WO2006032391A2 - Manual appliance for drawing blood or other body fluids - Google Patents

Abstract

The invention relates to a portable manual appliance for puncturing the skin, especially for drawing blood or other body fluids, said appliance comprising a lancet (4) and a lancet sterilisation device (3) that can be used to sterilise the lancet (4) in a non-contact manner. The invention also relates to a lancet (4) that can be reused many times.

Description

 Hand-held device for removing blood or other body fluids

The invention relates to a portable hand-held device for generating a puncture wound, in particular for removing blood or other body fluids, comprising a lancet which can be moved with a lancet drive from a rest position into a puncturing position.

For the qualitative and quantitative analysis of Körper¬ liquids, especially blood, are widely used in test methods that 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 sample and reagent leads to a characteristic change of the test element, which is detected and evaluated by means of a suitable Meßein¬ direction.

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

With regard to the measuring principle, colorimetric analysis systems are widespread. With them leads the reaction the sample with reagents contained in the test element to a color change, which can be measured visually or by means of a photometric measuring device. In addition, electrochemical analysis systems have acquired great importance, in which the reaction of the samples with the reagents of the test element leads to an electrically measurable change (an electrical voltage or an electrical current), which is measured with a corresponding measuring electronics.

In order to remove a small amount of blood from a body part (usually the finger or the ear lobe) for such analytical or diagnostic purposes, the lancets are used which are pricked into the corresponding body part. In order to make this puncture as simple and painless as possible, hand tools are used which move a lancet with a lancet drive from a rest position into a puncturing position.

For a number of diseases, regular monitoring of certain analytical values of the blood or of other body fluids is necessary. This applies in particular to diabetics, who frequently have to control their blood sugar levels in order to protect them from a dangerous increase by insulin injections.

Portable analysis systems make it possible for medical laypersons to carry out independently simple analyzes of the blood or other body fluids. For example, there are analysis systems that diabetics can carry with them constantly and thus determine the blood sugar level several times a day. These portable analysis systems comprise a hand-held device with a lancet and a lanyard drive for taking blood, and an analysis handpiece with an analysis measuring device for examining the blood by, a puncture of the lancet won blood. In such a portable analysis system, the handheld device for taking blood and the handheld analyzer can be designed as two different devices or integrated into a single device.

In your practice, an analysis system is expected to be as easy to use as, for example, devices for determining blood glucose levels are often used by persons whose manual dexterity is limited due to illness or age. Also of great importance is a device that is as compact and slim as possible, so that patients are as little burden as possible when constantly bringing along the device or devices. Finally, the puncture process should be as painless as possible and a risk of infection by the lancet used should be excluded.

The object of the invention is to show a way how these requirements can be met even better in practice.

This object is achieved by a portable hand-held device of the type mentioned at the outset in that it comprises a lancet sterilization device with which a lanyard can be sterilized without contact.

In. a hand-held device according to the invention, the lancet can be sterilized immediately before a puncture, so that a risk of infection can be largely excluded. Even in the case of hand-held devices which use disposable lanyards, that is to say use only a single lancet, there is a risk of infection in the prior art, since lancets are damaged by improper loading or when inserted into the hand-held device . Spores or other pathogens can come into contact.

Since a lancet can be sterilized immediately before a puncture procedure in a erfinchangesgemgemäßen hand device, even a multiple use of a lancet is possible. Multiple use of the lancet means a significant advantage over the prior Tech¬ nik. In the case of hand-held devices according to the prior art, a considerable part of the device volume is required for a lancet magazine for the positional deflection of disposable lancets. Such a lancet magazine can be dispensed with in the case of a multiple use of a lancet, so that a much smaller and slender handpiece can be created. For patients who constantly carry a hand-held device, for example for an analysis system for measuring the blood sugar content, and have to use it several times a day, a smaller and more compact design means a considerable relief.

By using a lancet several times, costs can be saved. This is particularly important because in some reimbursement systems only costs for the consumables required for carrying out an analysis, for example used test elements or test carriers, are reimbursed, but not costs for accessories such as lanyards.

- Used lancets are a source of danger because they are sharp and can easily cause injury. Lancets used can be transmitted in the event of injury to HIV, hepatitis and other diseases and must therefore be disposed of expensively as hazardous substances. For multiple use of lancets This effort can be reduced considerably, since fewer lancets must be disposed of.

