DE10361562A1 - Blood analyzer for the determination of an analyte - Google Patents

Abstract

The invention relates to a blood analyzer (2) having a housing body (4), a blood sampling device (8) having a plurality of lancing elements (10), with a plurality of test means (14) for analyzing a minimum amount of blood, with an evaluation electronics comprehensive evaluation device and with a display device (6), which form a handle as a single device complete system, wherein the housing body (4) has a working position (30) of a respective piercing element (10) associated piercing position (12) for applying a skin surface of a user , wherein a plurality of test means (14) and lancing elements (10) can be inserted into the device, which can be brought to perform several measurements successively in a working position (30), wherein when positioning a lancing element (10) in its working position (30) the Lancing element (10) can be pierced into the skin surface of a user which is applied to the lancing position (12) and blood exiting the skin surface can reach a test agent (14), characterized in that a negative pressure generating device (18) is provided, by means of which it is already immediately prior to execution or simultaneously with the execution or immediately following the execution of Lancing process to assist in obtaining a minimal amount of blood a negative pressure can be applied to the skin surface.

Description

The invention relates to a blood analyzer for the determination of an analyte such as fructosamine, lactate, cholesterol or glucose, in particular, taken immediately before minimal amounts of blood of a user, having the features of the preamble of claim 1. Such a device is made DE 102 08 575 C1 known.

The The invention therefore deals with so-called "all-in-one" complete devices. The Test agents can for example in the form of a diaphragm defining a measuring field be formed with the extracted minimum amount of blood is wetted and includes test reagents, by means of which the analysis accomplished becomes. The evaluation device may, for example, optically, preferably work reflectometrically, electro-chemically or electrophysically.

US-A-5,971,941 shows according to one embodiment a complete system in the above sense, wherein a Inserted cassette with unused strip-shaped test media into a basic unit and then by means of a slider a respective test agent in a respective working position can be brought. Via a triggering device, which forms part of the blood sampling device, is by means of a pestle Lancing element for blood sampling pushed outward to the skin surface of a User to pierce, so that capillary blood won for analysis can be. The lancing elements are each on a test strip integrated and so together with the test strip in position brought. details designs, how the analysis is done , can not be found in this document. After a another embodiment described in this document becomes a disposable cylindrical tower or use described which a lancing element and a tablet-shaped test membrane with a passage opening for the Having lancing element. This essay or insert is then in a Holding recess of a plunger assembly used, which pushes the lancing element for blood withdrawal to the outside. In front and after each test, the disposable unit must be mounted or dismantled.

Also after DE 198 19 407 A1 According to one embodiment, a plurality of strip-shaped test means with lancing elements integrated in a manner not described thereon can be inserted into an analysis device and brought into a working position one after the other. Clear references to the technical feasibility can not be found in the document.

Out US-A-4,787,398 is a blood glucose meter known with a base unit with a plunger assembly for deflecting a lancing element and with an evaluation device and a display device. For Each measurement must be an interchangeable unit on the basic unit are arranged, which the lancing element and a to be wetted with blood Test agent in the form of a test strip comprises. This interchangeable Unit is discarded after each use.

On off EP 0 449 525 A1 Although known blood analyzer also includes an integrated blood sampling device with a lancing element. However, before each start-up, a new lancing element must be manually inserted into the triggering device as part of the blood sampling device and then a test strip inserted into the device.

Also US-A-4,627,445 shows a blood glucose meter with integrated blood sampling device. Also but here, before each measurement, a new interchangeable unit must be created made of lancing element and test equipment, consuming mounted on a basic unit and then dismantled.

The same shows US-A-5,951,492. According to this Reference includes a disposable unit a capillary tube to their body turned away End of a test strip is provided, with the minimum amount removed is applied by blood. The capillary tube is at its front end formed with a lancing element. Again, before and after everyone has to Measuring a new disposable unit of the just described Art assembled or disassembled.

Furthermore, are off EP 0 877 250 A2 . EP 0 949 506 A2 and EP 0 811 843 A2 non-generic blood analysis devices are known in which a plurality of test means are arranged on a rotatable disc as a carrier for the test means, wherein the test means are successively brought into a working position and for wetting with a minimum amount of blood from the housing body pushed out.

Out US 6,228,100 B1 and US 4,794,926 are Blutentnahme- or -stechvorrichtungen known in which a number of piercing elements are arranged on a relative to a housing body rotatable carrier. According to US 6,228,100 B1 the piercing elements are ejected radially by means of a jar and according to US 4,794,926 the lancing elements are oriented in the axial direction and activated.

Out EP 1 060 707 A2 is a vacuum assisted lancing device with a single Ste chelement known. Out US 4,637,403 and US 4,627,445 and WO 98/24366 discloses blood analyzers having a vacuum-assisted lancing device with a single piercing element.

According to EP 0 199 484 B1 For example, blood is sucked through negative pressure through a capillary piercing element to a test agent.

Of the The present invention is based on the object, in a blood analyzer of the above called type, the blood collection from the skin surface of a User more effectively, d. H. in still further Measures ensure that one for the analysis required minimum amount of blood largely painless and especially without piercing the skin surface several times have to or to apply pressure with the fingers of the other hand.

These Task is in a blood analyzer of the generic type according to the invention thereby solved, that your negative pressure generating device is provided by means of which already immediately before the execution or at the same time with the execution or immediately after the execution of the lancing process Support the Obtaining a minimum amount of blood a negative pressure to the skin surface can be applied is.

