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WO2007070719A2 - Dispositif de penetration tissulaire - Google Patents

Dispositif de penetration tissulaire Download PDF

Info

Publication number
WO2007070719A2
WO2007070719A2 PCT/US2006/048129 US2006048129W WO2007070719A2 WO 2007070719 A2 WO2007070719 A2 WO 2007070719A2 US 2006048129 W US2006048129 W US 2006048129W WO 2007070719 A2 WO2007070719 A2 WO 2007070719A2
Authority
WO
WIPO (PCT)
Prior art keywords
lancet
analyte sensor
penetrating member
housing
sample
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.)
Ceased
Application number
PCT/US2006/048129
Other languages
English (en)
Other versions
WO2007070719A3 (fr
Inventor
Ajay Deshmukh
Dominique M. Freeman
Dirk Boecker
Don Alden
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.)
Pelikan Technologies Inc
Original Assignee
Pelikan Technologies Inc
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
Priority claimed from US11/318,334 external-priority patent/US20060195133A1/en
Application filed by Pelikan Technologies Inc filed Critical Pelikan Technologies Inc
Priority to EP06845671A priority Critical patent/EP1968461A4/fr
Publication of WO2007070719A2 publication Critical patent/WO2007070719A2/fr
Anticipated expiration legal-status Critical
Publication of WO2007070719A3 publication Critical patent/WO2007070719A3/fr
Ceased 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
    • A61B5/15—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
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A61B5/150152—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by an adequate mechanical impact on the puncturing location
    • A—HUMAN NECESSITIES
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    • 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
    • A61B5/150167—Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
    • A—HUMAN NECESSITIES
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    • A61B5/150175—Adjustment of penetration depth
    • A—HUMAN NECESSITIES
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    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/15019—Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
    • A—HUMAN NECESSITIES
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    • 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
    • A61B5/150213—Venting means
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61B5/150251—Collection chamber divided into at least two compartments, e.g. for division of samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150816—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by tactile feedback, e.g. vibration
    • A—HUMAN NECESSITIES
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    • 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
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    • A61B5/150007—Details
    • A61B5/150885—Preventing re-use
    • A61B5/150916—Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
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    • A61B5/150954—Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
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    • 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
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    • 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
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    • 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
    • A61B5/15123—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 magnets or solenoids
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    • 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
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    • 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
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    • 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
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    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
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    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
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    • A61B5/15171—Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
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    • 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
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    • 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
    • A61B5/15178—Stocking means comprising separate compartments or units for new and for used piercing elements
    • 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.
    • A61B5/15184—Piercing device comprising a separate compartment or unit for used piercing elements
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502715—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A61M2005/005—Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
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    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • B01L2200/147—Employing temperature sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B01L2300/0663—Whole sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/18—Means for temperature control
    • B01L2300/1805—Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
    • B01L2300/1827—Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks using resistive heater
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0605—Valves, specific forms thereof check valves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502707—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the manufacture of the container or its components

