WO2005065545A2

WO2005065545A2 - Blood analysis device for determining an analyte

Info

Publication number: WO2005065545A2
Application number: PCT/EP2004/013825
Authority: WO
Inventors: Armin Lohrenhel; Herbert STÖHR; Wolfgang Ostertag
Original assignee: Paul Hartmann Ag
Priority date: 2003-12-23
Filing date: 2004-12-04
Publication date: 2005-07-21
Also published as: EP1699356A2; WO2005063124A1; WO2005063124A8; DE10361560A1; WO2005065545A3; EP1699355A1; DE10361562A1

Abstract

The invention relates to a blood analysis device (2) comprising a housing body (4), a blood withdrawal device (8) comprising a plurality of pricking elements (10), a plurality of testing means (14) which are used to analyse a minimal amount of blood, an evaluation device comprising an electronic evaluation system and a display device (6), which together form one complete hand-held system which is embodied as a single device. The housing body (4) can be arranged in a pricking position (12) corresponding to an operational position (30) of a respective pricking element (10) which is applied to the surface of the skin of a user. A plurality of testing means (14) and pricking elements (10) can be introduced into the device and can be arranged in a successive manner in an operational position (30) in order to carry out several measurements. When a pricking element (10) is positioned in an operational position (30), the pricking element can be inserted into the surface of the skin of a user in a pricking position (12). Blood emanating from the surface of the skin can reach to a test means (14). The invention is characterised in that said blood analysis device comprises a device (18) which produces a low pressure, which can be applied to the surface of the skin immediately prior to the pricking or simultaneously with the pricking or immediately after the pricking in order to obtain a minimal amount of blood.

Description

Title: Blood analyzer for the determination of an analyte

description

The invention relates to a blood analyzer for determining an analyte such as e.g. Fructosamine, lactate, cholesterol or, in particular, glucose, on minimally withdrawn minimal amounts of blood from a user, with the features of the preamble of claim 1. Such a device is known from DE 102 08 575 Cl.

The invention therefore deals with so-called "all-in-one" complete devices. The test means can be designed, for example, in the form of a membrane defining a measuring field, which is wetted with the minimal amount of blood withdrawn and comprises test reagents with which the analysis is carried out. The evaluation device can, for example, work optically, preferably reflectometrically, electrochemically or electro-physically.

According to one embodiment, US-A-5, 971, 941 shows a complete system in the sense described above, wherein a cassette with unused strip-shaped test means can be inserted into a basic device and a respective test means can then be brought into a respective working position by means of a slide. Via a trigger device, which forms part of the blood sampling device, a lancing element is pushed outwards for blood sampling by means of a plunger in order to pierce the skin surface of a user, so that capillary blood can be obtained for analysis. The lancing elements are each integrated on a test strip and are thus positioned together with the test strip. Further details of how the analysis is carried out cannot be found in this document. According to another embodiment described in this document, a disposable described cylindrical attachment or insert, which has a lancing element and a tablet-shaped test membrane with a passage opening for the lancing element. This attachment or insert is then inserted into a holding recess in a plunger arrangement, which presses the lancing element outwards to draw blood. The disposable unit must be assembled and disassembled before and after each test.

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

From US-A-4, 787, 398 a blood sugar measuring device is known with a basic device with a plunger arrangement for deflecting a lancing element and with an evaluation device and a display device. For each measurement, an exchangeable unit must be arranged on the basic device, which comprises the lancing element and a test agent to be wetted with blood in the form of a test strip. This interchangeable unit is discarded after each use.

A blood analysis device known from EP 0 449 525 A1 also includes an integrated blood sampling device with a lancing element. Before each start-up, however, a new lancing element must be manually inserted into the trigger device as part of the blood collection device, and then a test strip must be inserted into the device.

US-A-4, 627, 445 also shows a blood glucose meter with an integrated blood collection device. Here, too, a new interchangeable unit must be used before each measurement Lancing element and test equipment are laboriously mounted on a basic device and then dismantled.

The same is shown in US-A-5, 951, 92. According to this document, a disposable unit comprises a capillary tube, on the end of which is remote from the body, a test strip is provided, which is subjected to the minimal amount of blood withdrawn. The capillary tube is formed with a lancing element at its front end. Again, a new disposable unit of the type just described must be assembled or disassembled before and after each measurement process.

Furthermore, EP 0 877 250 A2, EP 0 949 506 A2 and EP 0 811 843 A2 disclose blood analysis devices of a non-generic type, in which a plurality of test devices are arranged on a rotatable disc as a carrier for the test devices, the test devices being successively divided into one Working position can be brought and can be pushed out of the housing body for wetting with a minimal amount of blood.

US Pat. No. 6,228,100 B1 and US Pat. No. 4,794,926 disclose blood withdrawal or puncturing devices in which a number of lancing elements are arranged on a carrier which is rotatable relative to a housing body. According to US 6,228,100 B1, the lancing elements are ejected radially by means of a pushing device, and according to US 4,794,926 the lancing elements are oriented in the axial direction and can be activated.

A vacuum-assisted lancing device with a single lancing element is known from EP 1 060 707 A2. From US 4,637,403 and US 4,627,445 and from WO 98/24366 blood analyzers with vacuum-assisted lancing device with a single lancing element are known. According to EP 0 199 484 B1, blood is sucked through a capillary lancing element to a test medium with the aid of negative pressure.

