EP1631193A1

EP1631193A1 - Blood collection system

Info

Publication number: EP1631193A1
Application number: EP04729840A
Authority: EP
Inventors: Paul Jansen; Juergen Rasch-Menges
Original assignee: F Hoffmann La Roche AG; Roche Diagnostics GmbH
Current assignee: F Hoffmann La Roche AG; Roche Diagnostics GmbH
Priority date: 2003-06-13
Filing date: 2004-04-28
Publication date: 2006-03-08
Also published as: WO2004110274A8; WO2004110274A1; DE10326692B3; CA2528633A1; US20060282109A1; JP2006527033A

Abstract

The invention relates to a blood collection system for collecting blood for the purpose of analysis or diagnosis. The aim of the invention is to provide a system which allows the multiple use of lancets (5) stored in a lancet storage container (6) and which reduces the time until the pricking movement is carried out. For this purpose, a lancet tip protective element (13) is provided in a parking position for the lancets (5), which protective element mechanically and hygienically protects the lancet tips.

Description

Blood Collection system

The invention relates to a blood collection system for drawing blood for analysis or diagnosis purposes.

For the qualitative and quantitative analysis of constituents of a liquid sample, in particular a body fluid of humans or animals, test methods are used which work with test elements. The test elements contain reagents. To carry out a reaction, the test element is brought into contact with the sample. The reaction of the sample and the reagent leads to a change in the test element which is characteristic of the analysis and which is evaluated with the aid of a suitable evaluation device. The evaluation device is _. generally suitable for the evaluation of a particular type of test elements of a particular ^{"manufacturer.} The test element and the evaluation unit forming mutually matched components and are collectively referred to as an analysis system.

Numerous different types of test elements are known, which differ in the measuring principle and the reagents used and in their structure.

With regard to the measurement principle, colorimetric analysis systems are particularly widespread. With them the reaction of the sample with those contained in the test element leads Color change reagents that can be measured visually or using a photometric measuring device. In addition, electrochemical analysis systems have become very important, in which the reaction of the sample with the reagents of the test element leads to an electrically measurable change (an electrical voltage or an electrical current), which is measured with appropriate measuring electronics.

With regard to the structure of the test elements, strip-shaped test elements (so-called test strips) are used in particular, which essentially consist of an elongated base layer made of plastic material and test feathers attached to it. The test fields usually consist of one or more test layers containing reagents. Such test strips are widely used in particular for blood and urine tests.

In a second type of test element, a test field, like a photographic slide, is surrounded by a frame. The test field of this type of test element usually consists of one or more test layers which are held by the frame and contain reagents suitable for colorimetric tests. After application of the sample to the test field and completion of the test reaction, the color formation can be observed or measured photometrically.

In order to draw a small amount of blood from a part of the body (usually the finger or the earlobe) for such analytical-diagnostic purposes, lancets are used which are inserted into the corresponding part of the body. As far as the lancets are inserted manually into the skin to create a wound specially trained personnel required. However, the puncture is associated with considerable pain.

Blood collection systems have been used for a long time, which consist of a lancing device and associated lancets specially adapted for the device in question. A lancet drive is contained in a housing of the lancing device, through which a lancet mechanically pierces the skin _. becomes. However, this is also not painless, and there are various developments to make blood collection as painless as possible.

This is particularly desirable when regular monitoring of certain analytical blood values is required. This applies in particular to diabetics who should check their blood sugar level frequently in order to keep their blood sugar level as constant as possible within certain target limits by adapting insulin injections to the strongly fluctuating needs.

In practice, however, a blood collection system is not only expected to meet the requirement for minimal pain sensation, but at the same time it should be simple to operate, have a compact, slim design and enable a simple, inexpensive construction. Based on these practical requirements, blood analysis devices have been and are being developed that meet these partially contradicting requirements as far as possible.

Especially in the area of the so-called "horn monitoring", that is, where medical laypersons carry out simple blood analyzes themselves, and there in particular for the regular blood collection by diabetics to be carried out several times a day for the control of blood glucose. concentration, lancets and matching devices, so-called "lancing aids", are offered that enable blood to be obtained as painlessly and reproducibly as possible.

While several milliliters of blood from a person to be examined are often obtained for analysis by a venipuncture in clinics and private practice doctors in order to have a large number of laboratory tests carried out, individual analyzes that are aimed specifically at one parameter are often sufficient today a few μl of blood. The collection of small amounts of sample in the range of a few μl or less for determining analytical parameters is particularly common for measuring the blood glucose level, but is also used, for example, in the determination of coagulation parameters, triglycerides, HBA Ic or lactate.

^' Such small amounts of blood do not require venipuncture but can be obtained using a sterile, sharp lancet which is pushed through the skin, e.g. into the fingertip or the earlobe of the person to be examined. This method is particularly suitable if the analysis of the blood sample can be carried out immediately after blood collection.