For a non-contact sterilization of a lancet, there are various possibilities. Therefore, the lancet sterilization device of a handheld device according to the invention can also be designed differently. It is generally sufficient if only the area of the tip of the lancet which penetrates into the tissue and an immediately adjacent piece is sterilized.

A great advantage of the invention is that the lancet sterilization device operates without contact, ie has no parts that come into contact with the lancet during a sterilization process. If parts of the lancet sterilization device come into contact with the lancet, there is a risk of contamination of the lancet sterilization device, for example due to blood. It has therefore proved to be disadvantageous to sterilize a lancet, for example, by being stung by a sponge soaked with a disinfectant. In such a procedure, the lancet sterilization is not contact-free, since the lancet comes into contact with the sponge.

A first possibility for non-contact sterilization of a lancet is to generate an electrical plasma with which the lancet is acted upon. Particularly advantageous are gas discharge plasmas, in particular under atmospheric pressure conditions, ie at normal pressure in ambient air, since they can be produced with relatively little effort. Details of the generation of such gas discharge plasmas are disclosed, for example, in US Pat. No. 6,147,452 and in the article "Mikrostrukturierte Elektrodensysteme - Universelle Atmospheric pressure plasmas ", Physics No. 31, March 2001.

For good performance of a gas separation plasma, the electrode spacing is preferably less than 1 mm, particularly preferably less than 0.5 mm. In order to be able to produce plasmas of sufficiently large dimensions with such small electrode spacings, multiple arrangements of electrodes are preferred. For example, a plurality of microelectrodes may be applied at a suitable distance, for example 0.5 to 1 mm, on a substrate, for example made of aluminum oxide. The electrodes are preferably provided with a plasma-chemically stable protective layer of preferably less than 10 μm in thickness.

In the case of plasma sterilization, surface properties of the lancet can also be changed at the same time and can be adapted specifically to the requirements of a puncture and subsequent transport of blood or another body fluid. For example, by plasma action, a surface can be deliberately rendered to a hydrophilic state, so that blood can be transported more quickly from the tip of the lancet to a test element or analysis measuring device. This is an important advantage, in particular, since hydrophilic surfaces generally have no long-term stability and lose their trydrophilic properties over a more or less short period of time. If the surface of a lancet is hydrophilized by plasma action only shortly before the puncturing process, then the advantages of hydrophilic surface properties can be utilized even during prolonged storage. By the action of a plasma, radical sites can be generated on the surface of the lancet, which in the air rapidly hydroxi-, hydroperoxide or other polar and thus liquid wetting funk¬ tional groups form, especially when the lancet is coated with a plastic.

A hand-held device according to the invention with a lancet sterilization device for generating a plasma is also particularly suitable for lancets which serve not only to produce a puncture wound, but at the same time also to take a blood sample. Such lancets preferably have a test field for the analysis of a removed one

Sample on. For example, such a test field may be provided with chemicals which serve for the quantitative investigation of the blood glucose content. Such lancets are known, for example, from WO 03/009759 A1, the content of which with regard to the configuration of such lancets is made the subject of the present application by reference.

In the prior art, the sterilization of lancets which are integrated into a test element represents a major problem, since the test particles react sensitively to the effects of temperature and radiation. The methods used in the prior art for sterilizing lancets after production are therefore of very limited use for such integrated lancets.

By means of a hand-held device according to the invention with a lancet sterilization device for generating a plasma, these problems are solved. Sterilization takes place only immediately before use and can be carried out without difficulty so that the test field is not impaired. The lancet is preferably inserted into the device so that the lancet tip is positioned in a parking position in the lancet sterilization device. Is the sterilization done? by a plasma, the Kapil¬ larkanal can be hydrophilized at the same time, so that a sample can be better transported from the lancet tip to the test field.

Alternatively or additionally, the sterilization of a lancet can also be effected by radiation generated by the lancet sterilization device, in particular in the visible or ultraviolet frequency range. For this purpose, the lancet sterilization device preferably comprises one or more light emitting diodes or laser diodes. In general, the smaller the wavelength of the radiation, the greater the sterilization effect of radiation. For this reason, light-emitting diodes which emit blue, in particular ultraviolet, light are opposite

Light emitting diodes, which emit red light, usually prefer. As a result of the action of radiation, as well as by the action of plasma on a material surface, it is possible to generate thermal or photic chemical radical sites which form polar and thus liquid-wettable groups in air. Sterilization by the action of radiation thus likewise offers the advantage of a targeted hydrophilization of the lancets.

