WO2005063124A1

WO2005063124A1 - Support with a number of puncturing elements puncturing device and blood analysis device

Info

Publication number: WO2005063124A1
Application number: PCT/EP2004/013836
Authority: WO
Inventors: Armin Lohrengel; Ralf Sprick
Original assignee: Paul Hartmann Ag
Priority date: 2003-12-23
Filing date: 2004-12-06
Publication date: 2005-07-14
Also published as: DE10361560A1; DE10361562A1; WO2005065545A2; EP1699355A1; WO2005065545A3; EP1699356A2; WO2005063124A8

Abstract

The invention relates to a support with a number of puncturing elements, for use in a blood analysis device, or in a puncturing device for taking a minimal amount of blood from the human or animal body for analytical or investigative purposes, whereby a housing sleeve is provided for each puncturing element, in which the puncturing element is movably housed.

Description

Title: Carrier with a plurality of lancing elements, lancing device and blood analyzer

description

The present invention relates to a carrier with a plurality of lancing elements for use in a blood analysis device or in a lancing device for obtaining a minimal amount of blood from the human or animal body for analysis or examination purposes, for example for determining an analyte, such as, for. B. fructosamine, lactate, cholesterol or in particular glucose.

Furthermore, the invention relates to a 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 of the aforementioned type, with a plurality of lancing elements provided on a carrier and insertable with the carrier into a housing body which can be driven by a drive mechanism.

In addition, the invention relates to a blood analysis device in the form of a so-called "all-in-one" complete device, with a housing body, with a blood sampling device having a plurality of lancing elements, with a plurality of test means for the analysis of a minimal amount of blood, with an evaluation electronics comprehensive evaluation device and with a display device which form a complete system which can be handled as a single device, the housing body having a lancing position assigned to a working position of a respective lancing element for applying a skin surface to a user, a plurality of test means and lancing elements being insertable into the device which can be brought into a working position in order to carry out a plurality of measurements, wherein when a lancing element is positioned in its working position, the lancing element can be inserted into the skin surface of a user applied at the lancing position and blood exiting the skin surface can reach a test medium.

Such a blood analyzer is known from WO 03/070099 AI.

The object of the present invention is to improve the provision, storage and use of the lancing elements, starting from a carrier of the aforementioned type with a plurality of lancing elements.

This object is achieved according to the invention in a carrier of the type mentioned in that a receiving sleeve is provided for each lancing element, in which the lancing element is slidably received.

In this way, the receiving sleeve can be used for positioning, guiding and protecting, in particular for the permanent arrangement and storage of the lancing elements. In an advantageous development, a respective receiving sleeve delimits an opening, in particular cylindrical, in the axial direction, in which the associated lancing element is received.

The opening expediently has a diameter of 2 to 7 mm, in particular 2.5 to 5 mm, in particular 3 to 4.5 mm. The receiving sleeve also expediently has an extension in the axial direction of 6 to 20 mm, in particular of 8 to 15 mm and further in particular of 8 to 14 mm. Furthermore, it proves to be particularly advantageous if a respective lancing element has a molded-on holding body, which at the same time guides the lancing element in the receiving ^sleeve .

Furthermore, it proves to be particularly advantageous if a respective lancing element has a preferably molded-on protective cap means. The protective cap means protects the free end of the lancing element, which can be inserted into the skin surface of a user, from contamination and in particular from germs. It can even do one in the course of a spraying process _. To effect sterilization of the lancing element in the area of the pierceable tip and to maintain it during storage of the lancing element.

According to a further inventive idea of independent importance, the protective cap means closes the receptacle towards the lancing side, in particular it forms a germ-tight seal of the interior of the receptacle.

The protective cap means can also advantageously comprise an elastically deformable, in particular elastomeric area or be formed from an elastically deformable, in particular elastomeric material.

Furthermore, the it may prove advantageous if the cap means passes in one piece via a predetermined breaking area to the holding body ^'. As a result, it can enclose the lancing element over its entire circumference and in particular in a germ-tight manner and preferably bring about a permanent sterile closure.

