EP1699356A2 - Appareil d'analyse de sang servant a determiner la presence d'une substance a analyser - Google Patents

Appareil d'analyse de sang servant a determiner la presence d'une substance a analyser

Info

Publication number
EP1699356A2
EP1699356A2 EP04803535A EP04803535A EP1699356A2 EP 1699356 A2 EP1699356 A2 EP 1699356A2 EP 04803535 A EP04803535 A EP 04803535A EP 04803535 A EP04803535 A EP 04803535A EP 1699356 A2 EP1699356 A2 EP 1699356A2
Authority
EP
European Patent Office
Prior art keywords
lancing
blood
receiving sleeve
carrier
blood analyzer
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP04803535A
Other languages
German (de)
English (en)
Inventor
Armin Lohrenhel
Herbert STÖHR
Wolfgang Ostertag
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Paul Hartmann AG
Original Assignee
Paul Hartmann 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 Paul Hartmann AG filed Critical Paul Hartmann AG
Publication of EP1699356A2 publication Critical patent/EP1699356A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • 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
    • A61B5/150374—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
    • A61B5/150435—Specific design of proximal end
    • 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150587—Joining techniques used for protective means by friction fit
    • 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150725—Procedure for removing protection means at the time of piercing removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
    • 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
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • 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
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149—Arrangement of piercing elements relative to each other
    • A61B5/15153—Multiple piercing elements stocked in a single compartment
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159—Piercing elements stocked in or on a disc
    • A61B5/15161—Characterized by propelling the piercing element in a radial direction relative to the disc
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159—Piercing elements stocked in or on a disc
    • A61B5/15163—Characterized by propelling the piercing element in an axial direction relative to the disc
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15176—Stocking means comprising cap, cover, sheath or protection for aseptic stocking
    • 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
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3008—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments having multiple compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/33—Trays

