MXPA06010039A - Body fluid sampling device - Google Patents

Abstract

Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, and the device further comprising a fluid receiving means remote spaced apart from said collection zone so that body fluid in said collection zone will not contact the fluid receiving means initially. Said collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0,5 s. Said fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from said collection zone is automatically or manually transported to said fluid receiving means to contact said fluid with said test zone.

Description

BODY FLUID SAMPLING DEVICE Field of the Invention The present invention relates to the field of the analysis of bodily fluids to verify the concentration of analytes such as the concentration of glucose in the blood. BACKGROUND OF THE INVENTION The invention relates to a device and system for sampling small amounts of a body fluid. A device for sampling a body fluid comprises a skin piercing element with a collection zone (eg, in a fluid path) for receiving body fluid therein. At least a portion of the collection zone is open to the environment so that the fluid can be sampled. The sampling device or a separate element comprises means for receiving the fluid that are out of fluid contact with the collection area of the skin piercing element, so that the fluid sampled in the collection zone will not initially contact the means of receiving the fluid. The device for sampling the body fluid with a connected collection zone or a system comprising a device for sampling the body fluid and means for receiving the fluid, can be taken to a second state in which at least a portion of the Collection area makes Ref. 175043 contact with the receiving media of the fluid so that the fluid is transferred. Based on the signals from a test zone of the fluid receiving means, the concentration of the analyte can be determined. The systems for sampling body fluids are already known in the prior art in which the body fluid is received in a disposable element. The blood collection and analytical systems are already known from EP 0 199 484 for example which comprises a disposable unit with a capillary for collecting the body fluid and for transporting the body fluid to a detection area. Further development of this concept is described in WO 97/42888. The arrangement described in this document is particularly suitable for the collection of relatively small amounts of bodily fluids which is effected mainly by the compression of a ring on the area surrounding a collection site and by the application of a pumping movement. A system for analysis based on small amounts of interstitial fluid is already known from EP 0 723 418. For this purpose, a very thin hollow needle is inserted into the dermis and the interstitial fluid is transported through the needle to a test area by applying pressure to the area surrounding the perforation site. A highly miniaturized arrangement which also uses a hollow needle to extract body fluid is already known from US 5,801,057. A particular advantage of this arrangement is the extremely thin needle that can be inserted into the region of a patient's arm essentially without any pain. Although the arrangement described in US 5,801,057 already satisfies many practical requirements, some features need to be improved. A general problem with the sampling devices according to the aforementioned document is to manufacture the hollow needle, which is as cost-effective and as small in size as possible. To this end, body fluid samplers that have an open collection area have been contemplated. US 2003/0018282 and US 2003/0028125 both describe skin piercing devices having an open channel for sampling body fluids, which is located at least partially in a region of a piercing needle. The body fluid sampled in the collection zone is transferred to a test area that is fixed to the skin piercing element. In particular US 2003/0028125 discloses that the skin piercing element is integral with a part of a test strip. An additional document contemplating a similar sampling and testing device that provides a collection area is described in US 2002/0168290.

WO 01/72220 describes a fluid analysis and sampling device with a dermal penetration probe. The penetration probe is in direct fluid communication with an analysis chamber. Consequently, this design of the device has the disadvantage that the sterilization of the penetration probe, which is regularly achieved by the gamma radiation, destroys the test chemical located in the analysis chamber. The additional sampling and analysis are spatially fixed to each other and therefore need to be close together to allow efficient transfer of the sample. The prior art sampling and sampling devices describe embodiments wherein the sample from a capillary channel is transferred directly to a test zone that is in fluid contact with the channel. Contrary to what the present invention proposes, the testing and sampling devices for body fluids where the collection zone, in a phase in which the sample is received, is out of fluid contact with a test zone. In a second phase, after having received a fluid sample in the collection zone, at least a portion of the collection zone is being transferred to a second position in which at least a portion of the collection zone becomes available. in contact with a means of receiving the fluid that receives the fluid from the collection zone.

Alternatively, the means for receiving the fluid can be moved or both the fluid receiving means and the collection zone can be moved. Brief Description of the Invention In a first preferred embodiment, a body fluid sampling device comprises a skin piercing element having a collection area for receiving body fluid and fluid receiving means comprising a test area. The means for receiving the fluid are out of fluid contact with the collection zone so that the fluid present in the collection zone will not make contact with the fluid receiving means. Alternatively, the fluid receiving means may not have an integrated test zone but are in contact with a separate test zone to achieve the analytical test. A second preferred embodiment comprises an integrated device with a skin piercing means having a fluid collection area as well as a fluid receiving means with a test area. The integrated device is adapted to undergo a physical change (in particular a movement of the collection area in relation to the fluid receiving means) during the actuation to assume a state of contact in which a fluid in the collection zone makes contact with the means of receiving the fluid.

A third preferred embodiment refers to a device according to the first preferred embodiment, wherein the device has a movable portion that can be moved and at least a portion of the fluid collection area or fluid receiving means is located on the movable portion. A fourth preferred embodiment refers to a device according to the first preferred embodiment, wherein the body fluid received in a collection zone is moved by electric drive on the fluid receiving means. A fifth preferred embodiment comprises a device according to the first preferred embodiment, wherein the body fluid received in the collection zone is transferred in contact with the fluid receiving means without using the body fluid as a means of transport. According to a sixth preferred embodiment of the invention, the body fluid sampling device is brought into contact with a separate transport element for receiving the fluid which in turn then comes into contact with a test area on an element separated. The present invention is useful in particular for portable test systems. further, it is preferable if the skin piercing element is a disposable element that is used only once. It is also preferred to employ disposable fluid receiving means that are only used once. According to a prior art embodiment, the means of transport comprise, for example, a capillary reaching from the collection area to the fluid receiving means (for example EP 1 360 931). The body fluid is received in the test zone and transferred to make contact with the fluid receiving means by capillary action, ie, the body fluid subsequently absorbed pushes the sample to the fluid receiving means. This volume of fluid additionally needed, the so-called dead volume, serves as a means of transport to transfer the fluid used for the analysis to make contact with the fluid receiving means. This means that in principle a greater amount of body fluid volume has to be collected than is necessary for the measurement and this dead volume increases with the increase of the transfer distance. According to the present invention, contrary to prior art, dead volume is not necessary. Ideally, the volume of the total sample that is collected in the collection zone is transferred to the fluid receiving means that will be used for the measurement. Of course, it is likely that some of the sample remains in the collection area, as is the case with the use of a capillary. Furthermore, according to the present invention, the volume of the body fluid necessary to be sampled for measurement does not necessarily increase with increasing distance between the collection zone and the