The present invention has for its object to make the blood withdrawal from the skin surface of a user more effective in a blood analyzer of the aforementioned type, i. H. to an even greater extent to ensure that a minimum amount of blood required for the analysis is obtained largely painlessly and in particular without having to pierce the skin surface several times or having to exert pressure with the fingers of the other hand.

This object is achieved according to the invention in a blood analysis device of the generic type in that your vacuum-generating device is provided, by means of which it is used immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process to support the collection of a minimal amount of blood a negative pressure can be applied to the skin surface.

The fact that the blood analyzer is provided with a device that generates negative pressure can promote and thereby assist the escape of blood from the surface of the skin. The collection of a required minimum amount of blood can also be accelerated thereby, and without the user having to do so Squeeze or pinch the skin surface to obtain the minimum amount of blood required.

In a further development of the invention, the device generating the negative pressure is provided in such a way that the negative pressure generated by it supports the transport of blood that has escaped from the skin surface to a test agent. Leaked blood is conveyed to a test device of the type explained above, as under a pumping or suction effect, where the analysis or examination of the blood is then carried out.

Furthermore, it proves to be advantageous if the test means is provided between the lancing position and the vacuum-generating device, since in such a case the test means is arranged on the suction path or flow path which arises as a result of the vacuum generation. The test means is preferably provided at least almost adjacent to or adjacent to the lancing position, so that blood obtained from the skin surface can directly act on or wet the test means without having to cover flow paths inside the blood analyzer beforehand, which in turn results in a loss of blood volume would be connected.

The vacuum generating device can be provided in any way on or in the blood analyzer. This can be a vacuum source driven by an electric motor or a vacuum reservoir that can be evacuated before start-up or during operation of the blood analysis device. In a development of the invention of particular importance, the vacuum generating device has a volume-changeable area. This can be a cylinder chamber, the volume of which can be changed by a piston interacting with the cylinder chamber, and in this way a vacuum can be provided or a vacuum reservoir can be provided for the operation of the blood analysis device by increasing the volume.

In an advantageous development of this inventive idea, the volume-changeable area could have a spring means, which in particular and preferably in the direction is biased to an increase in volume. In this way, air could be displaced outward from the volume-changeable area by a volume reduction, in particular and preferably manually, counter to the pretensioning of the spring means. If the spring means then tries to increase the volume again, a negative pressure is generated in this way or a negative pressure reservoir is made available for the operation of the blood analysis device.

The volume-variable region could preferably have a bellows, in particular a bellows, or be formed or delimited by a bellows.

It proves to be particularly advantageous if the device generating negative pressure can be activated manually, that is to say in particular by finger pressure or another manually executable movement, in order to generate negative pressure.

This activation can particularly preferably take place, as indicated above, by activating or tensioning the vacuum-generating device by reducing the volume of the volume-variable region for the subsequent generation of a vacuum.

It has proven to be advantageous and desirable that the vacuum generating device can be activated and operated without requiring motor drive means, which limits the complexity of the blood analysis device according to the invention and, above all, the need for electrical energy.

In a further development of the invention, it is proposed that the device producing the pressure be functionally coupled to the blood collection device in this way is that the negative pressure is only generated immediately or simultaneously with or immediately after the lancing process has been carried out and can then be applied immediately to the skin surface. This makes the construction of the vacuum generation and provision on the skin surface particularly simple. In particular, elaborate sealants or sealing measures can be dispensed with, and instead occurring leaks and leakage-related flows inside the housing body can be deliberately accepted and used to transport blood from the skin surface pierced immediately before to a test agent of the type discussed at the outset.

In a further development of this inventive idea, it is proposed that the vacuum generating device is functionally coupled to the blood sampling device in such a way that when the vacuum generating device is activated, a tensioning process is associated with the blood sampling device. The device generating negative pressure is preferably functionally coupled to the blood sampling device. The blood collection device comprises a push or drive mechanism for the lancing elements and requires a drive energy for this purpose, which is preferably provided by tensioning spring means. The tensioning of such spring means or, in the broadest sense, the activation of the blood sampling device should, according to the inventive concept described above, be accompanied or triggered by the activation of the vacuum-generating device, preferably by means of purely mechanical functional coupling.

The test means and the lancing elements are arranged on a carrier, preferably the same carrier that is rotatable relative to the housing body, and can be inserted into the device with this carrier. A respective used test equipment or Lancing element could be ejected from the housing body and discarded immediately after the test procedure was carried out. In contrast, it proves to be advantageous and desirable if the used test means and lancing elements remain on the carrier and can be removed from the housing body together with the carrier after use.

In a further development of the invention, the vacuum generating device is functionally coupled to the above-mentioned carrier for the lancing elements and test means in such a way that an activation movement of the carrier goes along with or is triggered by activation of the vacuum generating device.