Thereby, that the blood analyzer is provided with a negative pressure generating device can promotes the escape of blood from the skin surface and thereby supported. The recovery of a required minimum amount of blood can thereby also be accelerated, without the user being concerned skin surface to press or pinch to get the required minimum amount of blood win.

In Further development of the invention is the negative pressure generating device provided so that the negative pressure generated by it the carriage from out of the skin surface escaped blood to a test agent. Spilled blood will be like under a pumping or suction effect to a test agent of the above explained Kind of promoted, where then the analysis or examination of the blood is carried out.

Of Furthermore, it proves to be advantageous if the test medium between the lancing position and the negative pressure generating device is provided, since then the test agent at the suction path or flow path, which arises as a result of the negative pressure generation, is arranged. Preferably, the test agent is at least almost at the piercing position subsequently or adjacent thereto, so that blood derived from the skin surface to be able to apply or wet the test agent directly, without previously flow paths inside the blood analyzer go back to have to, which in turn would be associated with a loss of blood.

The Vacuum generating device may be in any desired manner on or in the blood analyzer be provided. It may be an electric motor driven Low pressure source or before commissioning or during the Operation of the blood analyzer act evacuatable vacuum reservoir. In development of the invention Of particular importance, the negative pressure generating device a volume changeable Range up. This can be a cylinder space, its volume by a cooperating with the cylinder chamber piston mutable is and in this way by increasing the volume of a negative pressure provided or a vacuum reservoir for the operation of the blood analyzer can be.

In Advantageous development of this inventive concept could the volume changeable range have a spring means, which in particular and preferably biased in the direction of an increase in volume. In this way could by a particular and preferably manually brought about volume reduction against the bias of the spring means air from the variable volume Area to outside repressed become. Now if the spring means following this the volume looking to enlarge again, Thus, a negative pressure is generated in this way or a vacuum reservoir for the Operation of the blood analyzer to disposal posed.

Preferably could the volume changeable Area a bellows, in particular a bellows, or have be formed or limited by a bellows.

When It is particularly advantageous if the negative pressure generating device manually, ie in particular by finger pressure or any other manually executable Movement, for the generation of negative pressure can be activated.

Especially Preferably, this activation can - as previously indicated - done by that the negative pressure generating device by reducing the Volume of the volume changeable Area for the subsequent thereto Generation of a negative pressure is activated or tensioned.

It proves to be advantageous and desirable that the vacuum generating A direction, without requiring motor drive means, is activatable and operable, which keeps the complexity of the blood analyzer according to the invention and especially the need for electrical energy in limits.

In still further development of the invention is proposed that the negative pressure generating means so with the blood sampling device is functionally coupled, that the negative pressure only immediately or at the same time as or immediately after the execution of the Lancing is generated and then immediately applied to the skin surface is. That is what this is doing the constructive training of vacuum generation and provision on the skin surface especially easy. It can be particularly expensive on sealants or sealing measures be waived, and it can instead, there are adjusting leaks and leakage currents in the air Inside the case body aware taken and used to blood from the immediate previously stung skin surface to transport a test agent of the type discussed above.

In Further development of this inventive idea is proposed that the negative pressure generating device in such a way with the blood sampling device is functionally coupled with that activating the negative pressure generating Establishment a clamping operation is accompanied by the blood sampling device. Preferably, the negative pressure generating device is with the blood sampling device mechanically functionally coupled. The blood sampling device comprises a shock or drive mechanism for the piercing elements and this requires a drive energy, the is preferably provided by tensioning spring means. The tensioning of such spring means or in the broadest sense activating The blood sampling device should according to the above-described inventive idea accompanied or triggered are activated by activating the negative pressure generating device, and preferably by purely mechanical function coupling.

The Test agent and lancing elements are on a support, preferably the same opposite the housing body rotatable Carrier, arranged and with this carrier in the device used. A respective used test agent or lancing element could immediately after execution the test process ejected from the housing body and be discarded. On the other hand, it proves to be advantageous and desirable if the used test agents and lancing elements remain on the carrier and can be removed from the housing body together with the carrier after use.

In Further development of the invention is the negative pressure generating device such with the aforementioned carrier for the Lancing elements and test agents functionally coupled with activation the negative pressure generating device is accompanied by an adjusting movement of the carrier or is triggered by this.

It proves to be further advantageous that to activate the negative pressure generating device an executable in particular by finger pressure axial Actuating movement is provided, the transmission means in a rotational adjustment movement for the Drive of the vehicle for the Test agent and / or lancing elements can be implemented. This can be done through various and in itself any possibilities mechanically will be realized. Advantageously, a by finger pressure actuated handle be provided, which is biased in one direction. He can advantageously at the same time indirectly or directly the volume changeable Limit area. This pusher can be equipped with a spur gear with an axially displaceable Actuate rotary element which is designed so that it first under the axial adjusting movement of the pusher an axial adjusting movement, especially against the action of a spring means, executes and then, in particular, after the release of forced guidance means, which is first a Prevent rotation, merges into a rotational movement. This rotational movement can then in turn turn over any transmission means, in particular in the form of meshing gears, for rotational drive of the carrier for the lancing elements and / or test agents.

In further embodiment of the present invention of independent significance the formation and arrangement of lancing elements, in particular the arrangement on an adjustable support, further developed according to the invention and improved. After a basic inventive idea is a respective lancing element slidably received in a receiving sleeve. This is intended to protect against the ingress of dirt and germs, in particular sterile storage and provision of lancing elements ensured become.

