect the measurement area  64  to a first electrode  66  on the first longitudinal side  20  and to two further electrodes  68  and  70  on the second longitudinal side  22  of the test element  14 . 
         [0047]    On the front edge  16  of the test element  14  there is a capillary inlet  62  of a capillary  92  through which, for example, a body fluid such as blood, emerging from an opening created by the lancet tip  28  in the skin of a test subject, passes into the measurement area  64 . In the measurement area  64 , an analyte in the body fluid from the test subject can be detected, for example by electrochemical means. In addition to an electro-chemical detection method, an optical detection method for determining an analyte in a body fluid from a test subject can also be effected in the measurement area  64 . In this case, instead of the film with electrode structure  96 , optical displays can be formed inside the measurement area  64 , for example optical windows, and the electrode structure  96  could then be dispensed with. The measurement area  64  on the rear face  60  of the test element  14  is closed off by a cover film  72 . A spacer layer  90  bridges the conductor tracks  71  to the electrodes  66 ,  68  and  70 . 
         [0048]    At the rear edge  18  of the rear face  60  of the test element  14  according to the view in  FIG. 2 , the material of the surface  24  of the test element  14  is removed along the recess contour  48  shown in  FIG. 1 . In this way, the rear area of the lancet body  32  and parts of the peripheral edge  56  are visible in  FIG. 2 . If the material of the test element  14  is removed in the area of the recess contour  48 , as is shown in  FIG. 2 , the energy of a puncturing drive mechanisms for permitting a rapid puncture movement can be applied unimpeded to the lancet body  32  of the lancet  26  at the blunt end  30 . 
         [0049]    The lancet system  10  proposed according to the invention operates in the following way: 
         [0050]    The lancet system  10  is fitted manually or automatically into the measurement position in a measurement appliance. When inserting the lancet system  10 , the film pouch surrounding the rear end of the lancet system  10  can be incised on both sides of the lancet  26  in the area of the recess contour  48 . The incision can also be made later in the measurement appliance, by the puncturing drive mechanism present therein, or can be omitted entirely. The front edge  16  of the lancet system  10  preferably assumes such a position that a user can bring the front edge  16  into contact with the skin, for example of a finger. The puncturing drive mechanism presents in the measurement appliance is then tensioned. The lancet system  10  is brought into contact with the skin via its front edge  16 A, and a trigger for the puncturing drive mechanism in the measurement appliance is activated. The puncturing drive mechanism can also be triggered by sufficiently powerful pressure being applied, for example by the finger, on the front edge  16  of the lancet system  10 . Upon activation of the trigger, the puncturing drive mechanism of the measurement appliance is set in motion. An advancing element of the puncturing drive mechanism, designed for example as a ram, pushes the lancet  26  forwards in the direction of the front edge  16  of the lancet system  10 . On its way forwards, the lancet tip  28  of the lancet  26  first pierces the film pouch  50  surrounding the lancet  26  at the fold  54  and then penetrates into the skin of the test subject. The depth of penetration of the lancet tip  28  of the lancet  26  into the skin is determined by the advance of a ram element, for example, of the puncturing drive mechanism. The puncture depth can be set on the measurement appliances by adjusting the advance travel of the ram, for example. 
         [0051]    With the forward movement of the lancet  26  relative to the test element  14 , the at least one elastic cord  38  of the elastomer spring  36  elastically fixing the lancet  26  on the test element  14  is also pretensioned. When the end of the advance movement of the puncturing drive mechanism is reached, the latter travels back to its starting position. By contrast, the at least one tensioned elastic cord  38  of the elastomer spring  36  draws the lancet  26  back into the film pouch  50  that has already been pierced during the puncture movement. 
         [0052]    A drop of blood or body fluid emerges through the puncture made in the skin. The opening of the capillary  62  is brought into contact with the drop of blood either automatically or manually. The emerging blood or body fluid is taken up by suction through the capillary  92  and wets the measurement area  64  on the rear face  60  of the test element  14  of the lancet system  10 . The measurement of the analyte concentration within the measurement area  64  takes place in a manner known per se. After completion of the measurement, the used lancet system  10  is discarded or is transferred into a magazine for collection of used lancet systems  10 . 
         [0053]    The views according to  FIGS. 3   a  and  3   b  are cross sections through the lancet system proposed according to the invention, which is shown from the front in  FIG. 1  and from the rear in  FIG. 2 . 