The lancets used to remove body fluid from a body part by creating a small puncture wound usually have a metal lancet needle, the tip of which can be ground. These lancets must be kept sterile until they are used and should preferably be disposed of after use so that they cannot cause injury. Blood sampling systems have therefore been proposed in which the lancets are in a lancet storage container in which a plurality of lancets for removal from the lancet storage container are kept in stock at a removal position.

A possible embodiment of such a lancet storage container is a drum magazine from which the lancets can be removed individually, the lancets being arranged in chambers in the drum magazine, each of which is individually closed. The used lancets are either disposed of outside the device or the analysis device or can also be returned to the lancet storage container for safe disposal after use.

Document DE 198 40 856 A1 describes a lancet dispenser for a blood sampling system and a corresponding method for removing a lancet from a lancet magazine. The lancet dispenser comprises a housing with a lancet storage container arranged therein, a lancet guide, and a lancet drive.

The current development of blood analysis devices is directed towards fulfilling the above-mentioned requirements also to provide highly integrated devices, in which preferably all functions are combined. Such blood analysis devices, for example glucose meters, comprise in a device that is as compact as possible both a blood withdrawal system with lancets, a magazine for the lancets, an analysis device or an analysis system and the necessary test elements, likewise preferably in a magazine. In this case, all the magazine materials, ie the lancets and the test elements, are preferably disposed of after their use in the device, for example after use in the magazine returned and kept there until the entire magazine is replaced.

For example, another known device concept for blood analysis devices assumes that integrated

"Disposables" are used, which are an integrated combination of a lancet and a test element. In this case, a lancet is provided or provided for a test element, which is integrated in the test element.

Various problems arise with such integrated or highly integrated measuring devices, in particular those for mobile use such as for home monitoring:

According to the state of the art, a fresh lancet is used each time the blood is drawn. The result is a lancet magazine that takes up more volume in the blood analysis device than the magazine for the test elements. To reduce the size of the blood analyzer, it is desirable to reduce the volume of the lancet reservoir.

In some reimbursement systems, only the costs for the consumables required to carry out the analysis, for example the test elements or test carriers used, are reimbursed, but not accessories such as lancets. This leads to the desire to use lancets several times for the extraction of blood, that is to say for several lancing movements. When using lancets several times, there is not only the need to protect the lancets mechanically and hygienically before they are used for the first time, but also to protect the lancets mechanically and hygienically until they are used again. Any blood and skin residues remaining on the lancet from the first use should be removed.

Finally, it should also be prevented that a last used lancet, which is disposed of in the lancet storage container or otherwise in or outside the blood analysis device or blood collection system, is contaminated and thus the risk of contamination of the unused in the lancet storage container is available held lancets.

Another problem with highly integrated blood analysis devices is that the time between starting a measurement process and performing an injection into the skin can be relatively long. From the point in time at which a measuring process is started, a time of up to 10 seconds can pass before the puncturing movement from the lancet into the skin is carried out. During this time, the body part to be stung, for example the finger, must be pressed against the outlet opening of the blood analysis device and the puncturing movement must be waited for.

Many users find this time period too long. However, it cannot be reduced significantly with the blood collection systems customary in the prior art, since this time is required to remove a lancet from the lancet storage container by means of the lancet drive and to transport it into the lancing position at the outlet opening for the lancet tip ,

The invention aims to solve the problems associated with the prior art blood collection systems that are associated with the multiple use of lancets. According to the invention, this object is achieved by a blood withdrawal system or a method for withdrawing blood with the features of the attached independent patent claims. Preferred refinements and developments of the invention result from the dependent patent claims and the following description with associated drawings.

A blood withdrawal system according to the invention for withdrawing blood for analysis or diagnostic purposes thus comprises a housing with an outlet opening for the lancet tip of the lancet needle of a lancet, which can be moved in the housing along a predetermined insertion path, a lancet guide by means of which the lancet is guided on the predetermined one The lancing path can be guided, a lancet drive, by means of which the lancet can be moved and moved along the predetermined insertion path in the insertion direction until its tip emerges from the outlet opening in a lancing position, and a lancet storage container which is arranged in the housing and in which a plurality of lancets for removal from the lancet storage container is kept in stock at a removal position, and has the special feature that it comprises a lancet tip protection element into which the lancet tip can be inserted before or after an insertion movement, the protection z element mechanically and hygienically protects an inserted lancet tip, and that the lancet tip protection element is arranged in a parking position of the lancets on the lancet tip, the parking position not matching the removal position and the lancing position.

A method according to the invention for taking blood with a blood collection system for analysis or diagnosis purposes, wherein the blood collection system comprises a housing with an outlet opening for the lancet tip of the lancet needle of a lancet, which is moved in the housing along a predetermined insertion path, comprises a lancet guide, by means of which the lancet is guided on the predetermined insertion path, comprises a lancet drive, by means of the lancet of which is moved and moved along the predetermined insertion path in the insertion direction until its tip emerges from the outlet opening in a lancing position, and comprises a lancet storage container which is arranged in the housing and in which a plurality of lancets for removal from the lancet If the storage container is kept in stock at a removal position, the special feature is that the lancet tip is inserted into a lancet tip protection element before or after a puncturing movement, the protection element mechanically and hygienically when a lancet tip is inserted therein enisch protects, and that the lancet tip protection element is arranged in a - parking position of the lancets on the lancet tip, the parking position does not match the removal position and the lancing position.