It also proves to be advantageous that for activating the vacuum-generating device, an axial adjusting movement, which can be carried out in particular by finger pressure, is provided, which can be implemented via gear means in a rotary adjusting movement for driving the carrier for the test means and / or the lancing elements. This can be achieved mechanically by various and any options. A pusher which can be actuated by finger pressure and is biased in one direction can advantageously be provided. It can advantageously limit the volume-changeable area either indirectly or directly. This pusher can cooperate with a spur gear toothing with an axially displaceable rotary element, which is designed such that it first executes an axial actuating movement under the axial actuating movement of the pusher, in particular against the action of a spring means, and then in particular after the release of positive guidance means, which is initially a Prevent rotation, turns into a rotational movement. This rotary movement can then, in particular, in turn by means of any gear, in particular in form of meshing gears, for the rotary drive of the carrier for the lancing elements and / or test means are used.

In a further embodiment of the present invention, which is of independent importance per se, the design and arrangement of the lancing elements, in particular the arrangement on an adjustable carrier, is further developed and improved according to the invention. According to a basic idea of the invention, a respective lancing element is slidably received in a receiving sleeve. This is intended to ensure, in particular, sterile storage and provision of the lancing elements that are protected against the ingress of dirt and germs.

The respective receiving sleeves are preferably held on a carrier and can be used together with the carrier in the housing body of a blood analysis device.

Further features according to the invention of the receiving sleeve and the arrangement and configuration of the lancing elements in a respective receiving sleeve and the configuration and arrangement of a protective cap means for the lancing elements and their arrangement as well as the arrangement of the test means on a receiving sleeve result from claims 16 to 39.

However, the present invention also relates, in addition to a blood analysis device designed as an "all-in-one" device, to a lancing device for piercing the surface of the body in order to remove a minimal 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 AI. It comprises a plurality of lancing elements which are provided on a carrier and can be inserted with the carrier into a housing body and can be driven by a drive mechanism. Proceeding from this, the invention is based on the further object of making the lancing process, in particular the extraction of a minimum amount of blood sufficient for analysis or examination purposes, simpler and less painful.

This object is achieved by a lancing device with the features of claim 40. Accordingly, the lancing device comprises a vacuum generating device, by means of which a vacuum can be applied to the skin surface immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process in order to support the extraction of a minimal amount of blood.

It goes without saying that the same advantages which were described in detail at the outset in connection with the blood analysis device according to the invention also apply correspondingly to the design of a pure lancing device according to the invention, so that reference is made to this. Advantageous further developments of the lancing device according to the invention and its features result from claims 41 to 67. Preferred embodiments, details and features of the present invention result from the dependent patent claims, for the features of which protection is claimed as independent inventive ideas, regardless of any possible reference becomes.

Further features, details and advantages of the invention are discussed on the basis of the drawing and the following description of a preferred embodiment of the blood analysis device according to the invention. The drawing shows:

FIG. 1 shows a perspective view of an embodiment of a blood analysis device according to the invention;

Figure 2 is a perspective view of the blood analyzer of Figure 1 in half-torn shape;

Figure 3 is a sectional view of the blood analyzer of Figures 1 and 2 seen in the direction of arrows III-III in Figure 1;

Figure 4a is an exploded view of a gear section of the blood analyzer according to the invention;

Figure 4b is a perspective view of the gear section of Figure 4a torn in half;

FIG. 5a shows a perspective view of an impact mechanism of the blood analysis device according to the invention (without other further components);

Figure 5b is a sectional view of the impact mechanism of Figure 5a;

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

Figure 7a-d four views of a lancing element received in a receiving sleeve in cooperation with a lower region of the push mechanism and

Figure 8 ac is a perspective view, a plan view and a sectional view of a carrier for a plurality of lancing elements; FIG. 9 shows a perspective view of a further embodiment of a blood analysis device according to the invention;

Figure 10 is a side view of the blood analyzer of Figure 9 and

Figure 11 is a perspective view of a carrier of the device of Figure 9 with radially arranged lancing elements.

A blood analyzer designated as a whole by reference number 2 can be seen from FIGS. 1 to 3. It comprises a housing body 4 with a display device 6 for displaying the result of the analysis or examination of a minimal amount of blood. However, the blood analysis device 2 also includes an integrated blood sampling device, designated overall by the reference numeral 8, which interacts with a plurality of lancing elements 10, which are able to penetrate a skin surface of a user applied to a lancing position 12 quickly and as painlessly as possible in order to obtain a minimal amount of blood , Blood emerging 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, not shown, can be an optically acting or electrochemically or electro-physically acting evaluation device, by means of which a test or analysis reaction which takes place in the test means can be recorded and evaluated, which is known per se and is therefore not described in more detail here. The evaluation device can interact with the test device in the lancing position 12 shown or in another position within the blood analysis device 2. For example, it would be conceivable for the test means 14 shown in FIGS. 2 and 3 to be brought into another position by rotating a carrier 16 for lancing elements 10 and test means 14 to be described in more detail, where the test means 14 interact directly with the evaluation device (not shown) can.

When the blood collection device 8 is started up, a negative pressure is generated within the housing body 4 and thus also in the area of the lancing position 12. For this purpose, a vacuum generating device 18 is provided, which comprises a volume-variable region 20, which is delimited by a bellows 22.

