HK1157605B

HK1157605B - Analysis system for determining an analyte in a bodily fluid, cartridge for an analysis unit and method for generating a wound in a body part for examining a bodily fluid which is being discharged

Info

Publication number: HK1157605B
Application number: HK11112052.7A
Authority: HK
Inventors: Stephan-Michael Frey; Hans List; Andrea Rittinghaus; Volker Zimmer; Günther Ihle; Wolfgang Roedel
Original assignee: F. Hoffmann-La Roche Ag
Priority date: 2008-06-07
Filing date: 2009-05-09
Publication date: 2014-07-25

Description

Analysis system for determining an analyte in a body fluid, cartridge for an analyzer and method for creating a wound in a body part for examining an escaping body fluid

Technical Field

The invention relates to an analysis system for determining an analyte in a body fluid sample obtained by piercing the skin, comprising a cartridge with a storage chamber and a reusable analyzer. The reservoir of the cartridge comprises an analysis member having a sample contact region and a reaction system containing at least one reagent, the reaction of which with the body fluid results in a measurable change of a measured parameter, a penetration member having a needle tip for penetrating the skin, and a capillary tube forming a fluid connection between the needle tip and the sample transfer region of the penetration member. The analyzer has a puncturing drive for driving a puncturing movement of the puncturing element to a movement path, a holder for receiving the magazine, and a measuring and evaluating device for measuring a measurable change in a measurement parameter for obtaining a desired analysis result. The invention also relates to a method for producing a wound in a body part for examining body fluid escaping from the wound with an analysis system having a cartridge comprising a storage chamber and a reusable analyzer.

The invention also relates to a cartridge with a storage compartment for an analyzer. The reservoir of the cartridge contains an analysis means with a sample contact area and with a reaction system containing at least one reagent and a piercing means with a needle tip with a capillary for piercing into the skin.

Background

In many fields of medical analysis, a body fluid sample, in particular an analyte in blood, is determined, which is obtained by penetrating the skin of a patient. A slight amount of body fluid is sufficient for the determination of analytes, such as sugars, for therapeutic and diagnostic purposes when body fluid is removed from a body part, preferably from the fingertip belly. The devices used are designed in such a way that they can be used without problems not only by medical professionals but also by laymen.

In order to determine the analysis in a body fluid sample that has escaped from a body part, two steps are necessary. First of all, a wound must be produced by puncturing the skin of the body part, which can be achieved, for example, with a puncturing device. In a second step, the spilled body fluid is received and analyzed in an analyzer. The use of two instruments working independently of each other is uncomfortable and cumbersome for the user. Thus, combined systems have been developed which allow the two instruments present to be combined into one instrument and perform two steps. The known apparatus is relatively large.

New developments include integrated analytical systems. Usually automated instruments are able to carry out a "one-step treatment", whereby the user has to use the system only once and can read out the analysis results without further operating steps.

In a first type of such integrated system separate piercing and analyzing means are used. The movement required for piercing into the skin and for transferring the sample droplets obtained therefrom to the analysis element is implemented within the combined piercing and analysis device by means of a movement mechanism integrated into the device. It is difficult to achieve the transfer of blood from the resulting wound to the analysis component. It is to be taken into account here that modern instruments can be operated with particularly small volumes of blood. Movement of the puncturing tip and puncturing element and the coupling mechanism create other problems.

The problem of transferring very small amounts of blood can be avoided and the mechanism of the device simplified if integrated sample acquisition and analysis means are used instead of separate piercing means and analysis means, which are combined in a disposable unit. Systems having such integrated sample acquisition and analysis components have been proposed primarily for this advantage.

For example, as described in the following documents:

1)WO 2006/092291A1

2)US 2003/0212345A1

3)US 6,607,658B1

disclosure of Invention

The object of the invention is to improve the known integrated system. In particular, the improved system has a compact overall size and can be produced cost-effectively.

This problem is solved by an analysis system having the features of claim 1, a cartridge having the features of claim 2 and a method having the features of claim 14.

Preferred developments as defined in the dependent claims based on the independent claims are the subject matter of the dependent claims.

An analysis system according to the invention for determining an analyte in a body fluid sample obtained by lancing comprises a cartridge having a storage chamber and a reusable analyzer having a lancing drive device, a holder for receiving the cartridge and a measurement and evaluation device.

The cartridge contains in its storage chamber an analysis means having a sample contact area and a reaction system containing at least one reagent, the reaction of which with body fluid leads to a change in a measurable measurement parameter, and a puncturing means having a puncturing tip for puncturing the skin, the puncturing tip having a capillary which forms a fluid connection between the puncturing tip of the puncturing means and the sample transfer area.

The lancing drive of the analysis system drives the lancing element in a lancing movement path, which includes a forward drive position in the lancing direction and a reverse position against the lancing direction after reaching a deflection point of the lancing movement. The magazine can be accommodated in a holder of the analyzer in such a way that the storage chambers of the magazine are each in a functional position in which the puncturing element can be moved by the puncturing drive in the storage chamber. The measuring and evaluating device is used for measuring measurable changes of the measured parameters and for determining the desired analysis result.

According to the invention, the magazine comprises two sub-magazines, namely a piercing element sub-magazine with piercing element storage chambers which each contain a piercing element and an analysis element sub-magazine with analysis elements which each contain an analysis element. The piercing element and the analysis element are thus preferably always contained in separate storage chambers, at least in the supply state of the cartridge.

The puncturing element storage chamber has a puncturing element outlet. The analysis component storage chamber has a piercing component inlet, which is closed with a closure membrane. When the magazine is in the functional position, the two partial magazines are arranged or can be brought into a position in which the piercing-element outlet of the piercing-element storage and the piercing-element inlet of the analysis-element storage are adjacent such that the two openings are aligned and the piercing element is moved from the piercing-element storage through the piercing-element outlet and the piercing-element inlet into the adjacent analysis-element storage. The sealing membrane, which seals the access opening of the puncturing element of the storage chamber of the analytical element at least in the supply state, is opened, for example pierced or punctured, before or during a puncturing movement of the puncturing element from the puncturing element storage chamber into the storage chamber of the analytical element. The piercing is used below without any general limitation as opening.

The piercing or piercing of the closure membrane can preferably be effected by the piercing element itself. However, it is also possible to open the membrane by means of other means before the piercing member has pierced from the outlet of the piercing member.

The advantage of a two-part magazine with piercing elements and analytical elements is that different and partially opposite requirements for analytical elements and piercing elements can be taken into account. The penetrating member can be sterilized alone, for example using beta radiation, without the need to place the analyzing member under the radiation. For example, the piercing elements can be provided with the piercing elements before the cartridge is assembled with the analytical element. Preferably, the piercing member outlet is closed by a closing membrane, thereby closing the piercing member storage compartment. The sealing is preferably effected before the sterilisation of the puncturing element-magazine and after the puncturing element is provided with a puncturing element storage compartment. The puncturing element capsules are then exposed to beta rays, thereby sterilizing all puncturing elements. Since the analytical elements containing the reagents are contained in separate compartments, they are not damaged by the radiation during the sterilization of the piercing elements.

According to the invention, the movement path of the puncturing element comprises a transfer position inside the storage chamber, in which a sample transfer zone of the puncturing element is adjacent to a sample contact zone of the analysis element, for establishing a fluid connection for the transfer of the body fluid sample from the puncturing element to the analysis element. The fluid contact between the puncturing element and the analysis element therefore only occurs in the transfer position of the puncturing element, in which the puncturing element is located in the storage chamber of the analysis element. At another point on the forward stroke of the puncturing element no liquid is delivered to the analyzing element. In this way, precise control of the liquid transfer can be achieved. In addition to local control, time control can also be implemented here. For example, the piercing member is held in the transfer position for a given time, such as a sample transfer zone for fluid delivery to the piercing member, and sample transfer is initiated before the piercing member is so adjacent to the analysis member. Force-controlled blood transfer can also be achieved in the preferred embodiment.