fluid receiving means. Another advantage of the invention is that, due to the fact that the skin piercing element and the fluid receiving means are not initially in fluid contact, they can easily be separated into two parts. The piercing element of the skin, or at least a part thereof, pierces the skin and therefore it needs to be sterilized. The test zones, in most cases however, are sensitive to sterilization. The separation of the perforating element from the skin and the fluid receiving means in two parts solves this problem because the skin piercing element can be sterilized separately from the fluid receiving means and consequently, prevents a destruction of the chemical substance. test. The fluid receiving means may themselves contain a test zone or they can be an element without a test zone that transports a sample to a separate test zone. In both cases, the wetting of the test zone, however, can be initiated in a controlled manner by the contacting stage. This activation of the wetting of the test zone has the advantage that the reaction time (ie the time between the contact of a test chemical with the fluid in the sample and the reading of the test results) can to be controlled which leads to a higher accuracy of the analyte determination. An additional advantage compared to the sampling devices of the prior art is that the sampling of the fluid and the contact of the sampling device with a test zone can be carried out in different locations. Fluid sampling, for example, can be done at the front end of a portable apparatus, while contact with a test zone can be done inside the apparatus. Due to this reciprocating function of the skin piercing element, the optical elements or other evaluation means can be moved into a housing which is advantageous with observation towards the limited space at the front end. In addition, a physical separation of the blood test zone during the sampling stage prevents the test chemical from diffusing into the human body during sampling. Thus, the present invention has significant advantages over the fluid sampling devices of the prior art. A particular field of application of the systems and devices for the extraction of small amounts of a body fluid is the so-called verification of a point at which the concentration of the particular analytes present in the bodily fluids is determined at a particular time. Such measurements can be carried out repeatedly at intervals of time to verify a change in the concentration of the analyte. Such an analysis employing disposable test elements has proven to be particularly advantageous especially in the field of blood sugar measurement for diabetics. If excessively high blood sugar concentration values (hyperglycemia) are present in a diabetic over a period of time, this can lead to serious long-term damage such as blindness and gangrene. If, on the other hand, a diabetic falls into a state of hypoglycemia because, for example, he has been injected with too large a dose of insulin, this can be life-threatening if the diabetic falls into a so-called shock. hypoglycemic Regular control of the blood sugar level makes it possible for the diabetic person to avoid the hyperglycemic and hypoglycemic states and also to learn how to coordinate their eating habits, body activity and insulin medication. In addition to maintaining and improving the health of diabetic people, regular verification of blood sugar is also considered a total economic advantage since the high costs of secondary diseases can be avoided. The reasons that prevent a greater diffusion and the consequent use of the verification of the sugar in the blood are mainly the pain caused by the required collection of the body fluid and the multiple management stages of the systems currently on the market. With commonly used systems, the diabetic person or medical group must first obtain a drop of blood which is usually obtained from the fingertip. The so-called lancet devices can "be used to reduce pain. A lancet device must first be loaded with a lancet, tensioned, placed on the surface of the body and fired. After the process with the lancet, the user has to squeeze his finger to transport a drop of blood out of the puncture wound. Prior to this procedure, the diabetic has already placed a test strip on a blood sugar measuring instrument and activated it. The drop of blood can now be supplied to the test strip and after for example 10 s, a blood sugar measurement is available. Finally, the user has to discard the used lancet and test strip. The present invention makes it possible for the blood sugar measurement process to be greatly simplified. However, the present invention can be used for other analytes as well. It is also possible to analyze the fluid sampled with different test zones simultaneously or consecutively. The simplification of the test according to the present invention is not only advantageous for ordinary users, but it is also hoped that this effect will cause more people with diabetes or other diseases to test their blood glucose concentration or other parameters. on a more regular basis. Brief Description of the Figures Figure 1 shows a preferred embodiment of a body fluid sampling device. Figure 2 shows a skin piercing element which may be a round or hollow solid lancet having sharp surfaces with edges for piercing. Figure 3 describes 7 blind holes with a diameter of 0.15 mm and a depth of 80 μm. Figure 4 shows an example of a hollow lancet comprising three elongated through holes. Figure 5 shows the concept of electrical activation of a contact of the sampling fluid with the test zone. Figure 6a shows the tip of the lancet with the perforating elements of the skin. Figure 6b shows the application of the finger on the tip of the lancet with the perforating elements of the skin. Figure 7 shows a cartridge for the skin piercing elements. Figure 8 shows a cartridge for the piercing elements of the skin in a cross-sectional view. Figure 9 shows a lancet with a collection area. Figure 10 shows how the piercing element of the skin is brought into contact with the finger. Figure 11 shows how the piercing element of the skin and the means of receiving the fluid used, they are extracted back to their base positions. Figure 12 shows another preferred embodiment of a skin piercing element comprising a lancet. Figure 13 shows a skin piercing element having a collection area which extends into an elongated portion of the skin piercing element. Figure 14 shows the piercing element of the skin together with a means for receiving the fluid. Figure 15 discloses a body fluid testing device that contains a plurality of test zones located on a cassette. Figure 16a, figure 16b and figure 16c show a suitable configuration for piercing the skin with a lancet and the way in which it moves. Figure 17a, figure 17b and figure 17c show a piercing element of the skin that already has the fluid sampled and its internal movement of the lancet. Figure 18a, Figure 18b and Figure 18c show a skin piercing element having two parts that can be moved relative to one another. Figure 19 shows an arrangement of the fluid receiving means. Detailed Description of the Invention A sampling device and system according to the present invention serves to extract small amounts of body fluid. Preferably, the body fluid sample is received in the collection zone while the collection zone is in the body, ie no blood is needed to drain from the perforation site and the user does not need to squeeze his finger and move the drop of blood on your finger towards a test area. Of course, it is also possible to use blood that drains from the drilling site. In this context, bodily fluids are understood in particular as blood, interstitial fluid and mixtures of these body fluids. While conventional blood collection systems usually carried out sampling on the fingertip, the collection system according to the present invention can also be used to draw blood from alternative sites of the body such as the forearm and the Palm. A skin piercing element for extracting small amounts of body fluid according to the present invention has a protruding portion with a sharp end for piercing the skin. Within at least one region of the projecting portion, a collection zone is located, which has the ability to collect body fluid. This can be achieved in particular by a capillary activity. At least a part of the structure that receives the body fluid is open. A capillary structure is understood within the scope of the invention as a body that transports body fluid as a result of capillary forces. In the case of a capillary, the channel fluid is transported towards the proximal end of the skin piercing element when the distal area is brought into contact with the body fluid. With respect to this embodiment, the capillary structure according to the invention is similar to the open needle structures described in US 2003/0018282 and US 2003/0028125 to which reference is made here. However, an important difference is that these documents describe microneedles where the capillary channel is in fluid contact with a test zone so that the body fluid received in the capillary channel is applied directly to the test zone and therefore starts the reaction.

