WO2001072225A1 - A disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet - Google Patents

A disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet Download PDF

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Publication number
WO2001072225A1
WO2001072225A1 PCT/DK2001/000180 DK0100180W WO0172225A1 WO 2001072225 A1 WO2001072225 A1 WO 2001072225A1 DK 0100180 W DK0100180 W DK 0100180W WO 0172225 A1 WO0172225 A1 WO 0172225A1
Authority
WO
WIPO (PCT)
Prior art keywords
lancet
carrying strip
reagent carrying
reagent
combined
Prior art date
Application number
PCT/DK2001/000180
Other languages
French (fr)
Inventor
Lars Peter Klitmose
Original Assignee
Novo Nordisk A/S
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 Novo Nordisk A/S filed Critical Novo Nordisk A/S
Priority to JP2001570189A priority Critical patent/JP2003527920A/en
Priority to AU2001242309A priority patent/AU2001242309A1/en
Priority to EP01915109A priority patent/EP1267720A1/en
Publication of WO2001072225A1 publication Critical patent/WO2001072225A1/en

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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
    • A61B5/157—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
    • A61B5/150015—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
    • A61B5/150358—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
    • A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • 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
    • A61B5/15186—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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/528—Atypical element structures, e.g. gloves, rods, tampons, toilet paper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

