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WO2006032391A2 - Appareil manuel pour le prelevement de sang ou d'autres liquides corporels - Google Patents

Appareil manuel pour le prelevement de sang ou d'autres liquides corporels Download PDF

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Publication number
WO2006032391A2
WO2006032391A2 PCT/EP2005/009816 EP2005009816W WO2006032391A2 WO 2006032391 A2 WO2006032391 A2 WO 2006032391A2 EP 2005009816 W EP2005009816 W EP 2005009816W WO 2006032391 A2 WO2006032391 A2 WO 2006032391A2
Authority
WO
WIPO (PCT)
Prior art keywords
lancet
tool according
hand tool
sterilization
plasma
Prior art date
Application number
PCT/EP2005/009816
Other languages
German (de)
English (en)
Other versions
WO2006032391A3 (fr
Inventor
Hans-Peter Haar
Hans List
Original Assignee
Roche Diagnostics Gmbh
F. Hoffmann-La Roche Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics Gmbh, F. Hoffmann-La Roche Ag filed Critical Roche Diagnostics Gmbh
Publication of WO2006032391A2 publication Critical patent/WO2006032391A2/fr
Publication of WO2006032391A3 publication Critical patent/WO2006032391A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150312—Sterilisation of piercing elements, piercing devices or sampling devices
    • A61B5/15032—Sterilisation of piercing elements, piercing devices or sampling devices by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/150198—Depth adjustment mechanism at the proximal end of the carrier of the piercing element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150312—Sterilisation of piercing elements, piercing devices or sampling devices
    • A61B5/150335—Sterilisation of piercing elements, piercing devices or sampling devices by radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A61B5/150511—Details of construction of shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced

Definitions

  • 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.
  • test elements For the qualitative and quantitative analysis of elaborate ⁇ 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.
  • test elements 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.
  • 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.
  • 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.
  • the lancets are used which are pricked into the corresponding body part.
  • hand tools are used which move a lancet with a lancet drive from a rest position into a puncturing position.
  • 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.
  • the handheld device for taking blood and the handheld analyzer can be designed as two different devices or integrated into a single device.
  • 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.
  • 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.
  • 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.
  • a lancet can be sterilized immediately before a puncture procedure in a erfinchangesgemizaen 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.
  • 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.
  • a smaller and more compact design means a considerable relief.
  • 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.
  • 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.
  • 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 "Mikrofigurediert Elektrodensysteme - Universelle Atmospheric pressure plasmas ", Physics No. 31, March 2001.
  • the electrode spacing is preferably less than 1 mm, particularly preferably less than 0.5 mm.
  • multiple arrangements of electrodes are preferred.
  • 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 ⁇ m in thickness.
  • 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.
  • 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.
  • 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.
  • lancets preferably have a test field for the analysis of a removed one
  • 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.
  • a hand-held device with a lancet sterilization device for generating a plasma
  • 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.
  • 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.
  • the lancet sterilization device preferably comprises one or more light emitting diodes or laser diodes.
  • the smaller the wavelength of the radiation the greater the sterilization effect of radiation.
  • light-emitting diodes which emit blue, in particular ultraviolet, light are opposite
  • Light emitting diodes which emit red light, usually prefer.
  • the lancet surface is preferably at least 25O 0 C, more preferably at least 300 0 C heated auf ⁇ .
  • 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.
  • a reflector can be used with which of the lancet so far that spores, germs and other pathogens are killed.
  • Incandescent generated radiation is reflected on the surface of the lancet to be sterilized.
  • 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-selbond chosen so high that due to the
  • 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.
  • 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.
  • 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.
  • the lancet sterilization device comprises a current consumer, which is flowed through by a .electric current during a sterilization process.
  • a current consumer for example, as a heating device be designed to evaporate a disinfectant or a pump; to spray it.
  • the current-carrying means comprises the production of an electrical plasma.
  • Fig. 1 shows an inventive hand-held device for removing blood comprising a lancet module and a
  • FIG. 2 shows the handset shown in FIG. 1 after removal of the lancet module from the base module
  • 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
  • FIG. 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. 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
  • FIG. 19 shows a further exemplary embodiment of a lancet sterilization device
  • 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.
  • 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.
  • 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
  • the lancet sterilization device 3 should also be triggered immediately before removal of the lancet module 1 from the base module 2.
  • the lancet sterilization device 3 should also be triggered immediately before removal of the lancet module 1 from the base module 2.
  • 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.
  • 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.
  • FIGS. 4 to 6 show how 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.
  • 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.
  • 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.
  • the analyzer handset 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.
  • the test strip 14 is attached to a cleaning device. facility 19 is passed, which receives excess blood and dirt.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a reflector 26 is arranged around the incandescent filament 25.
  • 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.
  • 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.
  • 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.
  • FIG. 4 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.
  • a resistance layer 32 having a thickness of about 10 to 50 ⁇ m.
  • 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.
  • 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.
  • the material for the lancet tip is corrosion-resistant steel, as used for conventional lancets.
  • a hardened alloy is preferably to be used, as is customary, for example, for surgical instruments, scalpels, etc.
  • FIGS. 14 to 17 A further exemplary embodiment is shown in FIGS. 14 to 17, in which the La.nzettenmodul 1 is integrated into the Analy ⁇ sehand réelle 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.
  • 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.
  • 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.
  • 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.
  • a dielectric in particular plastics,.
  • An electrode 61 preferably a metal electrode, is arranged around the insulating sleeve 60 *
  • 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.
  • FIG. 3 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 ⁇ m to 100 ⁇ m.
  • a high voltage 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.
  • 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.
  • perforated ignition elements which are suitably curved or bent.
  • 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.
  • 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.
  • both a DC voltage and a AC voltage are suitable.
  • high frequency AC voltages have the advantage over DC voltages of being easier to produce and are therefore preferred.

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  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un appareil manuel portatif pour la production d'une piqûre, en particulier pour le prélèvement de sang ou d'autres liquides corporels, comprenant une lancette (4) et un dispositif de stérilisation de la lancette (3) au moyen duquel la lancette (4) est stérilisable sans contact. L'invention concerne en outre une lancette pouvant être utilisée plusieurs fois.
PCT/EP2005/009816 2004-09-22 2005-09-13 Appareil manuel pour le prelevement de sang ou d'autres liquides corporels WO2006032391A2 (fr)

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DE102004045804A DE102004045804B4 (de) 2004-09-22 2004-09-22 Handgerät zum Entnehmen von Blut oder anderen Körperflüssigkeiten
DE102004045804.9 2004-09-22

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WO2006032391A3 WO2006032391A3 (fr) 2006-05-04

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US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
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DE60238914D1 (de) 2001-06-12 2011-02-24 Pelikan Technologies Inc Integriertes system zur blutprobenanalyse mit mehrfach verwendbarem probennahmemodul
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US9802007B2 (en) 2001-06-12 2017-10-31 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9795334B2 (en) 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
GB2517694A (en) * 2013-08-27 2015-03-04 Khaldoun F S Al Sahali Integrated lancing device with testing meter

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DE102004045804B4 (de) 2006-07-27
WO2006032391A3 (fr) 2006-05-04

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