The vacuum generating device 18 can be actuated by finger pressure on a pusher 24. In the course of depressing the pusher 24, air is displaced outward from the volume-variable region 20 and the housing body 4. When it is subsequently released again, a vacuum is generated under the action of a first spring 26 in the interior of the volume-variable region 20 and thus in the interior of the housing body 4. When the pusher 24 is depressed for the first time, a rotary movement is generated via a gear device 28 to be described in detail, which is applied to the carrier 16 for a plurality of at least 4, in particular at least 6, in particular at least 8, in particular at least 10, and further transmitted in particular by at least 12 lancing elements 10 and a corresponding number of test means 14 in order to bring a new, yet unused lancing element 10 and associated test means 14 into the working position 30 assigned to the lancing position 12.

Furthermore, when the pusher 24 is depressed for the first time via a coupling device 32 to be described in more detail with a Bowden cable 34, a drive mechanism 36 of the Blood collection device 8 excited. When the pusher 24 is depressed, the Bowden cable 34 is moved in the direction of the arrow 40 under the action of a third spring 38. As a result, a driving lever 42 protruding to the side from the Bowden cable 34 is displaced in the direction of arrow 46 with the aid of a tensioning means 44 for a pull wire of the drive mechanism 36 of the blood collection device 8. The driving lever 42 can be fixed in the tensioned state with a rear end 48 in a locking device 50. When the locking device 50 is released, the tensioning means 44 for the pulling wire is released and the pulling wire snaps in the direction of the working position 30 under the action of spring means to be described in more detail and drives a lancing element 10 arranged there to carry out the lancing process.

The negative pressure prevailing in the area of the lancing position 12 supports the extraction of a minimum amount of blood from the surface of the skin and also supports the transport of the minimum amount of blood to the test means 14. By pressing the button 24 again, the lancing element 10 just used is removed from its working position 30 together with brought to the test means 14, and the test means 14 is brought into a working position for interaction with the evaluation device (not shown), where the test reaction of the blood with the test means 14 is then evaluated optically, electro-physically or electro-chemically.

The gear device 28 for converting an axial actuating movement into a rotary movement is explained below in conjunction with FIGS. 4a, 4b and 3. The gear device 28 comprises a guide bush 52 fixed to the housing, in which a pressure piece 54 can be displaced to a limited extent by a step stop 55. The pusher 24 is pressed in at the free end of the pressure piece 54. The other end of the fixed guide bush 52 engages Shaft section 56 with a spur toothing 58, which spur toothing 58 cooperates with a spur toothing 60 of the pressure piece 54 facing it. The shaft section 56 is prestressed in the direction of the pressure piece 54 by a second spring 62. The shaft section 56 comprises on its outer surface a plurality of radially projecting and longitudinally extending webs 64, which engage in longitudinal grooves 66 in the interior of the fixed guide bush 52 and prevent the shaft section 56 from rotating relative to the guide bush 52 while maintaining axial displaceability. When the pusher 24 is pressed down, the pressure piece 54 is moved axially, its spur toothing 60 interacting with the spur toothing 58 of the shaft section 56 and thereby generating a rotational driving force. However, a rotational movement is prevented by engagement of the webs 64 in the longitudinal grooves 66, so that the shaft section 56 is also moved axially, contrary to the action of the second spring 62, and downwards in the illustration in FIG. 3. As soon as the webs 64 come out of the longitudinal grooves 66, an incremental rotational movement of the shaft section 56 corresponding to the spur toothing is generated, which is ended by a positive engagement of the spur toothing 58 and 60 in one another.

The aforementioned rotary movement of the shaft section 26 is transmitted to a pair of gearwheels 70, 72, the latter of which is arranged in a rotationally fixed manner on a hub section 74 of the carrier 16.

The gear device 28 described above is designed as a rotary unit such that when the pusher 24 is actuated for the first time, an axial stroke movement and a rotary movement of 360 ° / 12/2 = 15 ° take place. Here, a new, unused lancing element 10 is brought into its working position 30. Under the action of the tensioned second spring 62 and the first spring 26, the shaft section 56 and the pressure piece 54 are moved back ₍ against the previous movement (upwards in FIG. 3). The return stroke of the pressure piece 54 is made by the axial step stop 55 inside the guide bushing 52 limited.

The function of the drive mechanism 36 of the blood collection device 8 is described below with reference to FIGS. 5a, b and 3. Starting from the lancing element 10, the drive mechanism 36 comprises a pushing element 78 which can be connected in a form-fitting manner to a head portion 76 of the lancing element 10 which can be gripped behind. It comprises an axial opening 84 through which a semi-rigid pulling wire 86 extends into a cylindrical cavity 88 of the pushing element 78 and is biased there in the pushing direction by means of a sixth spring 90. The semirigid pull wire 86 extends through an opening in the wall section 82 and further through a tensioning means 44, consisting of a clamping cone 92 and a clamping device 94, and further through an opening in the driving lever 42. In the released state of the clamping device 94, the clamping cone 92 is movable with respect to the pull wire 86. It is axially limitedly movable with respect to the driving lever 42 in such a way that when the driving lever 42 is adjusted, its persistence or frictional forces between the clamping cone 92 and a cylinder wall surrounding it cause clamping or release of the pull wire 86 in the clamping device 94.

