CA2401164A1 - Combined lancet and electrochemical analyte-testing apparatus - Google Patents

Combined lancet and electrochemical analyte-testing apparatus Download PDF

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Publication number
CA2401164A1
CA2401164A1 CA002401164A CA2401164A CA2401164A1 CA 2401164 A1 CA2401164 A1 CA 2401164A1 CA 002401164 A CA002401164 A CA 002401164A CA 2401164 A CA2401164 A CA 2401164A CA 2401164 A1 CA2401164 A1 CA 2401164A1
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Canada
Prior art keywords
skin
sensor
cutting member
analyte
electrochemical
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Granted
Application number
CA002401164A
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French (fr)
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CA2401164C (en
Inventor
Piet Moerman
Jerome F. Mcaleer
Matthias Stiene
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Diabetes Diagnostics Inc
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Individual
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Priority to CA2732195A priority Critical patent/CA2732195A1/en
Publication of CA2401164A1 publication Critical patent/CA2401164A1/en
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Expired - Lifetime legal-status Critical Current

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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
    • A61B5/145—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
    • A61B5/1486—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 using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • 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
    • A61B5/150053—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
    • 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
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • 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
    • A61B5/150221—Valves
    • 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
    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150809—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by audible feedback
    • 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
    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • 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
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/15087—Communication to or from blood sampling device short range, e.g. between console and disposable
    • 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
    • A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • 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
    • A61B5/15101—Details
    • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
    • A61B5/15128—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads
    • 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
    • A61B5/15163—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
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood

Abstract

An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte.

Claims (26)

1. An apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid, quantization:
(a) a meter unit comprising a housing, means disposed within the housing for engaging a cutting member and moving an engaged cutting member, a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to user;

(b) a cutting member engaged within the housing;
(c) an electrochemical sensor comprising an sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving fine cutting member moves the cutting member in a cycle from an initial position to a piercing position in which shin of the user is pierced, and wherein the electrochemical sensor is disposed such that the sample uptaking or accepting member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus.
2. An apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid, comprising:
(a) a meter unit comprising a housing, means disposed within the housing for engaging a cutting member and moving an engaged cutting member, a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to user;

(b) a cutting member engaged within the housing, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial position to a piercing position in which the skin of the user is pierced at a point of entry, and wherein the connector is positioned in relationship to the cutting member and the point of entry such that when a sensor or plurality of sensors comprising a sample uptake or accepting member are engaged with the connector, the sensor or plurality of sensors are able to take up or accept sample generated at the point of entry as a consequence of piercing of the skin without movement of the apparatus.
3. The apparatus of claim 1 or 2, wherein the electrochemical sensor and the cutting member are disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user.
4. The apparatus of any of the preceding claims, wherein the means for moving the cutting member moves the cutting member back to a retracted position which may be the same or different from the initial position after piercing the shin of the user.
5. The apparatus of any of the preceding claims, further comprising a skin-contact ring disposed to apply pressure to an area surrounding the piercing of the skin when the apparatus is pressed against the skin of the user.
6. The apparatus of any of the preceding claims, further comprising a vacuum mechanism disposed within the housing to accelerate extraction of sample after piercing when the apparatus is pressed against the skin of the user.
7. The apparatus of claim any of the preceding claims, comprising a plurality of electrochemical sensors and an equal plurality of cutting members.
8. The apparatus of any of claim 7, wherein the plurality of electrochemical sensors are provided on a disk.
9. The apparatus of claim 8, wherein the housing is a flattened disk having a top and a bottom surface, and further comprising means for holding the bottom surface of the housing against the skin of a user, wherein the electrochemical sensors are disposed adjacent to the bottom surface and the cutting members move to pierce the skin adjacent to the bottom surface.
10. The apparatus of claim 9, wherein the means for holding the bottom surface of the housing against the skin of the user is a strap.
11. The apparatus of claim 9 or 10, wherein the display is visible to the user when the bottom surface is held against the skin of the user.
12. The apparatus of any of claims 1, 2, 4, 5 or 6, wherein the cutting member is a hollow cannula having a proximal end and a distal end, and wherein the proximal end is in juxtaposition with the electrochemical sensor to permit absorption of fluid passing through the hollow cannula by the sample uptaking or accepting member.
13. The apparatus of claim 12, comprising a plurality of electrochemical sensors.
14. The apparatus of claim 13, wherein the plurality of electrochemical sensors are provided on a disk.
15. The apparatus of any of claims 7-11, 13 or 14, further comprising a timer operatively connected to the plurality of cutting members for automatically taking and evaluating a sample at pre-defined time intervals.
16. The apparatus of claim 15, wherein the time intervals are adjusted in response to amounts of analyte as determined by the apparatus.
17. The apparatus of any preceding claim, further comprising an sample alarm for indicating to the user that sufficient sample has been collected.
18. The apparatus of any preceding claim, further comprising an testing alarm for indicating to the user that it is time to take a sample.
19. The apparatus of any preceding claim, further comprising an results alarm for indicating measured levels of analyte which are above or below preestablished thresholds.
20. The apparatus of claim 19, wherein the results alarm transmits a signal to a remote receiver.
21. A sensor assembly for electrochemical detection of an analyte when associated with a meter unit, said assembly comprising a collar member, a skin-contact ring and an electrochemical sensor, wherein the skin-contact ring comprises a wall member having a central opening with first and second open ends formed therethrough, the electrochemical sensor is disposed adjacent to the skin-contact ring and extends across the first open end of the skin-contact ring, said sensor comprising reagents for generation of an electrochemical signal in response to the presence of analyte and an adsorptive member for absorbing fluid placed within the central opening of the ring and transporting the fluid into reactive proximity to the reagents, and an electrical contact for transmitting the electrochemical signal from the sensor; and the collar member comprises a wall member having a central opening for receiving a portion of the meter unit and holding it in position with respect to the electrochemical sensor and the skin-contacting portion.
22. The sensor assembly of claim 21, wherein the sensor is disposed between the skin contact ring and the collar member, and wherein the collar member further comprising an electrical connector in contact with the electrical contact portion of the electrochemical sensor for transmitted an electrical signal from the electrical contact to an electrical contact in a meter unit received within the collar member.
23. A sensor assembly for electrochemical detection of an analyte when associated with a meter unit, said assembly comprising a housing formed from a collar portion and a base portion, a cutting member in the form of a hollow tube and an electrochemical sensor, wherein the electrochemical sensor is disposed in contact with a first surface of the base portion, said sensor comprising reagents for generation of an electrochemical signal in response to the presence of analyte and an adsorptive member for absorbing and transporting fluid into reactive proximity to the reagents, and an electrical contact for transmitting the electrochemical signal from the sensor;