Definitions

  • a disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet
  • the invention relates to a disposable lancet combined with a reagent carrying strip
  • the lancet has a sharp distal end for piercing the skin of a user, and a reagent carrying strip, which reacts to a blood sample
  • the invention furthermore relates to a system for extracting and analysing blood in a body utilizing a disposable lancet in combination with a reagent carrying strip
  • a skin pricker comprises of a disposable lancet, a lancet holder and a body
  • the holder is, when armed, worked upon by a spring
  • the disposable lancet inserted in the holder is shot forward by the spring
  • a droop of blood can then be obtained from the punctured finger and placed onto the reagent carrying strip
  • the lancet is disposed of
  • the strip is also disposed of
  • the patient has to place a new lancet in the holder of the skin pricker and get a hold of a new reagent carrying strip
  • the reagent carrying strips are often carried in a separate container, which is very inconvenient, since such a separate container are often forgotten or mislaid
  • Such blood-sampling units are known from US A 5 231 993 and EP A1 164 148 These known units have a lancet, which is sharpened for piercing the tip of a finger and an integrated reagent carrying strip They are however not designed to be used in a typical skin pncker of the type described above The force needed to pierce the finger is delivered by the patient, but for many patients it is psychological difficult to pierce them- selves Such patients prefer to use an ordinary skin pncker with a disposable lancet The change of the reagent carrying strip in these known blood-sampling units is unreadable by the standard glucose meters on the market, since these are designed to read an inserted rectangular strip
  • a disposable lancet combined with a reagent carrying strip comprising a lancet, with a distal end, which is sharpened for piercing the skin of the user, and a reagent carrying strip, which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith,
  • the reagent carrying strip is a sheet-like strip having a first side and a second side, which sides are both accessible for the user, and that the lancet is connected to the reagent carrying strip
  • the disposable lancet can be inserted in a skin pncker having the attached reagent carrying strip sliding in a groove in the skin pncker, but the reagent carrying strip could also be disengaged from the lancet before inserting the lancet in the skin pncker In both ways it is assured that the patient always has a reagent carrying strip available when inserting a new lancet in the skin pncker After the blood sample has been placed on to the reagent carrying strip, the strip is easily inserted in a standard blood glucose meter
  • the lancet is made from a moldable polymeric material, and the reagent carrying strip is attached to the lancet Attaching the reagent carrying strip to the lancet can be done by gluing the reagent carrying strip to the lancet If the reagent carrying st ⁇ p is made from paper or another fibrous material the strip can however be fasten to the disposable lancet without the use of glue simply by folding the strip around the lance
  • the reagent carrying strip is made from a moldable polymeric material, which is moulded around the lancet
  • the strip can be made by moulding a moldable polymeric material to a very thin sheet-like strip of film, on to which the reagent material is placed
  • the lancet can be made by another material, and the reagent carrying strip can be attached to the lancet by moulding it around the lancet
  • the reagent carrying strip has a number of edges between the first and the second side, and the lancet is attached to the reagent carrying strip at one of these edges
  • the lancet is connected to a frame, which frame is attached to the edges of the reagent carrying strip
  • an arm is connecting the lancet to the reagent carrying strip or to the frame framing the reagent carrying strip
  • the reagent carrying strip can then be situated a distance from the disposable lancet, but still in connection therewith, forming a combined
  • the connecting point between the reagent carrying strip or the frame and the disposable lancet or the arm has a weakened tear line
  • the blood-coated strip has to be manually removed from the position where it is coated with blood and to the position where the change in the reagent is being measured This is very inconvenient for the user
  • a housing including a spring actuated hammer, into which housing the disposable lancet combined with a reagent carrying strip is placed in a guided position,
  • a display for showing a visual readout representing the changes in the reagent which system is characterized in that said sensor is situated in a position in the housing where it can sense the changes in the reagent without manually moving the disposable lancet combined with a reagent carrying strip
  • the disposable lancet combined with a reagent carrying strip just need to be placed in the guided position and fired There after the user merely has to place a drop of blood onto the reagent carrying strip and to actuate the device, then the change in the reagent is being read without removing the disposable lancet combination from the guided position
  • Figure 1 Schematically shows a disposable lancet combination, where the strip is connected through a thin arm
  • FIG. 2 Schematically shows a disposable lancet combined with a reagent carrying strip, where the strip is connected directly to the lancet
  • Figure 3 Shows a sectional view along line AA in figure 2
  • FIG. 4 A-D Schematically shows a disposable lancet in combination with a reagent carrying strip
  • Figure 5 A Schematically shows a disposable lancet combination having a weakened
  • Figure 5 B Shows an expanded sectional view along line AA in figure 5 A