If, starting from the position shown in FIG. 5b, the pusher 24 (FIG. 3) is pressed downward, the driving lever 42 is pressed upwards under the action of the third spring 38. By pulling the clamping cone 92, the pull wire 86 is clamped in the clamping device 94 and together with the driving lever 42 moved upward in the direction of the locking device 50. In the

Locking device 50, the graspable end 48 of the driving lever 42 is fixed. The tensioning process described above takes place against the spring force of the fifth spring 80, which stores the impact energy required for the drive mechanism 36. If the locking device 50 is released by actuating a trigger 96, that is to say the end 48 of the driving lever 42 which can be gripped behind is released, the persistence of the clamping cone 92 leads to the clamping device 94 releasing the pulling wire 86. The thrust member 78 and with it the puller wire 86 then snap down under the action of the fifth spring 80. Due to the coupling of the pushing element 78 and the lancing element 10, the lancing element 10 then carries out a lancing process. It snaps over the free end of a receptacle 98 to be described in more detail and is pulled back again behind the free end.

The design and arrangement of the lancing elements 10 are described with reference to FIGS. 6a to d. A respective lancing element 10, which is a metallic needle-shaped element with a length of 6-15 mm, has a molded-on holding body 100 and also a molded-on protective cap means 102, which protects the lancing element 10 against contamination and a preferably germ-tight, preferably sterile Ensures closure against the environment. A respective lancing element 10 with holding body 100 and protective cap means 102 is accommodated in a receiving sleeve 98 which has already been mentioned and is displaceable in the axial direction. The lancing element 10 is inserted with its engaging head portion 76 into the opening at the free end 104 of the receiving sleeve 98 and passed through the receiving sleeve 98 until the protective cap means 102 abuts an axial step 106 inside the preferably cylindrical opening 107 of the receiving sleeve 98. In The figures also show a resilient return means 108, the resilient arms 110, which can be integrally formed on the holding body 100, rest on an annular collar-like section 112 of the receiving sleeve 98. When a lancing process is carried out, these restoring means 108 cause the lancing element 10 to be pulled back again behind the end 104 of the receiving sleeve 98. The pretensioning of the restoring means 108 in the initial state of the lancing element 10 can also be used to hold 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 thus an improved, preferably germ-tight closure of the receiving sleeve 98 to effect.

FIGS. 7a to d illustrate how the head section 76, which can be formed in particular in one piece with the molded-on holding body 100, is positively gripped or gripped behind in a groove 114 of the pushing element 78 which can be gripped behind. The thrust member 78 interacts with a ramp means 116 formed thereon, which also forms an insertion opening 118 for the head section 76 of the lancing element 10, as can be seen in FIG. 7b. This ramp means 116 acts with a run-on slope 120, which is formed on the annular collar section 112 of the receiving sleeve 98. If the receiving sleeve 98 with the lancing element 10 accommodated therein is moved in the circumferential direction on the carrier 16, the run-up slope 120 slides against the ramp means 116 and the entire receiving sleeve 98 is axially moved in the direction of the arrow 122. Due to the positive engagement of the head portion 76 of the lancing element 10 in the groove 114 of the pushing element 78, the lancing element is held in its original axial position, so that it does not carry out the axial movement in the direction of the arrow 122. The lancing element 110 is therefore withdrawn relative to the receiving sleeve 98. As a result, the cap means 102 dated free end of the lancing element 10 comes free. It can fall down. The blood collection device 8 is then ready to perform a lancing process. When the protective cap means 102 is removed, the test means 14 is also released, which is advantageously accommodated in the region of the free end 104 of the receiving sleeve 98. As indicated in FIG. 6 a, the test means 14 can be provided in an opening in the wall of the receiving sleeve 98. In the case shown, the test means is overlaid on the inside by the protective cap means 102 and in this way protected against contamination, in particular against the ingress of atmospheric moisture and germs, which is to be regarded as particularly advantageous. The protective cap means 102 thus performs a double function, it serves both to cover the lancing element 10 and to cover and protect the test means 14.

FIGS. 6 and 7 also show helical webs on the outer circumference of the receiving sleeve 98. These are spring-back means 124 which are molded onto the collar-shaped section 112 at their upper end. If the carrier 16 is moved further and the receiving sleeve 98 just considered is thereby moved out of its working position 30 and thus out of the influence of the ramp means 116, these spring-back means 124 cause the receiving sleeve 98 to be withdrawn again against the arrow 122.

FIGS. 8a to c show the carrier 16 for the plurality of lancing elements 10 and test means 14 in different views. In the case shown, twelve receiving sleeves 98 with twelve lancing elements 10 and twelve test means 14 are received. A respective receiving sleeve 98 is inserted into an open-edged recess 126 of a disk-shaped part 128 of the carrier 16 in the axial direction. So that the receiving sleeves 98 are in their working position 30 cannot rotate when interacting with the ramp means 116, the open-edged recesses 126 and the outer circumference of the receiving sleeves 98 are non-circular, in the case shown slightly elliptical. This has the further significant advantage that a respective receiving sleeve 98 is held in a preferred orientation on the carrier 16, which is very important with regard to the positioning of the test means 14 received in the receiving sleeve 98, because it is at a predetermined position and orientation the evaluation device must be able to interact. The carrier 16 with a centrally arranged polygonal opening 130 for the engagement of an appropriately designed hub section 74 for the rotary drive of the carrier can be inserted together with the lancing elements 10 and test means 14 in the housing body 4 of the blood analysis device according to the invention and together with the used lancing elements and test means removable from the housing body. This can be seen from FIG. 2, where a cover which opens or closes the insertion opening is provided.