The respective receiving sleeves are preferably on a support held and together with the carrier in the housing body of a Blood analyzer used.

Further inventive features of the receiving sleeve and the arrangement and design of the piercing elements in a respective receiving sleeve and the design and arrangement of a protective cap means for the piercing elements and de Ren arrangement and the arrangement of the test agent on a receiving tube arise from the claims 16 to 39.

The However, the present invention also relates to a lancing device in addition to a blood analyzer designed as an "all-in-one" device for piercing the body surface to Taking a minimum amount of blood from the human or animal body for analysis or examination purposes. Such a generic lancing device is known from WO 03/070099 A1. It comprises a plurality of a carrier provided and with the carrier can be used in a housing body Lancing elements, which can be driven by a drive mechanism.

Of these, Based on the invention, the further object, the Lancing, in particular the extraction of a for analysis or investigation purposes sufficient minimal amount of blood easier, and painless to design.

These The object is achieved by a lancing device with the features of the claim 40 solved. Therefore the lancing device comprises a vacuum generating device, by means of which already immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process Support the Obtaining a minimum amount of blood a negative pressure to the skin surface can be applied is.

It It goes without saying that the same advantages, in the beginning in connection with the blood analyzer according to the invention in detail were described, also for the inventive construction of a pure lancing device apply accordingly, so that reference thereto is taken. Advantageous developments of the lancing device according to the invention and their features will be apparent from the claims 41 to 67. Preferred Embodiments, Details and features of the present invention will become apparent from the dependent ones Claims, for their Characteristics also detached from any possible relationship Protection as independent Inventive idea is claimed.

Further Features, details and advantages of the invention will become apparent the drawing and the following description of a preferred embodiment the blood analyzer according to the invention discussed.

In the drawing shows:

1 a perspective view of an embodiment of a blood analyzer according to the invention;

2 a perspective view of the blood analyzer after 1 in half torn form;

3 a sectional view of the blood analyzer according to 1 and 2 seen in the direction of arrows III-III in 1 ;

4a an exploded view of a transmission section of the blood analyzer according to the invention;

4b a perspective view of the transmission section after 4a half torn open;

5a a perspective view of a shock mechanism of the blood analyzer according to the invention (without other other components);

5b a sectional view of the impact mechanism after 5a ;

6a - 6d three views and a sectional view of a received in a receiving sleeve lancing element;

7a - 7d four views of a received in a receiving sleeve lancing element in cooperation with a lower portion of the impact mechanism and

8a - 8c a perspective view, a plan view and a sectional view of a support for a plurality of lancing elements;

9 a perspective view of another embodiment of a blood analyzer according to the invention;

10 a side view of the blood analyzer after 9 and

11 a perspective view of a carrier of the device according to 9 with radially arranged lancing elements.

A total with the reference numeral 2 designated blood analyzer is from the 1 to 3 seen. It comprises a housing body 4 with a display device 6 for displaying the result of the analysis or examination of a minimum amount of blood. The blood analyzer 2 but also includes an integrated total with the reference numeral 8th designated blood sampling device with a plurality of lancing elements 10 The one interacts with a lancing position 12 Applied skin surface of a user quickly and painless as possible to pierce able to to gain a minimum amount of blood. Blood leaking from the skin surface wets a test agent 14 in which an analysis or test reaction takes place, which can be evaluated by means of an evaluation device, not shown. The evaluation device, which is not shown, may be an evaluation device which has an optical or electrochemical or electrophysical effect and by means of which a test or analytical reaction which takes place in the test medium can be detected and evaluated, which is known per se and therefore this point is not described in detail. The evaluation device can with the test agent in the illustrated lancing position 12 or in another position within the blood analyzer 2 interact. For example, it would be conceivable that from the 2 and 3 apparent test agents 14 by a rotation of a carrier to be described later 16 for lancing elements 10 and test agents 14 placed in a different position where the test agent 14 can interact directly with the evaluation device, not shown.

When starting up the blood sampling device 8th becomes inside the case body 4 and thus also in the area of the lancing position 12 generates a negative pressure. For this purpose, a negative pressure generating device 18 provided that a volume changeable area 20 includes, that of a bellows 22 is limited.

The negative pressure generating device 18 is by finger pressure on a pusher 24 actuated. In the course of depressing the pusher 24 Air is released from the volume changeable area 20 and the housing body 4 displaced to the outside. The subsequent reopening is under the action of a first spring 26 inside the volume changeable area 20 and thus inside the case body 4 generates a negative pressure. The first time you press the trigger 24 is at the same time about a still to be described in detail transmission device 28 generates a rotational movement on the wearer 16 for a plurality of at least 4 , in particular of at least 6 , in particular of at least 8th , in particular of at least 10 , and more particularly of at least 12 piercing elements 10 and a corresponding number of test agents 14 is transferred to a new unused lancing element 10 and associated test agent 14 in the lancing position 12 assigned work item 30 bring to.

Furthermore, the first time you press the trigger 24 about a coupling device to be described later 32 with a Bowden cable 34 a drive mechanism 36 the blood collection device 8th curious; excited. When depressing the pusher 24 becomes the Bowden cable 34 under the action of a third spring 38 in the direction of the arrow 40 emotional. As a result, one of the Bowden cable 34 to the side projecting driving lever 42 taking a clamping device 44 for a pull wire of the drive mechanism 36 the blood collection device 8th in the direction of the arrow 46 relocated. The driving lever 42 can with a tangible end 48 in a locking device 50 be set in the tensioned state. When releasing the locking device 50 the clamping device releases 44 for the puller wire and the puller wire jumps under the action closer to be described spring means in the direction of the working position 30 and drives a lancing element arranged there 10 to execute the lancing process.