  • Figure 6 A-B Schematically shows a side-view and a bottom-view of a disposable lancet combined with a reagent carrying strip, where the lancet is attached to one of the sides of the reagent carrying strip
  • Figure 7 A Schematically shows a disposable lancet combined with a reagent carrying strip, which strip is moulded around the lancet Figure 7 B Shows an expanded view along line AA in figure 7 A
  • Figure 8 Schematically shows a system for extraction and analysing blood
  • a disposable lancet 1 ,10 combined with a reagent carrying strip 3 comprises a lancet 1 ,10 with a sharpened distal end 2 for piercing the skin of a patient and a reagent carrying strip 3 connected to the lancet 1 ,10
  • the reagent carrying strip 3 has two sides 4, 5, both or one of which can carry the reagent that indicates the concentration of glucose in a blood sample
  • the reagent part of the reagent carrying strip 3 perform a chemical reaction resulting in for instance a colour change or a current according to the glucose concentration This change can then be read by a not shown glucose meter, into which the strip 3 is placed
  • the disposable lancet 1 ,10 can be connected to the reagent carrying strip 3 through a thin arm 6 As shown in figure 1 the connecting point 7 between the arm 6 and the reagent carrying strip 3 is situated at one of the edges of the reagent carrying strip 3
  • the arm 6 or the disposable lancet 1 ,10 could however be connected to one of the two sides 4, 5 of the reagent carrying strip 3
  • Figure 6 A-B shows the disposable lancet 1 ,10 being connected directly to the frame at one of the two sides 4, 5
  • Both the disposable lancet 1 ,10 and the arm 6 can be made of metal, but is preferably made from a mouldable polymeric material However the material chosen should preferably be a material suitable to be sterilized In this way the disposable lancets with reagent carrying strip could be sterilized prior to packing the units
  • the reagent carrying strip 3 is connected to the lancet 1 ,10 preferably through gluing, but can also be applied through melting, as is best shown in figure 2 and 3
  • the reagent carrying strip 3 made from a fibrous material such as paper, around the disposable lancet 1 ,10, made from a mouldable polymeric material, and applying heat, the polymeric material will tend to melt on the surface and thereby be locked on to the fibrous reagent carrying strip 3
  • the reagent carrying strip 3 can be connected directly to the disposable lancet 1 ,10, or the reagent carrying strip 3 can be connected to a frame 8, framing a number of the edges of the reagent carrying strip 3
  • the frame 8 can as indicated with a dotted line in figure 6 A be designed as one unitary frame - somewhat like a well - into which the reagent is placed without differing from the scope of the claims if wanted the unitary frame 8 could have a well-like depression on both sides, both carrying a reagent
  • the disposable lancet 1 ,10 with reagent carrying strip 3 When in use the disposable lancet 1 ,10 with reagent carrying strip 3 is first inserted into the armed skin pncker The reagent carrying strip 3 may slide in a groove in the skin pncker The skin pncker is then fired, and the lancet 1 ,10 penetrates the skin of the patient A drop of blood is disposed on to the attached reagent carrying strip 3, which is then placed in a glucose meter After the reading of the blood glucose value, the disposable lancet 1 ,10 and the attached reagent carrying strip 3 is disposed of
  • the attached reagent carrying strip Before loading the disposable lancet 1 ,10 into the skin pncker, the attached reagent carrying strip can be separated from the lancet 1 ,10 In order to accommodate such a detachment the connecting point 7 between the reagent carrying strip 3, or the frame 8, and the disposable lancet 1 ,10, or the arm 6, can be equipped with a weakened tear-line, which is best seen in figure 5 B
  • connection 7 between the lancet 1 , 10 and the frame 8 need not to run along the entire length of a side of the frame as shown in figure 5 A
  • the connection needs only to be at one or at a few points along the side
  • a weakened tear-line as shown in figure 5 B
  • the reagent carrying strip 3 can be made from a polymeric material which is formed into a very thin film 3
  • the reagent is applied onto the film 3
  • the film 3 can be attached to the lancet 1 10 by moulding the film in a way having a part 9, which surrounds the lancet 1 ,10 and attached to the lancet 1 ,10
  • the disposable lancet 1 ,10 with reagent carrying strip 3 can be moulded in one process, by first placing the lancet 1 ,10, which is made from metal or from a polymeric material, into the mould and then apply the polymeric
  • the system comprises a housing 15, a hammer 14, a spring 16, a release button 13 and a display 12
  • the disposable lancet 1 ,10 combined with a reagent carrying strip 3 is placed in a guided position in the housing with the spring 16 in the shown compressed position Releasing the spring 16 by pressing the release button 16 caused the spring 16 carrying the hammer to move forward When the hammer 14 impacts the lancet 1 ,10 this is also moved forward
  • the length of the spring 16 is determined so that the tip 2 of the lancet 1 , 10 is outside the boundaries of the housing 15 when the sp ⁇ ng is released and gone beyond its normal posi- tion, but inside the boundaries of the housing 15 when the spring 16 exceeds to its normal position In this way the finger will be pierced when pressed against the housing 15 upon firing the lancet 1 ,10
  • a droop of blood can be placed onto the reagent carrying st ⁇ p 3, which is then automatically guided into the combined skin pncker and glucose meter where a sensor senses the change in the reagent
  • the strip 3 can be winded around the lancet 1 ,10, or the whole disposable lancet 1 ,10 with reagent carrying strip 3 can be automatically shifted to a readable position