For this purpose, the piercing element and the analysis element are preferably moved relative to one another until they preferably come into contact with one another. The relative movement between the two parts can be achieved by a lateral movement of one or both parts (depending on the puncturing direction), preferably by a lateral movement of the puncturing part.

In an embodiment, the relative movement between the evaluation element and the puncturing element is effected by a pivoting movement of a connecting element, which is coupled to the puncturing element and which establishes a connection between the puncturing element and the puncturing drive. The connecting element extends at least partially into the puncturing-element storage chamber. The deflecting movement of the connecting element can be realized, for example, by a control cam of the drive mechanism. It is also conceivable that the connecting part moves perpendicular to the puncturing device.

In the processing of the two-part cartridge according to the invention, a plurality of steps are carried out, the sequence of which may differ from that given here or individual steps may be included therein and/or work together.

The two sub-boxes are separated from each other when the process is started. Piercing elements-the sub-cartridge is equipped with piercing elements. Both the piercing-part outlet and the connecting-part inlet of each piercing-part storage chamber are closed by a closure membrane. The puncturing elements contained in the puncturing element magazine are sterilized in a further step. In other steps, the two partial boxes are connected or coupled to one another. The sub-compartments can be connected to each other in a movable manner. The partial boxes are preferably connected to one another in such a way that a relative rotational movement between them is precluded. The membrane closing the outlet of the piercing element can also close the inlet of the piercing element of the analytical element magazine.

A further method step comprises closing the analytical component storage chamber of the analytical component magazine by means of a closure membrane at the puncturing component inlet of the analytical component storage chamber and at the magazine outlet thereof, respectively. A further processing step provides for the analytical elements to be provided in analytical element cassettes. The fitting is performed before the analysis member storage chamber is completely closed or before the opening is closed. The analysis component is preferably positioned in the processing chamber.

The individual processing steps can vary in their sequence, in particular two sub-boxes can be provided before their connection. During the production, it is important to sterilize the piercing elements as long as the analytical elements are separated from one another.

In a preferred embodiment of the method, the piercing member inlet of each analysis member storage compartment is closed by a closure membrane before the two sub-compartments are connected to each other. The two partial boxes are preferably provided and closed separately from one another and only then subsequently assembled.

In a preferred embodiment of the method, the rotational strength of the two sub-cartridges is established only when the cartridge is installed in an analysis system or in a reusable analyzer.

The problem in integrated cartridges (which have a common storage chamber for the puncturing element and the analysis element), in which the radiation used for sterilization damages the reagents of the analysis element and is partly unusable, is thereby solved, increasing the amount of reagents in the analysis element. In the sterilization, a sufficient amount of the functional reagent remains in the analytical element, so that the analyte in the liquid sample can be determined. But increasing the amount of reactants results in significantly higher costs.

A further advantage of the separate portion is that the reagent of the reagent system of the analysis component cannot come into contact with the piercing component, in particular not during processing or inventory. Since the reagent is not allowed to enter the skin, it is important that the piercing elements are not contaminated.

Apart from the possibility of separate processing and sterilization, the analytical system according to the invention has the advantage that the two sub-cartridges can be optimized for various requirements. It is necessary for the material of the analysis element, the partial cassette, to form a very good water vapor barrier, so that the analysis element remains dry. When using a photoelectric analysis element, it is necessary for the material of the partial reactants to be at least partially, preferably completely, transparent. The analysis element sub-cartridge is preferably made of transparent, see-through plastic, in any case with a transparent area. The polymeric materials are suitable, preferably cycloolefin copolymers, i.e. amorphous, transparent copolymers based on cyclic and linear paraffins, which also exhibit high transparency, good moisture barrier and high strength with little deformation.

The piercing elements and the cartridge materials are considered to be free of additives which could damage the coating of the piercing elements and their normally aqueous medium. The material is also not damaged by the (beta) radiation used to sterilize the penetrating member.

The two sub-compartments are preferably made of a plastic material and are preferably manufactured in an injection moulding process. The plastic is selected according to requirements.

It has been confirmed within the scope of the present invention that there are significant drawbacks to using integrated sample acquisition and analysis components, as described in the aforementioned documents (1) to (3). Integration results in increased processing costs. In addition, there is a risk that the reagent in the analysis part contaminates the puncture tip of the sample acquisition part. The two-part cartridge according to the invention makes it possible to exploit the advantages of separate piercing and analysis parts, but at the same time enables a compact design and a simple mechanical construction.

The cartridge according to the invention is preferably a cartridge having a piercing element cartridge and an analysis element cartridge. The use of cartridge magazines enables in particular a very compact construction. Cartridge cartridges are the most efficient and attractive solution to the state of the art in terms of system parameters, based on the number of possible tests for determining an analyte. It is also an option to have the magazine be a (square) rectilinear magazine.

In a preferred embodiment of the magazine with two sub-magazines, four membranes are present, namely a first membrane, through which the connecting element can be coupled to the puncturing element, a second membrane, which is arranged between the two sub-magazines and separates the puncturing element storage chamber from the analysis element storage chamber, and a third membrane, through which the puncturing element can be punctured out of the magazine in the puncturing direction into its (straight) movement path. Preferably the magazine has four diaphragms whereby each end face of the sub-magazine is closed by a membrane.

Drawings

The invention is explained in detail below with the aid of preferred embodiments shown in the drawings. The features shown in the drawings can be used individually or in combination for realizing preferred embodiments of the invention. The described embodiments are not limited by the generality of the content defined in the claims. In the drawings:

fig. 1 shows a schematic diagram of an analysis system, comprising an analyzer and a cartridge,

figure 2 shows a detail view of a first embodiment of the cartridge,

figure 3 shows another view of the cartridge of figure 2,

figure 4 shows a detail view of the piercing member,

fig. 5 shows another embodiment of the cartridge, with a biasing member,

figure 6 shows a detail view of the cartridge of figure 5,

fig. 7a, b, cc show a detail of the press part of fig. 5,

figure 8 shows a further embodiment of a cartridge,

figure 9 shows another embodiment of a cartridge.

Detailed Description

In fig. 1, an analysis system 1 according to the invention is shown, comprising an analyzer 2 and a cartridge 3.

The analyzer 2 has a power source 4, a lancing drive 5, a measuring and evaluating device 6 with an optical measuring unit 7 and a holder 8 for receiving the magazine 3. The lancing drive device 5 comprises a coupling mechanism 9 with a connecting part 10, a coupling part 11 being located at the free end of the connecting part, and a drive part 12, which is an electric motor. The movement of the drive member 12 is converted into a movement of the coupling member 10 and the puncturing member coupled to the coupling member 10, whereby a puncturing movement of the puncturing member in and opposite to the puncturing direction is achieved.

The cartridge 3 is preferably constituted by a cartridge-type cartridge 13, as shown in the following figures. The stationary body 8 for receiving the magazine 3 comprises a drive shaft 14 which is inserted into a receiving body of the magazine 3, not shown here, and thus transmits the movement of the shaft 14 to the magazine 3. The drive shaft 14 is driven by a motor 16 via a belt drive 15.

The analyzer 2 comprises components, not shown here, such as a processor, which controls the individual components and ensures the desired process.

The analyzer 2 has a housing 17 comprising a main contact ring 18 on which a finger pad is placed for creating a wound in the skin. The piercing elements (preferably partially) pierce from the magazine 3 and then protrude from the analyzer 2 through the primary contact ring 18 and pierce into the skin. The magazine 3 is mounted in the holder 8 in such a way that a distance 18a exists between the front end face 19 of the magazine 3 in the puncturing direction and the main contact ring 18. The distance 18a is required because the membrane that pierces the covered end surface 19 is separated in time and space from the piercing finger. The axial length of this intermediate space (i.e. the distance 18a) is minimized in the desired compact form of the analyzer 2. Preferably at most 5mm, particularly preferably at most 2mm and particularly preferably at most 1 mm.