The peculiarity of the invention can be seen essentially in the fact that for the lancets in addition to one

In the storage position (in the lancet storage container or in its removal position) and an application position (in the lancing position at the outlet opening), a further standby position (the parking position) is provided, in which they are inserted into and protected by a lancet tip protection element become.

The first-time use of a lancet for blood collection can either be done in the usual way by removing it the lancet from the lancet storage container and directly fed to the outlet opening. Alternatively, it is also possible to have the lancet ready in the parking position before it is used for the first time. However, the lancet is used repeatedly from the parking position into which it is brought after the first use and the further uses before it is finally disposed of. After the last use of a lancet for taking blood, it can either be disposed of directly, for example in the lancet storage container or outside the device, but it can also be returned to the parking position before disposal in order to clean it and prevent contamination to avoid other elements, for example the lancet storage container.

With the invention it is possible to use lancets several times, even in integrated blood analyzers, and to use them in each case before use, i.e. to protect the puncture through the skin, mechanically and hygienically, while at the same time a short period of time can be achieved between triggering a blood sample and performing the piercing process. In the parked position, the lancet can be largely cleaned, e.g. sterilized, and at the same time is protected against environmental influences, e.g. Shocks, protected.

If the lancet is temporarily arranged in the park position, it can be kept ready for use there. If the arrangement and / or the travel path of the lancet is optimized in such a way that it can be fed from the parking position into the puncture position at the outlet opening in the blood analysis system faster than from the removal position in the lancet front container, the time that elapses before the piercing movement is carried out can be reduced as desired.

Accordingly, it is proposed according to a further advantageous feature that the lancet tip protection element and the parking position are arranged in the immediate vicinity of the outlet opening.

A mechanically inexpensive and thus preferred embodiment consists in that the lancet tip protection element is stationary, i.e. is arranged at a fixed place in the housing of the blood collection system or the blood analysis device. In other embodiments, however, it can also be provided that the lancet tip protection element can be moved onto the lancet tip by means of a drive.

According to a further preferred feature, it is proposed that the lancet tip protection element comprise an elastic material into which the lancet tip can be inserted. This can be a plastic body, for example, which consists of an elastic material in the area of the lancet tip. At least the tip of the lancet needle is completely surrounded on all sides by this elastic material, ie embedded in it, and thus closed off from the surroundings. The elastic material is characterized, for example, by the fact that it is soft, deformable and can be pierced by the tip of the lancet needle without damaging the lancet tip. Another important property of the elastic material is that it closes again when the lancet needle is withdrawn from the lancet tip protection element, so that the lancet needle is closed after one Lancing process or another lancet needle can be reinserted into the elastic material.

The elastic material provides mechanical protection for the lancet tip and thus prevents one

Damage to the lancet tip. However, by enclosing it also contributes to the sterility of the lancet tip before it is used, especially if it is germ-tight for the penetration or escape of germs, depending on whether the lancet needle is unused or used.

Suitable elastic materials are described in documents WO 01/66010 A1 and US 2001/0041904 A1. To this extent, these documents are referred to. Suitable elastic materials are, for example, silicone, rubber or elastomers (e.g. polybutadiene or isoprene such as polyisoprene = rubber, possibly vulcanized to increase hardness), elastomeric copolymers (e.g. styrene-butadiene copolymers) or thermoplastic elastomers (e.g. polyurethane) , They are soft, deformable, can be pierced by the lancet needle without damaging the lancet tip and close tightly around the used lancet tip. Thermoplastic elastomers can also be processed by injection molding processes and are therefore inexpensive to produce.

In the elastic material, for example a soft plastic, preferably with a germicidal / microbicidal property, the lancet tip can remain protected before its first use or between uses and is kept sterile. The soft plastic should be so soft that the lancet tip or lancet is not damaged when immersed and does not become excessively blunt. At the same time, the material should be so tough that it encloses the lancet well after multiple use, ie seals it, and does not crumble.

Another advantageous embodiment consists in that the lancet tip protection element comprises a sterilizing, microbicidal, inactivating, disinfecting, bactericidal or fungicidal material for cleaning or protecting the lancet tip. It is preferred if the elastic material described above is formed in this way 10. In the park position, a lancet is then both protected and cleaned and can therefore be used several times.

Suitable sterilizing materials are disclosed in document US 2001/0041904 A1, which is referred to in this respect. Suitable materials are, for example, oxidants, phenols, epoxides, peroxides, polymers of formaldehyde and other mono-, di- and polyaldehydes (e.g. glutaraldehyde), systems containing hydrogen peroxides, complexes containing iodine and metal salts of

Silver or copper. The SAM polymers from Degussa, for example Limago T100 or Amina T100, which have been shown to be admixed with a plastic, have proven to be particularly advantageous within the scope of the invention.