Abstract

A disposable lancet combined with a reagent carrying strip which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact with the strip. The lancet has one end, which is sharpened for piercing the skin of a user and has the reagent carrying strip connected to the lancet e.g. by moulding. The strip is sheet-like and has a first side and a second side, which sides are both accessible for the user, such that the reagent carrying strip can be inserted into a blood glucose meter without having to disconnect the strip from the lancet. It is however possible to disconnect the strip from the lancet if so wanted.

Description

A disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet
The invention relates to a disposable lancet combined with a reagent carrying strip The lancet has a sharp distal end for piercing the skin of a user, and a reagent carrying strip, which reacts to a blood sample
The invention furthermore relates to a system for extracting and analysing blood in a body utilizing a disposable lancet in combination with a reagent carrying strip
Patients with certain illnesses like diabetes must verify several times a day the sugar content of their blood This is often done by placing a drop of blood on to a reagent carrying strip, which causes the reactive reagent on the strip to react with the blood Usually the reagent carrying strip carries an enzyme that reacts with the blood component to be measured The result of the test is read by a blood glucose meter before or/and after applying blood Most such blood glucose meters on the market today either reads the change of colour due to the chemical reaction, or it reads the current produced from the chemical reaction between reagent or blood glucose
The drop of blood is obtained by piercing the tip of a finger or the earlap using a potable skin pricker E g as known from US A 4 469 1 10 Such a skin pricker comprises of a disposable lancet, a lancet holder and a body The holder is, when armed, worked upon by a spring When firing the skin pricker, the disposable lancet inserted in the holder is shot forward by the spring By pressing the tip of the finger against the skin pricker the finger is pierced by the sharp end of the lancet A droop of blood can then be obtained from the punctured finger and placed onto the reagent carrying strip After use the lancet is disposed of When the change in the reagent carried on the strip has been measured, the strip is also disposed of
Next time a blood sample is required, the patient has to place a new lancet in the holder of the skin pricker and get a hold of a new reagent carrying strip The reagent carrying strips are often carried in a separate container, which is very inconvenient, since such a separate container are often forgotten or mislaid Some times the container is integrated with the skin pricker, but since the lancet and the reagent carrying strip are two separate pieces, they are often available in an unequal number The user therefore often runs out of one of the items first As a result of this the user most always remember to refill the container with the item needed
In order to avoid these inconveniences the disposable lancet are sometimes combined with the reagent carrying strip Such blood-sampling units are known from US A 5 231 993 and EP A1 164 148 These known units have a lancet, which is sharpened for piercing the tip of a finger and an integrated reagent carrying strip They are however not designed to be used in a typical skin pncker of the type described above The force needed to pierce the finger is delivered by the patient, but for many patients it is psychological difficult to pierce them- selves Such patients prefer to use an ordinary skin pncker with a disposable lancet The change of the reagent carrying strip in these known blood-sampling units is unreadable by the standard glucose meters on the market, since these are designed to read an inserted rectangular strip
It is an object of the invention to provide an ordinary disposable lancet for a skin pncker, which lancet is combined with a reagent carrying strip in order to minimise the amount of loose items a diabetes patient has to carry around It is also an object to provide a disposable lancet combined with a reagent carrying strip, which strip can easily be read in a standard glucose meter
This is obtained by a disposable lancet combined with a reagent carrying strip comprising a lancet, with a distal end, which is sharpened for piercing the skin of the user, and a reagent carrying strip, which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith,
Which disposable lancet combination is characterized in that the reagent carrying strip is a sheet-like strip having a first side and a second side, which sides are both accessible for the user, and that the lancet is connected to the reagent carrying strip
The disposable lancet can be inserted in a skin pncker having the attached reagent carrying strip sliding in a groove in the skin pncker, but the reagent carrying strip could also be disengaged from the lancet before inserting the lancet in the skin pncker In both ways it is assured that the patient always has a reagent carrying strip available when inserting a new lancet in the skin pncker After the blood sample has been placed on to the reagent carrying strip, the strip is easily inserted in a standard blood glucose meter In one embodiment of the disposable lancet according to the invention the lancet is made from a moldable polymeric material, and the reagent carrying strip is attached to the lancet Attaching the reagent carrying strip to the lancet can be done by gluing the reagent carrying strip to the lancet If the reagent carrying stπp is made from paper or another fibrous material the strip can however be fasten to the disposable lancet without the use of glue simply by folding the strip around the lancet and apply heat and pressure The surface of the lancet will then start to melt, and connect to the reagent carrying strip
In another embodiment of the disposable lancet combined with a reagent carrying strip according to the invention the reagent carrying strip is made from a moldable polymeric material, which is moulded around the lancet Instead of making the strip from a fibrous material as paper, the strip can be made by moulding a moldable polymeric material to a very thin sheet-like strip of film, on to which the reagent material is placed The lancet can be made by another material, and the reagent carrying strip can be attached to the lancet by moulding it around the lancet
In another embodiment of the disposable lancet combination according to the invention the reagent carrying strip has a number of edges between the first and the second side, and the lancet is attached to the reagent carrying strip at one of these edges By applying the disposable lancet onto the reagent carrying strip at one of the edges, disconnecting the two items is made very easy
In an appropriate embodiment of the disposable lancet according to the invention the lancet is connected to a frame, which frame is attached to the edges of the reagent carrying strip By framing the reagent carrying strip a stiff construction is possible, which accommodates an easy insertion into the glucose meter
In yet another embodiment of the disposable lancet combined with a reagent carrying strip according to the invention an arm is connecting the lancet to the reagent carrying strip or to the frame framing the reagent carrying strip The reagent carrying strip can then be situated a distance from the disposable lancet, but still in connection therewith, forming a combined In an embodiment of the disposable lancet combined with a reagent carrying strip according to the invention the connecting point between the reagent carrying strip or the frame and the disposable lancet or the arm has a weakened tear line By this the attached reagent carrying strip can easily be separated from the lancet
In an embodiment of the disposable lancet combined with a reagent carrying strip according to the invention the reagent carrying strip is rectangular Most glucose meters present on the market accommodates rectangular reagent carrying strips
It is also an object of the invention to provide a system for extracting and analysing blood in a body utilizing a disposable lancet combined with a reagent carrying strip, where the disposable lancet is kept in the same position both when obtaining the blood sample and when analysing the blood sample In the known systems of this kind e g as known from WO A 95/24233, especially figure 25, the blood-coated strip has to be manually removed from the position where it is coated with blood and to the position where the change in the reagent is being measured This is very inconvenient for the user