         [0054]    The cross-sectional view according to  FIG. 3   a  shows that the lancet system  10  has a layered structure  98 . 
         [0055]    From the layered structure  98  shown in  FIG. 3   a,  it will be seen that the lancet system  10  can be produced as a continuous band which, on a top face, comprises a continuous band  84  with lancets  26  that are spaced apart from one another and are each enclosed by the plastic sheath  34 . A large number of lancets  26 , spaced apart from one another by the width of a test element, are connected via a hot-melt elastomer (for example Geniomer produced by Wacker, Burghausen) to form a continuous band  84 . This continuous band  84  comprising mutually spaced-apart lancets  26  is enclosed at both ends by the film pouch  50 . In  FIG. 3 , the top face of the film pouch  50  is indicated by reference number  52 , and the underside of the film pouch  50  is indicated by reference number  82 . By means of the film pouch  50 , the continuous band  84  with the individual lancets  26  connected to one another by the elastic elastomer is sealed off by the film pouch  50 . It will be seen, from the view according to  FIG. 3   a,  that the plastic sheath  34  enclosing the individual lancets  26  is connected via the individual cords  38  of the elastomer spring  36  to the first widened area  42  and to the second widened area  44 . The first widened area  42  or second widened area  44  of the lancet system  10  has a thickness indicated by reference number  102  and corresponding to about ¼ to 5/4 of the thickness of the lancet  26 . The elastomer spring  36  is formed in the hot-melt elastomer at a thickness  100 , which is a maximum of 200 μm. The plastic sheath  34  extends along the length of the lancet  26  by at least 1/10 of its length. The widened first and second areas  42 ,  44  of the continuous band  84  extend in a width of between 1/10 and ¼ of the width of the test elements  14  and have a length which is at least 1/10 of the length of the lancet  26 . The elastomer spring  36  indicated in  FIG. 3   a  (cf. view in  FIG. 1 ) is produced by punching or cutting or shaping within the areas of the continuous band  84  formed in the thickness  100 . The continuous band  84  is bonded by means of an adhesive layer  86 , for example a hot-melt adhesive, to a band of film  88  that serves as a support band. In the view according to  FIG. 3   b,  along section IIIb-IIIb from  FIG. 2 , a two-sided adhesive spacer layer  90  extends above the band of film  88  and has capillary channels  92  formed in it via which the body fluid collected at the puncture site is transported to the measurement area  64  (not shown in  FIG. 3   b ) of the lancet system  10 . The film with electrode structure  96 , shown on the rear face  60  of the lancet system  10  in  FIG. 2 , is located on the underside of the band of film  88 . The capillary channels  92  and the spacer layer  90  are covered by the cover film  72  which is shown partially in  FIG. 2  and there covers the measurement area  64  of the lancet system  10 . Reference number  52  designates the top face of the film pouch  50  made of a sterile protective band of film. 
         [0056]    In the view according to  FIG. 3   a,  the lancets  26  connected to one another within the continuous band  84  are designed as needles. The lancets  26  can be made from a special-grade steel with a diameter of 0.8 to 0.25 mm. The lancet tip  28  is ground to a point, and a wide variety of ground surfaces are possible that permit perforation of the skin of a test subject. To produce the test strips according to the invention, a large number of lancets  26 , at a mutual spacing of one test element width, are connected by a hot-melt elastomer (Pellethane produced by Dow Plastics) to form a continuous band  84 . It is ensured that the individual lancets  260  are enclosed by the elastomer along at least 1/10 of their length, as a result of which the plastic sheath  34  is formed. A widened area is formed centrally between two lancets  26 , see the first widened area  42  and second widened area  44  whose widths are at least 1/10 and at most ¼ of the width of the test element  14  and which extend along at least 1/10 of the length of the lancet  26 . The widened areas  42  and  44  have a thickness  102  which measures ¼ to 5/4 of the thickness of the lancet  26 . Between the lancet  26  and the first and second widened areas  42  and  44 , the continuous band  84  is reduced in thickness to a thickness of at most 200 μm (reference number  100 ). In this area of reduced thickness  100 , at least two individual cords  38  (compare plan view according to  FIG. 1 ) of the elastomer spring  36  are formed by punching, cutting or incision, which individual cords  38  on both sides of the lancet  26  create connections to the first and second widened areas  42  and  44  acting as spring abutments  40 . 