The cartridge magazine 13 is a two-part magazine 3 with a piercing part-magazine 20 and an analyzing part-magazine 21. The puncturing member magazine 21 has puncturing member storage chambers 22 adjacent to each other, each containing a puncturing member 24 therein, which are aligned in the axial direction of the magazine. The analysis part magazine 21 includes analysis part storage chambers 23 adjacent to each other, in which analysis parts 25 are contained, respectively. The two sub-compartments 20, 21 of the magazine 3 are designed in such a way that the puncturing element storage chamber 22 and the analyzing element storage chamber 23 are different from each other.

In fig. 1, the magazine 3 is mounted in the functional position in the fixing body 8, in which the linkage element 10 can be coupled to the puncturing element 24 in the puncturing element storage 22. After the puncturing into the skin and the further movement of the connecting part 10 out of the puncturing-part storage 22, the magazine 3 is rotated again about its rotational axis until the next, preferably adjacent puncturing-part storage is provided in such a way that the connecting part 10 can be coupled to the puncturing part 24 located in the storage. The magazine 3 is then again brought into the functional position.

The magazine 3 can also be arranged in the functional position in such a way that the optical measuring cells 7 of the analysis component storage 23 are adjacent. The magazine 3 or the two partial magazines 20, 21 is preferably arranged such that the analysis component storage 23 adjacent to the measuring cell 7 is aligned with the puncturing component storage 22, into which the connecting part 10 can be moved. Optically measuring on the photometric evaluation component 25 is advantageous, in that very small, cost-effective test fields can be used for the measurement and only a small amount of blood is required for the analysis. The cartridge 13 is furthermore expediently positioned in front of the optoelectronic measuring unit 7.

The optoelectronic measuring unit 7 is arranged radially with respect to the analysis component storage 23 in such a way that its optical path is aligned perpendicularly to the housing surface 13a of the cartridge magazine 13 and can photometrically measure the change in the measured values in the analysis component 25. The analysis component sub-magazine 21 has a transparent region 73 on its outer lateral surface 13a, so that the measuring unit 7 can measure the change in the measurement parameter via the transparent region 73 (preferably when the magazine 3 is in the functional position). The analysis component 25 is arranged relative to a transparent area 73 (e.g., a transparent window) in such a way that photometric measurements can be carried out. Preferably, the entire outer surface 13a is transparent. The outer surface 13a of the cartridge magazine 13 thus has planar sections (surface sections 76) which are parallel to the beam path of the evaluation component 25 and the measuring cell 7. The planar surface section 76 comprises transparent regions 73 or is completely transparent. The puncturing element, sub-cartridge 20, also preferably has a planar surface section 76.

Figures 2 and 3 show the cartridge 3 according to the invention in its functional position, the cartridge having been rotated into the functional position by means of the drive shaft 14 being inserted into the receiving body 26 of the cartridge 3. It is preferred that the receiving body 26 and the upper end of the drive shaft 14 are formed by a toothed rim or gear and form a geared connection, which enables a reliable and accurate magazine positioning. In fig. 2, the coupling part 10 of the puncturing drive 5 is arranged outside the magazine 3, and in fig. 3 the puncturing element 23 is moved over its path of movement to a position substantially parallel to the analyzing element 25.

The two sub-cartridges 20, 21 of the cylindrical cartridge magazine 13 are securely connected to one another in the embodiment according to fig. 2, 3. Between the partial boxes, a closing film 28 is arranged, which is applied or glued or welded to the respective end faces of the partial boxes 20, 21. The sealing membrane 28 separates the puncturing-part storage chamber 22 from the analysis-part storage chamber 23. The closure membrane closes the piercing member inlet 32 of the analysis member storage chamber 23 and simultaneously closes the piercing member outlet 33 of the piercing member storage chamber 22.

The analytical element magazine 21 is preferably covered at its front end 29 in the puncturing direction by a film 30 in such a way that a magazine outlet 31 of the analytical element storage chamber 23 is closed at the front end face 19. A completely closed analysis component storage chamber 23 is thus obtained. The closure films 28, 30 of the analytical component storage chamber 23 form a water vapor barrier. All the films are as easy to tear further after piercing as possible, so as not to obstruct the piercing element 24 during the movement path of the piercing element and not to come into contact in the return state of the piercing movement, so as not to be wiped by the piercing element 24.

The analysis component 25 is held in a holder, not shown here, in the analysis component storage chamber 23. The analysis component 25 is preferably positioned in a two-body delivery position that is axially fixed (in the puncturing direction). Due to its small size, the holding and evaluation part 25 can be fixed by means of a slot. In any case, the position of the analysis element is fixed in the puncturing direction, so that fluid can be transported from the puncturing element 24 to the analysis element 25.

In a preferred embodiment, the puncturing element storage chamber 22 is likewise covered at a rear end 35 of the magazine 3 in the puncturing direction by a closing membrane 36, thereby closing the connecting element access opening 34 of the puncturing element storage chamber 22. The closing membrane 36 is preferably opened by the connecting element 10 before the piercing movement for the insertion of the connecting element 10 into the piercing element storage chamber 22. The puncturing-part storage chamber 22 is closed in a gas-tight manner by two closing films 28, 36. This ensures that the piercing elements 24 remain sterile during storage. The membranes 28, 36 are therefore not allowed to be damaged by the sterilization process.

The puncturing element 24, which is shown in detail in fig. 4, is clamped in a puncturing element holder 27 of the puncturing element storage 22. The puncturing element 24, which is preferably embodied flat, has a needle tip 37 and, at its end opposite the needle tip 37, has two slits 38 such that a central tongue 39 and two edge tongues 40 are formed. The tongues 39, 40 are resiliently flexible, thereby allowing the puncturing element 24 to be placed on the puncturing element holder 27, which is preferably formed by a pointed projection. The puncturing element 24 is arranged and securely supported in a fixed position in the puncturing element holder 27 before and after the puncturing movement is performed. The preferably flat piercing elements 24 can be produced by corrosion and are therefore correspondingly inexpensive. Without any difficulty for the shaping bending process.

A capillary 41 extends from the piercing tip 37 of the piercing member 24 on the flat side to the sample transfer zone 42. The capillary 41 may also be open on both sides, for example it may be constituted by a (continuous) slit. The sample transfer zone 42 is a spatial region within the capillary 41 which can be brought into contact with the sample contact zone of the analysis member 25 at the transfer position. In the preferred embodiment capillary 41 extends beyond sample transfer region 42 to sample excess region 43 ("waste region"). An advantage of this preferred embodiment of the puncturing element 24 is that the transfer of body fluid preferably takes place only when the first component of the body fluid, which is initially accommodated in the capillary after puncturing into the skin, has passed the sample transfer zone 42 and is located in the sample excess zone 43. The second component of the bodily fluid sample is located (for this moment) at the sample transfer zone 42, thereby transferring the second component to the sample contact zone of the analysis component 25. Thereby achieving time-controlled sample delivery.

The puncturing element 24 has a coupling structure formed by a coupling receptacle 44, which is formed, for example, by an opening. The corresponding coupling part 11 of the connecting part 10 engages in the coupling receptacle 44 for producing a form-locking connection, as a result of which the puncturing element 24 can be moved over its path of movement. This results in a preferably bidirectional coupling of the puncturing element 24 to the puncturing drive 5.

The principle movement process is described with the aid of fig. 2 and 3. Further embodiments of the special movements are explained with the aid of fig. 5, 6 and 8.