The one in the area of the lancing position 12 prevailing negative pressure assists in obtaining a minimal amount of blood from the skin surface and further assists in transporting the minimal amount of blood to the test agent 14 , By pressing the button again 24 becomes the lancing element just used 10 from his working position 30 together with the test agent 14 spent, and the test agent 14 is brought into a working position for the interaction with the evaluation device, not shown, where then optically, electro-physically or electro-chemically, the evaluation of the test reaction of the blood with the test agent 14 he follows.

The following is in conjunction with the 4a . 4b and 3 the transmission device 28 explained to implement an axial actuating movement in a rotary motion. The transmission device 28 includes a housing-fixed guide bushing 52 in which a pressure piece 54 through a stepped stop 55 is limited shiftable. At the free end of the pressure piece 54 is the pusher 24 pressed. In the other end of the fixed guide bush 52 engages a shaft section 56 with a spur toothing 58 a, which spur toothing 58 with a facing spur toothing 60 of the pressure piece 54 interacts. About a second spring 62 is the shaft section 56 in the direction of the pressure piece 54 biased. The shaft section 56 comprises on its outer surface a plurality of radially outwardly projecting and longitudinally extending webs 64 in the longitudinal grooves 66 inside the fixed guide bush 52 engage and prevent rotation of the shaft section 56 opposite the guide bush 52 while maintaining an axial displaceability effect. When depressing the pusher 24 becomes the pressure piece 54 moved axially, wherein the spur toothing 60 with the spur toothing 58 of the shaft section 56 cooperates and thereby generates a rotational driving force. However, a rotational movement is achieved by engagement of the webs 64 in the longitudinal grooves 66 prevents so that the shaft section 56 against the action of the second spring 62 also axially and in the representation of 3 to un is moved. Once the jetties 64 from the longitudinal grooves 66 come free, one of the spur gear corresponding incremental rotational movement of the shaft portion 56 generated by a positive engagement of the spur toothing 58 and 60 is ended in one another.

The aforementioned rotary motion of the shaft section 26 gets on a gear pair 70 . 72 transferred, of which the latter on a hub section 74 of the carrier 16 is arranged rotationally fixed.

The transmission device described above 28 is designed as a rotary unit such that in the described first operation of the pusher 24 an axial lifting movement and a rotary movement of 360 ° / 12/2 = 15 °. Here is a new unused lancing element 10 in his working position 30 brought.

Under the action of the tensioned second spring 62 and the first spring 26 becomes the shaft section 56 and the pressure piece 54 contrary to the previous movement (in the 3 moved up). The return stroke of the pressure piece 54 is by the axial step stop 55 inside the guide bush 52 limited.

The following is based on the 5a . 5b and 3 the function of the drive mechanism 36 the blood collection device 8th described. The drive mechanism 36 includes starting from the lancing element 10 a form-fitting with a grasping behind the head section 76 of the lancing element 10 releasably connectable impact member 78 , The shock organ 78 is about a fifth spring 80 against a housing-fixed wall section 82 biased in the direction of impact. It includes an axial opening 84 through which a semi-rigid pull wire 86 in a cylindrical cavity 88 of the shock organ 78 hineinerstreckt and there by means of a sixth spring 90 is biased in the direction of impact. The semi-rigid pull wire 86 extends through an opening in the wall portion 82 through and through a clamping device 44 , consisting of a clamping cone 92 and a clamping device 94 through and through an opening in the driving lever 42 therethrough. In the released state of the clamping device 94 is the clamping cone 92 opposite the pull wire 86 movable. He is opposite the driving lever 42 so axially limited movable that when adjusting the driving lever 42 its inertia or frictional forces between clamping cone 92 and a surrounding cylinder wall clamping or release of the pull wire 86 in the clamping device 94 cause.

Is based on the in 5b shown position of the pushers 24 ( 3 ) pressed down, so is the driving lever 42 under the action of the third spring 38 pushed up. By the entrainment of the clamping cone 92 becomes the pull wire 86 in the clamping device 94 clamped and together with the driving lever 42 upwards in the direction of the locking device 50 emotional. In the locking device 50 becomes the tangible end 48 of the driving lever 42 fixed. The clamping operation described above takes place counter to the spring force of the fifth spring 80 which are the for the drive mechanism 36 stores the required impact energy. Will the locking device 50 by pressing a trigger 96 solved, so the tangible end 48 of the driving lever 42 released, so the inertia of the clamping cone leads 92 to that the clamping device 94 the pull wire 86 releases. The shock organ 78 and with him the pull wire 86 then fast under the action of the fifth spring 80 downward. Due to the coupling of impactor 78 and lancing element 10 guides the lancing element 10 then a lancing off. It jumps over the free end of a receiving sleeve to be described later 98 and is withdrawn behind the free end again.