25

A blood withdrawal system according to the invention is preferably designed such that a lancet can be used multiple times for withdrawing blood and can be moved between the piercing movements into the lancet tip protection element.

Due to the multiple use of lancets, a blood collection system or a corresponding blood analysis device according to the invention can be designed such that the number of lancets provided is smaller than the number of associated test elements and not as in

35 State of the art equal to the number of associated test elements. In this way, both space and cost savings can be achieved.

Operating elements are advantageously provided, by means of which the user can specify whether a new lancet from the lancet storage container or a lancet already used for taking blood from the parking position in the lancet tip protection element is used for the subsequent blood withdrawal. In this way, the user can decide at which point in time he wishes a new lancet if the lancet tip becomes less sharp and the resulting greater pricking pain occurs. This can also be done, for example, in such a way that the user presets the number of blood withdrawals that are carried out with a lancet and the lancet is disposed of after this preset number of uses has been reached.

The invention proves to be particularly advantageous as a highly integrated analysis system, the system additionally containing test elements in addition to a lancet magazine. If both lancet and test elements are provided in the system, this results in a complex movement sequence of the lancet for exiting the housing - as described - since the lancet magazine cannot be positioned directly above the housing opening. A complex movement sequence in the X and Y directions is consequently required to carry out a lancing process, it being possible to simplify this movement sequence by the described parking position. According to an advantageous feature, it is therefore proposed that the blood collection system comprises a test element magazine which is integrated in the blood collection system, preferably arranged in the housing is. The test element magazine is preferably exchangeable.

The invention is explained in more detail below on the basis of exemplary embodiments illustrated in the figures. The special features described therein can be used individually or in combination with one another in order to create preferred embodiments of the invention. Show it:

1 shows the structure of a glucose meter according to the prior art,

2 shows step 1 of a sample collection according to FIG. 1,

3 shows step 2 of a sample collection according to FIG. 1, FIG. 4 shows step 3 of a sample collection according to FIG. 1,

5 shows step 4 of a sample collection according to FIG. 1,

6 shows step 5 of a sample collection according to FIG. 1,

7 shows step 6 of a sample collection according to FIG. 1,

8 shows the structure of a glucose meter according to the invention, FIG. 9 shows a detail of FIG. 8,

10 shows a further detail of FIG. 8, FIG. 11 shows a modification of FIG. 10,

12 shows step 1 of a sample collection according to FIG. 8, FIG. 13 shows step 2 of a sample collection according to FIG. 8, 14 shows step 3 of a sample collection according to FIG. 8,

15 shows step 4 of obtaining a sample according to FIG. 8, FIG. 16 shows step 5 of obtaining a sample according to FIG. 8,

17 shows a modified step 1 of a sample collection according to FIG. 8,

18 shows a modified step 2 of obtaining a sample according to FIG. 8,

19 shows a modified step 5 of a sample collection according to FIG. 8,

20 shows a modification to FIG. 8,

21 shows a detail of FIG. 20, FIG. 22 shows a further detail of FIGS. 20 and

23 shows a further modification to FIG. 10.

1 schematically illustrates the blood withdrawal system 1 of a blood analysis device 2 according to the prior art in the form of an integrated glucose meter in which the consumables required for the blood analysis are stored and the processes required for the blood analysis are integrated. The test elements with which the blood drawn is analyzed are not shown for the sake of clarity.

The blood collection system 1 comprises a housing 3 with an outlet opening 4, from which a blood sample can be taken by means of a lancet 5. The lancets 5 are located in a lancet storage container 6, which in the exemplary embodiment shown is a rotatable drum magazine. The multiple lancets 5 are in the lancet ten storage container 6 and can be present, for example, loose or clamped by holding elements. The lancet storage container 6 can be rotated about an axis of rotation 7 in order to bring a lancet 5 contained in the lancet storage container 6 and to be removed into a removal position.

By means of a lancet drive 8, for example in the form of a lifting and swiveling unit with an adapted gripper 9, a lancet 5 can be removed from the lancet storage container 6 and transported to the location of the sample collection, the lancing position at the outlet opening 4 and after the blood withdrawal for disposal be transported back into the lancet storage container 6. The lancet drive 8 can be pivoted about an axis of rotation 10 and can be moved along a linear axis 11 which is oriented in the piercing direction.

The sequence of sampling with a blood collection system 1 according to the prior art according to FIG. 1 is explained in the following figures. 2, the lancet storage container 6 first rotates such that a lancet 5 to be removed, preferably the one from the next available position, is brought into the removal position in which it can be gripped by the gripper 9 of the lancet drive 8. 3, the lancet drive 8 first moves upward from a starting position (not shown) into a rotational position, then rotates the gripper 9 about the axis of rotation 10 into the receiving position, ie below the position of the lancet 5 to be removed from the lancet storage container 6, and then the lancet 5 is attached to the gripper 9 by a further movement upwards. The lancet 5 is then pulled out of the lancet storage container 6 by the downward movement shown in FIG. 4 and has arrived in a position in which it can be rotated about the axis of rotation 10.