The capillary structures in the collection zone can be manufactured by photolithographic methods similar to those described in US 5,801,057 and which are known in the field of semiconductor technology. It is also possible to provide channels, notches, holes, etc., which are open to the outside on the solid needles by polishing, etching with an acid and the like. Such structures are preferably generated by etching processes with an acid as well as photochemical polishing (PCM). PCM is based on transfer processes of an optical configuration and etching with an acid. This is already known to be a micromachining technology. In addition to the methods already mentioned for the incorporation of capillary structures in the surfaces, it is also possible to generate the capillary channels by assembling the bodies in a way that capillary holes are created. Accordingly, it is possible for example to hold two or more solid needles together, for example, by welding in such a way that the contact areas of the solid needles form the capillary channels. In a corresponding manner it is also possible to twist wires or fibers together in the form of a twisted wire in such a way that numerous contact areas are formed, which generate the capillary channels. The wires or fibers must be made of metal, glass or carbon, and may be solid or hollow, for example it may be necessary to polish a surface of the lancet to achieve open capillaries. It is also possible that the capillary is not open to the environment for a full period of time, for example, it can only be opened during the skin piercing stage to collect body fluid. Additional skin piercing elements can be created with fluid paths by applying one or more layers of the materials (eg laminated metal sheets) onto a flat needle in a manner that creates a capillary gap between the layers or is provided in one such layer. The capillary structures according to the present invention, however, are not restricted to the capillary channels leading from a distal end to a proximal end of the skin piercing element. Also the porous structures or holes can be used to sample the fluid. With the present invention, it is not essential that the capillaries transport the fluid over a macroscopic distance to achieve wetting of a test zone. Instead, the collection zone and the fluid receiving means are moved in proximity. To achieve proper sampling of the body fluid in the channel of the skin piercing element and to improve the sampling rate, it is preferred to employ hydrophilic materials, particularly for the collection zone. Alternatively or in addition to the hydrophilic materials, hydrophilic coatings may be employed. The perforating devices of the skin are introduced into the skin and therefore have to be sterile to prevent infections and inflammations. Accordingly, the skin piercing elements can be packaged in a sterile manner, for example, in an ampoule. In a preferred embodiment, the tips of the skin piercing elements are covered, for example, by a plastic to prevent contamination after the skin piercing elements are sterilized (for example, by gamma radiation). Particularly preferred are the tip guards as described in WO 01/66010. Such protective covers of the tip that surround the needle can be produced easily and can also be easily removed so that an automatic removal within a system becomes feasible. A system for the analysis according to the present invention may comprise an actuator for pulling out a lid of the tip before the skin piercing is initiated. Alternatively, the piercing element of the skin can be transferred to a position where the protective cap is maintained (for example, by adjusting the shape) and is removed from the piercing element of the skin by the movement of the piercing element of the skin moving away of the fixed lid. Prefer this movement can be carried out by means of transport or driving the lancet which is used in any way. Still further embodiments are possible wherein the protective cap is pierced by the lancet tip of the skin piercing elements as shown for example in Figure 1 or Figure 6 of WO 0166010. Alternatively, it is possible to sterilize the piercing element of the skin. the skin inside the port device directly before use, for example, by ultraviolet radiation or heating. A preferred embodiment is described in Figure 1. A body fluid sampling device according to an aspect of the invention is shown, wherein the collection zone comprises orifices or a porous surface in or on which the received body fluid is collected. It is preferred that the sampling device has 3 or more holes to receive the sample or even many more in the case of the porous surfaces. The skin piercing element shown is a flat lancet (1) made for example of stainless steel, silicon or a plastic carrier film with a thickness of 0.05 to 1 mm, prefer 0.2 mm, having small holes (2) close to the perforation edges (3) of the lancet. The holes (2) can be through holes or blind holes, and can have a diameter prefer of 0.01 to 0.5 mm. The number of holes can vary from a small number of holes to a few hundred holes, prefer 3 or more holes, 50 to 100 holes are even more preferred. A preferred diameter is around 20 μm. Alternatively, the skin piercing element may be a solid round (4) or hollow (5) lancet having sharp surfaces with edges for perforation as shown in Figure 2. Round lancets typically comprise three surfaces (6-8). ). Prefer, a solid, round lancet may have the collection area on its third surface (8). Figure 2, for example, exhibits a collection zone (9) comprising 70 through holes (2) of 20 μm in diameter, Figure 3 describes 7 blind holes (2) with a diameter of 0.15 mm and a depth of 80 mm. μm. Figure 4 shows an example of a hollow lancet (5) comprising three elongated through holes (2) in the range of 0.15 mm to 0.35 mm. Additional embodiments for a porous surface for collecting body fluid are roughened areas on one of the surfaces of the skin piercing element made for example by polishing. The recesses made by polishing form a deposit to collect the body fluid. Alternatively the pores can be applied to form the collection zone. This can be achieved, for example, by a porous coating or by etching with a selective acid from the lancet material, for example a special alloy of a solvent-resistant metal, creating a spongy surface. Especially when flat lancets are used, the thin fibers of a second material can be incorporated in the surface, for example, by rolling, which can be etched selectively with an acid. According to the above embodiments it is possible that the direction of flow of the fluid in the collection zone and out of it within a fluid receiving means is the same (for example in the case of through-holes, the receiving means of the fluid are brought into contact with the side of the holes opposite the sample inlet) or the direction of flow can be reversed (the fluid receiving means are brought into contact with the opening or holes within which the sample is received). As previously estshed, it is advantageous that the capillary channels are open to the outside so that they can receive body fluid while the capillary structure is inserted into the body. The shape of the skin piercing element is relatively non-critical. It can be for example in the form of a small cube. Usually no special measurements are necessary to mount the skin piercing element in a drive unit, but a retaining region located at the proximal end of the skin piercing element is preferred. Advantageously, the retention area is formed integrally with the other regions of the skin piercing element. Perforator designs that are known for disposable lancets of conventional blood sampling systems may be employed. For example, the retention region may have stepped zones within which the spring elements of a fastener of a drive unit engage to retain the piercing element. The perforating element is advantageously placed inside a fastener in such a way (for example by compressing the end of the perforating element away from the tip against a stop) that it allows a good control of the depth of the perforation. Reference is made to EP B 0 565 970 with respect to such a fastener and to the interaction between the fastener and the disposable lancet unit. A body fluid sampling device in addition to the skin piercing element has a fluid receiving means that is spatially separated from the collection area of the skin piercing element in a manner that the fluid in the fluid collection region of the skin The skin piercing element will not make contact with the fluid receiving means during filling. The means for receiving the fluid and the collection zone, however, are brought into contact with each other after the sample of the fluid has been received in at least a part of the collection zone and when the start of the analytical reaction is desired. . Such contact is mainly a mechanical act where the channel that retains the sample fluid and the fluid receiving means are moved together. This contact includes the compression of the fluid collection zone and the fluid receiving means together or may signify a rubbing movement. The separation of the perforating element from the skin and the means for receiving the fluid make possible the modalities in which the skin piercing element is used as a reciprocating device for transporting the sampled fluid to a medium for receiving the fluid. This is particularly advantageous when the sampling of the fluid is done in a spatially restricted area (e.g., the front end of the apparatus) and the fluid receiving means do not fit well in this limited space. The latter is the case in particular for the means for receiving the fluid fixed to a belt as described, for example, in EP 0 202 6242.4; US 4,218,421 and EP 0 299 517. The oscillating function makes possible a testing process with the steps of: piercing the skin with the skin piercing element - receiving the body