Based on 6a to 6d is the training and arrangement of lancing elements 10 described. A respective lancing element 10 , which is a metallic needle-shaped element of a length of 6-15 mm, has a molded-on holding body 100 as well as a likewise molded-on protective cap means 102 on which the lancing element 10 protects against contamination and ensures a preferably germ-proof, preferably sterile closure against the environment. A respective lancing element 10 with holding body 100 and protective cap means 102 is in an already mentioned receiving sleeve 98 slidably received in the axial direction. The lancing element 10 is doing with his tangible head section 76 into the opening at the free end 104 the receiving sleeve 98 inserted and through the receiving sleeve 98 passed through until the cap means 102 to an axial step 106 inside the preferably cylindrical opening 107 the receiving sleeve 98 strikes. Recognizable in the figures is further a resilient return means 108 whose springy arms 110 , which are integral to the holding body 100 can be formed on an annular collar-like section 112 the receiving sleeve 98 rest. When performing a lancing process, these return means cause 108 in that the lancing element 10 again behind the end 104 the receiving sleeve 98 is withdrawn. The bias of the return means 108 in the initial state of the lancing element 10 Can also be used to protect the cap 102 in contact with the receiving sleeve 98 , in particular in contact with the axial stop 106 the receiving sleeve 98 to maintain and so an improved, preferably germ-tight completion of receiving sleeve 98 to effect.

The 7a to 7d illustrate how the head section 76 in particular in one piece with the molded-on holding body 100 may be formed in a tangible groove 114 of the shock organ 78 positively gripped or engaged behind. The shock organ 78 acts with a molded-on ramp means 116 together, which is also an off 7b apparent insertion opening 118 for the head section 76 of the lancing element 10 forms. This ramp means 116 acts with a run-on slope 120 attached to the annular collar section 112 the receiving sleeve 98 is trained. When the receiving sleeve 98 with the lancing element received therein 10 on the carrier 16 is moved in the circumferential direction, so slides the run-on slope 120 against the ramp means 116 on, and the entire receiving sleeve 98 is doing in the direction of the arrow 122 moved axially. Due to the positive engagement of the head section 76 of the lancing element 10 in the groove 114 of the shock organ 78 The lancing element is held in its original axial position, so that it moves axially in the direction of the arrow 122 not with executes. The lancing element 110 So it is relative to the receiving sleeve 98 withdrawn. This has the consequence that the protective cap means 102 from the free end of the lancing element 10 is released. It can fall down. The blood sampling device 8th is then ready to perform a lancing process. If the cap means 102 is removed, so there is also the test agent 14 free, which advantageously in the area of the free end 104 the receiving sleeve 98 is included. As in 6a hinted, the test agent can 14 in an opening in the wall of the receiving sleeve 98 be provided. The test agent is in the illustrated case inside through the cap means 102 covered and protected in this way from contamination, especially against access of humidity and germs, which is considered to be particularly advantageous. The cap mean 102 thus performs a dual function, it serves both the cover of the lancing element 10 as well as the coverage and protection of the test agent 14 ,

One recognizes in the 6 and 7 furthermore helically extending webs on the outer circumference of the receiving sleeve 98 , This is springback 124 , which at its upper end to the annular collar-shaped section 112 are formed. If the carrier 16 is continued and thus the just considered receiving sleeve 98 from her working position 30 and thus out of the influence of the ramp means 116 brought, lead this spring-back means 124 to that the receiving sleeve 98 again against the arrow 122 is withdrawn.

The 8a to 8c show in different views the carrier 16 for the majority of lancing elements 10 and test agents 14 , In the case shown, twelve receiving sleeves 98 with twelve lancing elements 10 and twelve test agents 14 added. A respective receiving sleeve 98 is in an open-edged recess 126 a disk-shaped part 128 of the carrier 16 used in the axial direction. So that the receiving sleeves 98 in their working position 30 when interacting with the ramp means 116 can not twist, are the open-edged recesses 126 and the outer circumference of the receiving sleeves 98 out of round, slightly elliptical in the illustrated case. This brings the further significant advantage that a respective receiving sleeve 98 in a preferential orientation on the carrier 16 is held, with regard to the positioning of the in the receiving sleeve 98 recorded test agent 14 is very important, because it must be able to interact at a predetermined location and orientation with the evaluation. The carrier 16 with a centrally arranged polygonal opening 130 for the engagement of a correspondingly formed hub portion 74 to the rotary drive of the carrier is together with the lancing elements 10 and test agents 14 in the housing body 4 can be used of the blood analyzer according to the invention and removed again from the housing body together with the used lancing elements and testing means. This is off 2 it can be seen where a cover which releases or closes the insertion opening is provided.

The 9 - 11 show a further embodiment of a blood analyzer according to the invention, in which the piercing direction and the piercing elements themselves are radially arranged with respect to a rotatably driven carrier for the lancing elements. Radially within the carrier, a drive device, not shown, is provided for the lancing elements.

The operation and function of the blood analyzer according to the invention in carrying out a blood collection and analysis is described below:
Starting from the in 3 shown basic position becomes the pusher 24 against the tension of the first spring 26 and the second spring 62 depressed a first time. During a first stroke section thereby the pressure piece 54 and the shaft section 56 axially displaced downwards. It creates a force in the circumferential direction. Meanwhile, the building move 34 the driving lever 42 free, under pressure of the third spring 38 in the direction of the arrow 40 emotional. At the same time the pull wire 86 in the clamping device 94 clamped and thus the pull wire 86 also pulled up. Meanwhile, however, the impact remains 78 another one of his starting position.