Another possibility for non-contact lancet sterilization is to heat up the lancet so far that spores, germs and other pathogens are killed. For thermal sterilization of the lancet, the lancet surface is preferably at least 25O ⁰ C, more preferably at least 300 ⁰ C heated auf¬. This is likewise possible by the action of radiation, which is generated for example by a laser diode, in particular as red light or infrared radiation. Preferably, the lancet sterilization device for thermal sterilization comprises an incandescent filament with which the lancet can be irradiated. Precious metals and noble metal alloys, which do not react with ambient air, are particularly suitable as material for this glass filament, so that the filament can be operated in air. It is particularly advantageous to associate the incandescent filament so that it axially surrounds the lancet during sterilization. In order to minimize the required heating energy, a reflector can be used with which of the

Incandescent generated radiation is reflected on the surface of the lancet to be sterilized.

A particularly efficient utilization of the heating energy, which is a great advantage in particular with battery-operated handheld devices, can be achieved in that the lancet sterilization device comprises a coil operated with alternating voltage, with which a heating current can be induced in the lancet. The frequency of the. Wecb-selspannung chosen so high that due to the

Skin effect of the lancet tip inductively generated Heizstroτn remains concentrated on a region of low penetration at the upper surface of the lancet tip. The geometry of the coil ensures that only the tip area of the lancet is heated. The ideal frequency: the AC voltage depends on the material of the lancet used, but is for most materials and especially for stainless steel between 500 kHz and 3 GHz, in particular between 1 GHz and 3 GHz.

Another possibility for non-contact sterilization of a lancet is to use a disinfectant which, for example, can be used as vapor or mist from a storage container of the lancet sterilization device is released to interact with the lancet. It is important that a disinfectant is used, which has at most a low toxicity for humans, since traces of the disinfectant can reach the human body with the disinfected lancet. Hydrogen peroxide is particularly suitable because it decomposes in oxygen and water, leaving behind no harmful decomposition products. In order to be able to release the disinfectant in a targeted manner, the lancet sterilization device preferably comprises one

Nozzle, which can be aligned in particular to the lancet tip.

A vapor or mist of a disinfectant can in principle also be released by purely mechanical means, for example an atomizer, or by a mechanically triggered chemical reaction. Preferably, however, the lancet sterilization device comprises a current consumer, which is flowed through by a .electric current during a sterilization process. Such a current consumer, for example, as a heating device be designed to evaporate a disinfectant or a _pump; to spray it. If the sterilization is carried out by an electrical plasma, then the current-carrying means comprises the production of an electrical plasma. Be ± sterilization by Strahlensein¬ effect or heat, the current consumer beispiels¬ example as light emitting or laser diode, filament or coil can be formed.

The invention will be explained in more detail below with reference to exemplary embodiments illustrated in the figures. The features described therein may be used alone or in combination with each other to provide preferred embodiments of the invention. Same and Corresponding parts are there at marked with matching reference numerals. Show it:

Fig. 1 shows an inventive hand-held device for removing blood comprising a lancet module and a

Basic module;

FIG. 2 shows the handset shown in FIG. 1 after removal of the lancet module from the base module; FIG.

FIG. 3 shows the handpiece shown in FIGS. 1 and 2 in cross section; FIG.

4 shows a further embodiment of a hand device according to the invention for removing blood;

5 shows a further view of the handset shown in FIG. FIG. 6 shows the hand-held device shown in FIGS. 4 and B in cross section; FIG.

7 shows a further embodiment of a hand-held device according to the invention;

FIG. 8 shows the embodiment shown in FIG. 7 during a puncture; FIG.

Fig. 9 is a first detailed view of the lancet and the lancet sterilization section;

10 shows a second detail view of the lancet and the lancet sterilization device; 11 shows a detailed view of the lancet and a further exemplary embodiment of the lancet sterilization device;

FIG. 12 shows a further detail view of the embodiment shown in FIG. 11; FIG. FIG. 13 shows a further embodiment of a reusable lancet; FIG. 14 shows a further embodiment of a hand-held device according to the invention;

FIGS. 15-17 show the embodiment described in FIG. 14 in further views; Fig. 18 is a schematic representation of another

Embodiment of a Lanzettensterdlisa- tion device;

19 shows a further exemplary embodiment of a lancet sterilization device, and FIG. 20 shows a detail view of the exemplary embodiment illustrated in FIG. 19 in a cross section.