According to FIG. 5, the lancet 5 is then positioned under the outlet opening 4 for sample collection by means of a rotary movement and the lancet 5 is moved upwards to or into the outlet opening 4 via a travel movement, where it is then in the lancing position. A body part, e.g. stored a fingertip 12. By means of a short, not shown, lancing movement, the lancet 5 with the lancet tip located on the lancet needle can pierce the fingertip 12 or the skin surface of another part of the body placed on the outlet opening 4 and thereby obtain a small blood sample.

After the blood has been obtained and analyzed using an analysis device or an analysis system (not shown), for example using test strips, either inside or outside the housing 3, the lancet is removed

5 brought back into the lancet storage container 6 according to FIG. 6. For this purpose, the lancet drive 8 first performs a downward movement to the rotational position. The lancet drive 8 then turns the gripper 9 with the lancet 5 to be disposed of, the lancet storage container 6, to the now empty magazine position, and the lancet 5 used is moved into the lancet storage container by a subsequent movement upwards

6 returned. Thereafter, the lancet drive 8 moves downward again, swivels back as shown in FIG. 7 and then moves downward into the starting position, not shown, from which the next blood withdrawal takes place. The above-mentioned steps are repeated for a new blood withdrawal, a new lancet 5 being removed from the lancet storage container 6 in each case and all movements or routes will be repeated.

The prior art sequence described in FIGS. 2 to 7 has several disadvantages. On the one hand, the travel paths and thus the travel times for the lancet drive 8 are long, so that the user has to wait a long time from triggering the blood withdrawal from the starting position of the lancet drive 8 until a lancet 5 is provided from the lancet storage container 6 and the piercing movement at the outlet opening 4 is carried out. Furthermore, the lancet storage container 6 requires a relatively large amount of space, since a new lancet 5 is provided for each blood sample. In the case of multiple use of a lancet 5 out of the storage container 6, the problem of long travel paths remains and the problems of sterilizing a used lancet 5 before its next use and avoiding contamination - the unused, sterile lancet 5 containing lancet storage container 6 through a lancet inserted therein.

These disadvantages are solved with a blood collection system 1 according to the invention according to FIG. 8. The structure corresponds to that of the blood collection system according to the prior art according to FIG. 1, with the difference that it comprises a lancet tip protection element 13 into which the lancet tip can be inserted before or after an insertion movement, the protection element 13 being one therein protects the inserted lancet tip mechanically and hygienically. The protective element 13 is arranged in a parking position of the lancets 5 on the lancet tip, ie the lancet tip is inserted into the protective element 13 in the parking position. The parking position does not correspond to that Removal position, in which the lancet 5 is removed from the lancet storage container 6, and also not the lancing position at the outlet opening 4, in which blood is withdrawn.

The parking position for the lancet tip, i.e. the position of the protective element 13 is preferably in the immediate vicinity of the outlet opening 4, preferably inside the housing 3. Another advantageous embodiment can consist in the fact that the lancet tip protection element 13 is arranged in the lancet storage container 6, i.e. is integrated into the magazine.

The elastic material 15 wears out during use, for example the plastic is perforated or it becomes dirty (blood residues, skin flakes, environmental influences). For this reason, it is advantageous if the lancet tip protection element 13 or the elastic material 15 is not a solid, i.e. fixed or permanent part of the device, but is interchangeable. For example, it is possible to design the protective element 13 or the elastic material 15 as a disposable, that is to say as a consumable that the user must replace at intervals to be defined, e.g. as a separate article or as an addition to every pack of lancets 5. It is also possible to integrate the lancet tip protection element 13 into the lancet storage container 6. It is exchanged with each magazine change and does not burden the user with additional service actions to be monitored.

Figures 9 to 11 illustrate embodiments of protective elements 13, which are arranged stationary, ie at a fixed location in the housing 3. FIG. 9 shows a protective element 13, which is on the inside of the Housing 3 is arranged. It comprises a solid molded body 14 which is filled with an elastic material into which the lancet tip can be inserted. It is filled with a soft plastic, which is mixed with a sterilizing, germicidal agent. The elastic material 15 protects the tip of the lancet 5 inserted therein from environmental influences, for example contamination, vibrations and associated damage, cleans it by wiping off the dirt when the lancet 5 is immersed in the elastic material 15 and disinfects it by the microbicidal admixture.

In the . in Fig. parking position of the lancet 5 9 shown in the lancet tip protecting member 13 ^• the lancet 5, by the lancet drive 8 and / or on a

Gripping section 16 can be held protected from falling out by a holding device, not shown. Such a holding device can function actively, i.e. have an active gripping element, or passively off--; be formed, for example as a clamping device.

FIGS. 10 and 11 illustrate details of FIG. 9. In FIG. 10, the lancet protection element 13 is integrated into the inside of the housing 3, in FIG. 11 it is placed on the inside of the housing 3. Another modification is shown in FIG. 23.

