DE10101658A1 - Analytical tool with integrated lancet - Google Patents

Abstract

The invention describes an analytical aid (1) which is suitable for the extraction and examination of body fluids, in particular blood. The aid (1) contains a test element (2) and a lancet (3), the test element (2) containing the following components: 1.) a frame element (7) and 2.) at least one detection element (6), which is also multi-layered may be and may have, inter alia, an erythrocyte separation layer, a spreading layer and an optical barrier layer, and which is connected directly or indirectly to the frame element (7); and the lancet (3) contains the following components: 1.) a needle (11) with a tip (23) and 2.) a lancet body (10) which at least partially surrounds the needle (11). The aid (1) of the invention is characterized in that the lancet body (10) is movable, for. B. foldable or pivotable, with the frame element (7) of the test element (2) is connected so that the lancet (3) can assume a storage position and a lancing position, the needle (11) in the storage position substantially parallel to the plane of the Test element (6) and in the piercing position is oriented substantially orthogonally to the plane of the test element (6).

Description

The present invention relates to analytical tools for extraction and sub search of body fluids, in particular blood, containing a test element and a Lancet, the test element being a frame element and at least one detection element, that is directly or indirectly connected to the frame element, and the lancet is a needle with a sharp tip and a lancet body that at least partially surrounds the needle, contains. The invention further relates to a system for storing analytical aids means and a system for determining the presence or content of an analyte in blood, comprising a measuring device for measuring and displaying the change in one with the Analyte correlated, characteristic property of a test element and a magazine, which is suitable for the inclusion of analytical aids.

For the qualitative or quantitative analytical determination of components of the body Liquids, especially blood, are often used in so-called carrier-bound tests det. In these carrier-bound tests, reagents are on or in corresponding ones Layers of a solid test carrier, which is brought into contact with the sample. The Reak tion of liquid sample and reagents leads to a detectable signal, in particular a change in color or a change in current or potential. The proof signal can be visual or with the help of a device - usually in the event of a color change reflection photometric, in the case of current or potential change ainpero be evaluated metrically or potentiometrically.

Test carriers are often designed as test strips, which essentially consist of an elongated Base layer made of plastic material and attached detection layers as a test fields exist. However, test carriers are also known which are square or right square plates are designed or where the functional layers of an art  fabric frame are held. In general, "test elements" be spoken.

The determination of the content of certain analytes in blood, for example glucose or lactate, requires the collection of a sufficient amount of sample (blood) and the Provision of a suitable measuring system for the analyte. In addition to medical practices and analysis Senlabors are increasingly medical laypersons such regulations for their own use by. Especially for the determination and control of the blood sugar value, that is the Blood glucose content, in diabetics, but also for the determination of other parameters such as Lactate or cholesterol levels must be checked by the person to be examined measuring systems in widespread use.

Conventional measuring systems often contain test elements in the form of so-called tests strips that together with appropriate measuring devices determine one or more Allow analytes in blood. In addition, the user generally still needs one Lancet, with the help of which the skin on certain parts of the body, for example on the fin gerberry or the earlobe, pierced and so blood can be obtained for the measurement is to be used. For a comfortable blood collection offer various manufacturer so-called lancing devices, which control and guide the lancets pierce the skin to control the depth of the puncture and minimize pain.

Since the user needs several separate components to measure an analyte in blood tigt (test elements, measuring device, lancing device, lancets etc.) and for an analysis "away from home", For example, when traveling or playing sports, it is understandable that before all diabetics who also have to carry insulin and an injection with them, consider a reduction of the items to be carried desirable.

Therefore, there is no shortage of different attempts, the number of individual parts for a blood parameter determination are necessary to reduce. One in the prior art The solution described consists of the required components such as measuring device, lancing device, Ver Lancets and test elements in a common blood collection and measurement system agree, in particular lancet and test element to a single analytical aid  medium can be combined. These analytical aids can advantageously be maga provided and used automatically, evaluated and disposed of.

In principle, two different approaches for analytical aids can be identified in the prior art, in which a flat test element is combined with a lancet in a single object (analytical aid): On the one hand, concepts are described in which the lancet or its needle or mandrel performs a lancing movement substantially perpendicular to the plane of the test element (for example described in US 5,035,704 and FIGS . 2 and 3 of DE-A 198 55 443, DE-A 198 55 458 and DE-A 198 55 465); on the other hand, this lancing movement is such that the lancet or its needle or mandrel moves largely parallel to the plane of the test element (cf. FIG. 1 in DE-A 198 55 443, DE-A 198 55 458 and DE-A 198 55 465). Both variants have in common that the orientation of the lancet relative to the test element remains the same both when carrying out the lancing movement (lancing position) and in the "idle state" (storage position).

A stackable test element with an integrated lancet is described in US 5,035,704 described. The test element consists of a flat, rectangular (plastic) frame, in which the lancet is inserted on the top and the one on the bottom parallel to the Base of the frame carries a detection element. The detection element only covers part of the bottom of the frame; the remaining part is practically open and serves as Passage opening for the lancet tip. Located between the lancet and the detection element a wick material, which covers the entire detection element and in which the Detection element not covered portion of the base area protrudes. The wick material is said to be blood Transport from the puncture site of the lancet into the skin to the detection element. The The lancet consists of a punched metal sheet on the bottom side, i.e. the side facing the detection element, a central, movable Tongue pointed, essentially perpendicular to the metal sheet (and thus to the plane of the Detection element) aligned metal mandrel. The tip of the thorn is at rest state of the test element within the boundary surfaces of the test element frame.  

When using the test element from US 5,035,704, the test element with the underside placed on the surface of the skin and the movable tongue with the thorn from above a plunger moved down. The thorn passes through a recess in the wick material into the skin surface and creates a small wound from which after the back pulling the thorn blood emerges. The blood is from the wick material on the skin surface overlying test element to the detection element and analyzed there.

DE-A 198 55 443, DE-A 198 55 458 and DE-A 198 55 465 describe, among others different embodiments of analytical aids, a test element and contain a lancet and are referred to therein as a "test cassette".