Portable analysis systems that enable patients to independently measure their blood glucose levels typically include a hand-held blood collection device and, in addition, an analysis hand-held device having an analysis device that is deliverable by blood drawn from a lancet. A hand-held device for removing blood for such a portable analysis system will be described below with reference to FIGS. 1 to 3. Figures 4 to 8 show an analysis system in which the hand-held device for removing blood is integrated into the analysis hand-held device.

The hand-held device shown in FIGS. 1 to 3 comprises a lancet module 1 and a base module 2, in which the lancet sterilization device 3 is arranged. The essential parts of the lancet module 1 are the lancet 4, a trigger button 5 and a lancet drive (not shown), which moves the lancet 4 from a rest position into a puncturing position. The lancet drive basically consists of a spring mechanism whose spring is tensioned by depressing the release button and subsequently the lancet 4 is moved from the rest position into the puncturing position at high speed. The lancet drive pulls after a puncture of Lan¬ chain 4 this immediately back to the rest position. In this way, the pain associated with a puncture can be minimized. A suitable lancet drive is described in DE 10223558 A1.

In a hand-held device according to the prior art, the lancet would have to be replaced before being used again in order to prevent a risk of infection. In a hand-held device according to the invention, however, this is not necessary. The lancet module 1 is inserted after a blood sample into the base module 2 with the Lanzettensterilisationseinrich¬ device 3. The base module 2 has an activation button 6 with which the lancet sterilization device 3 can be triggered.

It is recommended that the lancet sterilization device 3 be triggered immediately after insertion of the lancet module 1 into the base module 2, so that germs and others

Pathogens can be killed before they multiply. In order to minimize the risk of infection, the lancet sterilization device 3 should also be triggered immediately before removal of the lancet module 1 from the base module 2. Preferably, the

Lancet sterilization device 3 automatically triggered when inserting the lancet module 1 in the base module 2, so that the activation button 6 is needed only for a lancet sterilization immediately prior to removal of the lancet module 1.

FIG. 3 shows a schematic representation of the base module 2 and the lancet module 1 in cross-section. The base module 2 contains a battery 7 as a power source for the lancet sterilization device 3. The lancet Sterilization device 3 comprises a coil operated with alternating voltage (see FIGS. 7 to 10), with which a heating current can be induced in the lancet 4. If the lancet module 1 is inserted into the designated chamber 8 of the base module 2, the tip of the lancet 4 is inserted axially into the coil of the lancet sterilization device 3. If the coil surrounds the lancet, by applying an alternating voltage with a frequency between 10 kHz and 50 MHz, in particular between 100 kHz and 5 MHz, a heating current can be induced in the lancet 4 whose heating effect kills germs and other pathogens.

Because of the skin effect, at higher frequencies the heating current induced in the lancet 4 flows only at the surface of the lancet 4, so that the lancet 4 is essentially heated only at the surface. This leads to an excellent utilization of the electrical heating energy. Further details of the lancet 4 and the lancet sterilization device 3 used will be explained later with reference to FIGS. 7 to 10.

First of all, another embodiment of the invention will be explained with reference to FIGS. 4 to 6, in which the hand-held device for taking blood into an analysis hand-held device is integrated with an analysis measuring device for the examination of withdrawn blood. This portable analysis system includes a lancet module 1 which is identical to the lancet module 1 of the exemplary embodiment described above. FIG. 4 shows how the lane module 1 is inserted into the handheld analyzer 10, which, like the base module 2 of the above-described embodiment, contains a lancet sterilization device 3. In addition, the analyzer handset contains an analysis measuring device 11, a display Device 12 for displaying an examination result and operating elements 13 in the form of buttons.

In the embodiment described below, a photometrically operating analysis measuring device 11 is provided, but of course the present invention can also be applied to an electrochemical analysis system.

The analysis measuring device 11 of the exemplary embodiment shown detects a change in color of a test strip 14 which is designed as a band. The test strip 14 is so long that it suffices for a large number of measurements, preferably 30 to 100, before it has to be exchanged.