fluid in a collection area of the piercing element of the skin. the skin contacting a portion of the collection zone with a fluid receiving means to provide a test zone with the sampled fluid - detecting a change in the test zone that is related to the concentration of an analyte. In a preferred embodiment, the transport means for transporting, or for applying with a reciprocating movement, and for bringing the sampled body fluid into contact with the fluid receiving means, are made automatically. Preferred but non-restrictive embodiments for the automatic transfer are electrical, mechanical, spring-loaded actuation, manual operation, for example by a user, the thrust of a slide, or a combination of these operating principles . In particular, electric motors can be used to achieve the. Contact. The mentioned means of transport can be controlled by a control unit that controls the movement of the means of transport including a spatial control as well as a synchronized control. By this time for filling the sampling element, the time course of the transportation, the time for contact with a means of receiving the fluid, and the time when the test zone is evaluated, can be controlled. Such control improves sampling and testing of the fluid and therefore increases reliability. In addition, a control unit in cooperation with a means of transport can be used to improve the sampling stage. In particular it is possible to remove the piercing element from the skin only partially by keeping it inserted in the skin but the lancet channel is already open so that body fluid can emerge more easily and be absorbed by the collection zone. It is still possible to rotate or move the piercing element of the skin in the wound to improve the release of body fluid. For piercing the skin with the lancet with skin piercing elements, conventional lancet-type lancet units can be used, for example. Additional electric motors for drilling with a lancet, such as those described in EP 1101443, can be used. The electric motors mentioned, alone or in combination with other means of transport, can be used for the movements described above of the skin piercing means. To improve sampling with the skin piercing means, a vacuum can be used to extract body fluid. Such a vacuum can be applied to the skin area where the skin piercing is performed or in the event that a vacuum for the hollow sampling needle can be applied to the channel of the sampling needle. The skin piercing element can be transferred to the fluid receiving means for contacting the piercing element of the skin with the fluid receiving means by the aforementioned transport means. Additionally, the skin piercing element can be manually transferred, for example, by the user, using for example a lancet inserted in a skin piercing device to pierce the skin and collect the fluid sample from the body. It can then be moved to a measuring instrument having a means of receiving the fluid inserted, and the collection area is brought into contact with the fluid receiving means that transfer the sample of body fluid. The test areas are especially prone to moisture deterioration. Therefore, the test zones need to be protected in some way when they are stored. The skin piercing means of the present invention can be used to perforate the sealing of a sealed fluid receiving element. This is advantageous since additional means or steps for unpacking or opening a seal can be avoided. According to the invention, it is possible that the skin piercing element is moved to the fluid receiving means, or that the fluid receiving means is moved to the skin piercing element, or that both elements are moved. When a cartridge with the fluid receiving means is used, there may also be the steps of exposing a specific fluid receiving means from the stored fluid receiving means to contact the piercing element of the loaded skin with the sampling fluid. When the specific fluid receiving means have been evaluated, other means of receiving the fluid may be exposed to contact with the sampling fluid on a skin piercing element. It is possible for the fluid receiving means used to be stored in the same cartridge or in an additional waste cartridge, or for the fluid receiving means to be discarded directly, for example manually. An automated system according to the previous reciprocating movement concept, has one or more skin piercing elements, a motor for driving a piercing element of the skin to pierce the skin, and a means of transport for carrying the piercing element of the skin. the skin in contact with a means of receiving the fluid. The motor for drilling and transport means can be used in the same drive unit. The means of transport may comprise, for example, an electric drive, a force actuation of a spring, a manual operation, for example by the thrust of a slide and a combination of these means. In a manual system according to the above reciprocating concept, the skin piercing element and the fluid receiving means are in separate units and the transport for contacting each other can be done manually, for example the user pierces the skin and collecting the sampling fluid with the skin piercing element and then moving the skin piercing element to the fluid receiving means, or vice versa, to bring the fluid sample into contact with the fluid receiving means. . Although it is preferable to move the skin piercing element to the fluid receiving means, it is also possible to transfer the fluid receiving means to the piercing element of the skin, or to move both elements. In addition, the systems may comprise a storage unit for the multiple fluid receiving means. The systems may further comprise an exposure unit for successively exposing the fluid receiving means for receiving the fluid. The skin piercing element can make contact with the fluid receiving means and the fluid sample is transferred on the fluid receiving means to the test zone, or the skin piercing element can make contact with the test area and the fluid sample is transferred directly to the test zone. In addition, a fluid receiving means may be employed that does not have a test zone but that a separate test area is brought into contact with the fluid receiving means so that finally the test zone is wetted with the fluid of the test fluid. sampling. The means for receiving the fluid are a structure that can receive the fluid from a collecting zone of the skin piercing element. This fluid reception can be effected, for example, by an electric potential applied between the fluid in the collection zone and the means for receiving the fluid. Figure 5 shows the concept of electrical activation of a contact of the sampling fluid with the test zone. A piercing element (14) of the skin having a collection zone (9) is spaced from a fluid receiving means (10) by spacers (11). A high electrical potential is applied between an electrode (12) which is in contact with the sample of body fluid in the collection zone (9) and the second electrode (13) is brought into contact with the means for receiving the fluid. This can cause either the fluid sample to move from the collection zone towards the test zone or it can cause a movement of the fluid receiving means in the direction of the collection zone. In both cases, the humidification of the test area by the sampling fluid can be triggered in a very short time cycle by the action of the electric potential. Preferably, the means for receiving the fluid have a higher capillary than the collection area of the skin piercing element so that during contact, the fluid is automatically absorbed, that is, the difference in capillarity serves as a means of contact . In this regard, the means for receiving the fluid can be made from the material of a fabric or fleece having a high capillarity and is hydrophilic (at least in the areas for receiving the fluid). The fluid receiving means may have a particular region comprising such high capillary material or the entire area of the fluid receiving means may act as the receiving means for the fluid from the fluid channel. The means for receiving the fluid can be a test zone by itself which can be covered with a woven or cloth material or the fluid receiving means can be more complex and allow the pre-processing of the fluid of the sample and / or the transport of the fluid to a sensor / test area. The pre-processing may comprise filtering the fluid sample and / or mixing with the reagents. Alternatively or to support the capillary force as the contact means, a mechanical force can be applied which compresses the collection zone and the reception element together, or - an overpressure on the side of the collection zone and / or a sub-pressure, for example, vacuum, on the receiving side, can be applied. In particular, in the collection zones comprising through holes, the overpressure on one end of the holes can be used to ensure that at least a portion of the sample leaves the collection zone through the other end and contacts the means of fluid reception. Means of mechanical or ultrasound compression (for example in a sawtooth operation), it is also possible to contact the means for transferring the fluid sample to the receiving means. The means for receiving the fluid comprise a test zone with at least one layer of chemical substances containing a reagent for detecting an analyte. The reagent suffers a detectable change due to the reaction with the analyte that is going to be detected. Typical reagents for the detection of glucose are based for example on glucose oxidase in conjunction with a chromogenic oxide-reduction system. The reagents are well known in the prior art for optical evaluation, which form a color with the body fluid glucose. Additional reagents are also known from the field of test strips for determining blood sugar that allow for the electrochemical detection of analytes. The reagent mixtures which are usually used are in a solid state