In Figs. 1 and 2 (and the corresponding passages of the description of the invention) of the three mentioned Offenlegungsschriften are flat, substantially rectangular "Testkas cassettes" disclosed where in a multi-part plastic frame, a lance element is inserted. This consists of a lancet needle, which is held by a plastic frame. The plastic frame fulfills the role of a guide element for the lancet needle and also serves to move the lancet needle back into the starting position as a spring element after the lancing movement has taken place. In contrast to the test element from US 5,035,704, the lancing movement of the lancet needle in the embodiments described in FIGS . 1A to 1E and 2A to 2B of DE-A 198 55 458 runs essentially parallel to the level of the detection element. This can either be supplied with blood via a capillary channel that either begins in the area of the outlet opening of the Lan needle or is located at any point on the test cassette housing.

Fig. 2C of DE-A 198 55 458 describes a similar test cassette in which the detection element lies in a side face of the plastic frame and surrounds the outlet opening of the lancet needle. In this embodiment, the lancing movement of the lancet needle is essentially orthogonal to the plane of the detection element.

Fig. 3 of DE-A 198 55 443, DE-A 198 55 458 and DE-A 198 55 465 discloses elongated, cylindrical "test cassettes" in which the lancet is guided in a plastic sleeve and the lancet needle when the lancing movement is carried out Base of the "test cassette" emerges. The exit opening of the lancet needle can be surrounded by a detection element. As is also the case with the test element from US 5,035,704, the lancing movement of the lancet needle in the embodiment described in FIG. 3 by DE-A 198 55 443, DE-A 198 55 458 and DE-A 198 55 465 is essentially vertical to the level of the detection element. In this embodiment, the lancet needle is surrounded by a lantern body which, in cooperation with the cylindrical plastic sleeve of the "test cassette", guides the lancet needle during the lancing process. The lancet body and the cylindrical plastic sleeve continue to work together with a helical spring, so that after the lancing movement, the lancet needle is moved back into the starting position.

The object of the present invention is to contain an analytical aid Provide test element and a lancet, which is stackable easily and safely, and regarding the lancet can be stored in such a way that unintentional injury to the lan Zette is largely excluded. In addition, the analytical aid should go through Mark small dimensions and for automated handling in one analysis be suitable.

The object is achieved by the subject matter of the invention as defined in the claims is resolved.

The invention relates to an analytical aid that is both for the extraction and also for the immediate examination of body fluids, in particular Blood. The analytical aid according to the invention contains a test element and a lancet. The test element comprises a frame element, at least one detection element, that is directly or indirectly connected to the frame element, and possibly others Components, such as a zone that is liquid for holding excess samples speed is suitable, and a carrier for the detection element and / or the zone for the on Excess sample liquid is suitable. The lancet contains a needle a tip and a lancet body that at least partially surrounds the needle. Essential for the analytical aid according to the invention, the lancet body is movable, the means foldable or pivotable, connected to the frame element of the test element  is so that the lancet has a storage position and one from the storage position can take different pricking position. The needle is in the storage position essentially parallel to the plane of the test element. In the lancing position, however it is oriented essentially orthogonally to the level of the test element. The tip of the needle points in the lancing position essentially in the direction of the test element.

An "analytical aid" in the sense of the invention is understood to be a device which consists of at least one test element with an integrated lancet. The lancet is used thereby obtaining a body fluid sample, which is then carried out using the test elements is examined for the presence and / or content of an analyte. The analytical aids according to the invention is therefore for obtaining a body fluid, especially of blood, a person to be examined. The Lan pierces tease the skin of this person briefly and with a defined puncture depth, which makes a tiny Wound occurs. A drop of body fluid collects on the surface of the wound speed, especially blood, of generally less than one microliter to a maximum of 100 Microliter volume. The body fluid is preferably immediately following the Extraction used for a diagnostic examination using the test element.

In particular, blood, preferably, can be obtained with the analytical aid according to the invention Capillary blood, from a part of the body, such as B. a fingertip or an earlobe, of an individual. The analytical tool can go both from that to examining individual himself, for example a diabetic who has his blood glucose want to determine salary, as well as from a third party, e.g. B. a doctor or a sick person sister, for the collection and analysis of blood samples.

The analytical aid is preferably suitable for storage in a magazine and can be evaluated in a largely automated process in a measuring device the. For example, analytical aids according to the invention can be superimposed as Stacked or stacked side by side in the form of a chain.

The test element contains a shaping, rigid component, which is referred to below as a frame element should be referred to. The frame element is used for mechanical stabilization of the detection element, the easy handling of the analytical aid and ensures  in combination with the foldable lancet for the risk of accidental Injury to the lancet needle is avoided.

In a particularly simple embodiment of the invention, the frame element can According to the test element, a rigid, for example rectangular plastic film or a stiffer Cardboard strips that carry the detection element on one side and on the other side is movably connected to the lancet, for example via a film hinge or a Adhesive tape strips. So that the lancet needle during the lancing process, if necessary, by the Can penetrate frame element, it can have a recess.

However, the frame element is preferably a substantially rectangular, flat one Plastic molded part, for example an injection molded part. The frame element can next to the actual frame inside a support surface for the detection element ready put. However, it is also possible that the detection element only on its edges from Frame is held. In both cases the detection element is fixed to the frame element connected.

Of course, the frame element can also be in several parts. For example, that Frame element consist of two halves and the detection element - similar to the frame a slide - hold it between the two halves.

Corresponding test elements are known from the prior art, for example from EP-A 0 885 591, EP-B 0 535 480 and EP-B 0 477 322.

Alternatively, the detection element can be on a different one from the frame element Carrier layer, for example a transparent plastic film, can be attached, which like which is held by the frame element. This variant can have manufacturing advantages of the analytical aid. In this case the detection element is indirect - via the carrier layer - connected to the frame element.

The detection element essentially consists of a reagent-containing detection layer, the on a carrier, for example the bearing surface of the frame described above menelements or a separate carrier layer is attached. The detection layer contains the reagents used to detect the target analyte in the test  Sample liquid are required. The reagents in the detection layer lead to Presence of the target analyte in the sample liquid to a direct or indirect optical or electrically observable signal, preferably a color change or a Current flow. The detection layer can be, for example, in the form of an analytical one Reagents and auxiliary materials soaked paper or one with reagents, fillers and Be formed film-coated plastic film. It is also possible that Detection element a reagent-containing membrane or a reagent-coated Electrode. Such detection elements according to the invention for the analytical test element are suitable for the person skilled in the art in a large number of embodiments known, for example from EP-A 0 821 234, EP-B 0 575 364, EP-A 0 016 387, EP-A 750 196, EP-A 0 654 659.