For analysis, a patient applies a blood drop obtained by a puncture with the lancet module 1 to the test strip 14. There, a chemical reaction with chemicals contained in the test strip 14 causes a color change of the test strip 14, which is detected and evaluated by the analysis measuring device 11. So that this evaluation is not disturbed by stray light, the analyzer handset includes a protective cap 15, which can be slipped over the housing opening 16, from which the test strip 14 emerges. The Schutz¬ cap 15 also serves to protect the test strip 14 from damage and is removed only fens for applying a Blutstrop¬.

The test strip 14 is moved further with a drive roller 17 after a completed examination, so that a fresh section of the test strip 14 is available for the next examination. In order to protect the drive roller 17 and the device interior 18 from contamination, the test strip 14 is attached to a cleaning device. facility 19 is passed, which receives excess blood and dirt. In the exemplary embodiment shown, the cleaning device 19 is a cleaning roller, on the surface of which the test strip 14 is guided past, thereby removing dirt from the test strip 14.

The analyzer handset 10 described with reference to FIGS. 4 to 6 is network-independent and has batteries 7 for the power supply.

FIGS. 7 and 8 show an exemplary embodiment in which the lancet module is integrated into the analysis hand-held device 10. In the cross-sectional view shown in FIG. 7, the lancet 4 is in a rest position, in which the tip of the lancet 4 protrudes into the incandescent filament 25 of the lancet sterilization device 3 surrounded by the reflector 26. FIG. 8 shows the lancet 4 in a puncturing position. Upon actuation of the activation knöpfes 6 via the connecting line 20 of the Prozes¬ the control and evaluation unit 21 sor triggered wor¬ this energy aufhin takes from the battery 7 and the lancet sterilization device 3 supplies so that the lancet is sterilized 4 ^•. Furthermore, the lancet drive 22 is tensioned. After the end of the sterilization process, the triggering element 5 is released. If the trigger button 5 is then actuated, the lancet 4 is moved by the lancet drive 22 for a puncture from the rest position shown in FIG. 7 into the puncturing position shown in FIG.

The lancet 4, as known from WO 03/009759 Al known lancets on a sample receiving channel (not shown), can be supplied to a test field 23 through the blood. There causes a chemical reaction with in the test field 23 contained a color change of the test field 23, which is detected by a measuring device 24 and evaluated by the control and evaluation unit 21.

FIGS. 9 and 10 show in detail, as in the exemplary embodiment according to FIG. 7, the coil 25 of the lancet sterilization device 3, which is operated with alternating voltage, axially surrounds the tip 27 of the lancet 4. In order for a heating current to be induced with the lowest possible energy losses in the surface of the lancet 4, the diameter of the coil 25 should be selected as small as possible.

The coil 25 is part of a resonant circuit belonging to the lancet sterilization device 3 (not shown). The optimum number of windings of the coil 25 depends on the frequency of the AC voltage, the capacitance of the resonant circuit and the effect of the lancet 4 on the inductance of the coil 25. If the frequency of the alternating voltage is between 500 kHz and 3 GHz, preferably 1 GHz and 3 GHz, the current induced in the lancet 4 remains limited to the surface, which leads to an efficient utilization of the heating energy. By Aus¬ use of the skin effect can be sufficient for a sterilization of the lancet 4 heating even with a heating power of only 1 watts reach. Such heating power can be achieved with commercially available 1.5 volt batteries, but 3 volt lithium batteries are preferred.

FIGS. 11 and 12 show in detail the lancet sterilization device 3 according to the exemplary embodiment of FIG. 7. A central component of this lancet sterilization device is an incandescent filament 25 which axially surrounds the lancet 4 during sterilization. In order to make even better use of the heating energy, a reflector 26 is arranged around the incandescent filament 25. In the simplest case, the reflector 26 consists of a metal foil. The reflector 26 leads to an even better utilization of the heating energy by reflecting infrared radiation, which emits the incandescent filament 25 during heating, onto the lancet 4, so that it is heated to at least 250 ^° C. At temperatures above 250 ⁰ C, insbeson dere are not only kills off pathogens, but also proteins comminuted puts into its component parts, will continue höht er¬ whereby the safety of sterilization than 300 ° C.

As can be seen from FIGS. 9 to 12, the coil or the incandescent filament 25 do not surround the lancet 4 over its entire length, but only in the region of the tip 27. This measure also contributes to reducing the energy consumption of the lancet sterilization device 3. Namely, it suffices if the lancet 4 is disinfected in the area which enters the body of the patient during a puncture movement. A portion of the lancet 4, which does not penetrate into the body during the puncture, can neither- transfer an infection, nor be contaminated at a puncture.