As can be seen from fig. 2, the coupling part 10 is moved in the puncturing direction 45 (arrow direction). The connecting element 10, which is formed for example by a push rod, is guided from the rear end 35 next to the magazine 3 and penetrates the film 36 for pushing into the puncturing element storage 22 beyond the connecting element inlet 34. During the further movement of the connecting part 10, the guide cams 46 of the connecting part 10 are guided on the ramps 47 in the puncturing-part storage 22 in such a way that the coupling part 11 engages in the coupling receptacles 44 of the puncturing parts 24 and couples the connecting part 10 to the puncturing parts 24 (in their fastening bodies).

The closure membrane 28 between the partial capsules 20, 21 is penetrated by the puncturing element 24 over a further at least partially linear movement path in the puncturing direction 45, and the puncturing element is moved beyond the puncturing-element outlet 33 and the puncturing-element inlet 32 into the analytical element storage chamber 23 until it finally penetrates partially through the partial capsule outlet 31 out of the partial capsule 3, with the film 30 being penetrated. This preferably largely linear forward drive of the lancing movement ends at a deflection point, at which the penetration into the skin takes place. At the turning point, a return position opposite to the puncturing direction 45 is then carried out. The at least partially forward-driven state of the needling movement is carried out as a rapid needling movement, wherein the closing film 28 between the two partial boxes 20, 21 is preferably penetrated slowly. Provision may be made for the piercing element to be clamped between a slow state and a fast state of the forward drive state, but this is not compulsory.

The magazine 3 is designed such that the puncturing element 24 is guided within the sub-magazine 3 during the entire puncturing movement. The guidance is preferably effected by the piercing elements, the partial magazine 20. A puncturing element 24, which is punctured by its puncturing tip 37 from the magazine 3 and which produces a wound, is always arranged with its rear end in the puncturing element storage 22. The piercing elements 24 here extend through the entire analysis element storage space 23 and are therefore significantly shorter than the piercing element storage space 22.

The guidance of the piercing element 24 on the path of movement is defined by the chamber side wall 51 (wall) of the piercing element storage chamber 22, for example, in that the connecting element 10 is supported (for example, by its guide projections 46) on the wall of the storage chamber 22.

After the piercing element 24 protrudes from the magazine 3 and has pierced into the finger-belly skin resting on the main contact ring 18, the piercing element 24 moves (in the return state) into a transfer position inside the analysis element storage chamber 23, fig. 3.

After the puncture wound has been produced, body fluid (blood) from the wound is received in the capillary 41 and guided further through the capillary to the sample transfer zone 42 of the preferably hydrophilic puncture element 24. At the transfer site a first component of the body fluid has passed through the sample transfer zone 42 and a second component enters the sample transfer zone 42. Since the first component may be soiled, for example by sweat, it cannot be used for analysis.

The axially positioned analysis component 25 in the fluid transfer position has a sample contact area 48 which preferably comprises a surface 49 aligned in the puncturing direction, which extends substantially parallel to the puncturing direction 45. The fluidic contact between the puncturing element 24 and the analysis element 25 is preferably established by the contact of the surface 49 of the sample contact area 48 with the sample transfer area 42 of the puncturing element 24.

In order to overcome the distance 50 between the sample contact area 48 and the sample transfer area 42, a relative movement between the analysis means 25 and the puncturing means 24 is preferably performed. Preferably a distance 50 of at most 1mm, particularly preferably at most 0.5mm and particularly preferably at most 0.3 mm. This relative movement may be, for example, a lateral movement. The method for performing the lateral movement is a movement or deflection of the connecting member 10.

Photometric measurements (e.g., reflectance photometry, absorption or fluorescence measurements) are initiated after the body fluid is transferred onto the sample contact area 48. Photoelectric measurements (e.g., amperometry, voltage analysis) may also be selected.

The puncturing element 24 is then moved back into its fastening position and positioned in the puncturing element fastening body 27. The coupling member 10 is uncoupled from the puncturing member 24 and moved out of the magazine 3.

Preferably, the relative movement between the puncturing element 24 and the analyzing element 25 is effected in such a way that the pressing element presses the puncturing element 24 positioned in the transfer position perpendicularly to the puncturing direction. Possible embodiments of such a press part are described below in fig. 5 to 7. Alternatively, the pressure element can also move the projecting piercing element 24 outside the analysis element magazine 21 at its front end 29 perpendicularly to the piercing direction in order to influence the contact with the analysis element 25.

Figures 5 to 7 show an alternative embodiment of a cartridge 3 according to the invention which is also a cartridge-type cartridge 13. The piercing element magazine 20 and the analysis element magazine 21 are spaced apart from one another in such a way that a pressure element 52 is located between them.

The piercing element magazine 20 has a receiving body 26, which is formed in the shape of a partially toothed ring, at its rear end for the drive shaft 14, which is not shown here. Inside the extension of the receiving body 26, the piercing element capsule 20 has a dome 53 with a (protruding) sleeve top 54. The dome 53 extends through a through-opening 55 of the pressure element 52 and an opening 56 of the analysis element sub-cartridge 21. The sleeve top 54, which is wider than the opening 56, projects from the magazine 3 and connects the two partial boxes 20, 21 and the press-on part 52 in such a way that they cannot be released from one another. Preferably, the dome 53 and the opening 56 correspond for producing a fixed-position (rotationally fixed and radially and axially fixed) connection between the sub-cartridges 20, 21. Relative movement between the two sub-compartments 20, 21 is excluded.

In contrast to the exemplary embodiment according to fig. 2 and 3, the partial boxes 20, 21 are arranged such that the puncturing-element inlet 32 and the puncturing-element outlet 33 are spaced apart from each other. The two openings 32, 33 are thus closed by the separate closing membranes 28, 28 a. Preferably, the membrane 28a is pierced before or during the piercing movement of the piercing member, preferably by the piercing member 24 itself before or during the piercing movement of the piercing member.

The through hole 55 of the press member 52 is preferably an elongated hole, as shown in fig. 7 a-c. The elongated hole enables a radial movement of the pressure element 52 between the two partial boxes 20, 21. It is preferably moved (and guided) by the analyzer 2, wherein the not shown moving part preferably engages on the tongue-shaped projection 59. The rotational movement of the cartridge 3 is completely decoupled from the translational movement of the pressing part 52 in the rotational direction (perpendicular to the puncturing direction). The plate-like pressure element 52 has a piercing element guide bore 57 with a preferably inclined pressure surface 58, which is formed by a side wall of the piercing element guide bore 57.

In the embodiment of the plate-like pressure element 52 according to fig. 7b, guide structures 52c are provided on its top surface 52a, which engage the analysis element magazine 21. The guide structure 52c is constituted by a guide rail 52 d. The biasing member 52 contacts the sub-cartridge 21 only at the rib 52d, thereby significantly reducing friction during movement of the biasing member 52. While achieving a determined distance between the top surface 52a and the analysis component magazine 21. The part of the membrane of the analysis element, which possibly protrudes through the closing membrane of the partial cassette 21, can extend into the intermediate space (gap) without interfering with the relative movement between the pressure element 52 and the partial cassette 21. Preferably, a guide structure 52c, for example a guide rail 52d or a rib, is also formed on the bottom 52b, so that the friction is further reduced and the pressure part 52 is supported in a defined position between the two partial boxes 20, 21.

In the alternative embodiment according to fig. 7c, the guide 52c is formed by a receiving space 52f on the bottom 52b of the press part 52. The receiving space 52f extends around the edge of the through hole 55. Between the accommodation space 52f and the through hole 55, an edge protruding compared to the concavity of the accommodation space 52f is formed, which may be, for example, a protrusion 52 g. Reducing friction when the cartridge 13 is rotated relative to the knock member 52. The film portion projecting from the opened closing film 28a of the piercing member outlet 33 can extend into the recessed accommodating space 52f without affecting the movement between the piercing member 52 and the sub-cartridge 20, 21. The force required for rotating the partial cassette 3 in the holder 10 can thereby be reduced, which minimizes the energy consumption, since the pressure element 52 is fixedly positioned on account of the rotation of the analyzer 2 (on account of the analyzer 2 only enabling a translational linear movement of the pressure element 52).