As analytical reagents in connection with the present invention are prinzi any kind of detection reagents and other reactive auxiliaries, such as usually used in analytical and / or diagnostic test elements, meant. Without wishing to be conclusive, these include indicators, mediators, Marking substances, buffer substances, spreading and wetting agents, activators, biochemical rea genes, enzymes, proteins, peptides, antigens or antibodies and their fragments, Haptens, and / or nucleic acids. Such reagents are known to a multitude of experts known analytical and / or diagnostic questions. Also if in the following text Often spoken of "reagents", there should also be the possibility that only one reagent is used to be included according to the invention.

Detection elements suitable according to the invention need not necessarily consist of only one Layer. Rather, it is possible for the detection element to consist of two or more Layers of different functions arranged horizontally or vertically side by side can be exists. For example, the detection element can be multi-layered and under among others an erythrocyte separation layer, a spreading layer and an optical barrier layer contain.  

In a preferred embodiment, the test element can have several detection elements contain. These can be used, for example, to analyze an analyte in different ways Determine concentrations or be specific for different analytes.

Furthermore, a detection layer can be specific for one or more target analytes. at The reagents for the different analytes can be specific for several analytes separate areas of the detection layer can be accommodated, so that a clear assignment of analyte and result of detection is possible. Techniques for making such Detection layers with several, separate areas are known to the person skilled in the art. at For example, printing processes such as screen printing, inkjet printing, photolitho may be mentioned graphic methods, or simply attaching differently impregnated test papers on a common carrier.

In addition to the detection element, the test element can contain further components. at for example, a zone for receiving excess sample liquid in the test element be provided. Such a zone is preferably in the immediate vicinity of the night looking element. It can be made possible with the detection element in a liquid transfer clearing contact, for example, by abutting position, by slight Overlap at the contact edges or through a connecting channel so that excess sample liquid can flow directly into the zone.

In a preferred embodiment, the test element can be a carrier layer for the Detection element and possibly other components included. The backing layer is in this embodiment preferably connected directly to the frame element, so that the detection element is in turn indirectly connected to the frame element.

As a carrier layer are, for. B. plastic films and molded parts, coated cardboard, glass, Ceramics, metal sheets and the like. The carrier layer should preferably be inert towards the sample materials and reagents used, not dependent on them are gripped or react with them. Have been found to be suitable according to the invention, for example white films made of inert, water-resistant plastics such as polyethylene, polypropylene, Polystyrene, polycarbonate, polyethylene terephthalate, polyamide and the like have been proven.  

In the preferred case that test elements to be optically evaluated are to be used, It must be ensured that the carrier layer or the bearing surface of the frame element for optical measurement methods are permeable if the measurement from the side of the test element is to be carried out on the carrier layer or the bearing surface of the frame elements rests. Carrier layer and / or contact surface can for example consist of one consist of transparent material or have an opening that allows optical measurement allowed. Such measures are known per se to the person skilled in the art.

The lancet contained in the analytical aid according to the invention has a needle Metal, ceramic or plastic, one end (the tip) of which is pointed, and if necessary - for example by a grinding process - is sharpened. At least the rear part of the lancet needle facing away from this tip (the blunt end) is from completely or partially enclosed a lancet body made of plastic. The production usually takes place in such a way that the lancet needle is positioned in a plastic injection mold and the lancet body is injected. It is also possible that the lancet body is made of consists of several interconnected parts.

The lancet body serves to hold and guide the lancet needle and provides the Connection between lancet and test element. It is essential to the invention that the The lancet body can be moved, for example by means of a hinge or joint, that is to say it folds bar or pivotally connected to the frame element of the test element. The The lancet body and the frame of the test element can be preferred Embodiment are made in one piece as an injection molded part. The connection of In this case, the lancet body and the frame element are preferably made via a film hinge. Alternatively, frame element and lancet body can be individual injection molded parts be movably connected to one another via a joint or hinge.

In this way, the lancet can have at least two defined orientations relative to the test element level or to the level of the test element: On the one hand, the lancets needle (and thus also the lancet) lie parallel to the plane of the test element, which is in the Hereinafter referred to as the "storage position"; the other is an orien tion possible, in which the lancet needle is essentially orthogonal, that is, right  at an angle to the plane of the test element, with the tip of the needle towards the Test element shows. The latter position of the lancet is referred to as the "lancing position" become. It is further preferred that the detection element is essentially parallel to Test element lies.

A space-saving stacking of the analyte according to the invention is in the storage position table aids possible. The parallel alignment of the lancet relative to the test element leads to compact external dimensions of the analytical aid. Preferably, the Lancet almost completely within the boundary surfaces in the frame element of the Test element can be stowed, as described in more detail with reference to the following figures will be. This ensures that the tip of the lancet needle is not exposed and so the risk of injury is minimized. It also becomes a simple stacking of several analytical aids possible.

In the lancing position, the lancet is folded out of the plane of the test element and stands perpendicular to it. The needle tip of the lancet needle is preferably also in this position initially hidden within the boundary surfaces of the frame element, so that a unintentional injury to the needle tip is almost impossible. The end of The lancet, which is surrounded by the lancet body, protrudes from the lancing position Boundary surfaces of the frame element out and can be in this exposed position easily captured by a drive element.

The lancing movement of the lancet is caused by the action of a drive element, for example example of a hammer or pestle, the part of a corresponding measuring device or one corresponding lancing device is on the blunt end of the lancet needle or on the initiated blunt end of the lancet needle located lancet body. The drive element can do both the forward movement of the lancet needle, that is the Movement in the direction of the skin area to be stung, as well as its backward movement in cause the initial situation. The drive element preferably acts linearly on the lancet a, which in turn then performs a linear lancing movement.

As will be described in more detail below in connection with the figures, in In a preferred embodiment, the drive element first pretensions the back  the spring of the lancet. Only in a subsequent step does the lancet needle advance, that is, driven in the direction of the skin surface to be pricked. By preloading the return spring is achieved that the piercing movement of the needle completely from the drive element of the measuring device or the lancing device is controlled. This way, a Controlled, controlled path-time curve for the lancet needle during the lancing movement that leads to a painless stinging.