Definitions

  • the invention relates to a blood analyzer for determining an analyte such as e.g. Fructosamine, lactate, cholesterol or, in particular, glucose, on minimally withdrawn minimal amounts of blood from a user, with the features of the preamble of claim 1.
  • analyte such as e.g. Fructosamine, lactate, cholesterol or, in particular, glucose
  • the test means can be designed, for example, in the form of a membrane defining a measuring field, which is wetted with the minimal amount of blood withdrawn and comprises test reagents with which the analysis is carried out.
  • the evaluation device can, for example, work optically, preferably reflectometrically, electrochemically or electro-physically.
  • US-A-5, 971, 941 shows a complete system in the sense described above, wherein a cassette with unused strip-shaped test means can be inserted into a basic device and a respective test means can then be brought into a respective working position by means of a slide.
  • a trigger device which forms part of the blood sampling device
  • a lancing element is pushed outwards for blood sampling by means of a plunger in order to pierce the skin surface of a user, so that capillary blood can be obtained for analysis.
  • the lancing elements are each integrated on a test strip and are thus positioned together with the test strip. Further details of how the analysis is carried out cannot be found in this document.
  • a disposable described cylindrical attachment or insert which has a lancing element and a tablet-shaped test membrane with a passage opening for the lancing element.
  • This attachment or insert is then inserted into a holding recess in a plunger arrangement, which presses the lancing element outwards to draw blood.
  • the disposable unit must be assembled and disassembled before and after each test.
  • a plurality of strip-shaped test means with lancing elements integrated thereon in a manner not described can be inserted into an analysis device and can be brought into a working position one after the other. Clear references to the technical feasibility cannot be found in the publication.
  • a blood sugar measuring device is known with a basic device with a plunger arrangement for deflecting a lancing element and with an evaluation device and a display device.
  • an exchangeable unit must be arranged on the basic device, which comprises the lancing element and a test agent to be wetted with blood in the form of a test strip. This interchangeable unit is discarded after each use.
  • a blood analysis device known from EP 0 449 525 A1 also includes an integrated blood sampling device with a lancing element. Before each start-up, however, a new lancing element must be manually inserted into the trigger device as part of the blood collection device, and then a test strip must be inserted into the device.
  • US-A-4, 627, 445 also shows a blood glucose meter with an integrated blood collection device.
  • a new interchangeable unit must be used before each measurement Lancing element and test equipment are laboriously mounted on a basic device and then dismantled.
  • a disposable unit comprises a capillary tube, on the end of which is remote from the body, a test strip is provided, which is subjected to the minimal amount of blood withdrawn.
  • the capillary tube is formed with a lancing element at its front end.
  • EP 0 877 250 A2 disclose blood analysis devices of a non-generic type, in which a plurality of test devices are arranged on a rotatable disc as a carrier for the test devices, the test devices being successively divided into one Working position can be brought and can be pushed out of the housing body for wetting with a minimal amount of blood.
  • US Pat. No. 6,228,100 B1 and US Pat. No. 4,794,926 disclose blood withdrawal or puncturing devices in which a number of lancing elements are arranged on a carrier which is rotatable relative to a housing body. According to US 6,228,100 B1, the lancing elements are ejected radially by means of a pushing device, and according to US 4,794,926 the lancing elements are oriented in the axial direction and can be activated.
  • a vacuum-assisted lancing device with a single lancing element is known from EP 1 060 707 A2. From US 4,637,403 and US 4,627,445 and from WO 98/24366 blood analyzers with vacuum-assisted lancing device with a single lancing element are known. According to EP 0 199 484 B1, blood is sucked through a capillary lancing element to a test medium with the aid of negative pressure.
  • the present invention has for its object to make the blood withdrawal from the skin surface of a user more effective in a blood analyzer of the aforementioned type, i. H. to an even greater extent to ensure that a minimum amount of blood required for the analysis is obtained largely painlessly and in particular without having to pierce the skin surface several times or having to exert pressure with the fingers of the other hand.
  • a blood analysis device of the generic type in that your vacuum-generating device is provided, by means of which it is used immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process to support the collection of a minimal amount of blood a negative pressure can be applied to the skin surface.
  • the blood analyzer is provided with a device that generates negative pressure can promote and thereby assist the escape of blood from the surface of the skin.
  • the collection of a required minimum amount of blood can also be accelerated thereby, and without the user having to do so Squeeze or pinch the skin surface to obtain the minimum amount of blood required.