12 to 19 illustrate the sequence of the sample collection with a blood collection system 1 according to FIG. 8. The preceding steps, in which the lancet 5 is removed from the lancet storage container 6 and the blood collection is carried out by a puncturing movement into the fingertip, are not shown becomes. These steps run in accordance with FIGS. 2 to 5. Alternatively, it is also possible to used lancet 5, which is removed from a lancet storage container 6, not to be used immediately for blood sampling, but first to bring it into the parked position in lancet tip protection element 13 and to remove the lancet at the point in time at which blood sampling is to be carried out to pick up the parking position. This also shortens the time that elapses when a new, unused lancet is used for the first time before the piercing movement is carried out.

FIGS. 12 to 19 illustrate the further sequence after a blood sample has been taken with a lancet 5. In the embodiments according to FIGS. 12 to 16, the lancet 5 remains in the parking position in the protective element 13 and the lancet drive 8 moves in a separate starting position. According to FIGS. 17 to 19, the lancet drive 8 remains in the park position together with the lancet 5.

In FIG. 12, after the lancing movement, the lancet drive with gripper 9 and gripped lancet 5 is first moved downwards. The gripper 9 is rotated under the protective element 13 by means of a rotary movement that takes place in a rotary plane that is as close as possible to the rotary plane in which the pivoting movement takes place to bring a lancet 5 out of the lancet storage container 13. The lancet 5 is brought into the park position by an upward movement, wherein it is pressed into the soft plastic in the protective element 13. There, they can not by a ^'shown, active or passive holder are held, the holding force provided by the elastic material 15 is not sufficient. The lancet 5 can preferably be moved by means of the lancet drive 8 into the parking position in which its tip is located in the protective element 13. If a higher design effort can be accepted, a separate drive can also be provided for this, which does not fulfill the function of fetching the lancets 5 from the lancet storage container 6.

The design effort and the travel paths of the lancet 5 are minimized if the lancet tip protection element 13 is arranged in such a way that the lancet tip can be inserted into the lancet tip protection element by a movement parallel to the piercing movement.

In Fig. 13, in which the lancet 5 without. Lancet drive remains in the protective member 13 8, the lancet drive 8 goes without ^"lancet 5 initially somewhat back down, then rotates in a throw-off position and moves further downward to the external to the Fig. 13 initial position.

The resulting end position, in which the lancet drive 8 is in a starting position shown outside the drawing and the lancet 5 is in the park position in the lancet tip protection element 13, is shown in FIG. 14. The lancet 5 can be brought out of the park position by means of the lancet drive 8 to carry out a further blood withdrawal. Parking the lancet 5 outside the lancet storage container 6 prevents the lancet storage container 6 or the unused lancets contained therein from being contaminated by sample material adhering to the lancet 5 used. Furthermore, the lancet can be transported from the parking position to the outlet opening for a new one The lancing process takes place more quickly since the lancet storage container 6 does not have to be repositioned in order to remove a new lancet therefrom.

In the figures 15 and 16 (also an unused lancet 5 or possibly ^') is illustrated as an already singly or multiply used lancet 5 picked up from the parking position to the protective element 13 for taking a blood sample and then discarded. 15, the lancet drive 8 first moves upward from the starting position, then pivots the gripper 9 under the lancet 5 in the park position and moves upward somewhat to grip the lancet 5. 16, the lancet drive 8 moves somewhat downward, the lancet 5 being pulled out of the protective element 13, swivels to the left and brings the lancet 5 into the lancing position at the outlet opening 4 by an upward movement, in order to place it in the fingertip 12 sting.

If the lancet 5 is then no longer required because, for example, the number of lancing operations to be performed with a lancet 5 determined by the user has been reached, the lancet 5 is brought into the lancet storage container 6 for disposal. These steps are carried out in accordance with FIGS. 6 and 7.

An advantage of the method according to the invention is that it can include a method step in which a lancet 5, with which a puncturing movement has been carried out, is returned to the lancet storage container 6. It is particularly advantageous that the invention enables the used lancets 5 to be re-stored without soiling the lancet storage container 6 by first moving the used lancet 5 into the parking position after the lancing process, before it is re-stored in the lancet storage container 6. Accordingly, it is proposed according to a preferred feature that the used lancet 5 is inserted into a lancet tip protection element 13 in the park position before being returned to the lancet storage container 6, that is to say that a used lancet 5 is also first transferred to the park position when it is not intended for any further lancing process. The lancet storage container 6 can be replaced at a suitable point in time, if necessary with used lancets 5 that have been re-stored.

The lancet storage container 6 thus only serves to transport the lancets 5 into the blood collection system 1 or the blood analysis device 2, to keep unused lancets in them and to dispose of the used lancets.