The protective cap means advantageously has a diameter perpendicular to the axial direction of the receiving sleeve of 2 to 7 mm, in particular 2.5 to 5 mm, in particular 3 to 4.5 mm. According to a further inventive idea, which in turn is of independent importance, it is proposed that a respective receiving sleeve for a lancing element simultaneously comprises or holds a test device. In such a case, the test means is preferably provided in the region of a free end of the receiving sleeve. The test means can be designed, for example, in the form of a membrane defining a measuring field, which can be wetted with a minimal amount of blood taken from the body surface. The test agent includes test reagents that are used to perform an analysis or examination of the blood. The analysis or investigation, ie the evaluation of the test agent or the reaction in the test agent can be carried out, for example, optically, in particular reflecto etrically, or electro-chemically or electro-physically. Evaluation devices and evaluation methods as well as test means of the type that can be used here are known and therefore do not require any further description.

Such a test means can advantageously be provided in the form of a pad or tablet and held in the area of the wall or in an opening in the wall of the receiving sleeve.

The protective cap means is advantageously designed and arranged such that the test means is covered by the protective cap means before a lancing process is carried out. As a result, the test agent can be covered or sealed in a sterile manner on its side that can be subjected to the blood to be examined before the ingress of dirt and moisture, preferably before the ingress of germs and furthermore.

In a further embodiment of the invention, the protective cap means can be placed against an axial stop of the receiving sleeve. In this way, a defined Position of the protective cap means and thus in particular of the lancing element connected to it within the receiving sleeve and thus relative to the carrier. For this purpose, the receiving sleeve can comprise a stepped opening with a step which forms the stop for the protective cap means. However, it would also be conceivable for the protective cap means in turn to be provided with a stepped outer periphery and / or a centering means in the broadest sense, which can be placed against the axial end of the receiving sleeve.

For a further preferred embodiment of the lancing element, it proves to be advantageous if the lancing element has at least one resilient restoring means, in particular formed integrally with the holding body, which causes or at least supports a restoring movement of the lancing element after the lancing process has been carried out. Such a resetting means could be realized, for example, in the form of a resilient arm which is molded onto the lancing element, preferably on its holding body, or is formed in one piece with it. Preferably several, in particular three resilient return means are provided. These resetting means can advantageously also be used to stabilize the lancing element within the receiving sleeve before carrying out a lancing process. In particular, they can pretension the lancing element in an axial direction, so that it is forced against a predetermined end position with respect to the receiving sleeve.

In a further development of this inventive idea, it proves to be particularly advantageous that a pretensioning of the restoring means in the initial state of the lancing element holds the protective cap means in contact with the receiving sleeve, in particular in contact with the above-mentioned axial stop of the receiving sleeve and thus for an improved, preferably germ-tight, closure the receiving sleeve leads. The restoring means mentioned can be supported against or on a section of the receiving sleeve, in particular an annular end section of the receiving sleeve, or it can be supported against a surface of the carrier.

According to a further advantageous inventive concept, a respective receiving sleeve can be inserted into a recess or other holder on the carrier. This has the advantage that the respective lancing elements can be produced separately and can be arranged in separate production or assembly processes inside a respective receiving sleeve. The carrier can then be equipped with receiving sleeves containing lancing elements for further use in lancing devices or blood analysis devices of the type mentioned at the outset, and can be carried out at a later time and in particular detached from the production of the lancing elements and receiving sleeves. Preference is given to assembly by the manufacturer. In principle, however, it would also be conceivable for the same user to use one and the same carrier several times and to equip each of these with new, unused receiving sleeves with lancing elements. Furthermore, it proves to be very particularly advantageous if a respective receiving sleeve is held in an open-edged recess in a part of the carrier which is in particular disk-shaped. This creates the possibility that a respective receiving sleeve protrudes in the radial direction over an outer circumferential surface of a part of the carrier and, if necessary, can cooperate there with other adjusting means of a lancing device or a blood analysis device.

It also proves to be advantageous if a respective receiving sleeve is slidably held on the carrier, in particular slidably in the axial or radial direction is held. In this way, a receiving sleeve for performing a lancing process can be shifted into an exposed lancing position and, if necessary, can be shifted back into its starting position or another position after the lancing process has been carried out. At this point, it should be expressly mentioned that the receiving sleeves and respective lancing elements can be arranged both axially and radially, that is to say with an axially extending lancing direction or with a radially extending lancing direction of the lancing elements, with respect to a rotatable, that is to say rotatable, carrier.

According to a further advantageous embodiment, when the carrier rotates, a respective receiving sleeve can be displaced by sliding against a positive guidance means. For example, the positive guidance means can be arranged in a lancing device or a blood analysis device in such a way that when a relevant lancing element with a receiving sleeve is moved into its working position, the receiving sleeve slides against a positive guide means fixed to the housing and this can result in the aforementioned displacement of the receiving sleeve.