  • the device generating the negative pressure is provided in such a way that the negative pressure generated by it supports the transport of blood that has escaped from the skin surface to a test agent. Leaked blood is conveyed to a test device of the type explained above, as under a pumping or suction effect, where the analysis or examination of the blood is then carried out.
  • test means is provided between the lancing position and the vacuum-generating device, since in such a case the test means is arranged on the suction path or flow path which arises as a result of the vacuum generation.
  • the test means is preferably provided at least almost adjacent to or adjacent to the lancing position, so that blood obtained from the skin surface can directly act on or wet the test means without having to cover flow paths inside the blood analyzer beforehand, which in turn results in a loss of blood volume would be connected.
  • the vacuum generating device can be provided in any way on or in the blood analyzer.
  • This can be a vacuum source driven by an electric motor or a vacuum reservoir that can be evacuated before start-up or during operation of the blood analysis device.
  • the vacuum generating device has a volume-changeable area.
  • This can be a cylinder chamber, the volume of which can be changed by a piston interacting with the cylinder chamber, and in this way a vacuum can be provided or a vacuum reservoir can be provided for the operation of the blood analysis device by increasing the volume.
  • the volume-changeable area could have a spring means, which in particular and preferably in the direction is biased to an increase in volume.
  • air could be displaced outward from the volume-changeable area by a volume reduction, in particular and preferably manually, counter to the pretensioning of the spring means. If the spring means then tries to increase the volume again, a negative pressure is generated in this way or a negative pressure reservoir is made available for the operation of the blood analysis device.
  • the volume-variable region could preferably have a bellows, in particular a bellows, or be formed or delimited by a bellows.
  • the device generating negative pressure can be activated manually, that is to say in particular by finger pressure or another manually executable movement, in order to generate negative pressure.
  • This activation can particularly preferably take place, as indicated above, by activating or tensioning the vacuum-generating device by reducing the volume of the volume-variable region for the subsequent generation of a vacuum.
  • the vacuum generating device can be activated and operated without requiring motor drive means, which limits the complexity of the blood analysis device according to the invention and, above all, the need for electrical energy.
  • the device producing the pressure be functionally coupled to the blood collection device in this way is that the negative pressure is only generated immediately or simultaneously with or immediately after the lancing process has been carried out and can then be applied immediately to the skin surface.
  • elaborate sealants or sealing measures can be dispensed with, and instead occurring leaks and leakage-related flows inside the housing body can be deliberately accepted and used to transport blood from the skin surface pierced immediately before to a test agent of the type discussed at the outset.
  • the vacuum generating device is functionally coupled to the blood sampling device in such a way that when the vacuum generating device is activated, a tensioning process is associated with the blood sampling device.
  • the device generating negative pressure is preferably functionally coupled to the blood sampling device.
  • the blood collection device comprises a push or drive mechanism for the lancing elements and requires a drive energy for this purpose, which is preferably provided by tensioning spring means.
  • the tensioning of such spring means or, in the broadest sense, the activation of the blood sampling device should, according to the inventive concept described above, be accompanied or triggered by the activation of the vacuum-generating device, preferably by means of purely mechanical functional coupling.
  • test means and the lancing elements are arranged on a carrier, preferably the same carrier that is rotatable relative to the housing body, and can be inserted into the device with this carrier.
  • a respective used test equipment or Lancing element could be ejected from the housing body and discarded immediately after the test procedure was carried out.
  • the used test means and lancing elements remain on the carrier and can be removed from the housing body together with the carrier after use.
  • the vacuum generating device is functionally coupled to the above-mentioned carrier for the lancing elements and test means in such a way that an activation movement of the carrier goes along with or is triggered by activation of the vacuum generating device.
  • an axial adjusting movement which can be carried out in particular by finger pressure, is provided, which can be implemented via gear means in a rotary adjusting movement for driving the carrier for the test means and / or the lancing elements.
  • a pusher which can be actuated by finger pressure and is biased in one direction can advantageously be provided. It can advantageously limit the volume-changeable area either indirectly or directly.
  • This pusher can cooperate with a spur gear toothing with an axially displaceable rotary element, which is designed such that it first executes an axial actuating movement under the axial actuating movement of the pusher, in particular against the action of a spring means, and then in particular after the release of positive guidance means, which is initially a Prevent rotation, turns into a rotational movement.