This is obtained by a system for extracting and analyzing blood in a body utilizing a disposable lancet combined with a reagent carrying strip according to anyone of the preceding claims which system comprises
a housing including a spring actuated hammer, into which housing the disposable lancet combined with a reagent carrying strip is placed in a guided position,
a button which releases the spring actuated hammer, which then pushes forward the disposable lancet combined with a reagent carrying strip,
means for guiding the disposable lancet combination from a retracted position to a deployed position where the tip of the disposable lancet with reagent carrying strip penetrates the skin of the user,
a sensor which senses the changes in the reagent placed on said reagent carrying strip,
a display for showing a visual readout representing the changes in the reagent which system is characterized in that said sensor is situated in a position in the housing where it can sense the changes in the reagent without manually moving the disposable lancet combined with a reagent carrying strip
In such a system the disposable lancet combined with a reagent carrying strip just need to be placed in the guided position and fired There after the user merely has to place a drop of blood onto the reagent carrying strip and to actuate the device, then the change in the reagent is being read without removing the disposable lancet combination from the guided position
The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which
Figure 1 Schematically shows a disposable lancet combination, where the strip is connected through a thin arm
Figure 2 Schematically shows a disposable lancet combined with a reagent carrying strip, where the strip is connected directly to the lancet
Figure 3 Shows a sectional view along line AA in figure 2
Figure 4 A-D Schematically shows a disposable lancet in combination with a reagent carrying strip
Figure 5 A Schematically shows a disposable lancet combination having a weakened
Figure imgf000006_0001
Figure 5 B Shows an expanded sectional view along line AA in figure 5 A
Figure 6 A-B Schematically shows a side-view and a bottom-view of a disposable lancet combined with a reagent carrying strip, where the lancet is attached to one of the sides of the reagent carrying strip
Figure 7 A Schematically shows a disposable lancet combined with a reagent carrying strip, which strip is moulded around the lancet Figure 7 B Shows an expanded view along line AA in figure 7 A
Figure 8 Schematically shows a system for extraction and analysing blood
The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out Throughout, the same reference numerals are used for identical or corresponding parts
Referring now to the drawing, it can be seen that a disposable lancet 1 ,10 combined with a reagent carrying strip 3 according to the invention comprises a lancet 1 ,10 with a sharpened distal end 2 for piercing the skin of a patient and a reagent carrying strip 3 connected to the lancet 1 ,10
The reagent carrying strip 3 has two sides 4, 5, both or one of which can carry the reagent that indicates the concentration of glucose in a blood sample When the reagent carrying strip 3 is placed in contact with a blood sample, the reagent part of the reagent carrying strip 3 perform a chemical reaction resulting in for instance a colour change or a current according to the glucose concentration This change can then be read by a not shown glucose meter, into which the strip 3 is placed
The disposable lancet 1 ,10 can be connected to the reagent carrying strip 3 through a thin arm 6 As shown in figure 1 the connecting point 7 between the arm 6 and the reagent carrying strip 3 is situated at one of the edges of the reagent carrying strip 3 The arm 6 or the disposable lancet 1 ,10 could however be connected to one of the two sides 4, 5 of the reagent carrying strip 3 Figure 6 A-B shows the disposable lancet 1 ,10 being connected directly to the frame at one of the two sides 4, 5
Both the disposable lancet 1 ,10 and the arm 6 can be made of metal, but is preferably made from a mouldable polymeric material However the material chosen should preferably be a material suitable to be sterilized In this way the disposable lancets with reagent carrying strip could be sterilized prior to packing the units The reagent carrying strip 3 is connected to the lancet 1 ,10 preferably through gluing, but can also be applied through melting, as is best shown in figure 2 and 3 By folding the reagent carrying strip 3, made from a fibrous material such as paper, around the disposable lancet 1 ,10, made from a mouldable polymeric material, and applying heat, the polymeric material will tend to melt on the surface and thereby be locked on to the fibrous reagent carrying strip 3
As shown in figure 4 A-D, the reagent carrying strip 3 can be connected directly to the disposable lancet 1 ,10, or the reagent carrying strip 3 can be connected to a frame 8, framing a number of the edges of the reagent carrying strip 3
The frame 8 can as indicated with a dotted line in figure 6 A be designed as one unitary frame - somewhat like a well - into which the reagent is placed without differing from the scope of the claims if wanted the unitary frame 8 could have a well-like depression on both sides, both carrying a reagent
When in use the disposable lancet 1 ,10 with reagent carrying strip 3 is first inserted into the armed skin pncker The reagent carrying strip 3 may slide in a groove in the skin pncker The skin pncker is then fired, and the lancet 1 ,10 penetrates the skin of the patient A drop of blood is disposed on to the attached reagent carrying strip 3, which is then placed in a glucose meter After the reading of the blood glucose value, the disposable lancet 1 ,10 and the attached reagent carrying strip 3 is disposed of
Before loading the disposable lancet 1 ,10 into the skin pncker, the attached reagent carrying strip can be separated from the lancet 1 ,10 In order to accommodate such a detachment the connecting point 7 between the reagent carrying strip 3, or the frame 8, and the disposable lancet 1 ,10, or the arm 6, can be equipped with a weakened tear-line, which is best seen in figure 5 B
The connection 7 between the lancet 1 , 10 and the frame 8 need not to run along the entire length of a side of the frame as shown in figure 5 A The connection needs only to be at one or at a few points along the side Instead of a weakened tear-line as shown in figure 5 B there could be E g two tear-points having the appearance of the tear-line shown in figure 5 B also when viewed from the side As shown in figure 7 A-B the reagent carrying strip 3 can be made from a polymeric material which is formed into a very thin film 3 The reagent is applied onto the film 3 The film 3 can be attached to the lancet 1 10 by moulding the film in a way having a part 9, which surrounds the lancet 1 ,10 and attached to the lancet 1 ,10 In this way the disposable lancet 1 ,10 with reagent carrying strip 3 can be moulded in one process, by first placing the lancet 1 ,10, which is made from metal or from a polymeric material, into the mould and then apply the polymeric material
In order to avoid the inconveniency of moving the blood-coated strip 3 around the system 11 shown in figure 8 uniting a skin pncker and a glucose meter has been developed The system comprises a housing 15, a hammer 14, a spring 16, a release button 13 and a display 12
The disposable lancet 1 ,10 combined with a reagent carrying strip 3 is placed in a guided position in the housing with the spring 16 in the shown compressed position Releasing the spring 16 by pressing the release button 16 caused the spring 16 carrying the hammer to move forward When the hammer 14 impacts the lancet 1 ,10 this is also moved forward The length of the spring 16 is determined so that the tip 2 of the lancet 1 , 10 is outside the boundaries of the housing 15 when the spπng is released and gone beyond its normal posi- tion, but inside the boundaries of the housing 15 when the spring 16 exceeds to its normal position In this way the finger will be pierced when pressed against the housing 15 upon firing the lancet 1 ,10
After the finger has been pierced a droop of blood can be placed onto the reagent carrying stπp 3, which is then automatically guided into the combined skin pncker and glucose meter where a sensor senses the change in the reagent In order to place the reagent carrying strip 3 in a readable position the strip 3 can be winded around the lancet 1 ,10, or the whole disposable lancet 1 ,10 with reagent carrying strip 3 can be automatically shifted to a readable position
Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject-matter defined in the following claims The sheet-like reagent carrying strip could, for example, be formed into a circular tube-shaped element, which are fitted around the lancet without falling outside the scope of the claims