The tongue-shaped projection 59 may have a grip socket 59a which provides the user with a grip when mounting the cartridge 3 in the holder 10 of the analysis part 2. Contact with transparent parts or surfaces of the housing is prevented, which may lead to distortion of the subsequent optical measurement results.

In a further preferred embodiment, the magazine 3, preferably the pressure part 52, has a code with which information about the evaluation curve or evaluation function can be coded for converting the measured values into the sought-for evaluation result. Since the evaluation conversion or evaluation curve is usually used for each analysis component with product characteristics specific to it, the code may contain the information necessary for the evaluation. The coding can be implemented in the form of a code, for example a binary code (2D code), or in the form of a transponder, for example an RFID transponder (radio frequency identification transponder).

In the piercing position (position in which the cartridge magazine 13 is located when the piercing process is started) the piercing part magazine 20 and the analysis part magazine 21 are aligned in such a way that the piercing part storage space 22, the analysis part storage space 23 and the piercing part guide opening 57 are aligned. The puncturing element 24 can be moved unhindered through the puncturing element guide opening 57 of the pressing element 52 and can perform the puncturing movement described with reference to fig. 2 and 3. As soon as the puncturing element 24 is in its transfer position, a relative movement perpendicular to the puncturing direction between the puncturing element 24 and the analyzing element 25 is effected for establishing a fluid contact.

Fig. 5 shows the transfer position of the puncturing element 24 after completion of the puncturing. In this position, the piercing elements 24 extend in the analysis element storage space 23 and in the piercing element storage space 22 and through the piercing element guide openings 57. The pressing member 52 is in its initial position.

Fig. 6 shows the pressing member 52 moving radially outwards (away from the rotational axis of the magazine in the direction of the measuring unit). In this pressed position, pressing surface 58 of piercing element guide bore 57 bears against piercing element 24 and is elastically deflected in such a way that sample transfer zone 42 of piercing element 24 comes into contact with sample contact zone 48 of analysis element 25 and a fluid transfer takes place between them.

If the two parts 24, 25 are in contact, the analysis part 25 is preferably located in an analysis position, in which optical measurement of the measurement parameter is effected. If the evaluation element 25 is held in its holder with a gap transversely to the puncturing direction, it is in each case brought into a defined evaluation position upon contact with the puncturing element 24, and it does not allow a gap perpendicular to the puncturing direction.

After the analysis of the body fluid sample, the pressure element 52 returns radially to its initial position. The (elastic) piercing member 24 again takes up its original shape. The movement stroke during the return state is continued.

In an alternative embodiment of the magazine 3 according to the invention with analysis element part-magazine 21 and puncturing element part-magazine 20, the two magazines 20, 21 can be moved relative to one another perpendicular to the puncturing direction.

A particular embodiment of such a two-part cartridge 13 constructed cartridge 3 is described with the aid of figure 8.

In this magazine 3, as in the exemplary embodiment of fig. 5 and 6, the two sub-magazines 20, 21 are also covered on their respective end faces by the films 28, 28a, 30, 36, thereby closing the respective openings of the storage chambers 22, 23.

In a preferred embodiment of the invention, the films 28, 28a, 30, 36 are bonded to the end faces of the sub-compartments 20, 21 by thermal bonding in a thermal bonding process in order to close the openings 31, 32, 33, 34 of the storage compartments 22, 23. The openings of the reservoirs 22, 23 preferably have thermal adhesive receiving voids in which excess adhesive (thermal adhesive) can be received. The thermal adhesive receiving voids may for example consist of recesses which surround the edges of the openings 31, 32, 33, 34. But may also be provided with a bin extending into the interior of the cartridge.

The two partial cassettes 20, 21 are arranged such that each piercing element storage chamber 22 is aligned with an analysis element storage chamber 23. The two partial boxes 20, 21 are arranged in a rotationally fixed manner relative to one another. In other words: the two sub-compartments 20, 21 cannot rotate relative to each other.

The piercing element magazine 20 has a through-opening 60, in which a receiving body 26 is integrated for receiving the drive shaft 14 of the analyzer 2. A lower end 61 of a hinge shaft 62, which is similar to a cardan shaft, is also positioned in the toothed ring-shaped receptacle 26. The lower hinge pin head 63 of the hinge pin 62 is formed by a toothed wheel and engages in the toothed ring-shaped receptacle 26. On the upper end 64 of the hinge axis 62, a gear-shaped upper hinge axis head 65 is provided, which engages in a blind-like hinge axis receptacle 66 of the analysis element sub-magazine 21.

Above the hinge pin head 65, a pin-shaped shoulder 67 is formed, which projects through an end wall opening 68 into the end wall of the analysis element sub-cartridge 21. The cotter pin can be snapped into a groove in a shoulder 67 provided on the outside of the magazine 3, whereby the hinge axis 62 cannot leave the magazine 3. The two sub-compartments 20, 21 are connected to one another in a rotationally fixed manner by the hinge axis 62 and are additionally axially fixed, i.e. relative movements of the sub-compartments 20, 21 in the axial direction are precluded.

The analysis element magazine 21 and the puncturing element magazine 20 can preferably be moved relative to one another, in particular radially, perpendicular to the puncturing direction. The hinge shaft 62 can be moved in the hinge shaft receptacle 66 in such a way that a radial displacement perpendicular to the puncturing direction is possible. By moving the two sub-cartridges 20, 21 relative to one another, the position of the analysis element 25 can be changed in the radial direction in such a way that the contact between the analysis element 25 and the puncturing element 24 arranged in the transfer position can be influenced. The relative movement includes a transverse movement path (offset), preferably at least 0.1mm, more preferably at least 0.3mm, particularly preferably 0.5 mm. The misalignment can also be up to 1.5 mm. The relative movement can be effected, for example, by a movement mechanism engaging the shoulder 67 or by a plunger or the like laterally pressing against the sub-compartments 20, 21. Preferably the analysis member-sub-magazine 21 is moved. In this radially displaced (deflected) position, an optical evaluation of the evaluation element 25 is preferably effected.

After the transfer of the body fluid, the analysis component magazine 21 is returned to its initial position, whereby the analysis component storage chamber 23 is again aligned with the puncturing component storage chamber 22. It is also possible to choose to perform the optical evaluation of the analysis component 25 in this initial position.

Figure 9 shows another particularity of the magazine 3. Positioning elements 74 are arranged in the outer surface 13a of the evaluation element sub-magazine 21, which allow positioning of the optoelectronic measuring unit 7. The positioning element 74 can be formed, for example, in the form of a gear 77. The measuring unit has a (movable) positioning arm 78 with a positioning contour 75 on its end, which corresponds to the positioning member 74 of the magazine 3.

The positioning contour 75 formed by the positioning element receiver 79 forms the negative shape of the gear wheel 77, so that the positioning element 74 can be received in the positioning contour 75.

The positioning element 74 is arranged as such on the front end 29 of the analysis element magazine 21, thus forming a circumferential toothed ring. They are preferably positioned so far on the front end 29 that the transparent region 73 of the envelope surface 13a remains free. The positioning part 74 is injection-molded onto the analysis part magazine 21.

The interaction of the positioning element 74 with the positioning contour 75 ensures that the same measuring distance between the evaluation element 25 and the beam path of the measuring cell 7 can be repeated. At the same time, the rotational position is also fixed by the toothed ring structure of the positioning element 74. A measuring unit 7 movable perpendicular to the axis of rotation (radial) is positioned in the tangential direction of the magazine 3. The axial positioning of the measuring unit 7 and the analysis component magazine 21 is achieved by means of suitable positioning contours 75 and the structure of the positioning component 74.