         [0057]    While controlling the spacing of the lancets  26  from one another and the position of the lancets  26 , the continuous band  84  (cf. view according to  FIG. 7 ) is transported onto the sterile protective band of film from which the film pouch  50  is formed. The sterile protective band of film is characterized by a low to moderate tear strength, by good thermal weldability and by its ability to be sterilized by radiation. The sterile protective band of film can, for example, be made from a foamed OPP (DuPont Teijin Films). The width of the sterile protective band of film is more than twice the length of the individual lancets  26 . The sterile protective band of film is provided on one side with pilot holes  112 , shown in  FIG. 4 . The plot holes  112 , which are formed in  FIG. 4  on the sterile protective band of film, and shown in  FIG. 4  from the direction of the top face  52 , permit an orientation and exact alignment of the individual layers  84 ,  88 ,  90  of the layered structure  98  relative to one another, as shown in  FIG. 3   a.  Since these are made of plastic material, it is entirely possible that they may become offset relative to one another during the production of the lancet system  10 , so that an exact orientation of the individual layers of the layered structure  98  of the lancet system  10  is achieved using the pilot holes  112  according to  FIG. 4 . The continuous band  84  with the individual, interconnected lancets  26  is thermally connected to the sterile protective band of film at the first and second widened areas  42  and  44 . The sterile protective band of film is folded over the lancet tips  284  to form a film pouch  50 . The turned-back fold  54  lies in front of the lancet tips  28 . The resulting film pouch  50  is thermally sealed, so that the individual lancets  26  on each lancet system  10  are individually packed and sterilized. The resulting band  84  is wound up and undergoes sterilization, for example by radiation. 
         [0058]    In parallel with the production of the continuous band  84  with the lancets  26  that are individually enclosed by the film pouch  50 , the test elements  14  are produced on a support band  88 . This band is a Melinex film with a thickness of 350 μm (manufacturer: Huhtamaki Deutschland, Ronsberg/Allgäu) in which the pilot holes  112  shown in  FIG. 5  are arranged at a defined distance from one another that corresponds to an integral multiple of the width of one test element  14 . 
         [0059]    The underside of the support band  88  is coated with a film having electrode structures  96 , from which, after removal of excess material, the individual electrodes  66 ,  68 ,  70  and conductor tracks  70  extending into the measurement area  64  are formed. Enzyme electrodes can be formed by applying an electrochemical detection reagent, for example a reagent paste. The spacer layer indicated by reference number  90  in  FIG. 3   a  comprises the capillary channels  92  and is closed off by a hydropohilic cover film  72 , so that sample fluid can be transported through the capillary channels  92 , which are closed off by the cover film  72  and laterally delimited by the space layer  90 , to the electrode connections of the electrodes  66 ,  68  and  70  lying in the measurement area. 
         [0060]    At a distance from the capillary  62  shorter than the length of the lancet  26 , and in alignment with the capillary  62 , rectangular recesses are formed in the support band  88 , these recesses being shown by recess contour  48  in connection with the description of  FIGS. 1 and 2 . The width of the recess contour  48  corresponds at least to the width of the ram provided on the appliance. The length of the recess contour  48  viewed in the direction of puncturing, results from the dimensions of the parts involved and from the desired travel of the lancet tip  28 . 
         [0061]    While the recess contour  48  in the views according to  FIGS. 1 and 2  is rectangular, it is alternatively possible for the recess contour  48  to have a semi-circular or V-shaped form, for example. This ensures that an advancing element of a puncturing drive mechanism can act unimpeded on the blunt end  30  of the lancet body  32 , so that the puncturing movement of the lancet  26  for creating a perforation in the skin of the test subject can be effected at the greatest possible speed, which reduces to a minimum any pain felt by the patient during the puncturing procedure. 