Claims

1 A disposable lancet (1 ,10) combined with a reagent carrying strip (3), comprising a lancet (1 ,10) with a distal end (2), which is sharpened for piercing the skin of a user, and a reagent carrying strip (3), which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith, characterized in that said reagent carrying strip (3) is a sheet-like strip (3) having a first side (4) and a second side (5), which sides (4,5) are both accessible for said user, and that said lancet (1 ,10) is connected to said reagent carrying strip (3)
2 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to claim 1 characterized in that said lancet (1 ,10) is made from a moldable polymeric material, and that said reagent carrying strip (3) is attached to said lancet (1 ,10)
3 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to claim 1 or 2 characterized in that said reagent carrying strip (3,9) is made from a moldable polymeric material, which is moulded around said lancet (1 ,10)
4 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to anyone of the claims 1 or 3, characterized in that said reagent carrying strip (3) has a number of edges between said first side (4) and said second side (5), and that said lancet (1 ,10) is attached to said reagent carrying strip (3) at one of these edges
5 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to claim 4, characterized in that said lancet (1 ,10) is connected to a frame (8), which frame (8) is attached to one or more of the edges of said reagent carrying strip (3)
6 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, characterized in that an arm (6) is connecting said lancet (1 ,10) to said reagent carrying strip (3) or to said frame (8)
7 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, characterized in that the connecting point (7) between the reagent carrying strip (3) or the frame (8) and the disposable lancet (1 ,10) or the arm (6) has a weak- 8 A disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, characterized in that said reagent carrying strip (3) is rectangular
9 A system (11) for extracting and analyzing blood in a body utilizing a disposable lancet (1 ,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, which system (1 1) comprises
a housing (15) including a spring (16) actuated hammer (14), into which housing (15) said disposable lancet (1 ,10) combined with a reagent carrying strip (3) is placed in a guided position,
a button (13) which released said spring (16) actuated hammer (14), which then pushes forward said disposable lancet (1 ,10) combined with a reagent carrying strip (3), means for guiding said disposable lancet (1 ,10) combined with a reagent carrying strip (3) from a retracted position to a deployed position where the tip of said disposable lancet (1 ,10) combined with a reagent carrying strip (3) penetrates the skin of the user,
a sensor which senses the changes in the reagent placed on said reagent carrying strip (3),
a display (12) for showing a visual readout representing the changes in the reagent
characterized in that said sensor is situated in a position in said housing (15) where it can sense the changes in the reagent without manually moving said disposable lancet (1 ,10) combined with a reagent carrying strip (3)
PCT/DK2001/000180 2000-03-24 2001-03-16 A disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet WO2001072225A1 (en)

Priority Applications (3)

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JP2001570189A JP2003527920A (en) 2000-03-24 2001-03-16 Disposable lancets in combination with reagent holding pieces and systems for extracting and analyzing blood in the body using such disposable lancets
AU2001242309A AU2001242309A1 (en) 2000-03-24 2001-03-16 A disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet
EP01915109A EP1267720A1 (en) 2000-03-24 2001-03-16 A disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet

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DKPA200000495 2000-03-24
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Cited By (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1441214A2 (en) 2003-01-21 2004-07-28 Bayer Healthcare, LLC Molded low volume waveguided optical cuvette
EP1581101A2 (en) * 2002-10-09 2005-10-05 CSP Technologies, Inc. A lancet system including test strips and cassettes
US7060192B2 (en) 2002-05-09 2006-06-13 Lifescan, Inc. Methods of fabricating physiological sample collection devices
CN1331440C (en) * 2002-05-09 2007-08-15 生命扫描有限公司 Analyte testing system in least operational process
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US8409113B2 (en) 2006-09-27 2013-04-02 Terumo Kabushiki Kaisha Body fluid sampling unit
US8690796B2 (en) 2002-04-19 2014-04-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US8945910B2 (en) 2003-09-29 2015-02-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
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
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
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
US9775553B2 (en) 2004-06-03 2017-10-03 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
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor

Families Citing this family (69)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6036924A (en) 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US6391005B1 (en) 1998-03-30 2002-05-21 Agilent Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
AUPR044000A0 (en) * 2000-09-28 2000-10-26 Norwood Abbey Ltd Diagnostic device
US6783502B2 (en) * 2001-04-26 2004-08-31 Phoenix Bioscience Integrated lancing and analytic device
ATE485766T1 (en) 2001-06-12 2010-11-15 Pelikan Technologies Inc ELECTRICAL ACTUATING ELEMENT FOR A LANCET
DE60234598D1 (en) 2001-06-12 2010-01-14 Pelikan Technologies Inc SELF-OPTIMIZING LANZET DEVICE WITH ADAPTANT FOR TEMPORAL FLUCTUATIONS OF SKIN PROPERTIES
US7749174B2 (en) 2001-06-12 2010-07-06 Pelikan Technologies, Inc. Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge
US7981056B2 (en) 2002-04-19 2011-07-19 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US8337419B2 (en) 2002-04-19 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7682318B2 (en) 2001-06-12 2010-03-23 Pelikan Technologies, Inc. Blood sampling apparatus and method
EP1404234B1 (en) 2001-06-12 2011-02-09 Pelikan Technologies Inc. Apparatus for improving success rate of blood yield from a fingerstick
US7004928B2 (en) 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
US8221334B2 (en) 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7229458B2 (en) 2002-04-19 2007-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7331931B2 (en) 2002-04-19 2008-02-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7297122B2 (en) 2002-04-19 2007-11-20 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US7371247B2 (en) 2002-04-19 2008-05-13 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US7232451B2 (en) 2002-04-19 2007-06-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7909778B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7291117B2 (en) 2002-04-19 2007-11-06 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7491178B2 (en) 2002-04-19 2009-02-17 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7175642B2 (en) 2002-04-19 2007-02-13 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7892185B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US20030211619A1 (en) * 2002-05-09 2003-11-13 Lorin Olson Continuous strip of fluid sampling and testing devices and methods of making, packaging and using the same
US20030212344A1 (en) * 2002-05-09 2003-11-13 Vadim Yuzhakov Physiological sample collection devices and methods of using the same
US20030143113A2 (en) * 2002-05-09 2003-07-31 Lifescan, Inc. Physiological sample collection devices and methods of using the same
US7815579B2 (en) * 2005-03-02 2010-10-19 Roche Diagnostics Operations, Inc. Dynamic integrated lancing test strip with sterility cover
WO2004066822A2 (en) * 2003-01-29 2004-08-12 Roche Diagnostics Gmbh Integrated lancing test strip
EP1628567B1 (en) 2003-05-30 2010-08-04 Pelikan Technologies Inc. Method and apparatus for fluid injection
DK1633235T3 (en) 2003-06-06 2014-08-18 Sanofi Aventis Deutschland Apparatus for sampling body fluid and detecting analyte
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
US20050240119A1 (en) * 2004-04-16 2005-10-27 Becton, Dickinson And Company Blood glucose meter having integral lancet device and test strip storage vial for single handed use and methods for using same
US20060006574A1 (en) * 2004-06-29 2006-01-12 Lang David K Apparatus for the manufacture of medical devices
US7727166B2 (en) * 2004-07-26 2010-06-01 Nova Biomedical Corporation Lancet, lancet assembly and lancet-sensor combination
EP1838209B1 (en) * 2004-09-20 2009-11-25 Bayer Healthcare, LLC System and method for repositioning a diagnostic test strip after inoculation
BRPI0518969A2 (en) * 2004-12-13 2008-12-16 Bayer Healthcare Llc independent test sensor
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US7935063B2 (en) * 2005-03-02 2011-05-03 Roche Diagnostics Operations, Inc. System and method for breaking a sterility seal to engage a lancet
US7695442B2 (en) * 2005-04-12 2010-04-13 Roche Diagnostics Operations, Inc. Integrated lancing test strip with retractable lancet
US7803319B2 (en) 2005-04-29 2010-09-28 Kimberly-Clark Worldwide, Inc. Metering technique for lateral flow assay devices
US7858384B2 (en) 2005-04-29 2010-12-28 Kimberly-Clark Worldwide, Inc. Flow control technique for assay devices
US20100081968A1 (en) * 2005-07-15 2010-04-01 Home Diagnostics, Inc. Test Strip With Integrated Lancet
US8636672B2 (en) * 2007-02-28 2014-01-28 Nipro Diagnostics, Inc. Test strip with integrated lancet
US8801631B2 (en) 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
EP1928304B1 (en) 2005-09-30 2012-10-24 Intuity Medical, Inc. Catalysts for body fluid sample extraction
US7279136B2 (en) 2005-12-13 2007-10-09 Takeuchi James M Metering technique for lateral flow assay devices
US7618810B2 (en) 2005-12-14 2009-11-17 Kimberly-Clark Worldwide, Inc. Metering strip and method for lateral flow assay devices
WO2007086843A2 (en) 2006-01-25 2007-08-02 Nova Biomedical Corporation Lancet sensor assembly and meter
JP2007282863A (en) * 2006-04-17 2007-11-01 Sumitomo Electric Ind Ltd Biosensor chip
US9044178B2 (en) 2007-08-30 2015-06-02 Pepex Biomedical, Llc Electrochemical sensor and method for manufacturing
WO2009032760A2 (en) 2007-08-30 2009-03-12 Pepex Biomedical Llc Electrochmical sensor and method for manufacturing
JP2009225935A (en) * 2008-03-21 2009-10-08 Nitto Denko Corp Bodily fluid collecting circuit board and biosensor
WO2009145920A1 (en) 2008-05-30 2009-12-03 Intuity Medical, Inc. Body fluid sampling device -- sampling site interface
EP2299904B1 (en) 2008-06-06 2019-09-11 Intuity Medical, Inc. Medical measurement method
WO2010056878A2 (en) 2008-11-14 2010-05-20 Pepex Biomedical, Llc Electrochemical sensor module
US8506740B2 (en) 2008-11-14 2013-08-13 Pepex Biomedical, Llc Manufacturing electrochemical sensor module
US8951377B2 (en) 2008-11-14 2015-02-10 Pepex Biomedical, Inc. Manufacturing electrochemical sensor module
US8758267B2 (en) * 2009-03-17 2014-06-24 Nova Biomedical Corporation Modified lancet carrier for single-use lancet sensor assembly
EP3106871B1 (en) 2009-11-30 2021-10-27 Intuity Medical, Inc. A method of verifying the accuracy of the operation of an analyte monitoring device
CA2803797A1 (en) 2010-06-25 2011-12-29 Intuity Medical, Inc. Analyte monitoring methods and systems
WO2012162151A2 (en) 2011-05-20 2012-11-29 Pepex Biomedical, Inc. Manufacturing electrochemical sensor modules
EP3407064B1 (en) 2011-08-03 2020-04-22 Intuity Medical, Inc. Body fluid sampling arrangement
WO2014089058A1 (en) 2012-12-03 2014-06-12 Pepex Biomedical, Inc. Sensor module and method of using a sensor module
US10729386B2 (en) 2013-06-21 2020-08-04 Intuity Medical, Inc. Analyte monitoring system with audible feedback
US11045124B2 (en) 2014-06-04 2021-06-29 Pepex Biomedical, Inc. Electrochemical sensors and methods for making electrochemical sensors using advanced printing technology
US10856782B2 (en) * 2018-12-19 2020-12-08 Anand Kumar Chavakula Multi-use monitor