FIGS. 9-11 show a further embodiment of a blood analysis device according to the invention, in which the lancing direction and the lancing elements themselves are arranged radially with respect to a carrier for the lancing elements which can be driven in rotation. A drive device (not shown) for the lancing elements is provided radially inside the carrier.

The operation and function of the blood analysis device according to the invention when performing a blood collection and analysis is described below:

Starting from the basic position shown in FIG. 3, the pusher 24 is depressed for the first time against the tension force of the first spring 26 and the second spring 62. As a result, the pressure piece 54 and the shaft section 56 are displaced axially downward during a first lifting section. A force is built up in the circumferential direction of rotation. In the meantime, the construction train 34 releases the driving lever 42, which moves under the pressure of the third spring 38 in the direction of the arrow 40. At the same time, the puller wire 86 is clamped in the clamping device 94 and thus the puller wire 86 is also pulled upwards. In the meantime, however, the impact member 78 still remains in its starting position.

Finally, in a further stroke section, the webs 64 come free from the longitudinal grooves 66 of the fixed guide bush 52 and the shaft section can carry out a rotational movement of 15 °. At the same time, the carrier is moved further by 15 ° via the gearwheel pair 70, 72 and brings a lancing element 10 into the working position 30. The head section 76 of the lancing element 10 slides into the opening 114 of the pushing element 78 and thus into the rear grip position. Almost simultaneously, the receiving sleeve 98 slides against the ramp means 116 with its chamfer 120 and is moved downward in the direction of the arrow 122, so that the protective cap means 102 is released from the lancing element 10. During the last section of the stroke movement of the push button 24, the free travel of the pull wire 86 within the cylindrical opening 107 of the pushing element 78 is used up and the pull wire tensions the drive mechanism 36 of the blood collection device 8 against the force of the fifth spring 80 as the main push spring 8. At the end of the tensioning movement fixes the engaging end 48 of the driving lever 42 in the locking device 50.

The vacuum generating device 18 is now activated and the drive mechanism 36 of the blood collection device 8 is cocked. By actuating the trigger 96, the locking device 50 can be released and thus quick the thrust member 78 under the force of the fifth spring 80 down and the lancing process is carried out. In the meantime, the pusher 24 is reset under the force of the first spring 26 and the second spring 62. In this way, the volume-changeable region 20 is enlarged and a negative pressure is generated which extends to the lancing position 12 in the region of the free end 104 of the receiving sleeve 98 and supports and promotes blood withdrawal.

Immediately after the lancing process has been triggered, the fourth spring and the sixth spring 90 push the pushing element 78 back into its starting position and thus bring about the retraction movement of the lancing element 10, which is also supported by the resilience means 124.

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

By pressing the button 24 again, the lancing element 10 just considered, together with its receiving sleeve 98 and the test means 14, is then rotated by a further 15 °; it is therefore removed from the working position 30 of the lancing elements. The stroke of the pusher 24 is limited in this second actuation by a suitable design of the transmission device 28, so that the drive device 36 is not tensioned. The test means 14 can thus be transported on to an optical, electro-chemical or electro-physical acting evaluation device, not shown. The predetermined positioning of the receiving sleeves 98 on the carrier 16 ensures that the test means are arranged in the correct orientation to the evaluation device. It would also be conceivable that the second rotation through 15 °, which brings the lancing element out of the working position, is not achieved by a renewed actuation of the pusher 24, but alternatively by the return movement of the shaft section 56. For this purpose, a bevel 132 can be provided at the free end of the webs 64 on the outer circumference of the shaft section 56. When the shaft section 56 re-enters the guide bushing 52, a further rotation of the shaft section 56 could be triggered by the interaction of these run-up bevels 132 with the longitudinal grooves 66.

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

Claims

claims

Blood analyzer (2) with a housing body (4), with a blood sampling device (8) having a plurality of lancing elements (10), with a plurality of test means (14) for analyzing a minimal amount of blood, with an evaluation device comprising an evaluation electronics and with a display device (6) which forms a complete system which can be handled as a single device, the housing body (4) having a lancing position (12) associated with a working position (30) of a respective lancing element (10) for applying a skin surface to a user, a plurality of test means (14) and lancing elements (10) can be inserted into the device, which can be brought into a working position (30) one after the other to carry out several measurements, the lancing element (10) being positioned when a lancing element (10) is positioned in its working position (30). into the skin surface of a user created at the lancing position (12) and from the skin surface che escaping blood can reach a test means (14), characterized in that a vacuum-generating device (18) is provided, by means of which immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process to support the Obtaining a minimum amount of blood, a negative pressure can be applied to the skin surface.

Blood analysis device according to claim 1, characterized in that the negative pressure generating device (18) is provided in such a way that the negative pressure generated by it supports the transport of blood escaping from the skin surface to a test means (14).

3. Blood analyzer according to claim 1 or 2, characterized in that the test means (14) between the lancing position (12) and the negative pressure generating device (18) is provided.

4. Blood analyzer according to claim 3, characterized in that the test means (14) is provided at least almost adjacent to the lancing position (12) or adjacent thereto.