Definitions

  • Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis. Biochemical analysis of blood samples is a diagnostic tool for determining clinical information. Many point-of- care tests are performed using whole blood, the most common being monitoring diabetic blood glucose level. Other uses for this method include the analysis of oxygen and coagulation based on Prothrombin time measurement. Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin. Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancing devices that contain a multitude of spring, cam and mass actuators to drive the lancet.
  • the device is pre-cocked or the user cocks the device.
  • the device is held against the skin and the user, or pressure from the users skin, mechanically triggers the ballistic launch of the lancet.
  • the forward movement and depth of skin penetration of the lancet is determined by a mechanical stop and/or dampening, as well as a spring or cam to retract the lancet.
  • Such devices have the possibility of multiple strikes due to recoil, in addition to vibratory stimulation of the skin as the driver impacts the end of the launcher stop, and only allow for rough control for skin thickness variation.
  • Different skin thickness may yield different results in terms of pain perception, blood yield and success rate of obtaining blood between different users of the lancing device. Success rate generally encompasses the probability of producing a blood sample with one lancing action, which is sufficient in volume to perform the desired analytical test.
  • the blood may appear spontaneously at the surface of the skin, or may be "milked" from the wound. Milking generally involves pressing the side of the digit, or in proximity of the wound to express the blood to the surface.
  • the blood droplet produced by the lancing action must reach the surface of the skin to be viable for testing. For a one-step lance and blood sample acquisition method, spontaneous blood droplet formation is requisite. Then it is possible to interface the test strip with the lancing process for metabolite testing.
  • Another problem frequently encountered by patients who must use lancing equipment to obtain and analyze blood samples is the amount of manual dexterity and hand-eye coordination required to properly operate the lancing and sample testing equipment due to retinopathies and neuropathies particularly, severe in elderly diabetic patients. For those patients, operating existing lancet and sample testing equipment can be a challenge. Once a blood droplet is created, that droplet must then be guided into a receiving channel of a small test strip or the like. If the sample placement on the strip is unsuccessful, repetition of the entire procedure including re-lancing the skin to obtain a new blood droplet is necessary.
  • What is needed is a device, which can reliably, repeatedly and painlessly generate spontaneous blood samples.
  • a method for performing analytical testing on a sample that does not require a high degree of manual . dexterity or hand-eye coordination is required. Integrating sample generation (lancing) with sample testing (sample to test strip) will result in a simple one-step testing procedure resulting in better disease management through increased compliance with self testing regimes.
  • a further object of the present invention is to provide a disposable cartridge with sterilization of penetrating members and maintenance of analyte sensors in a dry condition.
  • Yet another object of the present invention is to provide a disposable cartridge with alignment of penetrating members to analyte sensors enables that upon penetration by a penetrating member of a skin surface, blood flows into an analyte sensor.
  • the analyte sensor housing is in a surrounding relationship to the penetrating member housing.
  • a body fluid sampling system for use on a tissue site has a drive force generator.
  • a plurality of penetrating members are included. Each penetrating member is configured to be coupled to the drive force generator.
  • a plurality of analyte sensors are fixed in an analyte sensor housing. Each analyte sensor is associated with a penetrating member.
  • a body fluid sampling system for use on a tissue site has a drive force generator.
  • a plurality of penetrating members are provided. Each penetrating member is configured to be coupled to the drive force generator.
  • a plurality of analyte sensors are housed in an analyte sensor housing. Each analyte sensor is associated with a penetrating member. At least one seal maintains each analyte sensor in a dry state.
  • a body fluid sampling system for use on a tissue site has a drive force generator.
  • a plurality of penetrating members are provided. Each penetrating member is configured to be coupled to the drive force generator.
  • a plurality of analyte sensors are housed in an analyte sensor housing. Each analyte sensor is associated with a penetrating member and has at least a first seal that maintains the analyte sensor in a dry state. The first seal being is opened at an analyte sensor prior to launch of a penetrating member associated with that analyte sensor.
  • a body fluid sampling system for use on a tissue site has a drive force generator.
  • a plurality of penetrating members are provided. Each penetrating member is configured to be coupled to the drive force generator.
  • a plurality of analyte sensors are housed in an analyte sensor housing. Each analyte sensor is associated with a penetrating member. Each analyte sensor is aligned to a penetrating member.
  • F(GS. 1-3 are graphs of lancet velocity versus position for embodiments of spring driven, cam driven, and controllable force drivers.
  • FIG. 4 illustrates an embodiment of a controllable force driver in the form of a flat electric lancet driver that has a solenoid-type configuration.
  • FIG. 5 illustrates an embodiment of a controllable force driver in the form of a cylindrical electric lancet driver using a coiled solenoid -type configuration.
  • FIG. 6 illustrates a displacement overtime profile of a lancet driven by a harmonic spring/mass system.
  • FIGS. 7 illustrates the velocity over time profile of a lancet driver by a harmonic.spring/mass system.
  • FIG. 8 illustrates a displacement over time profile of an embodiment of a controllable force driver.
  • FIGS. 9 illustrates a velocity over time profile of an embodiment of a controllable force driver.
  • FIG. 10 illustrates the lancet needle partially retracted, after severing blood vessels; blood is shown following the needle in the wound tract.
  • FIG. 11 illustrates blood following the lancet needle to the skin surface, maintaining an open wound tract.
  • FIG. 12 is a diagrammatic view illustrating a controlled feed-back loop.
  • FIG. 13 is a graph of force vs. time during the advancement and retraction of a lancet showing some characteristic phases of a lancing cycle.
  • FIG. 14 illustrates a lancet tip showing features, which can affect lancing pain, blood volume, and success rate.
  • FIG. 15 illustrates an embodiment of a lancet tip.