In this respect, it proves to be advantageous if a respective receiving sleeve has at least one resilient return means which effects or at least supports a return movement of the receiving sleeve, in particular after a lancing process has been carried out.

According to a further inventive idea of particular importance, the respective receiving sleeve, together with the lancing element accommodated therein, can only be arranged on the carrier in a preferred orientation. Such a measure proves to be particularly advantageous if the receiving sleeve also holds or carries the test agent. In such a case, it can then be ensured that the test means can be positioned in a predetermined orientation to the wearer and thus in a predetermined orientation to an evaluation device of the type mentioned in a blood analysis device.

The receiving sleeve can have a non-circular outer circumference, that is to say which deviates from the circular shape. With a corresponding design of a recess or any other holder for the receiving sleeve on the carrier, it can be achieved that the receiving sleeve can only be arranged on the carrier in a predetermined orientation.

Furthermore, it proves to be advantageous if the lancing elements have an end portion that can be gripped behind, with which they can be coupled to a drive device within a lancing device or within a blood analysis device for performing the lancing process. This coupling is preferably brought about by the end portions of the lancing elements which can be reached behind being moved into a rear engagement position or coupling position with a correspondingly designed organ of the drive device by displacement, in particular rotation of the carrier, and by further displacement, in particular further rotation of the carrier after carrying out a lancing process out of engagement with the aforementioned Organ of the drive device are brought.

The subject of the present invention, as stated at the outset, is also a lancing device for piercing the body surface for taking a minimal amount of blood from the human or animal body for analysis or examination purposes, with a plurality of ones provided on a carrier and with the carrier in a housing body insertable lancing elements by a

Drive mechanism can be driven. According to the invention, the lancing device is characterized by a carrier of the design according to the invention described above, that is a carrier according to one or more of claims 1 to 25, which can be used together with the lancing elements in the housing body and can be removed from the housing body again after use of the lancing elements.

The invention also relates to a blood analysis device with the features of claim 27, that is to say a blood analysis device which is characterized by a carrier of the design according to the invention described above, that is to say a carrier according to one or more of claims 1 to 25, which together with the lancing elements in the housing body can be used and can be removed from the housing body after use of the lancing elements.

Preferred embodiments of the blood analyzer according to the invention are claimed with claims 28 to 44.

Further details, features and advantages of the invention result from the attached patent claims and from the drawing and the following description of preferred embodiments of 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 the arrows Hill I 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;

6a-d show three views and a sectional view of a lancing element accommodated in an accommodating 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

FIG. 8 a-c show a perspective view, a top 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 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 that the test means 14 shown in FIGS. 2 and 3 is brought into a different 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 directly with the evaluation device, not shown can work together.

When the blood collection device 8 is put into operation, it is inside the housing body 4 and thus also in the area of the

Lancing position 12 generates a negative pressure. There is one for this

Vacuum generating device 18 is provided which Volume-changeable area 20, which is limited by a bellows 22.

The vacuum generating device 18 can be actuated by finger pressure on a printer 24. In the course of the low pressure of the printer 24, air is displaced outward from the volume-variable region 20 and the housing body 4. During the subsequent releasing, 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 printer 24 is first depressed, a rotary movement is generated at the same time via a gear device 28, which will be described in detail, and 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, still unused lancing element 10 and associated test means 14 m into the working position 30 assigned to the lancing position 12.

Furthermore, when the printer 24 is first depressed, a coupling mechanism 32 of the blood collection device 8 is tensioned via a coupling device 32 to be described in more detail with a Bowden cable 34. When printer 24 is depressed, Bowden cable 34 is moved under the action of a third spring 38 m in the direction of arrow 40. As a result, a drive lever 42 protruding to the side from the Bowden cable 34 is displaced 8 m 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. The driving lever 42 can be fixed in the tensioned state with an engaging end 48 m of a locking device 50. When the locking device 50 is released, the clamping means 44 is released the pulling wire and the pulling wire snap under the action of spring means to be described in more detail in the direction of the working position 30 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. In the other end of the fixed guide bushing 52 a shaft section 56 engages 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. At the Depressing the pusher 24, the pressure piece 54 is moved axially, its spur gear teeth 60 interacting with the spur gear teeth 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 limited by the axial step stop 55 inside the guide bush 52.