and, because of their constituents (eg, aluminum oxide, kieselguhr and the like), have such high capillarity that they can receive body fluid from the capillary channel. Since these detection systems are well known from the prior art, they are not described in greater detail here, but reference is made to US 5,762,770 and US 36,268. A preferred embodiment of a body fluid collection system according to the present invention additionally has a drive unit, which, when activated, moves the piercing element of the skin from a first position to a second position in such a way that perform a movement similar to that of a lancet. Suitable drive units are well known from the top of the blood sampling systems. They may contain, for example, a spring that is cocked by the user and when released, it pushes the piercing element of the skin. A particularly advantageous drive unit is described in EP B 0 565 970. The systems for the analysis of body fluids comprise a detection unit. If a sensor / test zone containing the reagent is used, which changes color or forms a color when an analyte is present, the system may have an optical detection unit comprising a light source and a detector for detecting light transmitted or reflected. When an electrochemical detection is used, the system has electrodes that make contact with the test zone or with the means of receiving the fluid. For the evaluation of the input signals, the system can have electronic devices known in the prior art to determine the concentration of the analyte by measuring for example the so-called Cotrell current (see for example US 36,268). With the skin piercing element, according to the present invention, body fluid can be extracted while the protruding portion is inserted into the skin or the protruding portion can be retracted from the body after piercing and receives the body fluid that It comes out on the surface of the body. The production portion comprising the collection zone in the body during the collection of body fluid is preferred. A partial extraction in which the protruding portion remains in the body to collect body fluid is especially suitable for arm sampling. This is due to the fact that small incisions made in the arm close more quickly, so that no fluid or only very small amounts of fluid come out after drilling. On the other hand, pain sensitivity is much less pronounced on the arm when compared for example with the finger, and therefore when the protruding portion remains in the body, it does not feel painful. In addition, an extraction process can be carried out with the sampling device according to the invention, which is a combination of the previously mentioned processes. In this combined process, the perforation is carried out first, the protruding portion can be pulled back over a portion of the drilling route and allowed to lie there during a collection period. Depending on the circumstances, it may be possible to remove the residual blood almost completely so that no blood is observed by the user. An additional decisive factor that is important for an efficient absorption of body fluid is the wetting capacity of the collection zone. When capillary structures made of silicon are used, they are usually suitably wettable due to a layer of silicon oxide on the surface. If the metals are used for the capillary structure, these are often relatively difficult to wet. This can be counteracted by a number of different hydrophilization measures such as surface silicate treatment. Wettability is usually adequate when the liquid in the capillaries has a concave meniscus which is the case when the wetting angle is less than 90 °. In a preferred embodiment of a body fluid collection system, the volume of the fluid sample is very small, ie less than 0.5 μl, preferably 3 to 10 ni. Such a small volume can be collected very quickly, for example using very small holes, for example 20 μm in diameter, which generate high capillary forces for rapid filling. The time to receive a sufficient amount of the body fluid sample may be less than 0.1 s, for example 1 to 10 ms. Accordingly, the interaction time between the piercing element of the skin and the body while the skin piercing element remains in the body and the sufficient amount of the body fluid sample is received can be less than 0.5 s., for example approximately 10 ms. Preferably, the body fluid sample is collected in the body so that eventually no blood is visible on the skin. According to the invention, the geometry of the collection zone and therefore the volume of the body fluid that is collected, are precisely defined, for example, the risk of overdosing or underdosing of the media receiving the fluid, It is significantly reduced. By using a sampling device according to the invention, the reception of the body fluid sample can take less than 0.1 s, preferably 10 to 15 ms. Advantageously, an expression means for expressing the sampling fluid from a portion of the body can be embodied in the present invention. A means of expression can be a cone (15) for the finger, specially formed, which is to be used to improve the collection of the sample, which is described in Figures 6a-6b. It shows an example of the operation and action of a cone (15) for the finger according to US 6,589,260. As shown in Figures 6A and 6B, a tip of the finger is pressed by the user on the finger cone in such a way that the finger cone is pressed together and the internal width (16) of the finger cone is reduced. As a result, a part of the finger tip is depressed and the internal pressure in this region (17) is increased. This design improves the sampling of body fluid in the collection area and minimizes the leakage of body fluid from the body. The internal width (16) should ideally be in the range of 8 to 11 mm so that it is suitable for the fingers of a large adult in this way for the fingers of a child. Uh sampling system of a body fluid with an automatic transfer of the collection area to the fluid receiving means according to the present invention, is a one-stage, rapid operation system, which is easy to use, even for the elderly, disabled or blind users. Due to the volume of the small sample that is collected, the contamination risk of the components of the system, especially the measuring instrument, is reduced, promoting the hygienic disposal of the means of receiving the fluid. The elevated mass of the skin piercing element compared to the volume of the very low fluid sample makes it easy to maintain the variation of the temperature of the sample in a small amount, preferably below 10 ° C, for example by heating the skin piercing element at a temperature of 20 ° C to 40 ° C, preferably 30 ° C. For the accurate test it is also preferred to provide a constant temperature in the test region which is in the range of 20 ° C to 40 ° C. Advantageously, the perforating elements of the skin and / or the means for receiving the fluid can be provided in cartridges. A possible embodiment may comprise, for example, a skin piercing device with a cartridge for the skin piercing elements and / or a cartridge for the fluid receiving means as a separate unit or integrated, for example, in the instrument of the invention. measurement. A preferred embodiment of the lancets as skin piercing elements and test strips as the fluid receiving means, arranged in a cartridge according to the present invention, is shown in Figs. 7-11. Figures 7 and 8 describe a cartridge (21) for the perforating elements of the skin and a case of a cylinder with the test strips, external, concentric (22), with separate chambers for each of the means of receiving the fluid (2. 3) . Each chamber is sealed by a sheet of rolled metal and each element has an external handle to which an actuation mechanism of the instrument can be connected to move the element out of the cartridge and back into the cartridge. The tear-off foil sheets (25) seal the chambers. The piercing element of the skin and the means for receiving the fluid are each mounted on respective slides (27) that guide the movement of the element. Figure 9 shows a lancet (24) with a collection area that is moved forward to penetrate the skin and collect the sample. During this movement, the respective sheet of metal sheeting is broken. Figure 10 shows how the skin piercing element (24) is brought to a contact position, for example by moving it backwards. The fluid receiving means (23) are also moved to the contact position, for example, by moving them forward. In a preferred embodiment, the fluid receiving means are bent when stored in the cavity and come to be in a position coo shown in Figure 10 when moved out of it. Therefore, the means for receiving the fluid come into contact with the fluid collection area. Alternatively, the means for receiving the fluid and the piercing element of the skin are pushed together by the appropriate driving means. When the means for receiving the fluid are pressed against the collection area of the element (24), the sample from the skin piercing element is transferred to the fluid receiving means to wet a test area with the sample. The test zone is read, for example, optically from the back side to confirm the transfer of the sample and to determine the concentration of the glucose. Figure 11 shows how after the test is complemented, the skin piercing element (24) and the fluid receiving means (23) used, are removed back to their respective cylinder chambers for storage. In a fluid sampling system according to the invention, preferably the flow collection direction of the body fluid sample that is introduced into the collection zone is not parallel, but preferably is perpendicular, with respect to the direction of Main / movement drive in the shape of a lancet, of the skin piercing element. A system according to the invention provides a disposable skin piercing element and fluid receiving means that prevent direct contact of the reactive chemical