The guidance of the measuring unit 7 and its precise positioning (distance and axial position) relative to the partial box 21, in particular its contact connection, ensures precise and error-free measurement. In order not to distort the measurement due to the movement of the measuring unit 7 relative to the magazine 3, the contact with the analyzing means 25 is made between the measuring unit 7 and the magazine 3 before the piercing means 23 is switched on, preferably before the piercing process is performed, particularly preferably already in the functional position of the magazine 3, i.e. before the coupling means 10 of the analyzer 2 is coupled with the piercing means 24.

The dimensional errors of the various components and possible play between the cartridge 3 and the fixed body 10 of the analysis component 2 are partially compensated by the contact between the measuring unit 7 and the cartridge 3, but are nevertheless minimized.

It is of course possible to use the locating members 74 on all of the cartridges 3 described herein. It is always suitable for photometric measurements of body fluids, since the measuring distance can be adjusted precisely.

In an equally preferred embodiment, alignment elements are provided on the housing surface 13a of the piercing element sub-magazine 20, which facilitate the mutual positioning of the two sub-magazines 20, 21 during the processing of the magazine 3 (during the assembly of the two sub-magazines 20, 21). The alignment and positioning elements 74 make it possible to easily and precisely align the reservoirs of the two sub-compartments 20, 21 with one another during assembly.

All embodiments of the cartridge 3 are preferably designed such that a desiccant storage chamber 70 is provided adjacent to each analysis component storage chamber 23. Preferably, the drying agent reservoir 70 and the analysis component reservoir 23 are connected to one another in such a way that an air exchange can take place between the two reservoirs 70, 23. A drying agent 71 is contained in the drying agent storage chamber 70 to absorb moisture and keep the analysis component 25 dry.

In the exemplary embodiment according to fig. 2 and 3, a second desiccant reservoir 72 is preferably contained in the piercing element capsule 20. The two pairs of reservoir chambers 70, 72 form a desiccant aggregate chamber. If the reservoirs 70, 72 are separated from each other by the closure film 28, they are pierced during processing. Only the drying agent reservoir 70 is directly connected to the analysis component reservoir 23 in such a way that an air exchange can take place. The desiccant reservoirs 70, 72 are not interchangeable with the piercing member reservoir 22. An advantage of this embodiment is that more drying agent is provided for use for keeping the analytical component 25 inside the analytical component storage chamber 23 dry.

The shown embodiments of the magazine 3 according to the invention are common, the puncturing movement being effected by a movement mechanism comprising the puncturing drive 5. The movement mechanism is designed in such a way that the individual steps, in particular the movement state of the puncturing element, are carried out automatically. Without user intervention. Instead, the user merely manipulates the analyzer 2 to begin the sample acquisition and analysis process after his finger has been pressed against the primary contact ring 18. After the puncturing movement and the evaluation, the user can read the evaluation result or the parameters corresponding thereto, for example, on a display. All necessary intermediate steps are performed automatically and self-manipulatively by the analyzer. The movement of the magazine 3 into the functional position and the continued cycling of the magazine 3 also belong to an automatic process, which, after performing the puncturing and the analysis, moves into a new functional position in which the connecting part 10 is in contact with a new, not yet used puncturing element 24 and the puncturing element 24 can be moved over its puncturing stroke.

The invention is described once more for a better understanding of the disclosure by means of the following clauses:

1. an analytical system for determining an analyte in a sample of body fluid obtained by lancing the skin comprises a cartridge (3) having a reservoir containing

An analysis component (25) having a sample contact area (48) and a reaction system containing at least one reagent, the reaction of which with the body fluid leads to a measurable change in the measured parameter,

a piercing member (24) having a piercing tip (37) for piercing the skin, having a capillary (41) forming a fluid connection between the piercing tip (37) of the piercing member (24) and the sample transfer zone (42),

a reusable analyzer (2) having

A puncturing drive (5) for driving a puncturing movement of the puncturing element (24) over a movement path, comprising a forward drive position in the puncturing direction and a retracted position against the puncturing direction after reaching a deflection point of the puncturing movement,

-a holder (8) for receiving the magazine (3) in such a way that the storage chambers of the magazine (3) are each in a functional position in which the piercing element (24) is movable in the storage chamber by the piercing drive (5),

a measuring and evaluating device (6) for measuring measurable changes in the measured parameters and for determining the desired analysis result, wherein

The magazine comprises two sub-magazines (20, 21), i.e.,

-a piercing member-cartridge (20) having piercing member reservoirs (22) containing piercing members (24) and piercing members (22) respectively

-an analysis component magazine (21) having analysis component storage chambers (23) which each contain an analysis component (25),

in the functional position of the magazine (3), the two sub-magazines (20, 21) can be brought into a relative position in which the piercing-element outlet (33) of the piercing-element storage chamber (22) is centrally adjacent to the piercing-element inlet (32) of the analysis-element storage chamber (23) in such a way that the piercing element (24) can be moved from the piercing-element storage chamber (22) through the piercing-element outlet (33) thereof and through the piercing-element inlet (32) of the adjacent analysis-element storage chamber (23) into the analysis-element storage chamber (23), and

the piercing-part inlet (32) of the analysis-part storage chamber (23) is closed by means of a closure membrane (28) and is opened before or during a piercing movement of the piercing part (24) from the piercing-part storage chamber (22) into the analysis-part storage chamber (23).

2. A cartridge for an analyser as part of the analysis system of clause 1 having a storage chamber containing

a piercing member (24) having a piercing tip (37) for piercing the skin, having a capillary (41) which forms a fluid connection between the piercing tip (37) of the piercing member (24) and the sample transfer zone (42),

wherein the magazine (3) is designed to be accommodated in a holder (8) of the analyzer (2) in such a way that the puncturing element (24) can be moved into a movement path in a storage chamber of the magazine (3) by a puncturing drive (5) of the analyzer (2), said magazine comprising a forward drive position in the puncturing direction for carrying out a puncturing movement,

the magazine (3) comprises two sub-magazines (20, 21), i.e.,

the two sub-cartridges (20, 21) are or can be arranged relative to each other such that the piercing-element outlet (33) of the piercing-element storage chamber (22) and the piercing-element inlet (32) of the analysis-element storage chamber (23) are aligned adjacent to each other such that the piercing element (24) can be moved from the piercing-element storage chamber (22) through the piercing-element outlet (33) thereof and through the piercing-element inlet (32) of the adjacent analysis-element storage chamber (23) into the analysis-element storage chamber (23), and

the piercing-part inlet (32) of the analytical-part storage chamber (23) is closed by a closure membrane (28) and is configured and constructed in such a way that it can be opened before or during a piercing movement of the piercing part (24) from the piercing-part storage chamber (22) into the analytical-part storage chamber (23).

3. The analysis system according to clause 1 or the cartridge according to clause 2, characterized in that the puncturing member outlet (33) of the puncturing member storage chamber (28) is closed with a closing film (28 a).

4. An analysis system or cartridge according to the preceding clause, characterized in that the piercing member storage compartment (22) has a connecting member access opening (34) which is closed by a closing membrane (36).

5. An analysis system according to the preceding clause, characterized in that the puncturing element (24) has a coupling structure and the puncturing drive (5) has a coupling element (11) associated therewith for the preferably double-acting coupling of the puncturing element (24) to the puncturing drive.

6. An analytical system or cartridge as in the preceding clause, characterized in that the analytical component (25) is positioned inside the analytical component storage chamber (23) in a fluid transfer position fixed in the puncturing direction.

7. An analysis system or magazine as claimed in the preceding clause wherein at least a part of the forward drive phase of the puncturing movement is linear.