When lancing, the lancet preferably penetrates the plane of the detection element. The however, does not necessarily mean that the lancet needle passes through the detection element must penetrate, although this is possible - although less preferred. In a preferred one In one embodiment, the test element contains a cutout in the area of the detection element or passage opening through which the lancet needle during the lancing process without the Touching the detection element can pass through. The proof preferably surrounds element this passage opening. Alternatively, such a recess can also be made in one other area of the test element, for example in the area of the frame element or in the area of other functional zones of the test element. It is also possible that the The lancet needle passes the frame element of the test element on the outside during its piercing movement to be led.

The detection element is preferably in the immediate vicinity of the passage opening of the lancet needle. This ensures that the user of the analytical aid according to the invention after the stinging of the part of the body which has been pierced, for example, the pricked finger, not to apply the blood sample to the test element must move to a different position. Rather, the body part can be used for this purpose remain in the same place, so that the blood sample collecting on the skin quasi from is given up on the detection element itself.

Alternatively, the start of a capillary trans Port route should be provided, with the help of which a blood sample on a not immediately Detection element located in the vicinity of the passage opening can be transported can. For example, the transport route can be a capillary channel or an absorbent wick  be, each in a fluid-permitting contact with the or Detection element (s) are available.

To prevent blood that is obtained from the lancet from stinging and getting collects as drops on the surface of the skin while using the analytical aid by means of the passage opening on the side of the test element facing away from the skin arrives, the passage opening with a membrane made of an elastic plastic to be introverted. The membrane is - similar to a septum - during the lancing process Lancet needle penetrates and closes due to its elasticity after the back pull the needle again.

Frame element and lancet body are preferably injection molded parts from a single injection castable material, in particular a plastic suitable for injection molding. Such Plastics are known to the person skilled in the art, e.g. B. polystyrene, polyamides, polyurethanes, cellu loose ethers and esters, polyethylene, polymethacrylic acid esters and other thermoplastics curing thermosets or vulcanizing elastomers made of rubber or silicone rubber and - albeit less preferred - foamed plastics. In a preferred embodiment form, the frame element and the lancet body are made in one piece and over a film hinge connected.

To return the lancet needle to its starting position after the lancing movement fetch, the lancet body can contain a return spring. This is preferably direct with the lancet needle or the part of the lancet body surrounding the lancet needle connected. The return spring can be, for example, a leaf spring or a coil spring be made of metal, which is pressed together during the lancing process and whose spring back into the relaxed state moves the lancet needle to its starting position. Preferably However, the return spring is a deformable, elastic part of the lancet body injection molded in one piece from the same plastic as the rest of the Lancet body. Of course it is also possible to use a different art for the return spring use fabric as for the rest of the lancet body. This is for example in Zweikom component injection molding processes possible.  

In order to optimize the lancing movement of the lancet needle, a preferred embodiment can be used embodiment of the analytical aid according to the invention in the lancet body and / or in the test element, in particular in the frame element of the test element, a guide element, for example in the form of a guide sleeve or a guide channel in the test element or in the form of a double leaf spring in the lancet body.

It has proven to be advantageous for use in largely automated test systems asked that the test element, in particular the frame element of the test element, on two opposite outer sides has a guide profile, which in a complementary Profile intervenes in the corresponding parts of a magazine or a test device. To this In this way the movement of the analytical aid can be guided and also its Fixation in the measuring position is possible. For example, the invention analytical tools from a stock position, for example in a tool magazine, be brought into the lancing and / or measuring position in a measuring device.

When transporting the analytical device from the stock position to the lancing or The measuring position is - preferably at the same time - the lancet from the storage position brought into the lancing position. This can be done automatically, without external influence, for example by using gravity and thereby "folding down" and raising the lancet. However, it is preferred that the movement of the lancet from the storage runs into the lancing position. For this purpose it has proven to be It is advantageously shown that the lancet body has at least one, but preferably one Has a pair of opposing, external cams in corresponding guide can intervene in the measuring device and / or the magazine. The linear one is preferred Movement of the analytical device from the storage position to the measurement position through curved guide grooves for the cams of the lancet body in a suitable "Folding down" the lancet implemented.

In an analogous manner, the analytical aid is transported further after it has been carried out analytical determination from the lancing or measuring position to the following position (for the purpose of ejecting or re-magazine) that the lancet is back in the Aufbe currency position is returned. It is possible that the storage position  before reaching the lancing or measuring position and the storage position afterwards are identical or different. It is only essential that the lancet consists of one Orientation orthogonal to the plane of the test element in an orientation parallel to the plane of the test element returns. In this way it is largely avoided that a Person inadvertently injured on the lancet of the analytical device.

Another object of the invention is a system for storing analytical aids convey. This system includes a magazine or storage container for analytical aids and a stock of analytical aids according to the invention. The analytical Aids can be essentially one above the other in the form of a stack or essentially be stored one behind the other or side by side in the form of a chain in the magazine.

The magazine preferably contains complementary guide profiles for the frame element the preferred embodiment of the analytical aid. This allows the safe and guided transport of the aids from the magazine can be guaranteed.

In an alternative, also preferred embodiment, the magazine of the inventor system according to the invention guide grooves for the cams of the lancet body of the analytical Aid in a preferred embodiment of the analytical described above Aids are included. As described above, the guide grooves are involved the cam together in order to transport the aid into the measuring or lancing position to move the lancet from the storage to the lancing position.

Another object of the invention is a system for determining the presence or the content of an analyte in blood. The system according to the invention comprises a measuring device for measuring and displaying the change in a character correlated with the analyte teristic property of a test element and a corresponding one in the measuring device usable analytical aid described above. Furthermore, the system can Contain magazine, for receiving the analytical aids according to the invention suitable is.

The measuring device preferably contains complementary guide profiles for the frame element the preferred embodiment of the analytical aid. This allows the safe  and guided transport of the aids in the measuring and lancing position and the fixation of the analytical aids can be guaranteed in this position.

In an alternative, likewise preferred embodiment, the measuring device of the inventor can system according to the invention guide grooves for the cams of the lancet body of the analytical Aid in a preferred embodiment of the analytical described above Aids are included. As described above, the guide grooves are involved the cam together in order to transport the aid into the measuring or lancing position to move the lancet from the storage to the lancing position.