Finally come in a further Hubabschnitt the webs 64 from the longitudinal grooves 66 the fixed guide bush 52 free and the shaft section can make a rotational movement of 15 °. At the same time, the carrier becomes over the gear pair 70 . 72 moved by 15 ° and brings a lancing element 10 in the working position 30 , The head section slides 76 of the lancing element 10 in the opening 114 of the shock organ 78 and thus in the rear grip position. Almost at the same time the receiving sleeve slides 98 with its run-on slope 120 against the ramp means 116 and will be in the direction of the arrow 122 moved down so that the protective cap means 102 from the lancing element 10 is released. During the last part of the stroke movement of the pusher 24 is the free path of the pull wire 86 inside the cylindrical opening 107 of the shock organ 78 used up and the pull wire clamps against the force of the fifth spring 80 as main shock spring the drive mechanism 36 the blood collection device 8th , At the end of the tensioning movement becomes the tangible end 48 of the driving lever 42 in the locking device 50 fixed.

The negative pressure generating device 18 is now activated, and the drive mechanism 36 the blood collection device 8th is curious. By pressing the shutter button 96 can the locking device 50 be solved and thus the impact organ fast 78 under the force of the fifth spring 80 down and the lancing process is performed. Meanwhile, taking place under the force of the first spring 26 and the second spring 62 a reset of the pusher 24 instead of. In this way, the volume variable range 20 enlarged and it creates a negative pressure, which extends to the lancing position 12 in the area of the free end 104 the receiving sleeve 98 spreads and promotes blood collection and promotes.

Immediately after the triggering of the lancing, press the fourth spring and the sixth spring 90 the shock organ 78 back to its original position and thus cause the return movement of the lancing element 10 which also by the springback means 124 is supported.

Meanwhile, the shaft section becomes 56 under the action of the first and second springs 26 . 62 back into the fixed guide bush 52 retracted.

By pressing the button again 24 becomes the lancing element just considered 10 along with its receiving sleeve 98 and the test agent 14 then rotated by another 15 °; So it will be off the working position 30 the lancing elements removed. By a suitable design of the transmission device 28 is the stroke of the pusher in this second operation 24 limited so that it does not cause a tensioning of the drive device 36 comes. The test agent 14 can thus be transported to an optical, electro-chemical or electro-physical acting not shown evaluation. Due to the predetermined positioning of the receiving sleeves 98 on the carrier 16 it is ensured that the test means are arranged in the correct orientation to the evaluation device.

It would also be conceivable that the second rotation by 15 °, which brings the lancing element from the working position, not by a renewed actuation of the pusher 24 but alternatively by the return movement of the shaft section 56 is reached. For this purpose, a run-on slope 132 at the free end of the footbridges 64 on the outer circumference of the shaft section 56 be provided. Upon reentry of the shaft section 56 in the guide bush 52 could be due to the interaction of these run-on slopes 132 with the longitudinal grooves 66 a further rotation of the shaft section 56 for more 15 to be triggered.

The result of the evaluation is then, for example, in the form of the current blood sugar content on the display device 6 of the blood analyzer 2 displayed.

Claims (67)