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 Lancing element 10 is a push member 78 which can be releasably connected to an engaging head section 76 of the lancing member 10. The push member 78 is biased in the pushing direction against a housing-fixed wall section 82 via a fifth spring 80. 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 semi-rigid puller 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 moved together with the driving lever 42 upwards 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 rear end 48 of the driving lever 42 is released, then the persistence of the Clamping cone 92 that the clamping device 94 releases the pull 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. A resilient return means 108 can also be seen in the figures, the resilient arms 110, which can be integrally formed on the holding body 100, rest on a 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 resetting 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, to hold in particular in contact with the axial stop 106 of the receiving sleeve 98 and thus to bring about an improved, preferably germ-tight closure of the receiving sleeve 98.

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 pressing element 78 cooperates with a molded-on ramp means 116, which also forms an apparent from Figure 7b insertion opening 118 for the ^'head portion 76 of the lancing element 10th 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 section 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 arrow 122. The lancing element 110 is therefore withdrawn relative to the receiving sleeve 98. As a result, the protective cap means 102 is released from the free end of the lancing element 10. 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 received 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 covered on the inside by the protective cap means 102 and in this way before Contamination, in particular protected from the ingress of air humidity 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 cannot twist in their working position 30 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 being 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 interact with the evaluation device must be able to. 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 exposes 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. During a first stroke section, the pressure piece 54 and the shaft section 56 are thereby displaced axially downward. 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 pair of gearwheels 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 path 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 the thrust member 78 shoots down under the force of the fifth spring 80 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.

In the meantime, 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

Patent claims

1. Carrier (16) with a plurality of lancing elements (10) for use in a blood analysis device (2) or in a lancing device for obtaining a minimal amount of blood from the human or animal body for analysis or examination purposes _, characterized in that for a respective piercing element (10) is provided with a receiving sleeve (98) in which the piercing element (10) is displaceably received.

2. Carrier according to claim 1, characterized in that a respective receiving sleeve (98) internally delimits an axially continuous, in particular cylindrical opening (107) in which the associated piercing element (10) is received.

3. Carrier according to claim 1 or 2, characterized in that the opening (107) has a diameter of 2 - 7 mm, in particular 2.5 - 5 mm, in particular 3 - 4.5 mm.

4. Carrier 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.

5. Carrier according to one ^or more of the preceding claims, characterized in that a respective piercing element (10) has a particularly molded holding body (100) which simultaneously guides the piercing element in the receiving sleeve (98).

6. Carrier according to one or more of the preceding claims, characterized in that a respective Lancing element (10) has a preferably molded protective cap means (102).

7. Carrier according to one or more of the preceding claims, characterized in that the protective cap means (102) closes the receiving sleeve (98) towards the piercing side, in particular in a germ-tight manner.

8. Carrier 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.

9. Carrier according to one or more of the preceding claims, characterized in that the protective cap means merges in one piece into the holding body via a predetermined breaking area.

10. Carrier 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 of 2 - 7 mm, in particular 2.5 - 5 mm, in particular 3 - 4.5 mm.

11. Carrier according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) simultaneously holds or holds the test means (14).

12. Carrier 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 (98).

13. Carrier according to one or more of the preceding claims, characterized in that the test agent (14) is covered by the protective cap means (102) before a piercing process is carried out.

14. Carrier 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).

15. Carrier according to one or more of the preceding claims, characterized in that the receiving sleeve (98) comprises a stepped opening (107) with a step which forms the stop (106) for the protective cap means.

16. Carrier according to one or more of the preceding claims, characterized in that the piercing element (10) has at least one resilient restoring means (108), in particular formed in one piece with the holding body (100), which enables a restoring movement of the piercing element (10) after execution of the piercing process is effected or at least supported relative to the receiving sleeve (98).

17. Carrier according to one or more of the preceding claims, characterized in that a preload of the restoring means (108) in the initial state of the piercing element (10) causes the protective cap means (102) to rest against the receiving sleeve (98), in particular against the axial stop (106) holds the receiving sleeve (98) and thus leads to an improved, preferably germ-tight seal of the receiving sleeve.

18. Carrier according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) can be inserted into a recess (126) on the carrier (16).

19. Carrier according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) is held in an open-edge recess (126) of a particularly disk-shaped part (128) of the carrier (16).

20. Carrier according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) is held displaceably on the carrier (16), in particular is held displaceably in the axial or radial direction.

21. Carrier according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) is displaceable by sliding against a positive guide means (116) when the carrier (16) rotates.

22. Carrier according to one or more of the preceding claims, characterized in that a respective receiving sleeve (98) has at least one resilient restoring means (124) which enables a restoring movement of the receiving sleeve (98) after the piercing process has been carried out relative to the carrier (16). effected or at least supported.