The system according to the invention can preferably be in the measuring device or in the magazine Pushing or pulling device, for example a motor or spring-driven ram, for have the analytical tools with which an analytical tool can be used in the measuring or Lancing position is moved. Furthermore, it can be preferred that the measuring device has a front direction for driving the lancet of the analytical aid according to the invention comprises, preferably a plunger for driving the lancet needle.

The inventive advantage of securely storing the lancet needle in an open preservation position and the exposed presentation of the lancet needle in one of the Storage position different lancing position can of course also from a counter stand that contains no verification element. In the broadest sense, such Object to be called a foldable lancet. It is another subject of Invention.

The folding lancet differs from the analytical device described above in that - as I said - it is not a detection element and therefore not a complete test contains element in the sense of the invention. However, it contains the invention Frame element with which it is movably, in particular hingedly connected. The frame element and the connection of the lancet to the frame element and the lancet itself are analogous to the aid according to the invention (containing test element and lancet) designed. In particular, the lancet of the folding lancet can have a storage position and assume a different lancing position, being in the storage position  essentially parallel to the plane of the frame element, in the lancing position, however, in is oriented substantially perpendicular to the plane of the frame element.

Another corresponding object of the present invention is a system for Stocking of the foldable lancet according to the invention. This system contains a magazine or storage container for foldable lancets and otherwise corresponds to the one above in connection with the storage system for analytical aids according to the invention projected.

The invention is explained in more detail by the following figures.

Fig. 1 shows a perspective view ( Fig. 1a), in a front view ( Fig. 1b) or in a view ( Fig. 1c) a preferred embodiment of the analytical aid according to the invention.

Fig. 2 shows in a sequence of four sub-figures ( Fig. 2a to d) schematically in side view the interaction of the preferred embodiment of the analytical aid from Fig. 1 with part of a measuring device during the transport of the analytical aid in or out the measuring position.

Fig. 3 shows in a sequence of four partial figures ( Fig. 3a to d) schematically in sectional view through the preferred embodiment of the analytical aid from Fig. 1, the interaction between analytical aid and measuring device during the lancing process.

FIG. 4 is a schematic sectional view of a preferred embodiment of the system according to the invention containing a measuring device, a magazine for analytical aids and the embodiment of the analytical aid from FIG. 1 preferred according to the invention.

Fig. 5 shows a schematic perspective view of the underside of a preferred embodiment of the analytical device of the invention. The analytical aid corresponds essentially to that shown in Fig. 1.

In Figs. 6 to 9 further alternative preferred embodiments of the analytical device to the invention OF INVENTION in a perspective plan view are shown on the bottom.

Fig. 10 shows in a sequence of 3 partial figures ( Fig. 10a to c) schematically in perspective view of the underside of the test element according to the invention (above) or in schematic side view (below) the interaction of a preferred embodiment of the analytical aid from Fig. 5 with part of a measuring device during the transport of the analytical aid into and out of the measuring position.

FIG. 11 shows a schematic perspective top view of the underside of a stack of analytical aids preferred according to the invention, such as are present in the magazine according to FIG. 4, for example.

The numbers in the figures mean

1

analytical tool

2

test element

3

lancet

4

guide plate

5

Lancets ram

6

detection element

7

frame element

8th

Zone for taking up excess sample liquid (waste zone)

9

Passage opening for lancet needle

10

Lancet body

11

Lancet needle

12

cam

13

return spring

14

needle plunger

15

spring plunger

16

cam groove

17

Guide groove for frame element

18

hinge

19

Direction of transport of the analytical aid

20

Folding direction of the lancet

21

septum

22

Passage opening for lancet plunger

23

Needle tip of the lancet needle

24

guide sleeve

25

gauge

26

optical module

27

magazine

28

platen

29

casing

30

ejector

31

chute

32

cover

33

Ram for analytical aid

34

Well for fingers

35

Opening for pestle

33

36

Opening for analytical tools

1

In Fig. 1, a preferred embodiment of the analytical aid according to the invention is illustrated by means of (1). Fig. 1a shows a perspective view of the analytical tool ( 1 ), partly in interaction with components of a measuring device (guide plate ( 4 ); lancet plunger ( 5 )). To illustrate the structure of the guide plate ( 4 ), it is shown in Fig. 1a (and in the following Fig. 1b and 1c) on the right side of its actual position folded to the side. The guide plate ( 4 ) which is folded away to the side is of course mounted in the real embodiment of the analytical aid ( 1 ) or the associated measuring device corresponding to the left guide plate ( 4 ).

The analytical aid ( 1 ) essentially consists of a test element ( 2 ) and a lancet ( 3 ). The test element ( 2 ) consists of a frame element ( 7 ), which in the preferred embodiment, which is shown here, is a substantially rectangular, flat injection molded plastic body. On the upper side of the frame member (7), a rectangular detection element (6), the excess of a zone of an absorbent material for receiving sample liquid (waste zone (8)) is centrally located is surrounded. Through the frame element (7) and the detection element (6) of the detection element (6) is perpendicular to the plane of the passage opening (9) for the lancet needle (11) of the lancet (3).

The frame element ( 7 ) has a profile on two opposite parallel outer cards, which serves the analytical device ( 1 ) in cooperation with the Füh approximately grooves ( 17 ) of the guide plate ( 4 ) during the movement of the analytical device ( 1 ) in different Positions of the measuring device.

The frame element ( 7 ) of the test element ( 2 ) is connected to the lancet ( 3 ) via a hinge. The lancet ( 3 ) - as can be seen in particular from FIG. 1b - consists of the lancet body ( 10 ), which, like the frame element ( 7 ), is a plastic molded body that is molded using injection molding technology, and a lancet needle ( 11 ), which is preferably is made of metal and has a ground point. The lancet body ( 10 ) has a pair of guide cams ( 12 ) on its lateral edges, which engage in corresponding guide grooves ( 16 ) in the guide plate ( 4 ). The interaction of the guide groove ( 11 ) and the guide cam ( 12 ) during the movement of the analytical aid ( 1 ) in the measuring device causes the lancet ( 3 ) to fold down from the storage position into the lancing position.

The lancet body ( 10 ) further contains return springs ( 13 ) which serve to bring the Lan needle ( 11 ) back into the starting position after the lancing movement.

As the lancet plunger (5) in FIG. 1b is also clearly seen, acts on the lancet (3). The lancet plunger ( 5 ) contains a plunger ( 14 ) which specifically interacts with the lancet needle ( 11 ) and a plunger ( 15 ) which is designed to bias the lancet return spring ( 13 ). The interaction of the individual plunger components with the lancet ( 3 ) will be described in more detail in connection with FIG. 3.