FIGS. 17 to 19 illustrate the alternative variant, in which the lancet drive 8 remains in the park position after the lancet 5 has drawn blood. 17 illustrates how the lancet 5 is brought into the park position; the process corresponds to the process shown in FIG. 12. However, in contrast to FIGS. 13 and 14, the lancet drive 8 is not moved away or pivoted away from the lancet 5 in the park position, but rather the gripper 9 remains in or in the immediate vicinity of the lancet 5 in the park position. This is shown in Fig. 18. Compared to the end position shown in FIG. 14, this has the advantage that even shorter travel times result for subsequent blood collection with the parked lancet 5, since the travel routes shown in FIG. 15 are omitted. The ones illustrated in FIG. 19 are for performing a further blood withdrawal Perform steps corresponding to those of FIG. 16. A lancet 5 that is no longer to be used is disposed of as in the first variant described above.

FIGS. 20 to 22 illustrate a modified embodiment of a blood analysis device 2 with a blood collection system according to the invention. On the top of the blood analyzer 2 there is a test element magazine 17 with a revolver-like removal device 18. On the underside there is the lancet storage container 6, which can be replaced independently of the test element magazine 17. In other embodiments, the lancets and the test elements can also be integrated in a storage container.

The lancets 5 are pushed from bottom to top through the lancet storage container 6 by a lancet drive, not shown. In addition to the lancet storage container 6, the lancet tip protection element 13 is arranged, which is filled with a gel-like, soft plastic. In other embodiments, the parking position defined by the position of the protective element 13 could also occupy a position in the lancet storage container 6. A holding device 19 is arranged under the protective element 13 as a parking aid for the lancets in the parking position, for example in the form of a holding clip.

The process flow is illustrated in FIG. 21 in three steps. The lancet drive penetrates from below into a storage position of a lancet 5 in the lancet storage container 6, for example a sealing film ensuring sterility up to this point being pierced. With a removal device tung is gripped a lancet and upwards out of the lance storage container 6, in turn, for example by a sealing film, moved out ^'. After the lancing has been triggered, the lancet drive moves the lancet back into the lancet storage container 6, where it is separated from the lancet drive and disposed of according to the prior art. According to the prior art, the lancet storage container 6 would rotate one position further for the next blood withdrawal and a new lancet would be used.

According to FIG. 21 (middle), however, the used lancet 5 is pulled down through the lancet storage container 6, swiveled to the side by means of the lancet drive, and pushed up into the lancet tip protection element 13 (FIG. 21 right), where it is used for a further use is available. To reuse the lancet from the park position, it is transported in reverse order, i.e. first pulled down, then pivoted to the side and conveyed upward through the lancet storage container 6.

22 shows a lancet 5 in the lancet tip protection element 13, which is filled with a raicrobicidal elastic material 15. It is secured by a holding device 19.

FIG. 23 illustrates a modified embodiment of the protective element 13. It may possibly happen that during the lancing process (to obtain blood) one

Capillary (capillary) is hit and an unexpectedly large amount of blood emerges. This could collect on the lancet 5 in the form of a drop 20. This drop 20 would when the lancet 5 was inserted into the surface of the elastic material 15 (of the parking gel) be stripped. From there, the still liquid blood could run down or accumulate in layers and thus subsequently contaminate the part of the lancet 5 that is not immersed in the elastic material 15. This is remedied by a cover 21 of the elastic material 15 with an absorbent material, for example cellulose or the like. This can absorb the possible drop of blood 20 and bind it. The requirements for the material of the cover 21 are sufficient strength, a high fabric density (suction power and stability for several punctures) and "lint-free".

LIST OF REFERENCE NUMBERS

1 blood collection system

2 blood analyzer

3 housing 4 outlet opening

5 lancet

6 lancet storage container

7 turning axis to 6

8 lancet drive 9 gripper

10 axis of rotation to 8

11 linear axis to 8

12 fingertip

13 lancet tip protection element 14 molded body

15 Elastic material

16 gripping section

17 test element magazine

18 removal device 19 holding device

20 drops

21 cover

Claims

claims

1. Blood collection system (1) for drawing blood for analysis or diagnosis purposes, comprising a housing (3) with an outlet opening (4) for the lancet tip of the lancet needle of a lancet (5), which is in the housing (3) along a predetermined insertion path is movable, a lancet guide, by means of which the lancet (5) can be guided on the predetermined piercing path, a lancet drive (8), by means of which the lancet (5) can be moved and moved along the predetermined piercing direction in the piercing direction until its tip is in a piercing position from * the -Out- • • exit opening (4), and a lancet storage container [S), which in the

Housing (3) is arranged and in which a plurality of lancets (5) for removal from the lancet storage container (6) is kept in stock at a removal position, characterized in that it comprises a lancet tip protection element (13) into which the The lancet tip can be inserted before or after a piercing movement, the protective element (13) mechanically and hygienically protecting an inserted lancet tip, and the lancet tip protective element (13) being arranged in a parking position of the lancets (5) on the lancet tip, the parking position Not corresponds to the removal position and the lancing position.

2. Blood collection system according to claim 1, characterized in that the lancet tip protection element (13) and the parking position are arranged in the immediate vicinity of the outlet opening (4).