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0164148A1 (en) * 1984-05-11 1985-12-11 Medscan B.V. Blood sampling unit
US4787398A (en) * 1985-04-08 1988-11-29 Garid, Inc. Glucose medical monitoring system
US5231993A (en) * 1991-11-20 1993-08-03 Habley Medical Technology Corporation Blood sampler and component tester with guide member
US5951492A (en) * 1996-05-17 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for sampling and analyzing body fluid

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2508305B1 (en) 1981-06-25 1986-04-11 Slama Gerard DEVICE FOR CAUSING A LITTLE BITE TO COLLECT A BLOOD DROP
US4966159A (en) 1981-12-14 1990-10-30 Maganias Nicholas H Allergy test strip
US4627445A (en) * 1985-04-08 1986-12-09 Garid, Inc. Glucose medical monitoring system
US5607401A (en) * 1991-09-03 1997-03-04 Humphrey; Bruce H. Augmented polymeric hypodermic devices
US5536249A (en) 1994-03-09 1996-07-16 Visionary Medical Products, Inc. Pen-type injector with a microprocessor and blood characteristic monitor
US5801057A (en) * 1996-03-22 1998-09-01 Smart; Wilson H. Microsampling device and method of construction
DE19705091A1 (en) 1996-03-29 1999-02-11 Wolfgang Dr Med Wagner Device-related method and puncture device for blood extraction from the skin of a living being and connected metabolism measurement
US6071294A (en) * 1997-12-04 2000-06-06 Agilent Technologies, Inc. Lancet cartridge for sampling blood
US5971941A (en) * 1997-12-04 1999-10-26 Hewlett-Packard Company Integrated system and method for sampling blood and analysis

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0164148A1 (en) * 1984-05-11 1985-12-11 Medscan B.V. Blood sampling unit
US4787398A (en) * 1985-04-08 1988-11-29 Garid, Inc. Glucose medical monitoring system
US5231993A (en) * 1991-11-20 1993-08-03 Habley Medical Technology Corporation Blood sampler and component tester with guide member
US5951492A (en) * 1996-05-17 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for sampling and analyzing body fluid

Cited By (50)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9937298B2 (en) 2001-06-12 2018-04-10 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
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
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US7713214B2 (en) 2002-04-19 2010-05-11 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US9907502B2 (en) 2002-04-19 2018-03-06 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US9795334B2 (en) 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8690796B2 (en) 2002-04-19 2014-04-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US9339612B2 (en) 2002-04-19 2016-05-17 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
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
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
CN1331440C (en) * 2002-05-09 2007-08-15 生命扫描有限公司 Analyte testing system in least operational process
US7060192B2 (en) 2002-05-09 2006-06-13 Lifescan, Inc. Methods of fabricating physiological sample collection devices
EP1581101A4 (en) * 2002-10-09 2007-07-04 Csp Technologies Inc A lancet system including test strips and cassettes
EP1581101A2 (en) * 2002-10-09 2005-10-05 CSP Technologies, Inc. A lancet system including test strips and cassettes
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
EP1441214A2 (en) 2003-01-21 2004-07-28 Bayer Healthcare, LLC Molded low volume waveguided optical cuvette
US8377381B2 (en) 2003-01-21 2013-02-19 Bayer Healthcare Llc Optical format
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US8945910B2 (en) 2003-09-29 2015-02-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
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
US9775553B2 (en) 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US8409113B2 (en) 2006-09-27 2013-04-02 Terumo Kabushiki Kaisha Body fluid sampling unit
US8460212B2 (en) 2006-09-27 2013-06-11 Terumo Kabushiki Kaisha Body fluid sampling unit
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation

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US6620112B2 (en) 2003-09-16
US20010027277A1 (en) 2001-10-04
AU2001242309A1 (en) 2001-10-08
JP2003527920A (en) 2003-09-24

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