In Fig. 1c is a plan view displayed on the analytical device (1). In particular, this view again shows the order in which the individual components of the test element ( 2 ) are arranged: A central recess in the test element ( 2 ) serves as a passage opening ( 9 ) for the lancet needle. The passage opening ( 9 ) is surrounded by an essentially rectangular detection element ( 6 ), which in turn is directly surrounded by the surrounding waste zone ( 8 ), which can consist, for example, of a piece of absorbent paper. Detection element ( 6 ) and waste zone ( 8 ) are attached to a bearing surface of the frame element ( 7 ), for example by gluing.

The surface of the analytical aid ( 1 ) depicted in the top view of FIG. 1c represents the area that comes into contact with the skin surface of the individual to be examined during operation of the analytical aid ( 1 ). For example, the individual to be examined places his finger on the upper surface of the analytical aid ( 1 ). The dimensions of the analytical aid ( 1 ) are selected such that the surface of the detection element ( 6 ) and the waste zone ( 8 ) can preferably be covered by the finger of the individual to be examined. During the lancing process through the lancet ( 3 ), which is driven by the lantern plunger ( 5 ), the lancet needle ( 11 ) penetrates the passage opening ( 9 ) and penetrates the skin of the individual to be examined. After withdrawing the lancet needle ( 11 ), the pierced skin area of the individual to be examined remains in an unchanged relative position to the analytical aid ( 1 ). The wound created by the Lan needle ( 11 ) causes a drop of blood to form on the surface of the skin, which is absorbed by the detection element ( 6 ). Any excess blood is taken up by the waste zone ( 8 ). The geometrical arrangement of the passage opening ( 9 ) and the detection element ( 6 ) makes it possible for the blood sample to be applied to the detection element ( 6 ) virtually at the moment it is created.

In Fig. 2 is shown with 4 partial figures in side view, how the analytical aid ( 1 ) from Fig. 1 with the guide plate ( 4 ) when transporting the analytical aid ( 1 ) from a storage position in the measuring or lancing position and then interacts from this measuring or piercing position.

In Fig. 2a the beginning of the transport of the analytical aid ( 1 ) from the storage position is shown in the measuring position. The storage position, in which the lancet ( 3 ) lies essentially completely within the boundary surfaces of the test element ( 2 ), is characterized in that the lancet needle ( 11 ) is essentially parallel to the plane of the test element ( 2 ), in particular to the plane of the detection element ( 6 ). This position can be seen in Fig. 2a. The measuring position corresponds to the state which the analytical aid ( 1 ) assumes when the guide cams ( 12 ) of the lancet ( 3 ) have reached the vertical section of the guide groove ( 16 ). In this state, the lancet ( 3 ) is arranged exactly opposite the lancet plunger ( 5 ) (consisting of needle plunger ( 14 ) and spring plunger ( 15 )) (cf. also FIG. 2c). In this case, the lancet needle ( 11 ) is oriented essentially perpendicular to the plane of the test element ( 2 ), in particular to the plane of the detection element ( 6 ), the needle tip pointing in the direction of the test element ( 2 ).

As can be seen in detail from FIGS. 2a to 2d, the frame element ( 7 ) of the test element ( 2 ) is guided through the guide groove ( 17 ) during transport of the analytical aid ( 1 ) in direction ( 19 ). The transport direction ( 19 ) runs straight through the guide horizontally. The curved guide groove ( 16 ) in interaction with the cams ( 12 ) ensures that in the course of the linear movement; of the analytical aid ( 1 ) the lancet body ( 10 ) is folded around the hinge ( 18 ) in the direction ( 20 ), ie essentially downwards, until the measuring or lancing position, which is shown in FIG. 2c, is reached. The analytical device ( 1 ) remains in this state until the lancing or measuring process is completed. The lancet ( 3 ) is in the lancing position, which differs from the storage position of the lancet ( 3 ) shown in FIG. 2a in that the lancet needle ( 11 ) is oriented essentially orthogonally to the level of the test element ( 2 ).

After the measurement has been carried out, as shown in FIG. 2d, the analytical aid ( 1 ) according to the invention is transported further in direction ( 19 ). The curved groove of the guide groove ( 16 ) ensures that the lancet ( 3 ) folds back in the direction ( 20 ) into the storage position. The lancet needle ( 11 ) in this storage position in the final state is again oriented parallel to the plane of the test element ( 2 ).

In FIG. 3, the interaction of the lancet plunger ( 5 ) with the lancet ( 3 ) of the analytical aid ( 1 ) from FIGS. 1 and 2 is shown schematically in four partial figures (FIGS . 3a-3d). Fig. 3a shows the analytical device (1) in measurement and lancing position, which essentially corresponds to Fig. 2c. The needle plunger ( 14 ) and spring plunger ( 15 ) of the lancet plunger ( 5 ) are arranged below the lancet ( 3 ) in the starting position shown in FIG. 3a. The lancet ( 3 ) is still in the rest position of the lancing position. The lancet needle ( 11 ) is held in the rest position by the return spring ( 13 ). The lancet body ( 10 ), in interaction with the guide groove ( 16 ), fixes the position of the lancet ( 3 ) and thus ensures a clear alignment of the lancet needle ( 11 ) relative to the lancet plunger ( 5 ) on the one hand and to the test element ( 2 ), in particular to the detection element ( 6 ), on the other hand. In Fig. 3a it can be clearly seen that the test element ( 2 ), which consists of the frame element ( 7 ) and the layer-shaped components detection element ( 6 ) and waste zone ( 8 ), which are attached to the support surface of the frame element in Area of the passage opening ( 9 ) has a rubber membrane as a septum ( 21 ). This can be penetrated during the lancing process the lancet needle (11) and is tightly sealed after the retraction of the Lan zettennadel (11) into the starting position again.

As can also be seen from FIGS . 3a to 3d, the lancet body ( 10 ) has a passage opening ( 22 ) for the lancet plunger ( 5 ). This lies on the side facing the blunt end of the lancet needle ( 11 ). The tip ( 23 ) of the lancet needle ( 11 ) is surrounded in the idle state by a guide sleeve ( 24 ), which is also part of the lantern body ( 10 ). In addition, the guide sleeve ( 24 ) serves to enclose the tip ( 23 ) in order to avoid inadvertent injury to the lancet needle ( 11 ).