the cutting member passes through the base portion thereby forming a channel for passage of fluid between the electrochemical sensor disposed in contact with the first surface of the base portion and a second opposed surface of the base portion, and the collar portion comprises a wall member having a central opening for receiving a portion of the meter unit and an electrical connector in contact with the electrical contact of the sensor for transmitting an electrical signal from the electrical contact to an electrical contact in the meter.
24. A method for detection and quantification of an electrochemically-detectable analyte in blood or interstitial fluid, comprising the steps of:

(a) positioning an apparatus against the skin of a test subject, said apparatus comprising a meter unit comprising a housing, means disposed within the housing for engaging a cutting member and moving an engaged cutting member, a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to user;
a cutting member engaged within the housing;
an electrochemical sensor comprising an sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial position to a piercing position in which skin of the user is pierced, and wherein the electrochemical sensor is disposed such that the sample uptaking or accepting member tales up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus;

(b) triggering the cutting member to initiate piercing of the skin of the test subject, whereby acquisition and analysis are performed as a result of triggering of the cutting member without further need to move the housing until the analysis has been performed.
25. The method of claim 24, wherein the apparatus is an apparatus in accordance with any of claims 3-20.
26. The method of claim 25, wherein the apparatus comprises a sensor assembly in accordance with any of claims 21-23.
CA2401164A 2000-03-02 2001-03-02 Combined lancet and electrochemical analyte-testing apparatus Expired - Lifetime CA2401164C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2732195A CA2732195A1 (en) 2000-03-02 2001-03-02 Combined lancet and electrochemical analyte-testing apparatus

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/518,075 2000-03-02
US09/518,075 US6706159B2 (en) 2000-03-02 2000-03-02 Combined lancet and electrochemical analyte-testing apparatus
PCT/US2001/007169 WO2001064105A1 (en) 2000-03-02 2001-03-02 Combined lancet and electrochemical analyte-testing apparatus

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2732195A Division CA2732195A1 (en) 2000-03-02 2001-03-02 Combined lancet and electrochemical analyte-testing apparatus

Publications (2)

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CA2401164A1 true CA2401164A1 (en) 2001-09-07
CA2401164C CA2401164C (en) 2011-04-26

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CA2732195A Pending CA2732195A1 (en) 2000-03-02 2001-03-02 Combined lancet and electrochemical analyte-testing apparatus

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US (2) US6706159B2 (en)
EP (2) EP1265530B1 (en)
JP (1) JP4727112B2 (en)
KR (1) KR100754237B1 (en)
CN (2) CN1217624C (en)
AU (2) AU2001249100B2 (en)
CA (2) CA2401164C (en)
CZ (1) CZ20022942A3 (en)
ES (2) ES2411721T3 (en)
HK (1) HK1051957A1 (en)
IL (2) IL151559A0 (en)
PL (1) PL357279A1 (en)
RU (1) RU2002126203A (en)
WO (1) WO2001064105A1 (en)

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