8. An analysis system or cartridge as in the preceding clause, characterized in that the movement stroke of the piercing member (24) comprises a transfer position inside the storage chamber of the cartridge (3) in which a sample transfer zone (42) of the piercing member (24) is adjacent to a sample contact zone (48) of the analysis member (25) for establishing a fluid connection for the transfer of the body fluid sample from the piercing member (24) to the analysis member (25).

9. The analysis system or cartridge according to clause 8, characterized in that the fluid contact is established by a relative movement between the piercing member (24) and the analysis member (25) oriented perpendicular to the piercing direction.

10. The analysis system or cartridge according to clause 9, characterized in that the sample contact area (48) of the analysis member (25) comprises a surface (49) oriented in the puncturing direction and that the fluid contact is established by the contact of the surface (49) of the sample contact area (48) of the analysis member (25) with the sample transfer area (42) of the puncturing member (24).

11. The analysis system or magazine according to clause 9 or 10, characterized in that the relative movement between the puncturing element (24) and the analysis element (25) is effected in such a way that a pressing element (52) moving perpendicular to the puncturing direction presses the puncturing element (24) in the transfer position.

12. The analysis system or magazine according to clause 11, characterized in that the pressing member (52) is positioned between the puncturing member magazine (20) and the analysis member magazine (21).

13. The analysis system or magazine according to clause 12, characterized in that the pressure part (52) has guide structures (52c), preferably guide rails (52d), on its top side (52a) and/or on its bottom side (52b), which engage a partial magazine (20, 21).

14. An analysis system or cartridge according to clause 9 or 10, characterized in that the relative movement between the analysis member (25) and the piercing member (24) is effected by a deflecting movement of a connecting member (10) which extends through the piercing member storage chamber (20) and which establishes a connection between the piercing member (24) and the piercing drive means (5).

15. An analytical system or magazine as set forth in the preceding clause, characterized in that the analytical component magazine (21) and the puncturing component magazine (20) are movable relative to each other perpendicular to the puncturing direction.

16. The analytical system or cartridge according to the preceding clause, characterized in that each analytical component storage chamber (21) is adjacent to a desiccant storage chamber (70) in which a desiccant (71) is contained, wherein the desiccant storage chamber (70) and the analytical component storage chamber (23) are in mutual connection in such a way that an air exchange takes place between the two storage chambers (23, 70).

17. An analysis system or cartridge according to the preceding clause, characterized in that the cartridge (3) is a cartridge (13).

18. A cartridge as claimed in the preceding clause, characterized in that the measuring and evaluating device (6) has an opto-electronic measuring unit (7) and the analysis component sub-cartridge (21) thus has at least one transparent point (73), with which opto-electronic measuring unit (7) the change of the photometrically measurable measuring parameter in the analysis component (25) can be photometrically measured.

19. The analytical system according to one of the preceding claims 8 to 17, characterized in that the capillary (41) of the puncturing element (24) extends beyond the sample transfer zone (42) thereof into the sample excess zone (43) and the body fluid sample is only transferred if a first component of the body fluid sample, which is initially received in the capillary (41) of the puncturing element (24) after puncturing into the skin, has passed the sample transfer zone (42) of the puncturing element (24) and is reliably located in the sample excess zone (43), wherein a second component of the body fluid sample is located in the sample transfer zone (42).

20. A cartridge as claimed in any of claims 8 to 17 wherein the capillary (41) of the piercing member (24) extends beyond its sample transfer region (42) into the sample surplus region (43).

21. A cartridge for an analyser as part of the analysis system of clause 1 having a storage chamber containing

a puncturing element (24) having a puncturing tip (37) for puncturing the skin, having a capillary tube (41) which forms a fluid connection between the puncturing tip (37) of the puncturing element (24) and the sample transfer zone (42),

wherein the magazine (3) is designed to be accommodated in a holder (8) of the analyzer (2) in such a way that the puncturing element (24) can be moved into a movement path in a storage chamber of the magazine (3) by a puncturing drive (5) of the analyzer (2), comprising a forward drive phase in the puncturing direction for carrying out a puncturing movement,

the magazine (3) comprises two sub-magazines (20, 21), i.e.,

-an analysis component, a sub-cartridge (21), with analysis components (23) which each contain an analysis component (25),

the two sub-compartments (20, 21) are or can be arranged such that the piercing-element outlet (33) of the piercing-element storage (22) and the piercing-element inlet (32) of the analysis-element storage (23) are arranged centrally adjacent to each other,

the analysis element sub-magazine (21) has a transparent region (73), the analysis element (25) being arranged inside the analysis element sub-magazine (21) relative to the transparent region (73) in such a way that a change in a photometrically measurable measurement variable in the analysis element (25) can be detected by means of an optoelectronic measuring unit (7) located outside the magazine (3).

22. An analysis system according to clause 18 or a cartridge according to clause 21, characterized in that the cartridge is designed to be moved into a functional position in which the piercing member (24) is movable within a storage chamber by the piercing drive means (5) of the analyzer (2) for performing the piercing movement, and in that the transparent portion (73) of the analysis member sub-cartridge (21) is arranged such that it is positioned in front of the light path of the opto-electronic measurement unit (7) in the functional position.

23. The analysis system or magazine as claimed in clause 22, characterized in that a positioning element (74) is provided on the analysis element sub-magazine (21) and the optoelectronic measuring unit (7) has a positioning contour (75) which corresponds to the positioning element (74) and which functions in such a way that the analysis element sub-magazine (21), in particular the transparent region (73), can be positioned precisely relative to the measuring unit (7).

24. The analytical system according to one of clauses 1 to 4 or the cartridge according to one of clauses 2 to 4, characterized in that the closure membrane (28, 28a, 36) is bonded to the sub-cartridge (20, 21) by a thermal bonding process using a thermal adhesive, and the openings (32, 33, 34) of the storage compartment (22, 23) have a thermal adhesive receiving space in which excess thermal adhesive can be received and which preferably surround the openings (32, 33, 34) at their edges.

25. The analysis system or magazine according to one of claims 11 to 13, characterized in that the top pressure part (52) has a recess on its bottom side (52b) facing the piercing element sub-magazine (20) in such a way that a receiving space (77) surrounding the through-opening (55) of the top pressure part (52) is formed, in which a film section protruding after opening the closing film (28a) of the piercing element outlet (33) can extend.

26. A method for manufacturing a two-part magazine with storage compartments, in particular for manufacturing a magazine according to clause 2 or 21, wherein the magazine (3) comprises two part-magazines (20, 21), namely a piercing member-part-magazine (20) and an analysis member-magazine (21), the piercing member-part-magazine having piercing member storage compartments (22) each containing a piercing member (24), the analysis member-part-magazine (21) having analysis member storage compartments (23) each containing an analysis member (25), wherein the two part-magazines (20, 21) are separated from each other in order to start the manufacturing process, characterized by the following steps:

a) the piercing element (24) is provided with a piercing element sub-magazine (20),

b) closing the puncturing-part outlet (33) of each puncturing-part storage chamber (22) with a closing film (28, 28a),

c) closing the connection member entrance (34) of each piercing member storage compartment (22) with a closing membrane (36),

d) sterilizing piercing elements-piercing elements (24) inside the sub-magazine (20),

e) two sub-boxes (20, 21) are connected,

f) closing the piercing member inlet (32) of each analytical member storage chamber (23) of the analytical member magazine with a closing film (28, 28a),

g) the analysis unit (25) is provided with an analysis unit sub-cartridge (21),

h) the cartridge outlet (31) of each analysis component storage chamber (23) of the analysis component sub-cartridge (21) is closed by a closing film (39).

27. The method of processing as described in the preceding clause, characterized by the further steps of: this adds a desiccant (71) to the desiccant storage chamber (70) so that the desiccant can receive moisture from the analysis component storage chamber (23).