         [0062]    From the view according to  FIG. 3   a,  it will be seen that the continuous band  84  (compare also the view according to  FIG. 7 ) in which the individual lancets  26  are individually spaced apart from one another is enclosed by the sterile protective band of film acting as film pouch  50  and is connected to the band of film  88  via the underside  82  of the film pouch  50 , by means of an adhesive layer  86 . The adhesive layer  86  can be a two-sided adhesive band or a hot-melt adhesive. After sterilization of the continuous band  84  with the lancets  26  packed in the film pouches  50 , the adhesive layer  86  is applied to that side of the support, band  88  of the test elements  14  lying opposite the electrode structure  96 . Excess material, both of the sterile protective band of film of the film pouch  50  and also of the support band  88  and spacer layer  90  in which the pilot holes  112  are located (compare view according to  FIGS. 4 and 5 ), is removed. The individual lancet systems  10  can then be packed individually or in groups into cartons, magazines or blister packs. 
         [0063]    The spacer layer  90  shown in  FIG. 5  comprises parts of the capillary channels  92 , which are punched into the latter. When an edge area of the spacer layer  90  is detached along a detachment edge  110 , openings of the capillary channels  92  are obtained which lie at the front edge  16  (compare view according to  FIG. 2 ) of the finished lancet system  10 . The support film  88  shown schematically in  FIG. 5 , with the affixed spacer layer  90 , additionally comprises pilot holes  112  which are arranged along opposite edges  108  and are spaced apart from one another by a distance corresponding to an integral multiple of the width of the test elements  14 . The pilot holes  112  permit an exact orientation of the individual layers  88 ,  90  and  72  and of the band  84  and of the sterile protective band of film relative to one another. 
         [0064]    The views according to FIGS.  6  and  6 . 1  show an alternative embodiment variant of the lancet  26  shown in  FIG. 1 . Instead of the lancet  26  shown in  FIG. 1  having a circular cross section and being designed as a needle, the lancet  26  can also be made as a flat lancet  114  from steel. The cross section of the flat lancet  114  shown, in  FIG. 5  can be rectangular, for example, as is indicated by reference number  118  in  FIG. 5.1 . It is equally possible for the lancet  26  to be designed with a square cross section, although this is not shown in the drawing, since it is simply a geometric variation of the embodiment of the lancet  26  according to FIGS.  6  and  6 . 1 . 
         [0065]    In a manner analogous to the way in which the lancet  26  designed as a needle is mounted elastically in the illustrative embodiment of the lancet system  10  shown in  FIG. 1 , the flat lancet  114  shown in FIGS.  6  and  6 . 1  can likewise be enclosed by a plastic sheath  34  and can be connected by at least two cords  38  of the elastomer spring  36  to the first, and second widened areas  42  and  44  serving as spring abutments  40  on the peripheral edge  56  of the test element  14 . Depending on the angle position of the at least two individual cords  38  of the elastomer spring  36 , which extend on both sides of the lancet  26  mounted centrally on the test element  14 , and depending on the spring characteristics of the material from which the continuous band  84  is made, the speed of the return movement and the puncturing speed to be applied by the puncturing drive mechanism can be configured so that the puncturing procedure for withdrawal of a body fluid can be carried out in a way that causes the patient the least possible pain. 
         [0066]    The view according to  FIG. 7  shows a continuous band containing a plurality of lancets spaced apart from one another. 
         [0067]    It will be seen from the view according to  FIG. 7  that the individual lancets  26  of the lancet system  10  are each elastically mounted between widened areas  42 ,  44  via cords, threads or strips  38 . Lying at the end remote from the lancet tip  28  of each individual lancet  26  is the blunt end face  30  of the lancet  26 , on which end face  30  a ram provided in the appliance acts in order to move the lancet  26  forwards. The continuous band  84  shown in a plan view in  FIG. 7  and containing individual lancets  26  is shown in the cross-sectional view of the lancet system  10  according to  FIG. 3 . 
         [0068]    It is noted that terms like “preferably”, “commonly”, and “typically” are not utilized herein to limit the scope of the claimed invention or to imply that certain features are critical, essential or even important to the structure or function of the claimed invention. Rather, these terms are merely intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the present invention. 
         [0069]    For the purposes of describing and defining the present invention it is noted that the term “substantially” is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation, The term “substantially” is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subjects matter at issue. 
         [0070]    Having described the invention in detail and by reference to specific embodiments thereof, it well be apparent that modification and variations are possible without departing from the scope of the invention defined in the appended claims. More specifically, although some aspects of the present invention are identified herein as preferred or particularly advantageous, it is contemplated that the present invention is not necessarily limited to these preferred aspects of the invention.