The lancet 4 preferably has a body made of metal, particularly preferably made of stainless steel, in particular hardened stainless steel, but may also be made of another material, for example of ceramic. If the body of the lancet 4 is not made of metal, then it is preferably coated with a metal oxide layer, so that efficient, inductive heating is possible. In the case of a lancet without a metabolic surface, heating by thermal radiation is possible. So that the lancet 4 does not become dull even with frequent use, it is preferably provided with a protective layer. This protective layer can consist of a polymer or an amorphous carbon or silicon layer. The protective layer is preferably less than 10 .mu.m, preferably less than 1 .mu.m thick, so that it can be heated rapidly and with low energy consumption to the temperatures required for sterilization when inductive heating of an underlying metal layer takes place.

A further exemplary embodiment of a multi-use, heat-sterilizable lancet 4 is shown in FIG. The lancet 4 has a jacket 30 made of hardened stainless steel, which surrounds a core 31 made of copper. The sheath 30 provides a hard tip 27 which allows a relatively non-intrusive puncture into a body part of a patient. Between the jacket 30 and the core 31 is a resistance layer 32 having a thickness of about 10 to 50 μm.

For sterilizing the lancet 4, a voltage is applied between the core 31 and the jacket 30. This causes a radially extending flow of current from the core 31 to the cladding 30. Since the electrical resistance of the resistance layer 32 is substantially greater than the resistance of the core 31 and the cladding 30, the applied voltage drops mainly at the resistance layer 32 , As a result, the resistance layer 32 primarily heats up, which in turn heats the thin shell 30 above it.

When choosing the material for the core 31 is to ensure the best possible conductivity, so as possible little heating energy is lost by heating up the core 31. Well suited are copper: and copper alloys.

The jacket 30 is made of stainless steel. The jacket 30 should be as thin as possible, so that it can be heated up quickly and with as little energy as possible. Its thickness is preferably 50 to 200 p.m.

The resistance layer 32 extends only in the region of the tip 27 of the lancet 4, which penetrates the body of a patient when it is pierced. Outside this range, there is a conductive layer 33 between the jacket 30 and the core 31, so that in a sterilization process only the front region of the lancet 4 is heated, which also really needs to be disinfected.

In all of these embodiments, the material for the lancet tip is corrosion-resistant steel, as used for conventional lancets. For the higher service life of the cutting edges of the chains, a hardened alloy is preferably to be used, as is customary, for example, for surgical instruments, scalpels, etc.

A further exemplary embodiment is shown in FIGS. 14 to 17, in which the La.nzettenmodul 1 is integrated into the Analy¬ sehandgerät 10. Similar to the embodiment explained with reference to FIGS. 4 to 6, an analysis measuring device 11 detects a color change of a test strip 14 in the form of a band. The test strip 14 is sieve, in a cassette 40, in which it can be pulled off from a supply roll 41 and wound on a driven by a shaft 42 drive roller 17 bar. The tape-shaped test strip 14 has a multiplicity of Number of tape sections 49, which are coated with Trochcenchemika- lien, which react with applied blood and thereby cause a glycerine ent¬ speaking, optically detectable color change.

As shown in FIGS. 15 to 17, the cassette 40 is arranged in an analysis module 39, which can be pivoted into the region of the housing opening 44 by means of suction arms 43 for receiving a blood drop emerging from a puncture wound produced by the lancet 4. By means of deflection rollers 45, a belt loop is formed with an exposed belt section 49 for receiving a blood drop. The analysis measuring device 11 is displaceable along the double arrow 46 between a rest position and a measuring position in which a reflection-photometric Nach¬ measurement is carried out.

The lancet module 1, which, like the analysis module 39, is pivotable away from the housing opening 44 by means of pivoting arms 43, is pivotally connected to the housing handpiece 44. The lancet module 1 contains the lanyard 4, which is moved between a rest position and a puncture position for a puncture and return movement in the direction of the double arrow 50 by means of the lancet drive 22. In its rest position, the tip of the lancet 4 is located in a lancet sterilization device 3. As with the embodiments described above, a puncture and return movement of the lancet 4 is effected by actuating the release button 5. In order to set the depth of the egg, the lancet module 1 is movable in the housing 51 of the analyte handheld device 10 in the puncturing direction indicated by the double arrow 52 by turning the puncturing depth adjusting knob 53. Further details regarding the construction of cassettes with tape-shaped test strips 14 and their use in analysis handsets are described in the applications WO 2004/056269, WO 2004/047642 and PCT / EP 2004/007785, to which reference is additionally made and dererx content in this respect Subject of the present application is made.