28. The processing method according to clause 26 or 27, characterized in that the sterilization of the puncturing element (24) inside the puncturing element magazine (20) is effected by means of beta-rays, preferably by means of radiation.

The method steps in clauses 26 to 28 may also be performed in varying orders.

Claims

1. An analytical system for determining an analyte in a sample of a body fluid obtained by lancing the skin, comprising

A cartridge (3) having a storage compartment, the cartridge comprising

a reusable analyzer (2) having

A puncturing drive (5) for driving a puncturing movement of the puncturing element (24) over a movement path, comprising a forward drive phase in the puncturing direction and a backward drive phase against the puncturing direction after reaching a deflection point of the puncturing movement,

-a stationary body (8) for receiving the cartridge (3) such that the storage compartment of the cartridge (3) is in a functional position in which the piercing member (24) is movable within the storage compartment by the piercing drive (5),

The magazine comprises two sub-magazines (20, 21), i.e.,

-a piercing member-cartridge (20) having a plurality of piercing member reservoirs (22) each containing a piercing member (24), and

-an analysis component magazine (21) having a plurality of analysis component storage chambers (23) each containing an analysis component (25),

in the functional position of the magazine (3), the two sub-magazines (20, 21) can be brought into a relative position in which the piercing-element outlet (33) of the piercing-element storage chamber (22) is centrally adjacent to the piercing-element inlet (32) of the analysis-element storage chamber (23), so that the piercing element (24) can be moved from the piercing-element storage chamber (22) through its piercing-element outlet (33) and through the piercing-element inlet (32) of the adjacent analysis-element storage chamber (23) into the analysis-element storage chamber (23), and

the piercing-part access (32) of the analysis-part storage chamber (23) is closed by means of a closure membrane (28) and is opened before or during a piercing movement of the piercing part (24) from the piercing-part storage chamber (22) into the analysis-part storage chamber (23),

the movement path of the piercing element (24) comprises a transfer position within the storage chamber of the cartridge (3), in which a sample transfer zone (42) of the piercing element (24) is adjacent to a sample contact zone (48) of the analysis element (25) for establishing a fluid connection for the transfer of the body fluid sample from the piercing element (24) to the analysis element (25).

2. An analysis system according to claim 1, wherein the piercing member outlet (33) of the piercing member storage chamber (22) is closed by a closing membrane (28 a).

3. An analytical system as claimed in any one of the preceding claims, wherein the analytical component (25) is positioned inside the analytical component reservoir (23) in a fluid transfer position fixed in the puncturing direction.

4. An analytical system as claimed in claim 1 or 2, characterized in that the fluid contact is established by a relative movement between the piercing element (24) and the analytical element (25) oriented perpendicularly to the piercing direction.

5. An analysis system according to claim 4, characterized in that the sample contact area (48) of the analysis member (25) comprises a surface (49) oriented in the puncturing direction and that the fluid contact is established by the contact of the surface (49) of the sample contact area (48) of the analysis member (25) with the sample transfer area (42) of the puncturing member (24).

6. An analysis system as claimed in claim 4, characterized in that the relative movement between the piercing element (24) and the analysis element (25) is effected such that the pressing element (52) moving perpendicularly to the piercing direction presses against the piercing element (24) located in the transfer position.

7. The analysis system according to claim 6, wherein the pressing element (52) is positioned between the piercing element magazine (20) and the analysis element magazine (21).

8. An analysis system as claimed in claim 1 or 2, wherein the cartridge (3) is a cartridge (13).

9. A cartridge for an analyser having a storage chamber containing

wherein the magazine (3) is designed to be accommodated in a holder (8) of the analyzer (2) in such a way that the piercing element (24) can be moved in one of the storage chambers of the magazine (3) by a piercing drive (5) of the analyzer (2) into a movement path which comprises a forward drive phase in the piercing direction for carrying out a piercing movement,

the magazine (3) comprises two sub-magazines (20, 21), i.e.,

the two sub-cartridges (20, 21) are or can be arranged relative to each other such that the piercing-element outlet (33) of the piercing-element storage (22) is centrally adjacent to the piercing-element inlet (32) of the analysis-element storage (23) such that the piercing element (24) can be moved from the piercing-element storage (22) through the piercing-element outlet (33) thereof and through the piercing-element inlet (32) of the adjacent analysis-element storage (23) into the analysis-element storage (23), and

the puncturing-part inlet (32) of the analysis-part storage chamber (23) is closed by a closing film (28) which is designed and designed in such a way that the puncturing-part inlet (32) can be opened before or during a puncturing movement of the puncturing part (24) from the puncturing-part storage chamber (22) into the analysis-part storage chamber (23), and

10. A cartridge as claimed in claim 9 wherein the piercing member outlet (33) of the piercing member storage chamber (22) is closed by a closure membrane (28 a).

11. A cartridge as claimed in claim 9 or 10 wherein the analysis component (25) is positioned within the analysis component storage chamber (23) in a fluid transfer position fixed in the piercing direction.

12. A cartridge as claimed in claim 9 or 10 wherein fluid contact is established by relative movement between the piercing member (24) and the analysis member (25) oriented transversely to the piercing direction.

13. A cartridge as claimed in claim 12 wherein the sample contact region (48) of the analysis member (25) comprises a surface (49) oriented in the piercing direction and the fluid contact is established by contact of the surface (49) of the sample contact region (48) of the analysis member (25) with the sample transfer region (42) of the piercing member (24).

14. A cartridge as claimed in claim 12, characterized in that the relative movement between the piercing member (24) and the analysis member (25) is effected such that a pressing member (52) moving perpendicularly to the piercing direction presses against the piercing member (24) in the transfer position.

15. A cartridge as claimed in claim 14, characterized in that the roof pressure means (52) are positioned between the piercing means-part (20) and the analysis means-part (21).

16. A cartridge as claimed in claim 9 or claim 10 wherein the cartridge (3) is a cartridge (13).

17. A cartridge as claimed in claim 12 wherein the capillary (41) of the piercing member (24) extends beyond its sample transfer region (42) to a sample excess region (43).

18. A cartridge as claimed in claim 9, characterized in that the analysis member-sub-cartridge (21) has a transparent region (73), the analysis member (25) being arranged relative to the transparent region (73) inside the analysis member-sub-cartridge (21) such that a photometrically measurable change in the analysis member (25) of the measurement parameter can be measured by means of an opto-electronic measurement unit (7) positioned outside the cartridge (3).

19. A cartridge as claimed in claim 18, characterized in that the cartridge is designed to be moved into a functional position in which the piercing element (24) can be moved by the piercing drive (5) of the analyzer (2) within one of the storage chambers for carrying out the piercing movement, and in that the transparent region (73) of the analysis element sub-cartridge (21) is arranged such that it is positioned in front of the light path of the optoelectronic measuring cell (7) in the functional position.

20. A cartridge as claimed in claim 19 wherein locating means (74) are provided on the analysis means-sub (21) and the opto-electronic measurement unit (7) has a locating profile (75) which corresponds to the locating means (74) and which acts together to enable accurate location of the analysis means-sub (21) relative to the opto-electronic measurement unit (7).

21. A cartridge as claimed in claim 19, wherein a locating member (74) is provided on the analysis member-sub (21) and the opto-electronic measurement unit (7) has a locating profile (75) which corresponds to the locating member (74) and which acts together to enable the transparent region (73) to be accurately located relative to the opto-electronic measurement unit (7).

22. A method for manufacturing a two-part cartridge according to claim 9, wherein the two sub-cartridges (20, 21) are separated from each other in order to start the manufacturing process, characterized by the following steps:

a) the piercing elements (24) are associated with the piercing element magazine (20),

d) sterilizing a piercing element (24) in a piercing element magazine (20),

e) two sub-boxes (20, 21) are connected,

g) an analysis component (25) is assigned to the analysis component sub-cartridge (21),