In Fig. 3b it is shown how at the beginning of the lancing process the spring plunger ( 15 ) first acts on the part of the lancet body ( 10 ) holding the lancet needle ( 11 ) and thus moves the return spring ( 13 ) into the tensioned state. In Fig. 3c is shown how following the bias of the return spring ( 13 ) through the spring plunger ( 15 ) of the needle plunger ( 14 ) acts on the lancet needle ( 11 ) and this with the tip ( 23 ) through the septum ( 21st ) moved so that the tip ( 23 ) of the lancet needle ( 11 ) protrudes from the upper surface of the analytical device ( 1 ) and can penetrate the skin of an individual to be examined. The lancing movement of the lancet needle ( 11 ) is guided through the guide sleeve ( 24 ) of the lancet body ( 10 ) and the passage opening ( 9 ) of the test element ( 2 ).

In Fig. 3d is shown schematically how after the withdrawal of the lancet plunger ( 5 ), that is, the needle plunger ( 14 ) and the spring plunger ( 15 ), the return spring ( 13 ) moves the lancet needle ( 11 ) back into the starting position. The septum ( 21 ) closes. The tip ( 23 ) of the lancet needle ( 11 ) is now completely inside the lancet body ( 10 ). The resealed septum ( 21 ) ensures that blood that collects on the upper surface of the test element ( 2 ) after the lancing process cannot penetrate onto the underside of the test element ( 2 ) and thus potentially contaminate parts of the measuring device.

In FIG. 4, a preferred embodiment is a measuring device (25) in a longitudinal sectional view shown. The measuring device ( 25 ) contains a magazine ( 27 ) for storing analytical aids ( 1 ), as described in particularly preferred embodiments in connection with FIGS. 1 to 3. If necessary, the magazine ( 27 ) can be removed from the measuring device ( 25 ) by removing the cover ( 32 ) and replaced with a new magazine. For this purpose, cover ( 32 ) is preferably attached to the measuring device housing ( 29 ) with the aid of a hinge.

The measuring device ( 25 ) also contains a plunger ( 33 ), with the aid of which analytical aids ( 1 ) can be transported from the magazine into the measuring or piercing position. For this purpose, the magazine ( 27 ) has an opening ( 35 ) through which the plunger ( 33 ) can penetrate and has an opening ( 36 ) opposite the opening ( 35 ) through which the analytical aid ( 1 ) can be removed Magazine ( 27 ) can get into the measuring position. Analytical tools ( 1 ) from the stock in the magazine can be moved to the position of the removed analytical tool ( 1 ) by a pressure plate ( 28 ), which is either part of the magazine ( 27 ) or an integrated part of the measuring device ( 25 ) Magazine ( 27 ) can be moved up. The pressure plate ( 28 ) can be driven by a manually operated slide, a motor or a spring.

In FIG. 4, an analytical device (1 ') is shown in the measuring or lancing position. The lancet ( 3 ) is unfolded so that it lies essentially perpendicular to the plane of the test element ( 2 ). The lancet tappet ( 5 ) is located opposite the lancet ( 3 ) in the measuring or piercing position. To evaluate the detection element, the measuring device ( 25 ) in the preferred embodiment has a movable optical module ( 26 ) which can be lowered for the transport of the analytical aid ( 1 ). The measurement of the test element with the optical module ( 26 ) is carried out according to methods known per se, for example by reflection photometry.

The measuring device ( 25 ) also contains an ejector ( 30 ) which, in cooperation with the frame element ( 7 ) of the analytical aid ( 1 ), removes it from the measuring device ( 25 ) after the measurement via the ejection channel ( 31 ). Alternatively, the analytical aid ( 1 ) used can be transferred to another magazine (not shown) for storage and disposal.

The measuring device ( 25 ) has a trough or groove ( 34 ) in which, for example, a finger of an individual to be examined can be placed. The finger can be brought into contact with the analytical device ( 1 ') in this recess ( 34 ). It can be kept in the same position during the entire lancing and measuring process.

FIG. 5 shows a further preferred embodiment of the analytical aid ( 1 ) according to the invention. The analytical aid ( 1 ) from FIG. 5 essentially corresponds to the analytical aid ( 1 ) as shown in FIG. 1. It contains a lancet ( 3 ) which is movably connected to the frame ( 7 ) of a test element ( 2 ) via a hinge ( 18 ). The lancet plunger ( 5 ), which interacts with the lancet ( 3 ) of the analytical device ( 1 ) during a lancing movement, is also shown schematically in FIG. 5. The function and designation of the other elements of the analytical aid ( 1 ) from FIG. 5 are essentially identical to those of the analytical aid ( 1 ) from FIG. 1. This figure is expressly referred to here.

In Figs. 6 to 9 are alternative, also preferred embodiments of the OF INVENTION to the invention the analytical device (1) in a partially exploded view of FIG. The analytical aids ( 1 ) of FIGS. 6 to 9 each contain a lancet ( 3 ) which is connected to a test element ( 2 ) via a hinge or joint ( 18 ). In Figs. 6 to 9, the lancet (3) and the test elements (2) are shown separated from each other. The arrows in these figures indicate how the two elements (lancet ( 3 ) and test element ( 2 )) can be brought together, for example, during production.

The analytical tools ( 1 ) from FIGS. 6 to 9 correspond essentially to the analytical tools ( 1 ), as already described in FIGS . 1 and 5. Reference is expressly made here to the description of these figures.

The analytical aid ( 1 ) from FIG. 6 is essentially constructed from sheet-like or tape-like materials. In particular, the frame ( 7 ) of the test element ( 2 ) and the lancet body ( 10 ) of the lancet ( 3 ) are made of film material. The hinge ( 18 ) is also made of foil material. The lancet ( 3 ) and test element ( 2 ) are connected to one another via the film joint ( 18 ). The connection can be made, for example, by gluing or welding.

In Figs. 7 to 9 analytical device (1) are shown in which the frame (7) of the lancet (3) is the test element (2) and the lancet body (10) made of injection molded parts. With these analytical aids ( 1 ), the lancet ( 3 ) and the test element ( 2 ) can be attached via a film hinge ( 18 ), as shown in FIG. 7, or - as shown in FIGS. 8 and 9 - via a joint ( 18 ), which essentially consist of a pair of cylindrical pins which engage in corresponding recesses in the frame ( 7 ) of the test element ( 2 ).