FIG. 18 shows an exemplary embodiment of a lancet sterilization device 3 which comprises means for generating an electrical plasma which acts on the lancet 4 for sterilization. The illustrated lancet sterilization device 3 can be used, for example, in the base module 2 shown in FIG. 3, in the hand-held device 10 shown in FIGS. 7 and 8 or in the hand-held device shown in FIG. The illustrated lancet sterilization device 3 comprises a sleeve 60 made from a high voltage resistant dielectric. As a dielectric in particular plastics,. For example, PTFE, PE or PEEK, and ceramic materials, such as Al ₂ O ₃ , suitable. An electrode 61, preferably a metal electrode, is arranged around the insulating sleeve 60 _*

To generate a plasma, a high-frequency alternating voltage is applied between the illustrated lancet 4 and the electrode 61. The frequency of this alternating voltage is preferably at least 100 MHz, more preferably at least 1 GHz. In general, it is true that the ignition of the plasma ^; The higher the frequency of the alternating voltage, the lower the required voltage is.

Suitable circuits and components for generating high-frequency alternating voltages are, for example, for Mobile phones are known and therefore require no detailed explanation. To ignite the plasma, it may be necessary to generate a high voltage of several hundred or even a thousand volts from a voltage of a few volts of an internal current source of the hand-held device, for example a commercially available battery. Suitable circuits and components for a corresponding voltage transformation are common, for example, in cameras for generating a flash of light.

A further exemplary embodiment of a lancet sterilization device 3 with means for generating an electrical plasma is shown in FIG. This lancet sterilization device 3 comprises perforated

Ignition elements 62,63 in the form of two plates, each having a plurality of small holes 64, preferably with a diameter of 5 .mu.m to 100 .mu.m, more preferably 10 .mu.m to 30 .mu.m.

FIG. 20 shows a detailed view of the ignition elements 62, 63 in a cross section. The ignition elements 62, 63 have an insulation layer 65 made of a dielectric, to each of which a conductive electrode layer 66, for example of copper, is applied on both sides. The thickness of the insulating layer 65 is preferably about 10 μm to 100 μm. For igniting a plasma, a high voltage of preferably 500 volts to 1000 volts is applied to the electrode layers 66 of each ignition element 62, 63, so that a strong electric field is formed across the thickness of the insulating layer 65 and thus in the holes 64. This electric field first causes a plasma to ignite in the holes 64 of the ignition elements 62, 63. By applying a DC voltage of a few volts, preferably the battery voltage tion of a handset, to a between the two ignition elements 62,63 arranged lancet 4 opposite to the two ignition elements 62,63 causes the plasma from the holes 64 to the lancet 4 expands.

Plate-shaped ignition elements 62, 63 can be produced in a particularly cost-effective manner and are preferred for a lancet sterilization device 3 for sterilizing flat lancets 4. For lancets with a round cross section, however, it may be favorable to use perforated ignition elements which are suitably curved or bent. In principle, a single ignition element is sufficient for generating a plasma, since the plasma formed in the holes 64 can be pulled out of the holes 64 by suitable electric fields and led to a lancet tip. However, several ignition elements 62, 63 are preferably used in order to ensure, as reliably as possible, an all-round plasma action of the lancet 4.

For igniting the plasma in the holes 64 of the ignition elements 62, 63, both a DC voltage and a AC voltage are suitable. However, high frequency AC voltages have the advantage over DC voltages of being easier to produce and are therefore preferred.