substance and the body. A skin piercing element can be made hydrophilic to improve the reception of body fluid. The hydrophilization can be carried out on the entire element or on the selected regions. In a preferred system according to the invention, the body fluid sample collected in the collection zone is moved on the fluid receiving means without using additional body fluid with the transfer medium, ie the sample is transferred by mechanical means. , preferably electric or manual, and not by fluid means. This method has the advantage that the body fluid can be transferred over a large distance if necessary without increasing the dead volume, and the sample can be delivered to a different, small point, ie the test zone. Accordingly, the size of the fluid receiving means can be reduced. Figure 12 shows another preferred embodiment of a skin piercing element comprising a solid lancet (4), round, with a notch or recess (31), for example polished or etched, to form a collection zone (2). ). Figure 13 shows a skin piercing element (14) having a collection zone (9) which extends into an elongated portion of the skin piercing element. This portion is connected to a fastener (32) in the form of a frame. The elongated portion has a protruding portion (33) which protrudes from the holding portion (32). At the front end of the projecting portion, a sharp tip (3) is located. The sharp point (3) makes it possible to penetrate the surface of the skin during puncture with the skin piercing element. The collection zone (9) is located in the region of the front end of the projecting portion. The collection zone is an open capillary channel which allows the body fluid which is in contact with the channel in the region of the projecting portion to move towards the movable portion of the collection zone (34) by means of capillary action. As shown in figure 13, the protruding portion (33), the movable portion (34) and the frame portion (32) of the skin piercing element (14) are integrally formed. The piercing element of the skin (14) can be made by etching processes with an acid. Coo is well known in silicon manufacturing processes, a silicon material insert can be etched with an acid to provide devices comprising tips and capillary channels. For mass production, however, it is advantageous to produce the skin piercing elements by etching with an acid of the thin metal plates. It is particularly advantageous that the sharp tip (3) of the protruding portion (33) can be formed during the etching process with an acid as well as to avoid the separate polishing steps. As can be seen from Figure 13, there is no reagent or sensor that is in contact with the fluid channel that could receive the body fluid immediately after the collection zone has been filled with the sampling fluid. The present invention proposes to locate a test zone or sensor separately on a medium for receiving the fluid. Figure 14 shows the skin piercing element (14) of Figure 13 together with a fluid receiving means (10) including a test area (35). Means of reception of fluid (10) are shown schematically. The fluid receiving means (10) are located on the upper side of the skin piercing element (14) on which the side of the fluid channel (9) is open to the environment. Means of reception of fluid (10) however, they are initially spaced from the collection zone (9) so that the sampling fluid within the collection zone does not contact the fluid receiving means. Therefore, no transfer of fluid from the collection zone onto the fluid receiving means occurs in this geometry of the fluid sampling device. In the embodiment shown, the fluid receiving means consist essentially of a retaining structure (11) which provides appropriate orientation and spacing of the fluid receiving means relative to the skin piercing element and to the test area ( 35). In the embodiment shown, the test zone includes a reagent that produces an optical signal based on the concentration of the analyte in the body fluid. Due to the incorporation of porous materials such as for example kieselguhr or titanium dioxide, the reagent already has a high capillarity that sucks the fluid from the capillary channel (9). The reagent is applied to a carrier surface. After the fluid has been received in the collection zone and has filled the movable section (34), the body fluid sampling device is ready for measurement. By means of mechanical actuation, the movable section (34) can be bent in the direction of the sensor (35) so that the body fluid located in the collection zone (9) makes contact with the test zone (35) and humecte to the reagent. This way of contacting the sensor with the test fluid has several advantages over prior art devices. A first advantage over prior art is that the measurement can be started at a specific time point in time. This means that the time between the wetting of the test area and the measurement of the final signal can also be chosen. The period of time, however, is shorter than the time of drying the blood in the capillary. Knowing or controlling the reaction time improves the accuracy of the measurement. In addition, a signal can be measured starting directly after the wetting that allows to verify the kinetic characteristics of the reaction. The evaluation of these initial signals can be used to also improve the accuracy of the measurement result. Fig. 15 discloses a body fluid testing device that contains a plurality of test zones located on a cassette (10) of the test medium that serves as a fluid receiving medium that allows multiple testing (see for example EP 1 424 040 ). The cassette (10) includes a supply portion that stores an uncontaminated section (41) of the tape of the test medium. A storage portion for storing a contaminated section (42) of the tape of the test medium is additionally employed. The test device is a portable device that can be conveniently operated by a user. The tape of the test medium (10) It can be part of the test device so that the complete device is discarded when the tape of the test medium is used up or the tape of the test medium can be arranged in a disposable cassette that is received in the test device . The body fluid will be applied over a sensitization region (43) which is positioned between the delivery portion (41) and the storage portion (42) to detect an analyte of the body fluid collected on the cassette of the test medium. The test device further comprises a piercing unit (skin piercing element 14) for piercing a portion of the body. The drilling unit is advantageously positioned close to the detection region. Figures 16a, 16b and 16c show an embodiment of the present invention wherein a skin piercing element (1 ') that includes a collection zone (2') and a fluid receiving means (10 ') are connected by means of a joint (50). Figure 16 a) shows a suitable configuration for piercing the skin with a lancet and sampling the body fluid with the collection zone (2 '). The collection zone for example can be chosen according to the modalities as described for figures 1 to 4. When the fluid has been sampled, the skin piercing element is removed and folded so that the collection area ( 2 ') makes contact with a test area (35') on the receiving means. The measurement can be made in this folded configuration from below. However, it is also possible to deploy the device and measure the color of the moistened portion (51) on the test area (35 ') from the upper side as shown in Figure 16 c). Alternatively, in order to fold an integrated sampling and testing device according to Figure 16, it is also possible to rotate the skin piercing element and the means of receiving the sample in a plane so that they contact the sample on the element. skin piercer with a test area. Figures 17a, 17b and 17c show a further embodiment for the transfer of the sample from a skin piercing element (1 '') onto a test area (35 ''). Figure 17a shows a piercing element of the skin which already has the fluid sampled and which has been retracted towards a housing. Two parts (60, 60 ') are provided, which compress a rubber seal (61) on the skin piercing element so that a region that retains the sampled fluid is sealed from one side. The application of additional pressure squeezes the rubber seal and the fluid from the skin piercing element is transferred over the test area (35") which is placed below it. Instead of, or in addition to transferring the fluid by contact, the transfer of the fluid is done by means of the pneumatic drive in this mode. Compared with the devices according to, for example, WO 01/72220 where the pneumatic actuator is also used, here a relative movement of the skin piercing element and the fluid receiving means (10") has been used before that the pneumatic drive is carried out. As described at the beginning, this allows to separate the portion of the lancet from the test portion and therefore the sterilization can be done without destroying the test chemical. The. Figures 17a, 17b and 17c further show that the sampling fluid from the orifices in the collection area of the skin piercing element is transferred to the opposite areas of the test area. The geometrical configuration of the holes in the collection zone leads to a similar configuration on the test area. When dry, conventional chemicals are used, the wetted areas on the test zone are initially roughly so large that the diameter of the holes in the collection zone and the fluid move vertically. It is preferred to evaluate the analyte-dependent reaction from the opposite side to the application of the sample to separate the transfer of fluid from the optical devices. Consequently, it is required to achieve complete wetting through the thickness of the test zone so that even the lowest portion of the test zone reacts. Sufficient wetting is achieved, for example, if the thickness of the test area is smaller than the depth of the holes in the collection zone.