Blood analyzer ( 2 ) with a housing body ( 4 ), with a plurality of lancing elements ( 10 ) having blood collection device ( 8th ), with a plurality of test agents ( 14 ) for the analysis of a minimum amount of blood, with an evaluation device comprising evaluation electronics and with a display device ( 6 ), which form a complete system that can be handled as a single device, wherein the housing body ( 4 ) one of a working position ( 30 ) of a respective lancing element ( 10 ) assigned puncturing position ( 12 ) for applying a skin surface of a user, wherein a plurality of test means ( 14 ) and lancing elements ( 10 ) can be used in the device, which in order to carry out several measurements successively in a working position ( 30 ) can be brought, wherein when positioning a lancing element ( 10 ) in its working position ( 30 ) the lancing element ( 10 ) into the lancing position ( 12 ) and the exiting skin surface of a user can be pierced on a test agent ( 14 ), characterized in that a negative pressure generating device ( 18 ) is provided, by means of which a negative pressure to the skin surface can be applied immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing operation to support the production of a minimum amount of blood. Blood analyzer according to claim 1, characterized in that the negative pressure generating device ( 18 ) is provided so that the negative pressure generated by it, the transport of escaped from the skin surface blood to a test agent ( 14 ) supported. Blood analyzer according to claim 1 or 2, characterized in that the test agent ( 14 ) between the lancing position ( 12 ) and the negative pressure generating device ( 18 ) is provided. Blood analyzer according to claim 3, characterized in that the test agent ( 14 ) at least almost to the lancing position ( 12 ) is provided adjacent thereto or adjacent thereto. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) a volume-changeable region ( 20 ) having. Blood analyzer according to one or more of the preceding claims, characterized in that the volume-changeable region ( 20 ) a spring means ( 26 ) having. Blood analyzer according to one or more of the preceding claims, characterized in that the volume-changeable region ( 20 ) a bellows, in particular bellows ( 22 ) having. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) can be activated manually to generate negative pressure. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) by reducing the volume of the volume changeable region ( 20 ) is activated. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) in such a way with the blood sampling device ( 8th ) is functionally coupled, that the negative pressure is generated only immediately before or simultaneously with or immediately after the execution of the lancing process and then directly to the skin surface can be applied. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) in such a way with the blood sampling device ( 8th ) is functionally coupled with that activation of the negative pressure generating device is accompanied by a clamping operation in the blood sampling device or thereby triggered. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) with the blood sampling device ( 8th ) is mechanically functionally coupled. Blood analyzer according to one or more of the preceding claims, characterized in that the test means ( 14 ) and the lancing elements ( 10 ) on a relative to the housing body ( 4 ) rotatable carrier ( 16 ) and can be used with this in the device and after use together with the carrier ( 16 ) from the housing body ( 4 ) are removable. Blood analyzer according to one or more of the preceding claims, characterized in that the negative pressure generating device ( 18 ) in such a way with the carrier ( 16 ) for the lancing elements ( 10 ) and test agents ( 14 ) is functionally coupled with activation of the negative pressure generating device, an actuating movement of the carrier ( 16 ) or triggered thereby. Blood analyzer according to one or more of the preceding claims, characterized in that for activating the negative pressure generating device ( 18 ) an axial adjusting movement is provided, which via transmission means ( 28 ) in a rotary actuating movement for the drive of the carrier ( 16 ) for the lancing elements ( 10 ) and / or test agents ( 14 ) can be implemented. Blood analyzer according to one or more of the preceding claims, characterized in that a respective lancing element ( 10 ) in a receiving sleeve ( 98 ) is slidably received, Blood analyzer according to one or more of the preceding claims, characterized in that the respective receiving sleeves ( 98 ) on a support ( 16 ) and together with the carrier ( 16 ) in the housing body ( 4 ) can be used. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve ( 98 ) inside an axially continuous, in particular cylindrical opening limited, in which the associated lancing element ( 10 ) is recorded. Blood analyzer according to one or more of the preceding claims, characterized in that the opening has a diameter of 2-7 mm, in particular of 2.5-5 mm, in particular of 3-4.5 mm. Blood analyzer according to one or more of the preceding claims, characterized in that the receiving sleeve ( 98 ) has an extension in the axial direction of 6-20 mm, in particular of 8-5 mm, in particular of 8-14 mm. Blood analyzer according to one or more of the preceding claims, characterized in that a respective lancing element ( 10 ) a molded-on holding body ( 100 ), which at the same time in the receiving sleeve ( 98 ) leads. Blood analyzer according to one or more of the preceding claims, characterized in that a respective lancing element ( 10 ) a preferably molded protective cap means ( 102 ) having. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means ( 102 ) the receiving sleeve ( 98 ) closes to the piercing side. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means ( 102 ) comprises an elastically deformable region or is formed from an elastically deformable material. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means ( 102 ) in one piece via a predetermined breaking area in the holding body ( 100 ) passes and thereby the lancing element ( 10 ) in particular germ-tight encloses. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means ( 102 ) has a diameter perpendicular to the axial direction of the receiving sleeve ( 98 ) of 2-7 mm, in particular of 2.5-5 mm, in particular of 3-4.5 mm. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve ( 98 ) the test agent ( 14 ), preferably in the area of its exit from the lancing element ( 10 ) serving end ( 104 ). Blood analyzer according to one or more of the preceding claims, characterized in that the test agent ( 14 ) in an opening in the wall of the receiving sleeve ( 8th ) is provided. Blood analyzer according to one or more of the preceding claims, characterized in that the test agent ( 14 ) before performing a lancing process by the protective cap means ( 102 ). Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means ( 102 ) against an axial stop ( 106 ) of the receiving sleeve ( 98 ) can be applied. Blood analyzer according to one or more of the preceding claims, characterized in that the receiving sleeve ( 98 ) comprises a stepped opening with a step which stops ( 106 ) for the cap means. Blood analyzer according to one or more of the preceding claims, characterized in that the lancing element ( 10 ) at least one resilient, in particular in one piece with the holding body ( 100 ) formed return means ( 108 ), which has a return movement of the lancing element after the execution of the lancing process relative to the receiving sleeve ( 98 ) causes or at least supports. Blood analyzer according to one or more of the preceding claims, characterized in that a bias of the return means ( 108 ) in the initial state of the lancing element ( 10 ) the protective cap means ( 102 ) in contact with the receiving sleeve ( 98 ), in particular in contact with the axial stop ( 106 ) of the receiving sleeve ( 98 ) and so to an improved, preferably germ-tight completion of the receiving sleeve ( 98 ) leads. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve ( 48 ) in an open-edged recess ( 126 ) of a particular disc-shaped part ( 128 ) of the carrier ( 16 ) is held. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve ( 98 ) in the axial direction displaceable on the carrier ( 16 ) is held. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve ( 98 ) during rotation of the carrier ( 16 ) by sliding against a forced guidance means ( 116 ) is displaceable in the axial direction. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve ( 98 ) at least one resilient return means ( 124 ), which has a return movement of the receiving sleeve ( 98 ) after the execution of the lancing process relative to the carrier ( 16 ) causes or at least supports. Blood analyzer according to one or more of the preceding claims, characterized in that the receiving sleeve ( 98 ) together with the lancing element received therein ( 10 ) only in a preferential orientation on the carrier ( 16 ) can be arranged. Blood analyzer according to one or more of the preceding claims, characterized in that the receiving sleeve ( 98 ) has a non-circular, deviating from the circular outer circumference and in a preferred orientation on the carrier ( 16 ) can be arranged. Puncture device for puncturing the body surface for taking a minimum amount of blood from the human or animal body for analysis or examination purposes, with a plurality of on a support ( 16 ) and with the carrier in a housing body ( 4 ) insertable lancing elements ( 10 ) driven by a drive mechanism ( 36 ) are drivable, characterized by a negative pressure generating device ( 18 ), by means of which a negative pressure to the skin surface can be applied immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing operation to support the production of a minimum amount of blood. Lancing device according to claim 40, characterized in that the negative pressure generating device ( 18 ) a volume-changeable region ( 20 ) having. Lancing device according to claim 40 or 41, characterized in that the volume changeable region ( 20 ) a spring means ( 26 ) having. Lancing device according to claim 42, characterized in that the volume changeable region ( 20 ) a bellows, in particular bellows ( 22 ) having. Lancing device according to one or more of claims 40-43, characterized in that the negative pressure generating device ( 18 ) can be activated manually to generate negative pressure. Lancing device according to one or more of claims 40-44, characterized in that the negative pressure generating device ( 18 ) by reducing the volume of the volume changeable region ( 20 ) is activated. Lancing device according to one or more of claims 40-45, characterized in that the negative pressure generating device ( 18 ) in such a way with the lancing mechanism ( 16 ) is functionally coupled, that the negative pressure is generated only immediately before or simultaneously with or immediately after the execution of the lancing process and then directly to the skin surface can be applied. Lancing device according to one or more of claims 40-46, characterized in that the negative pressure generating device ( 18 ) in such a way with the lancing mechanism ( 36 ) is functionally coupled with activation of the negative pressure generating device ( 18 ) a clamping operation of the lancing mechanism ( 36 ). Lancing device according to one or more of claims 40-47, characterized in that the negative pressure generating device ( 18 ) is technically functionally coupled with the lancing mechanism. Lancing device according to one or more of claims 40-48, characterized in that a respective lancing element ( 10 ) in a receiving sleeve ( 98 ) is slidably received, Lancing device according to one or more of claims 40-49, characterized in that the respective receiving sleeves ( 98 ) on a support ( 16 ) and together with the carrier ( 16 ) in the housing body ( 4 ) can be used. Lancing device according to one or more of claims 40-50, characterized in that a respective receiving sleeve ( 98 ) inside an axially continuous, in particular cylindrical opening limited, in which the associated lancing element ( 10 ) is recorded. Lancing device according to one or more of claims 40-51, characterized characterized in that the opening a diameter of 2-7 mm, in particular from 2.5-5 mm, in particular 3-4.5 mm. Lancing device according to one or more of claims 40-52, characterized in that the receiving sleeve ( 98 ) has an extent in the axial direction of 6-20 mm, in particular 8-15 mm, in particular 8-14 mm. Lancing device according to one or more of claims 40-53, characterized in that a respective lancing element ( 10 ) a molded-on holding body ( 100 ), which at the same time in the receiving sleeve ( 98 ) leads. Lancing device according to one or more of claims 40-54, characterized in that a respective lancing element ( 10 ) a preferably molded protective cap means ( 102 ), which the receiving sleeve ( 98 ) closes in particular germ-tight to the piercing side. Lancing device according to one or more of claims 40-55, characterized in that the protective cap means ( 102 ) comprises an elastically deformable region or is formed from an elastically deformable material. Lancing device according to one or more of claims 40-56, characterized in that the protective cap means ( 102 ) in one piece via a predetermined breaking area in the holding body ( 100 ) passes and thereby surrounds the lancing element in particular germ-tight. Lancing device according to one or more of claims 40-57, characterized in that the protective cap means ( 102 ) has a diameter perpendicular to the axial direction of the receiving sleeve ( 98 ) of 2-7 mm, in particular of 2.5-5 mm, in particular of 3-4.5 mm. Lancing device according to one or more of claims 40-58, characterized in that the protective cap means ( 102 ) against an axial stop ( 106 ) of the receiving sleeve ( 98 ) can be applied. Lancing device according to one or more of claims 40-59, characterized in that the receiving sleeve ( 98 ) comprises a stepped opening with a step which stops ( 106 ) for the protective cap means ( 102 ). Lancing device according to one or more of claims 40-60, characterized in that the lancing element ( 10 ) at least one resilient, in particular one-piece with the holding body ( 100 ) formed return means ( 108 ), which has a return movement of the lancing element ( 10 ) after the execution of the lancing process relative to the receiving sleeve ( 98 ) causes or at least supports. Lancing device according to one or more of claims 40-61, characterized in that a respective receiving sleeve ( 98 ) in a particular open-edged recess ( 126 ) of a particular disc-shaped part ( 128 ) of the carrier ( 16 ) is held. Lancing device according to one or more of claims 40-62, characterized in that a respective receiving sleeve ( 98 ) in the axial direction displaceable on the carrier ( 16 ) is held. Lancing device according to one or more of claims 40-63, characterized in that a respective receiving sleeve ( 98 ) during rotation of the carrier ( 16 ) by sliding against a forced guidance means ( 116 ) is displaceable in the axial direction. Lancing device according to one or more of claims 40-64, characterized in that a respective receiving sleeve ( 98 ) at least one resilient return means ( 124 ), which has a return movement of the receiving sleeve ( 98 ) after the execution of the lancing relative to the carrier causes or at least supported. Lancing device according to one or more of claims 40-65, characterized in that the receiving sleeve ( 98 ) together with the lancing element received therein ( 100 ) only in a preferential orientation on the carrier ( 16 ) can be arranged. Lancing device according to one or more of claims 40-66, characterized in that the receiving sleeve ( 98 ) has a non-circular, deviating from the circular outer circumference and in a preferred orientation on the carrier ( 16 ) can be arranged.