5. Blood analyzer according to one or more of the preceding claims, characterized in that the vacuum generating device (18) has a volume-variable region (20).

6. Blood analyzer according to one or more of the preceding claims, characterized in that the volume-variable region (20) has a spring means (26).

7. Blood analyzer according to one or more of the preceding claims, characterized in that the volume-variable region (20) has a bellows, in particular bellows (22).

8. 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.

9. Blood analyzer according to one or more of the preceding claims, characterized in that the vacuum generating device (18) can be activated by reducing the volume of the volume-variable region (20).

10. Blood analyzer according to one or more of the preceding claims, characterized in that the Device (18) generating negative pressure is functionally coupled to the blood sampling device (8) in such a way that the negative pressure is only generated immediately before or simultaneously with or immediately after the lancing process is carried out and can then be applied directly to the skin surface.

11. Blood analyzer according to one or more of the preceding claims, characterized in that the vacuum generating device (18) is functionally coupled to the blood sampling device (8) in such a way that when the vacuum generating device is activated, a tensioning process in the blood sampling device is associated with or is triggered thereby.

12. Blood analyzer according to one or more of the preceding claims, characterized in that the vacuum generating device (18) is mechanically functionally coupled to the blood sampling device (8).

13. Blood analyzer according to one or more of the preceding claims, characterized in that the test means (14) and the lancing elements (10) are arranged on a rotatable carrier (16) relative to the housing body (4) and can be inserted into the device with and after Use together with the carrier (16) from the housing body (4) can be removed.

14. Blood analysis device according to one or more of the preceding claims, characterized in that the vacuum generating device (18) is functionally coupled to the carrier (16) for the lancing elements (10) and test means (14) in such a way that when the vacuum generating device is activated an adjusting movement of the carrier (16) goes hand in hand or is triggered thereby.

15. Blood analyzer according to one or more of the preceding claims, characterized in that for activating the vacuum-generating device (18) an axial actuating movement is provided, which via gear means (28) in a rotary actuating movement for driving the carrier (16) for the Lancing elements (10) and / or test means (14) can be implemented.

16. Blood analyzer according to one or more of the preceding claims, characterized in that a respective lancing element (10) is slidably received in a receiving sleeve (98),

17. Blood analyzer according to one or more of the preceding claims, characterized in that the respective receiving sleeves (98) are held on a carrier (16) and can be used together with the carrier (16) in the housing body (4).

18. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) delimits a continuous, in particular cylindrical, opening in the axial direction, in which the associated lancing element (10) is received.

19. 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 2.5-5 mm, in particular 3-4.5 mm.

20. Blood analysis device 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 8-15 mm, in particular 8-14 mm.

21. Blood analyzer according to one or more of the preceding claims, characterized in that a respective lancing element (10) has a molded-on holding body (100) which at the same time guides the lancing element in the receiving sleeve (98).

22. Blood analysis device according to one or more of the preceding claims, characterized in that a respective lancing element (10) has a preferably molded-on protective cap means (102).

23. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means (102) closes the receiving sleeve (98) to the lancing side.

24. 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.

25. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means (102) integrally merges into the holding body (100) over a predetermined breaking area and thereby surrounds the lancing element (10) in particular in a germ-tight manner.

26. Blood analysis device 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.

27. Blood analyzer according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) at the same time includes or holds the test means (14), preferably in the region of its end (104) serving to exit the lancing element (10).

28. Blood analysis device according to one or more of the preceding claims, characterized in that the test means (14) is provided in an opening in the wall of the receiving sleeve (8).

29. Blood analyzer according to one or more of the preceding claims, characterized in that the test means (14) is covered by the protective cap means (102) before performing a lancing process.

30. Blood analyzer according to one or more of the preceding claims, characterized in that the protective cap means (102) can be placed against an axial stop (106) of the receiving sleeve (98).

31. 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 forms the stop (106) for the protective cap means.

32. Blood analysis device according to one or more of the preceding claims, characterized in that the lancing element (10) has at least one resilient restoring means (108), in particular formed in one piece with the holding body (100), which restores a movement of the lancing element after the lancing process has been carried out relative to the Receiving sleeve (98) causes or at least supports.

33. Blood analyzer according to one or more of the preceding claims, characterized in that a bias of the restoring means (108) in Initial state of the lancing element (10) holds 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 thus to an improved, preferably germ-tight seal of the receiving sleeve (98) leads.

34. Blood analysis device according to one or more of the preceding claims, characterized in that a respective receiving sleeve (48) is held in an open-edged recess (126) of a particularly disc-shaped part (128) of the carrier (16).

35. Blood analysis device according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) is held on the carrier (16) so as to be displaceable in the axial direction.

36. Blood analysis device according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) when the carrier (16) rotates. Sliding against a positive guide means (116) is displaceable in the axial direction.

37. The blossom analysis device as claimed in one or more of the preceding claims, characterized in that a respective receiving sleeve (98) has at least one resilient return means (124) which perform a return movement of the receiving sleeve (98) relative to the carrier (16) after the lancing process has been carried out. effected or at least supported.

38. Blood analysis device according to one or more of the preceding claims, characterized in that the receiving sleeve (98) together with the lancing element (10) accommodated therein can only be arranged in a preferred orientation on the carrier (16).