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

24. Carrier according to one or more of the preceding claims, characterized in that the receiving sleeve (98) has a non-round outer circumference that deviates from the circular shape.

25. Carrier according to one or more of the preceding claims, characterized in that the piercing elements (10) have an end section which can be gripped behind, with which they can be coupled to a drive device (36) for carrying out the piercing process.

26. Lancing device for piercing the body surface in order 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 which can be inserted into a housing body (4) with the carrier ), which can be driven by a drive mechanism (36), characterized by a carrier (16) according to one or more of the preceding claims, which can be inserted into the housing body (4) together with the piercing elements (10) and removed again after the piercing elements have been used can be removed from the housing body.

27. Blood analysis device (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 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) has a piercing position (12) assigned to a working position (30) of a respective piercing element (10) for applying a user's skin surface, wherein 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, wherein when a lancing element (10) is positioned in its working position (30), the lancing element is in the skin surface placed at the piercing position (12). The user can be pierced and blood emerging from the skin surface can reach a test agent (14), characterized by a carrier (16) according to one or more of claims 1 - 25, which can be inserted into the housing body (4) together with the pricking elements (10). and can be removed again from the housing body (4) after using the piercing elements (10).

28. Blood analysis device according to claim 27, characterized in that the carrier (16) can be driven in rotation in the housing body (4).

29. Blood analysis device according to claim 27 or 28, characterized in that the plurality of test means (14) is arranged on a carrier (16) and can be inserted into the housing body (4) together with the carrier (16) and removed from the housing body again after use (4) can be removed.

30. Blood analysis device according to claim 29, characterized in that the test means (14) and the lancing elements (16) are arranged on the same carrier (16).

31. Blood analysis device according to one or more of claims 27-30, characterized in that a negative pressure 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 A negative pressure can be applied to the skin surface to obtain a minimal amount of blood.

32. Blood analysis device according to one or more of claims 27-31, characterized in that the negative pressure generating device (18) is provided such that the negative pressure generated by it enables the transport of blood from the Blood that has escaped from the skin surface is supported to form a test agent (14).

33. Blood analysis device according to one or more of claims 27-32, characterized in that the test means (14) is provided between the piercing position (12) and the negative pressure generating device (18).

3. Blood analysis device according to one or more of claims 27-33, characterized in that the test means (14) is provided at least almost adjacent to or adjacent to the piercing position (12).

35. Blood analysis device according to one or more of claims 27-34, characterized in that the negative pressure generating device (18) has a volume-changeable region (20).

36. Blood analysis device according to one or more of claims 27-35, characterized in that the volume-changeable region (20) has a spring means (26).

37. Blood analysis device according to one or more of claims 27-36, characterized in that the volume-changeable region (20) has a bellows, in particular a bellows (22).

38. Blood analysis device according to one or more of claims 27-37, characterized in that the negative pressure generating device (18) can be activated manually to generate negative pressure.

39. Blood analysis device according to one or more of claims 27-38, characterized in that the negative pressure generating device (18) can be activated by reducing the volume of the volume-changeable region (20).

40. Blood analysis device according to one or more of claims 27-39, characterized in that the negative pressure generating device (18) is functionally coupled to the blood sampling device (8) in such a way that the negative pressure is only activated immediately before or simultaneously with or immediately after the execution is generated during the piercing process and can then be applied directly to the surface of the skin.

41. Blood analysis device according to one or more of claims 27-40, characterized in that the negative pressure ι generating device (18) is functionally coupled to the blood collection device (8) in such a way that activation of the negative pressure generating device is accompanied by a tensioning process in the blood collection device or as a result is triggered.

42. Blood analysis device according to one or more of claims 27-41, characterized in that the negative pressure generating device (18) is mechanically functionally coupled to the blood sampling device (8).

43. Blood analysis device according to one or more of claims 27-42, characterized in that the negative pressure generating device (18) is functionally coupled to the carrier (16) for the lancing elements (10) and test means (14) in such a way that the negative pressure is activated generating device is accompanied by an adjusting movement of the carrier (16) or is triggered thereby.

44. Blood analysis device according to one or more of claims 27-43, characterized in that to activate the device (18) generating negative pressure, an axial actuating movement is provided, which is converted into a rotary actuating movement for the drive via gear means (28). of the carrier (16) for the lancing elements (10) and/or test means (14) can be implemented.