3. Blood collection system according to one of the preceding claims, characterized in that the lancet tip protection element (13) stationary in the housing

(4) is arranged.

4. Blood collection system according to one of the preceding claims, characterized in that the lancet tip protection element (13) can be moved onto the lancet tip by means of a drive.

• 5th Blood collection system according to one of the preceding claims, characterized in that the lancet

(5) can be moved by means of the lancet drive into the parking position in which the lancet tip is located in the lancet tip protection element (3).

6. Blood collection system according to one of the preceding claims, characterized in that it comprises a holding device (19) for holding the lancet (5) in the park position.

7. Blood collection system according to one of the preceding claims, characterized in that the lancet tip protection element (13) is arranged in such a way that the lancet tip is parallel to the puncture Movement movement can be introduced into the lancet tip protection element (13).

8. Blood collection system according to one of the preceding claims, characterized in that the lancet tip protection element (13) is arranged in the lancet storage container (6).

9. Blood collection system according to one of the preceding claims, characterized in that the lancet tip protection element (13) comprises an elastic material (15) into which the lancet tip can be inserted.

10. Blood collection system according to one of the preceding

Claims, characterized in that the lancet tip protection element (13) comprises a sterilizing, microbicidal, inactivating, disinfecting, bactericidal or fungicidal material for cleaning or protecting the lancet tip.

11. Blood collection system according to claim 9, characterized in that the elastic material (15) is designed according to claim 10.

12. Blood collection system according to claim 9, characterized in that the elastic material (15) has a cover (21) made of an absorbent material.

13. Blood collection system according to one of the preceding claims, characterized in that the lancet tip protection element (13) or the elastic material (15) can be replaced.

14. Blood collection system according to one of the preceding claims, characterized in that it is designed in such a way that a lancet (5) can be used multiple times for taking blood and can be moved between the lancing movements into the lancet tip protection element (13).

15. Blood collection system according to one of the preceding claims, characterized in that it has operating elements by means of which the user can specify whether a new lancet (5) from the lancet storage container (6) or one already for the subsequent blood withdrawal The lancet (5) used for taking blood is used from the park position in the lancet tip protection element (13).

16. Blood collection system according to one of the preceding claims, characterized in that it comprises a test element magazine (17) which in the blood collection—. measuring system is integrated, preferably arranged in the housing (3).

17. Blood analyzer (2), in particular portable, mobile blood analyzer, characterized in that it comprises a blood collection system (1) according to one of claims 1 to 16.

18. A method for withdrawing blood using a blood withdrawal system (1) for analysis or diagnosis purposes, the blood withdrawal system comprising a housing (3) with an outlet opening (4) for the lancet tip of the lancet needle of a lancet (5) which is located in the housing ( 3) is moved along a predetermined penetration path, comprises a lancet guide, by means of which the lancet (5) is guided on the predetermined piercing path, comprises a lancet drive (8), by means of which the lancet (5) is moved and moved along the predetermined piercing path in the piercing direction until its tip is in a piercing position the outlet opening (4) emerges and comprises a lancet storage container (6) which is arranged in the housing (3) and in which a plurality of lancets (5) for removal from the lancet storage container (6) are available at a removal position is held, characterized in that the lancet tip is inserted into a lancet tip protection element (13) before or after a piercing movement, the protection element (13) mechanically and hygienically protecting an inserted lancet tip, and in that the lancet tip protection element (13) in a parking position of the lancets (5) is arranged on the lancet tip, the parking position not being aligned with the E Take position and the lancing position.

19. The method according to claim 18, characterized in that the lancet tip protection element (13) and the parking position in the immediate vicinity of the outlet opening (4) are arranged.

20. The method according to any one of the preceding claims, characterized in that the lancet tip protection element (13) is arranged stationary in the housing (4).

21. The method according to any one of the preceding claims, characterized in that the lancet tip protection element (13) is moved by means of a drive on the lancet tip.

22. The method according to any one of the preceding claims, characterized in that the lancet (5) is moved by means of the lancet drive into the parking position in which the lancet tip is in the lancet tip protection element (13).

23. The method according to any one of the preceding claims, characterized in that the lancet (5) by means of a holding device (19) which is held in the parking position.

24. The method according to any one of the preceding claims, characterized in that the lancet tip protection element (13) is arranged such that the

Lancet tip is inserted into the lancet tip protection element (13) by a movement parallel to the piercing movement.

25. The method according to any one of the preceding claims, characterized in that it comprises a method step in which a lancet (5), with which a lancing movement has been carried out, is brought back into the lancet storage container (6).

26. The method according to claim 25, characterized in that the used lancet (5) is inserted into a lancet tip protection element (13) in the park position before being brought back into the lancet storage container (6).

27. The method according to any one of the preceding claims, characterized in that it comprises a method step in which the lancet storage container (6) is replaced.

28. The method according to any one of the preceding claims, characterized in that a lancet is used several times for taking blood and is moved between the piercing movements in the lancet tip protection element (13).