39. Blood analyzer according to one or more of the preceding claims, characterized in that the receiving sleeve (98) has a non-circular outer circumference which differs from the circular shape and can be arranged in a preferred orientation on the carrier (16).

40. lancing device for piercing the body surface to remove a minimal amount of blood from the human or animal body for analysis or examination purposes, with a plurality of lancing elements (10) provided on a carrier (16) and insertable with the carrier into a housing body (4) ), which can be driven by a drive mechanism (36), characterized by a vacuum generating device (18), by means of which immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process in order to support the extraction of a minimum amount of Blood a vacuum can be applied to the skin surface.

41. Lancing device according to claim 40, characterized in that the vacuum generating device (18) has a volume-variable region (20).

42. Lancing device according to claim 40 or 41, characterized in that the volume-variable region (20) has a spring means (26).

43. Lancing device according to claim 42, characterized in that the volume-variable region (20) has a bellows, in particular bellows (22).

44. Lancing device according to one or more of claims 40-43, characterized in that the vacuum generating device (18) can be activated manually to generate vacuum.

45. Lancing device according to one or more of claims 40-44, characterized in that the vacuum generating device (18) can be activated by reducing the volume of the volume-variable region (20).

46. Lancing device according to one or more of claims 40-45, characterized in that the vacuum generating device (18) is functionally coupled to the lancing mechanism (16) in such a way that the vacuum is only immediately before or simultaneously with or immediately after the execution of the lancing process is generated and can then be applied directly to the skin surface.

47. Lancing device according to one or more of claims 40-46, characterized in that the vacuum-generating device (18) is functionally coupled to the lancing mechanism (36) in such a way that when the vacuum-generating device (18) is activated, the lancing mechanism (36 ) goes hand in hand.

48. Lancing device according to one or more of claims 40-47, characterized in that the vacuum generating device (18) is mechanically functionally coupled to the lancing mechanism.

49. lancing device according to one or more of claims 40-48, characterized in that a respective lancing element (10) is slidably received in a receiving sleeve (98),

50. Lancing device according to one or more of claims 40-49, characterized in that the respective receiving sleeves (98) are held on a carrier (16) and can be inserted into the housing body (4) together with the carrier (16).

51. Lancing device according to one or more of claims 40-50, characterized in that a respective receiving sleeve (98) delimits a continuous, in particular cylindrical, opening in the axial direction inside, in which the associated lancing element (10) is received.

52. Lancing device according to one or more of claims 40-51, characterized in that the opening has a diameter of 2-7 mm, in particular 2.5-5 mm, in particular 3-4.5 mm.

53. Lancing device according to one or more of claims 40-52, characterized in that the receiving sleeve (98) has an extension in the axial direction of 6-20 mm, in particular 8-15 mm, in particular 8-14 mm.

54. Lancing device according to one or more of claims 40-53, characterized in that a respective lancing element (10) has a molded-on holding body (100) which at the same time guides the lancing element in the receiving sleeve (98).

55. Lancing device according to one or more of claims 40-54, characterized in that a respective lancing element (10) has a preferably molded-on protective cap means (102) which closes the receiving sleeve (98) towards the lancing side in particular in a germ-tight manner.

56. Lancing device according to one or more of claims 40-55, characterized in that the protective cap means (102) comprises an elastically deformable area or is formed from an elastically deformable material.

57. Lancing device according to one or more of claims 40-56, characterized in that the protective cap means (102) merges in one piece over a predetermined breaking area into the holding body (100) and thereby surrounds the lancing element in particular in a germ-tight manner.

58. 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.

59. Lancing device according to one or more of claims 40-58, characterized in that the protective cap means (102) can be placed against an axial stop (106) of the receiving sleeve (98).

60. Ξtech 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 forms the stop (106) for the protective cap means (102).

61. Lancing device according to one or more of claims 40-60, characterized in that the lancing element (10) has at least one resilient restoring means (108), in particular formed in one piece with the holding body (100), which follows a restoring movement of the lancing element (10) causes or at least supports the execution of the lancing process relative to the receiving sleeve (98).

62. Lancing device according to one or more of claims 40-61, characterized in that a respective receiving sleeve (98) is particularly open-edged Recess (126) of a particularly disc-shaped part (128) of the carrier (16) is held.

63. Lancing device according to one or more of claims 40-62, characterized in that a respective receiving sleeve (98) is held on the carrier (16) so as to be displaceable in the axial direction.

64. Lancing device according to one or more of claims 40-63, characterized in that a respective receiving sleeve (98) can be displaced in the axial direction when the carrier (16) rotates by sliding against a positive guidance means (116).

65. Lancing device according to one or more of claims 40-64, characterized in that a respective receiving sleeve (98) has at least one resilient return means (124) which brings about a return movement of the receiving sleeve (98) relative to the carrier after the lancing process has been carried out or at least supported.

66. Lancing device according to one or more of claims 40-65, characterized in that the receiving sleeve (98) together with the lancing element (100) accommodated therein can only be arranged in a preferred orientation on the carrier (16).

67. Lancing device according to one or more of claims 40-66, characterized in that the receiving sleeve (98) has a non-circular outer circumference which deviates from the circular shape and can be arranged in a preferred orientation on the carrier (16).