  • This rotary movement can then, in particular, in turn by means of any gear, in particular in form of meshing gears, for the rotary drive of the carrier for the lancing elements and / or test means are used.
  • a respective lancing element is slidably received in a receiving sleeve. This is intended to ensure, in particular, sterile storage and provision of the lancing elements that are protected against the ingress of dirt and germs.
  • the respective receiving sleeves are preferably held on a carrier and can be used together with the carrier in the housing body of a blood analysis device.
  • the present invention also relates, in addition to a blood analysis device designed as an "all-in-one" device, to a lancing device for piercing the surface of the body in order to remove a minimal amount of blood from the human or animal body for analysis or examination purposes.
  • a generic lancing device is known from WO 03/070099 AI. It comprises a plurality of lancing elements which are provided on a carrier and can be inserted with the carrier into a housing body and can be driven by a drive mechanism. Proceeding from this, the invention is based on the further object of making the lancing process, in particular the extraction of a minimum amount of blood sufficient for analysis or examination purposes, simpler and less painful.
  • the lancing device comprises a vacuum generating device, by means of which a vacuum can be applied to the skin surface immediately before the execution or simultaneously with the execution or immediately after the execution of the lancing process in order to support the extraction of a minimal amount of blood.
  • FIG. 1 shows a perspective view of an embodiment of a blood analysis device according to the invention
  • Figure 2 is a perspective view of the blood analyzer of Figure 1 in half-torn shape
  • Figure 3 is a sectional view of the blood analyzer of Figures 1 and 2 seen in the direction of arrows III-III in Figure 1;
  • Figure 4a is an exploded view of a gear section of the blood analyzer according to the invention.
  • Figure 4b is a perspective view of the gear section of Figure 4a torn in half;
  • FIG. 5a shows a perspective view of an impact mechanism of the blood analysis device according to the invention (without other further components);
  • Figure 5b is a sectional view of the impact mechanism of Figure 5a;
  • Figure 6a-d three views and a sectional view of a lancing element received in a receiving sleeve
  • Figure 7a-d four views of a lancing element received in a receiving sleeve in cooperation with a lower region of the push mechanism
  • Figure 8 ac is a perspective view, a plan view and a sectional view of a carrier for a plurality of lancing elements;
  • FIG. 9 shows a perspective view of a further embodiment of a blood analysis device according to the invention.
  • Figure 10 is a side view of the blood analyzer of Figure 9 and
  • Figure 11 is a perspective view of a carrier of the device of Figure 9 with radially arranged lancing elements.
  • a blood analyzer designated as a whole by reference number 2 can be seen from FIGS. 1 to 3. It comprises a housing body 4 with a display device 6 for displaying the result of the analysis or examination of a minimal amount of blood.
  • the blood analysis device 2 also includes an integrated blood sampling device, designated overall by the reference numeral 8, which interacts with a plurality of lancing elements 10, which are able to penetrate a skin surface of a user applied to a lancing position 12 quickly and as painlessly as possible in order to obtain a minimal amount of blood , Blood emerging from the skin surface wets a test agent 14, in which an analysis or test reaction takes place, which can be evaluated by means of an evaluation device (not shown).
  • the evaluation device can be an optically acting or electrochemically or electro-physically acting evaluation device, by means of which a test or analysis reaction which takes place in the test means can be recorded and evaluated, which is known per se and is therefore not described in more detail here.
  • the evaluation device can interact with the test device in the lancing position 12 shown or in another position within the blood analysis device 2.
  • the test means 14 shown in FIGS. 2 and 3 can be brought into another position by rotating a carrier 16 for lancing elements 10 and test means 14 to be described in more detail, where the test means 14 interact directly with the evaluation device (not shown) can.
  • a vacuum generating device 18 which comprises a volume-variable region 20, which is delimited by a bellows 22.
  • the vacuum generating device 18 can be actuated by finger pressure on a pusher 24. In the course of depressing the pusher 24, air is displaced outward from the volume-variable region 20 and the housing body 4. When it is subsequently released again, a vacuum is generated under the action of a first spring 26 in the interior of the volume-variable region 20 and thus in the interior of the housing body 4.
  • a rotary movement is generated via a gear device 28 to be described in detail, which is applied to the carrier 16 for a plurality of at least 4, in particular at least 6, in particular at least 8, in particular at least 10, and further transmitted in particular by at least 12 lancing elements 10 and a corresponding number of test means 14 in order to bring a new, yet unused lancing element 10 and associated test means 14 into the working position 30 assigned to the lancing position 12.
  • a drive mechanism 36 of the Blood collection device 8 excited.
  • the Bowden cable 34 is moved in the direction of the arrow 40 under the action of a third spring 38.