Preferably, the thickness of the fluid receiving zone of the test zone is from 10 to 80% of the depth of the holes in the collection zone. This means that very small, thin skin piercing elements can be employed as will become more apparent by the following example. In our days it is very feasible to produce dry chemical substances that have a liquid reception structure with a thickness of the order of 10 to 50 micrometers only. To ensure proper wetting, the depth of the holes in the skin piercing element need only be in the order of 50 to 500 micrometers to collect sufficient volumes of the fluid even if the collection holes are not completely filled. This in turn means that skin piercing elements of this thickness or slightly greater thickness can be used. It is therefore preferred if the skin piercing element has a thickness below 500, still more preferably below 250 micrometers. The skin piercing means of the present invention can therefore be made approximately as thin as today's lancets that do not sample the fluid. Although the sampled volume of the collected fluid is in the nanoliter range only, reliable measurements can be achieved due to the availability of the test zones for the adequately dry chemical substances.

Figure 18 shows a skin piercing element having two parts (70, 70 ') that can be moved relative to one another. In Figure 18a the parts (70, 70 ') are aligned to form a capillary channel in which the sample is received. The filled device (Fig. 18b) is rearranged as shown in Fig. 18c. At one end of the channel, the parts are moved away from each other and therefore the sample is concentrated in the region (71) where the parts are still close together. Figure 19 shows an arrangement of sealed fluid receiving means (83) which are sealed against the environment by means of a sheet metal foil seal (88) (eg, an alumina laminate). The skin piercing means (84) are located in a portable device (80). The perforating means of the skin as shown, are already filled with the sample and are moved towards the arrangement of the fluid receiving means. The skin piercing element itself or as shown, a separate tip (85), may be employed to pierce the metal foil seal. The tip of the skin piercing element then contacts a test area below the broken metal foil to transfer the sampling fluid. The measurement of the analyte concentration can be made from the bottom side with an optical device (86) as shown schematically. To allow optical inspection, the test zone is located on a transparent support (87). Preferred features of the present invention are listed below: A body fluid sampling device comprising a skin piercing element having a collection area for receiving body fluid and a fluid receiving means comprising an area of test that is spaced from the collection zone so that the fluid in the collection zone will not make contact with the fluid receiving means, wherein the skin piercing element has two or more collection zones. The body fluid sampling device according to the invention, wherein the collection zone comprises through holes or blind holes. The device for sampling the body fluid according to the invention, wherein the collection zone comprises a rough surface or a recess for receiving body fluid. The body fluid sampling device according to the invention, wherein the volume of the body fluid received by the sampling device is from 3 to 10 ni. The body fluid sampling device according to the invention, wherein the time that the piercing element of the skin remains in the body to receive the body fluid sample is 10 msec. The body fluid sampling device according to the invention, characterized in that the time to receive a sufficient amount of the body fluid sample is less than 0.1 sec, preferably 1 to 10 msec. The system for the analysis of the body fluid comprising a skin piercing element with a collection area for receiving the body fluid, wherein at least a portion of the collection area is open to the environment and a means of receiving the fluid remote from the collection zone so that the fluid in said route will not make contact with the fluid receiving means, the fluid receiving means comprise a test zone, wherein the system comprises a meter with a detection unit for receive the signals from the test zone to determine the presence and / or concentration of the analyte. The system according to the invention, wherein the meter includes a fastener in which the means for receiving the fluid are received and a transmission of the signal from the test area to the detector is enabled. The system according to the invention, wherein the meter has a processing unit that receives a signal indicating that the contact means have contacted the collection area with the fluid receiving means or that the sampling fluid has reached the test area The system according to the invention, further comprising an exposure unit for successively exposing the fluid receiving means from the cartridge to receive the fluid. A method to determine a concentration of the analyte in the body fluid, comprising the steps of: a) receiving the body fluid in a collection area of a skin piercing element, b) contacting the collection area of the skin piercing element with the fluid receiving means in a manner that that the body fluid reaches a test zone on the fluid receiving means, c) receives the signals from the test zone that are characteristic for an analyte concentration, d) processes the signals to determine the concentration of the analyte, where a period of time beginning with step b) is verified and the determination of the concentration of the analyte is initiated based on the time that has elapsed. The method according to the invention, wherein step b) initiates a verification of the signals and the change of the signal during the course of time is used to determine a point in time for the determination of the concentration. It is noted that . in relation to this date, the best method known by the applicant to carry out the aforementioned invention is that which is clear from the present description of the invention.