RDG 127 / OA / WO

LIST OF REFERENCE NUMBERS

1 lancet module

2 basic module

3 lancet sterilization device

4 lancet 5 trigger button

6 activation button

7 battery

8 chamber

10 Hand-held analyzer 11 Analysis measuring device

12 display device

13 controls

14 test strips

15 Protective cap 16 Housing opening

17 drive roller

18 device interior

19 cleaning device;

20 connecting line 21 control and evaluation unit

22 lancet drive

23 test field

24 measuring device

25 coil / filament 26 reflector

27 tip of the lancet

30 coat

31 core

32 resistance layer 33 conductive layer 39 analysis module

40 cassette

41 supply roll

42 shaft ^'43 swivel arms

44 housing opening

45 pulleys

46 Displacement direction 49 Band section 50 Insertion direction

51 housing

52 adjustment direction

53 penetration depth adjustment knob 60 sleeve 61 electrode

62.63 ignition elements

64 holes

65 insulation layer

66 electrode layer

Claims

claims Portable hand-held device for generating a puncture wound, in particular for removing blood or other body fluids, comprising: a lancet (4) which can be moved from a rest position to a puncturing position by a lancet drive, characterized in that it has a lancet sterilization device (3, 25) , 26), with which the lancet (4) can be sterilized without contact. 2. Hand tool according to claim 1, characterized in that the lancet sterilization device (3) comprises a power consumer, which is traversed by a current in a Sterilisati¬ onsvorgang. 3. Hand tool according to one of the preceding claims, characterized in that the Lanzettensterilisa¬ tion device (3) comprises means for generating an elec¬ cal plasma, which acts on the lancet (4) for sterilization. 4. Hand device according to claim 3, characterized in that the plasma is a gas discharge plasma. 5. Hand tool according to claim 3 or 4, characterized gekenn¬ characterized in that the plasma is generated under atmospheric pressure conditions. 6. Hand tool according to one of claims 3 to 5, characterized in that the means for generating an electric plasma comprise at least one perforated ignition element (62,63) having an on both sides, each with an electrode layer (66) covered Iso- ILationsschicht (65) characterized in that by applying a voltage to the electrode layers (66) in continuous holes (64) of the ignition element (62,63) a plasma is ignited. 7. Hand tool according to one of the preceding claims, characterized in that the Lanzettensterilisa¬ tion device (3) comprises means for generating radiation, in particular in the ultraviolet Fre¬ frequency range, with the sterilization on the lancet (4) is acted upon , 8. Hand tool according to claim 7, characterized in that the lancet sterilization device (3) comprises a light emitting diode or laser diode for generating the radiation. 9. Hand tool according to one of claims 3 to 8, characterized in that a surface of the lancet (4) is hydrophilized by plasma or radiation exposure. 10. Hand tool according to one of the preceding claims, characterized in that the lancet sterilization device (3) comprises an incandescent filament, with which the lancet (4) can be heated up by the action of radiation. 11. Hand tool according to one of the preceding claims, characterized in that the lancet sterilization tion means (3) comprises an AC voltage betrie¬ bene coil (25) with which in the lancet (4) a heating current is inducible. 12. Hand tool according to claim 11, characterized in that the frequency of the AC voltage between 500 kHz and 3 GHz, preferably 1 GHz and 3 GHz. 13. Hand tool according to one of claims 10 to 12, characterized in that the filament or the coil (25) axially surrounds the lancet (4) during sterilization. 14. Hand tool according to one of claims 10 to 13, characterized in that the Lanzettensterilisationsein¬ direction- (3) comprises a reflector (26) which is arranged around the filament (25) around. 15. Hand tool according to one of the preceding claims, characterized in that the Lanzettensterilisati- OnseinrAchtung (3) comprises a reservoir for a Des¬ infektionsmittel which is for sterilization ^'of the lancet (4), preferably as a vapor or mist, released. 16. Hand tool according to claim 15, characterized in that the lancet sterilization device (3) comprises a nozzle for releasing the disinfectant. 17. Hand tool according to one of the preceding claims, characterized in that the Lanzettensterilisa¬ tion device (3) & by a return movement of the lancet (4) is triggered after a puncture. 18. Hand tool according to one of the preceding claims, characterized in that the lancet (4) has a protective layer. 19. Hand tool according to claim 18, characterized in that the protective layer consists of a polymer or an amorphous carbon or silicon layer. 20. Hand tool according to claim 18 or 19, characterized in that the lancet (4) has a body made of metal, in particular stainless steel. 21. A portable analysis system comprising a handset according to one of the preceding claims and an analyzer handheld device (10) with an analysis measuring device (11), the blood or other body fluid, which are obtained by a puncture of the lancet (4) can be fed. : 22. Portable analysis system according to claim 21, characterized ge indicates that the hand-held device for removing blood or other body fluids in the Analy¬ sehandgerät (10) is integrated. 23. Multiple-use lancet comprising a metallic core (31) and. a jacket (30) made of stainless steel, between which there is a resistance layer (33).