  • a driving lever 42 protruding to the side from the Bowden cable 34 is displaced in the direction of arrow 46 with the aid of a tensioning means 44 for a pull wire of the drive mechanism 36 of the blood collection device 8.
  • the driving lever 42 can be fixed in the tensioned state with a rear end 48 in a locking device 50.
  • the tensioning means 44 for the pulling wire is released and the pulling wire snaps in the direction of the working position 30 under the action of spring means to be described in more detail and drives a lancing element 10 arranged there to carry out the lancing process.
  • the negative pressure prevailing in the area of the lancing position 12 supports the extraction of a minimum amount of blood from the surface of the skin and also supports the transport of the minimum amount of blood to the test means 14.
  • the lancing element 10 just used is removed from its working position 30 together with brought to the test means 14, and the test means 14 is brought into a working position for interaction with the evaluation device (not shown), where the test reaction of the blood with the test means 14 is then evaluated optically, electro-physically or electro-chemically.
  • the gear device 28 for converting an axial actuating movement into a rotary movement is explained below in conjunction with FIGS. 4a, 4b and 3.
  • the gear device 28 comprises a guide bush 52 fixed to the housing, in which a pressure piece 54 can be displaced to a limited extent by a step stop 55.
  • the pusher 24 is pressed in at the free end of the pressure piece 54.
  • the other end of the fixed guide bush 52 engages Shaft section 56 with a spur toothing 58, which spur toothing 58 cooperates with a spur toothing 60 of the pressure piece 54 facing it.
  • the shaft section 56 is prestressed in the direction of the pressure piece 54 by a second spring 62.
  • the shaft section 56 comprises on its outer surface a plurality of radially projecting and longitudinally extending webs 64, which engage in longitudinal grooves 66 in the interior of the fixed guide bush 52 and prevent the shaft section 56 from rotating relative to the guide bush 52 while maintaining axial displaceability.
  • the pressure piece 54 is moved axially, its spur toothing 60 interacting with the spur toothing 58 of the shaft section 56 and thereby generating a rotational driving force.
  • a rotational movement is prevented by engagement of the webs 64 in the longitudinal grooves 66, so that the shaft section 56 is also moved axially, contrary to the action of the second spring 62, and downwards in the illustration in FIG. 3.
  • an incremental rotational movement of the shaft section 56 corresponding to the spur toothing is generated, which is ended by a positive engagement of the spur toothing 58 and 60 in one another.
  • a new, unused lancing element 10 is brought into its working position 30.
  • the shaft section 56 and the pressure piece 54 are moved back ( against the previous movement (upwards in FIG. 3).
  • the return stroke of the pressure piece 54 is made by the axial step stop 55 inside the guide bushing 52 limited.
  • the drive mechanism 36 comprises a pushing element 78 which can be connected in a form-fitting manner to a head portion 76 of the lancing element 10 which can be gripped behind. It comprises an axial opening 84 through which a semi-rigid pulling wire 86 extends into a cylindrical cavity 88 of the pushing element 78 and is biased there in the pushing direction by means of a sixth spring 90.
  • the semirigid pull wire 86 extends through an opening in the wall section 82 and further through a tensioning means 44, consisting of a clamping cone 92 and a clamping device 94, and further through an opening in the driving lever 42.
  • the clamping cone 92 In the released state of the clamping device 94, the clamping cone 92 is movable with respect to the pull wire 86. It is axially limitedly movable with respect to the driving lever 42 in such a way that when the driving lever 42 is adjusted, its persistence or frictional forces between the clamping cone 92 and a cylinder wall surrounding it cause clamping or release of the pull wire 86 in the clamping device 94.
  • Locking device 50 the graspable end 48 of the driving lever 42 is fixed.
  • the tensioning process described above takes place against the spring force of the fifth spring 80, which stores the impact energy required for the drive mechanism 36.
  • the locking device 50 is released by actuating a trigger 96, that is to say the end 48 of the driving lever 42 which can be gripped behind is released, the persistence of the clamping cone 92 leads to the clamping device 94 releasing the pulling wire 86.
  • the thrust member 78 and with it the puller wire 86 then snap down under the action of the fifth spring 80. Due to the coupling of the pushing element 78 and the lancing element 10, the lancing element 10 then carries out a lancing process. It snaps over the free end of a receptacle 98 to be described in more detail and is pulled back again behind the free end.
  • a respective lancing element 10 which is a metallic needle-shaped element with a length of 6-15 mm, has a molded-on holding body 100 and also a molded-on protective cap means 102, which protects the lancing element 10 against contamination and a preferably germ-tight, preferably sterile Ensures closure against the environment.
  • a respective lancing element 10 with holding body 100 and protective cap means 102 is accommodated in a receiving sleeve 98 which has already been mentioned and is displaceable in the axial direction.