Claims (43)

1. CLAIMS Having described the invention as above, the content of the following claims is claimed as property. A sampling device for a body fluid, characterized in that it comprises: - a skin piercing element having a collection area for receiving body fluid, wherein at least a portion of the collection area is open to the environment and - a fluid receiving means comprising in particular a test area and spaced from the collection area so that the fluid in the collection zone is out of contact with the medium for receiving the fluid, so that the sampling of the fluid and the contacting of the fluid with the receiving means can be carried out in different locations. The device according to claim 1, characterized in that it is adapted to undergo a physical change during the actuation to assume a state of contact in which a fluid in the collection zone contacts the fluid receiving means. The device according to claim 2, characterized in that it has a movable portion that can be moved and at least a portion of the collection area is located on the movable portion. 4. The device according to claim 1, characterized in that the body fluid received in the collection area is moved on the means for receiving the fluid by electric drive. The device according to claim 1, characterized in that the body fluid received in the collection zone is transferred to make contact with the fluid receiving means without using the body fluid as a means of transport. The device according to claim 1, characterized in that the collection zone comprises orifices in which the received body fluid is collected. The device according to claim 1, characterized in that the collection zone comprises a porous surface for receiving the body fluid. The device according to claim 1, characterized in that the volume of the body fluid received by the sampling device is 0.5 μl or less. The device according to claim 1, characterized in that it also comprises means of expression. 10. The device according to claim 9, characterized in that the means of expression comprise a cone for the finger. 11. A system for the analysis of a body fluid, characterized in that it comprises: a skin piercing element with a collection area for receiving body fluid, wherein at least a portion of the collection area is open to the environment; and - a means for receiving the fluid away from the collection area so that the fluid in the pathway is out of contact with the fluid receiving means, so that the sample taking of the fluid and the fluid contacting present in the non-fluid path with the receiving means can be carried out in different locations, - the fluid receiving means comprise in particular a test area. 12. The system according to claim 11, characterized in that it comprises a contact means that establishes the contact of a portion of the collection area of the perforating means of the skin with the means of receiving the fluid to supply the area of test with the sampling fluid. The system according to claims 11 or 12, characterized in that the collection area receives the body fluid sample while at least a portion of the collection area is in the body. The system according to claims 11 or 12, characterized in that the collection area is located at the tip of the skin piercing element and the collection area is completely inserted into the body. 15. The system according to claim 11 or 12, characterized in that it comprises means for adjusting the temperature of the test zone to a temperature in the range of 20 ° C to 40 ° C. The system according to claim 11 or 12, characterized in that the skin piercing means has a movable portion and the contact means applies a force to the movable portion to move at least a portion of the collection area in contact with the means of receiving the fluid. 17. The system according to claim 11 or 12, characterized in that it comprises an actuation means for actuating the perforating means of the skin inside the skin, for piercing the skin to obtain a sample of the body fluid. 18. The system according to claim 11 or 12, characterized in that the contact means comprise voltage means for applying an electric potential between the collection zone and the fluid receiving means, so that the fluid from the zone of collection make contact with the means of receiving the fluid. 19. The system according to claim 11 or 12, characterized in that it further comprises a means of transport for transporting the piercing element of the skin in relation to the means for receiving the fluid. The system according to claim 11 or 12, characterized in that the contact means comprises ultrasound means for forcing the sample of the body fluid in the collection zone so that the fluid from the collection zone contacts the means of fluid reception. The system according to claim 11, characterized in that the time that the piercing element of the skin remains in the body to receive the body fluid sample is less than 0.5 seconds. 22. A system for the analysis of body fluid, characterized in that it comprises: - a skin piercing element that has a collection area for receiving body fluid, where at least a portion of the collection area is open to the environment , - a transport element is spaced from the collection area so that the fluid in the route will not make contact with the transport element, - a means of receiving the fluid comprising a test area, which includes: - a transport means for bringing the skin piercing element into contact with the fluid receiving means, and - a detection unit for receiving the signals from the fluid receiving means for determining the presence and / or concentration of an analyte in the body fluid sample. 23. The system in accordance with the claim 22, characterized in that the transport means comprise the electric drive. 24. The system according to claim 22, characterized in that the transport means comprise the drive with a spring force. 25. The system according to claim 22, characterized in that the transport means comprise the manual operation. 26. The system according to claim 22, characterized in that the means of transport comprises a combination of an electric drive, a spring force or the manual actuation. 27. The system according to claim 11 or 22, characterized in that it further comprises a cartridge for storing multiple means of receiving the fluid. 28. A method for determining the concentration of an analyte in the body fluid, characterized in that it comprises the steps of: a) receiving the body fluid in a collection area of a skin piercing element, b) contacting the area of collection of the skin piercing element with the fluid receiving means, so that the body fluid reaches a test area on the fluid receiving means, c) receiving the signals from the test area that are characteristic for the concentration of an analyte, d) process the signals to determine the concentration of the analyte. 29. The method of compliance with the claim 28, characterized in that it also comprises piercing the skin with the piercing element of the skin. 30. The method according to claim 28, characterized in that the piercing element of the skin is transferred by the transport means to the means for receiving the fluid to establish the contact of the piercing means of the skin with the means for receiving the skin. fluid. 31. The method according to claim 28, characterized in that the piercing element of the skin is automatically transferred to the fluid receiving means to establish contact of the skin piercing element with the fluid receiving means. 32. The method according to claim 28, characterized in that the piercing element of the skin is manually transferred to the fluid receiving means to establish contact of the skin piercing element with the fluid receiving means. 33. The method according to claim 28, characterized in that the time that the piercing element of the skin remains in the body to receive the body fluid sample is less than 0.5 seconds. 34. A method for sampling a body fluid, characterized in that it comprises the steps of: a) receiving the body fluid in a collection area of a skin piercing element, and b) removing the piercing element from the skin from the body maintaining the body fluid sample in the collection area. 35. The method according to claim 34, characterized in that it further comprises determining the presence and / or concentration of an analyte in the body fluid sample. 36. The method according to claim 34, characterized in that step a) comprises the collection of a body fluid sample in the collection area while the skin piercing element is introduced into the body. 37. The method according to claim 34, characterized in that it comprises piercing the skin with the piercing element of the skin prior to step a). 38. A system for the analysis of a body fluid, characterized in that it comprises: - a skin piercing element having a collection area for receiving body fluid, wherein at least a portion of the collection area is open to the medium environment, - a transport element is spaced from the collection area so that the fluid in the route will not make contact with the transport element, - a means of receiving the fluid comprising a test zone, - a means of transport for bringing the transport element into contact with the means for receiving the fluid, and - a detection unit for receiving the signals from the fluid receiving means for determining the presence and / or concentration of an analyte. in the body fluid sample. 39. A device for sampling a body fluid, characterized in that it comprises: a skin piercing element having a collection area for receiving body fluid, wherein at least a portion of the collection area is open to the environment and wherein the collection zone comprises 3 or more orifices in which received body fluid is collected. 40. The device according to claim 39, characterized in that the collection zone comprises a porous surface for receiving the body fluid. 41. The device according to claim 39, characterized in that the volume of the body fluid received by the sampling devices is 0.5 μl or less. 42. The device according to claim 39, characterized in that the thickness of the piercing element of the skin is below 500 micrometers, preferably below 250 micrometers. 43. A system for the analysis of a sample with a device according to claim 39, characterized in that it also comprises means for receiving the fluid with a test area, where the thickness of the test area is from 10 to 80% of the depth of the holes in the fluid receiving area of the skin piercing element.