As can be seen in the comparison of FIGS. 6, 7 and 9 with FIG. 8, the return spring ( 13 ) of the lancet ( 3 ) can be designed differently. While the return spring ( 13 ) in FIGS . 6, 7 and 9 is formed in one piece with the lancet body 10 , a coil spring ( 13 ), which is preferably made of metal, is shown in FIG. 8.

In Fig. 10 three snapshots ( Fig. 10a, b and c) of the movement of the analytical aid ( 1 ) during transport from the storage position to the measurement position are shown in perspective. The upper part of the figure is a perspective top view of the underside of the analytical aid, while the lower part of the figure represents a simplified side view. The stages shown in FIGS. 10a to c correspond to those shown in FIGS. 2b to d. For details, reference is made to the description of FIG. 2 above.

In FIG. 11, a stack of analytical aids ( 1 ), as described in more detail in FIG. 5, is shown schematically in a perspective view of the underside. Such a stack of analytical aids ( 1 ) is located, for example, in the magazine ( 27 ) of the measuring device ( 25 ) from FIG. 4.

The lowest analytical aid ( 1 ) in Fig. 11 is in the storage position. The lancet ( 3 ) is folded into the frame of the test element ( 2 ). The lancet needle is essentially parallel to the plane of the test element.

In the uppermost analytical aid ( 1 ) in FIG. 11, the lancet ( 3 ) and the test element ( 2 ) are again shown separately. Of course, in reality the lancet ( 3 ) and the test element ( 2 ) are connected to each other via the hinge. In contrast to the bottom analytical aid ( 1 ) from FIG. 11, in the top analytical aid ( 1 ) in FIG. 11 the lancet ( 3 ) is oriented essentially perpendicular to the plane of the test element ( 2 ). This would correspond to the orientation of these two components of the analytical aid ( 1 ) in the lancing position.

Claims (19)

1. Analytical aid ( 1 ) for the extraction and investigation of a Köiper liquid, containing a test element ( 2 ) and a lancet ( 3 ), wherein

• a) the test element ( 2 ) contains the following components:
  a frame member ( 7 );
  at least one detection element ( 6 ) which is connected directly or indirectly to the frame element ( 7 ); and
• b) the lancet ( 3 ) contains the following components:
  a needle ( 11 ) with a tip ( 23 );
  a lancet body ( 10 ) which at least partially surrounds the needle ( 11 );

characterized in that the lancet body ( 10 ) is movably connected to the frame element ( 7 ) of the test element ( 2 ), so that the lancet ( 3 ) can assume a storage position and a lancing position different from the storage position, the needle ( 11 ) is oriented in the storage position substantially parallel to the plane of the test element ( 6 ) and in the lancing position substantially ortho gonal to the plane of the test element ( 6 ). 2. Analytical aid ( 1 ) according to claim 1, characterized in that the test element ( 2 ) in the immediate vicinity of the detection element ( 6 ) contains a separate zone ( 8 ) made of absorbent material, which is suitable for receiving excess sample liquid. 3. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the detection element ( 6 ) of the test element ( 2 ) and optionally the zone ( 8 ) made of absorbent material are attached to a common carrier layer. 4. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the lancet body ( 10 ) is movably connected to the frame element ( 7 ) of the test element ( 2 ) via at least one hinge ( 18 ) or joint. 5. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the frame element ( 7 ) of the test element ( 2 ) and the lancet body ( 10 ) are injection molded plastic parts. 6. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the test element ( 2 ) has a passage opening ( 9 ) for the lancet needle ( 11 ). 7. Analytical aid ( 1 ) according to claim 6, characterized in that the passage opening ( 9 ) is in the region of the detection element ( 6 ). 8. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the lancet body ( 10 ) contains a return spring ( 13 ) for the Lan needle ( 11 ). 9. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the lancet body ( 10 ) and / or the frame element ( 7 ) have a guide sleeve ( 24 ) for the lancet needle ( 11 ). 10. Analytical aid ( 1 ) according to one of the preceding claims, characterized in that the frame element ( 7 ) has a guide profile on two opposite parallel sides. 11. Analytical device ( 1 ) according to one of the preceding claims, characterized in that the lancet body ( 10 ) has a pair of external cams ( 12 ). 12. System for storing analytical aids ( 1 ) comprising a magazine ( 27 ) and a supply of analytical aids ( 1 ) according to one of the preceding claims. 13. System according to claim 12, characterized in that the magazine ( 27 ) contains complementary guide profiles for the frame element ( 7 ) of the analytical aid ( 1 ) according to claim 10. 14. System according to claim 12 or 13, characterized in that the magazine ( 27 ) contains guide grooves for the cams ( 12 ) of the lancet body ( 10 ) of the analytical aid ( 1 ) according to claim 11. 15. System for determining the presence or content of an analyte in blood, comprising a measuring device ( 25 ) for measuring and displaying the change in a characteristic property of a test element ( 2 ) correlated with the analyte and a magazine ( 27 ) suitable for receiving analytical aids ( 1 ) according to one of claims 1 to 11. 16. System according to claim 15, characterized in that the measuring device ( 25 ) contains complementary guide profiles ( 17 ) for the frame element ( 7 ) of the analytical aid ( 1 ) according to claim 10. 17. System according to claim 15 or 16, characterized in that the measuring device ( 25 ) contains guide grooves ( 16 ) for the cams ( 12 ) of the lancet body ( 10 ) of the analytical aid by means of ( 1 ) according to claim 11. 18. System according to claim 15, characterized in that the measuring device ( 25 ) comprises a device ( 5 ) for driving the lancet ( 3 ) of the analytical aid ( 1 ) according to claim 1. 19. Foldable lancet comprising in a frame member (7) and a lancet (3), wherein the lancet (3) includes a needle (11) with tip (23) and a lancet needle (11) partially surrounds the lancet body (10), characterized that the lancet body ( 10 ) is movably connected to the frame element ( 7 ), so that the lancet ( 3 ) can assume a storage position and a lancing position different from the storage position, the needle ( 11 ) in the storage position essentially parallel to The plane of the frame element ( 7 ) and the lancing position is oriented essentially orthogonally to the plane of the frame element ( 7 ).