  • the lancing element 10 is inserted with its engaging head portion 76 into the opening at the free end 104 of the receiving sleeve 98 and passed through the receiving sleeve 98 until the protective cap means 102 abuts an axial step 106 inside the preferably cylindrical opening 107 of the receiving sleeve 98.
  • the figures also show a resilient return means 108, the resilient arms 110, which can be integrally formed on the holding body 100, rest on an annular collar-like section 112 of the receiving sleeve 98. When a lancing process is carried out, these restoring means 108 cause the lancing element 10 to be pulled back again behind the end 104 of the receiving sleeve 98.
  • the pretensioning of the restoring means 108 in the initial state of the lancing element 10 can also be used to hold the protective cap means 102 in contact with the receiving sleeve 98, in particular in contact with the axial stop 106 of the receiving sleeve 98, and thus an improved, preferably germ-tight closure of the receiving sleeve 98 to effect.
  • FIGS. 7a to d illustrate how the head section 76, which can be formed in particular in one piece with the molded-on holding body 100, is positively gripped or gripped behind in a groove 114 of the pushing element 78 which can be gripped behind.
  • the thrust member 78 interacts with a ramp means 116 formed thereon, which also forms an insertion opening 118 for the head section 76 of the lancing element 10, as can be seen in FIG. 7b.
  • This ramp means 116 acts with a run-on slope 120, which is formed on the annular collar section 112 of the receiving sleeve 98.
  • the run-up slope 120 slides against the ramp means 116 and the entire receiving sleeve 98 is axially moved in the direction of the arrow 122. Due to the positive engagement of the head portion 76 of the lancing element 10 in the groove 114 of the pushing element 78, the lancing element is held in its original axial position, so that it does not carry out the axial movement in the direction of the arrow 122. The lancing element 110 is therefore withdrawn relative to the receiving sleeve 98. As a result, the cap means 102 dated free end of the lancing element 10 comes free. It can fall down.
  • the blood collection device 8 is then ready to perform a lancing process.
  • the test means 14 is also released, which is advantageously accommodated in the region of the free end 104 of the receiving sleeve 98.
  • the test means 14 can be provided in an opening in the wall of the receiving sleeve 98.
  • the test means is overlaid on the inside by the protective cap means 102 and in this way protected against contamination, in particular against the ingress of atmospheric moisture and germs, which is to be regarded as particularly advantageous.
  • the protective cap means 102 thus performs a double function, it serves both to cover the lancing element 10 and to cover and protect the test means 14.
  • FIGS. 6 and 7 also show helical webs on the outer circumference of the receiving sleeve 98.
  • These are spring-back means 124 which are molded onto the collar-shaped section 112 at their upper end. If the carrier 16 is moved further and the receiving sleeve 98 just considered is thereby moved out of its working position 30 and thus out of the influence of the ramp means 116, these spring-back means 124 cause the receiving sleeve 98 to be withdrawn again against the arrow 122.
  • FIGS. 8a to c show the carrier 16 for the plurality of lancing elements 10 and test means 14 in different views.
  • twelve receiving sleeves 98 with twelve lancing elements 10 and twelve test means 14 are received.
  • a respective receiving sleeve 98 is inserted into an open-edged recess 126 of a disk-shaped part 128 of the carrier 16 in the axial direction. So that the receiving sleeves 98 are in their working position 30 cannot rotate when interacting with the ramp means 116, the open-edged recesses 126 and the outer circumference of the receiving sleeves 98 are non-circular, in the case shown slightly elliptical.
  • a respective receiving sleeve 98 is held in a preferred orientation on the carrier 16, which is very important with regard to the positioning of the test means 14 received in the receiving sleeve 98, because it is at a predetermined position and orientation the evaluation device must be able to interact.
  • the carrier 16 with a centrally arranged polygonal opening 130 for the engagement of an appropriately designed hub section 74 for the rotary drive of the carrier can be inserted together with the lancing elements 10 and test means 14 in the housing body 4 of the blood analysis device according to the invention and together with the used lancing elements and test means removable from the housing body. This can be seen from FIG. 2, where a cover which opens or closes the insertion opening is provided.
  • FIGS. 9-11 show a further embodiment of a blood analysis device according to the invention, in which the lancing direction and the lancing elements themselves are arranged radially with respect to a carrier for the lancing elements which can be driven in rotation.
  • a drive device (not shown) for the lancing elements is provided radially inside the carrier.
  • the pusher 24 is depressed for the first time against the tension force of the first spring 26 and the second spring 62.
  • the pressure piece 54 and the shaft section 56 are displaced axially downward during a first lifting section.
  • a force is built up in the circumferential direction of rotation.
  • the construction train 34 releases the driving lever 42, which moves under the pressure of the third spring 38 in the direction of the arrow 40.
  • the puller wire 86 is clamped in the clamping device 94 and thus the puller wire 86 is also pulled upwards.
  • the impact member 78 still remains in its starting position.
  • the webs 64 come free from the longitudinal grooves 66 of the fixed guide bush 52 and the shaft section can carry out a rotational movement of 15 °.
  • the carrier is moved further by 15 ° via the gearwheel pair 70, 72 and brings a lancing element 10 into the working position 30.
  • the head section 76 of the lancing element 10 slides into the opening 114 of the pushing element 78 and thus into the rear grip position.
  • the receiving sleeve 98 slides against the ramp means 116 with its chamfer 120 and is moved downward in the direction of the arrow 122, so that the protective cap means 102 is released from the lancing element 10.
  • the vacuum generating device 18 is now activated and the drive mechanism 36 of the blood collection device 8 is cocked.
  • the trigger 96 By actuating the trigger 96, the locking device 50 can be released and thus quick the thrust member 78 under the force of the fifth spring 80 down and the lancing process is carried out.
  • the pusher 24 is reset under the force of the first spring 26 and the second spring 62. In this way, the volume-changeable region 20 is enlarged and a negative pressure is generated which extends to the lancing position 12 in the region of the free end 104 of the receiving sleeve 98 and supports and promotes blood withdrawal.
  • the fourth spring and the sixth spring 90 push the pushing element 78 back into its starting position and thus bring about the retraction movement of the lancing element 10, which is also supported by the resilience means 124.
  • the lancing element 10 just considered, together with its receiving sleeve 98 and the test means 14 is then rotated by a further 15 °; it is therefore removed from the working position 30 of the lancing elements.
  • the stroke of the pusher 24 is limited in this second actuation by a suitable design of the transmission device 28, so that the drive device 36 is not tensioned.
  • the test means 14 can thus be transported on to an optical, electro-chemical or electro-physical acting evaluation device, not shown.
  • the predetermined positioning of the receiving sleeves 98 on the carrier 16 ensures that the test means are arranged in the correct orientation to the evaluation device.
  • the result of the evaluation is then displayed, for example, in the form of the current blood sugar content on the display device 6 of the blood analysis device 2.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Geometry (AREA)
  • Dermatology (AREA)
  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un appareil d'analyse de sang (2) comportant un corps de boîtier (4), un dispositif de prélèvement sanguin (8) pourvu d'une pluralité d'éléments de piqûre (10), une pluralité de moyens de test (14) servant à analyser une quantité minimale de sang, un dispositif d'évaluation comprenant un système électronique d'évaluation, et un dispositif d'affichage (6), le tout formant un système complet pouvant être manipulé sous la forme d'un seul appareil. Le corps de boîtier (4) peut être placé dans une position de piqûre (12) qui correspond à une position de travail (30) d'un élément de piqûre (10) respectif et dans laquelle il est appliqué à la surface de la peau d'un utilisateur. Une pluralité de moyens de test (14) et d'éléments de piqûre (10) peuvent être introduits dans l'appareil et être placés successivement dans une position de travail (30) pour réaliser plusieurs mesures. Lorsqu'un élément de piqûre (10) est placé dans sa position de travail (30), il peut être piqué dans la couche superficielle de la peau, en contact avec le corps de boîtier (4) en position de piqûre (12), et le sang s'écoulant de la surface de la peau peut parvenir sur un moyen de test (14). L'invention est caractérisée en ce que l'appareil d'analyse de sang présente un dispositif (18) produisant une dépression qui peut être appliquée à la surface de la peau immédiatement avant la piqûre, simultanément à la piqûre ou immédiatement après la piqûre, pour faciliter l'obtention d'une quantité minimale de sang.
EP04803535A 2003-12-23 2004-12-04 Appareil d'analyse de sang servant a determiner la presence d'une substance a analyser Withdrawn EP1699356A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10361560A DE10361560A1 (de) 2003-12-23 2003-12-23 Träger mit einer Mehrzahl von Stechelementen, Stechvorrichtung und Blutanalysegerät
DE10361562A DE10361562A1 (de) 2003-12-23 2003-12-23 Blutanalysegerät zur Bestimmung eines Analyten
PCT/EP2004/013825 WO2005065545A2 (fr) 2003-12-23 2004-12-04 Appareil d'analyse de sang servant a determiner la presence d'une substance a analyser

Publications (1)

Publication Number Publication Date
EP1699356A2 true EP1699356A2 (fr) 2006-09-13

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EP04803535A Withdrawn EP1699356A2 (fr) 2003-12-23 2004-12-04 Appareil d'analyse de sang servant a determiner la presence d'une substance a analyser
EP04803545A Withdrawn EP1699355A1 (fr) 2003-12-23 2004-12-06 Support pourvu d'une pluralite d'elements de perforation, dispositif de perforation et appareil d'analyse de sang

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP04803545A Withdrawn EP1699355A1 (fr) 2003-12-23 2004-12-06 Support pourvu d'une pluralite d'elements de perforation, dispositif de perforation et appareil d'analyse de sang

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EP (2) EP1699356A2 (fr)
DE (2) DE10361562A1 (fr)
WO (2) WO2005065545A2 (fr)

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Also Published As

Publication number Publication date
EP1699355A1 (fr) 2006-09-13
WO2005063124A1 (fr) 2005-07-14
WO2005065545A3 (fr) 2005-10-27
DE10361560A1 (de) 2005-07-28
DE10361562A1 (de) 2005-07-28
WO2005063124A8 (fr) 2005-09-22
WO2005065545A2 (fr) 2005-07-21

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