  • FIG. 16 is a graph showing displacement of a lancet over time.
  • FIG. 17 is a graph showing an embodiment of a velocity profile, which includes the velocity of a lancet over time including reduced velocity during retraction of the lancet.
  • FIG. 18 illustrates the tip of an embodiment of a lancet before, during and after the creation of an incision braced with a helix.
  • FIG. 19 illustrates a finger wound tract braced with an elastomer embodiment.
  • FIG. 20 is a perspective view of a tissue penetration device having features of the invention.
  • FIG. 21 is an elevation view in partial longitudinal section of the tissue penetration device of FlG. 20.
  • FIG. 24 is a transverse cross sectional view of the tissue penetration device of FIG. 21 taken along lines 24-24 of FIG. 21.
  • FIG. 27 is a side view of the drive coupler of the tissue penetration device of FIG. 21.
  • FIGS. 29A-29C show a flowchart illustrating a lancet control method.
  • FIG. 34 is a diagrammatic view of the lancet tip penetrating the skin of a patient's finger.
  • FIG. 36 is a diagrammatic view of the lancet tip withdrawing from the skin of a patient's finger.
  • FIG. 43 illustrates a sectional view of the layers of skin with a lancet disposed therein.
  • FIG. 44 is a graphical representation of velocity vs. position of a lancing cycle.
  • FIG.45 is a graphical representation of velocity vs. time of a lancing cycle.
  • FIG. 46 is an elevation view in partial longitudinal section of an alternative' embodiment of a driver coil pack and position sensor.
  • FIG. 47 is a perspective view of a flat coil driver having features of the invention.
  • FIG. 48 is an exploded view of the flat coil driver of FIG. 47.
  • FIG. 52 shows a housing that includes a driver and a chamber where the module shown in FIG. 51 can be loaded.
  • FIG. 56 illustrates the tissue penetration sampling device during a lancing event.
  • FIG. 57 illustrates a thermal sample sensor having a sample detection element near a surface over which a fluid may flow and an alternative position for a sampled detection element that would be exposed to a fluid flowing across the surface.
  • FIG. 58 shows a configuration of a thermal sample sensor with a sample detection element that includes a separate heating element.
  • FIG. 59 depicts three thermal sample detectors such as that shown in FIG. 58 with sample detection elements located near each other alongside a surface.
  • FIG. 60 illustrates thermal sample sensors positioned relative to a channel having an analysis site.
  • FIG. 64 is a top view in partial section of a sampling module of the tissue penetration sampling device of FIG. 63.
  • FIG. 65 is a cross sectional view through line 65-65 of the sampling module shown in FIG. 64.
  • FIG. 66 schematically depicts a sectional view of an alternative embodiment of the sampling module.
  • FIG. 67 depicts a portion of the sampling module surrounding a sampling port.
  • FIG. 74 is a perspective view in partial section of a tissue penetration sampling device with a cartridge of sampling modules.
  • FIG. 75 is a front view in partial section of the tissue penetration sampling device of FIG. 56.
  • FIG. 76 is a top view of the tissue penetration sampling device of FIG. 75.
  • FIG. 77 is a perspective view of a section of a sampling module belt having a plurality of sampling modules connected in series by a sheet of flexible polymer.
  • FIG. 78 is a perspective view of a single sampling module of the sampling module belt of FIG. 59.
  • FIG. 79 is a bottom view of a section of the flexible polymer sheet of the sampling module of FIG. 78 illustrating the flexible conductors and contact points deposited on the bottom surface of the flexible polymer sheet.
  • FIG. 80 is a perspective view of the body portion of the sampling module of FIG. 77 without the flexible polymer cover sheet or lancet.
  • FIG. 81 is an enlarged portion of the body portion of the sampling module of FIG. 80 illustrating the input port, sample flow channel, analytical region, lancet channel and lancet guides of the sampling module.
  • FIG. 82 is an enlarged elevational view of a portion of an alternative embodiment of a sampling module having a plurality of small volume analytical regions.
  • FIG. 83 is a perspective view of a body portion of a lancet module that can house and guide a lancet without sampling or analytical functions.
  • FIG. 84 is an elevational view of a drive coupler having a T-slot configured to accept a drive head of a lancet.
  • FIG. 85 is an elevational view of the drive coupler of FIG. 84 from the side and illustrating the guide ramps of the drive coupler.
  • FIG. 86 is a perspective view of the drive coupler of FIG. 84 with a lancet being loaded into the T-slot of the drive coupler.
  • FIG. 87 is a perspective view of the drive coupler of FIG. 86 with the drive head of the lancet completely loaded into the T-slot of the drive coupler.
  • FIG. 88 is a perspective view of a sampling module belt disposed within the T-slot of the drive coupler with a drive head of a lancet of one of the sampling modules loaded within the T-slot of the drive coupler.
  • FIG. 91 is a side view of an alternative embodiment of a drive coupler having a lateral slot configured to accept the L-shaped drive head of the lancet that is disposed within a lancet module and shown with the L-shaped drive head loaded in the lateral slot.
  • FIG. 92 is an exploded view of the drive coupler, lancet with L-shaped drive head and lancet module of FIG. 91.
  • FIG. 93 is a perspective view of the front of a lancet cartridge coupled to the distal end of a controlled electromagnetic driver.
  • FIG. 94 is an elevational front view of the lancet cartridge of FIG. 93.
  • FIGS. 97-101 illustrate an embodiment of an agent injection device.
  • FIGS. 102-106 illustrate an embodiment of a cartridge for use in sampling having a sampling cartridge body and a lancet cartridge body.
  • FIGS. 107-110 illustrate embodiments of a disposable cartridge of the present invention with a sensor housing and a penetrating member housing.
  • FIG. 1 Displacement velocity profiles for both spring driven and cam driven tissue penetration devices are shown in FIG, 1 and 2, respectively.
  • Velocity is plotted against displacement X of the lancet.
  • FIG. 1 represents a displacement/velocity profile typical of spring driven devices.
  • the lancet exit velocity increases until the lancet hits the surface of the skin 10. Because of the tensile characteristics of the skin, it will bend or deform until the lancet tip cuts the surface 20, the lancet will then penetrate the skin until it reaches a full stop 30. At this point displacement is maximal and reaches a limit of penetration and the lancet stops. Mechanical stops absorb excess energy from the driver and transfer it to the lancet.
  • the energy stored in the spring can cause recoil resulting in multiple piercing as seen by the coiled profile in FIG. 1. This results in unnecessary pain from the additional tissue penetration as well as from transferring vibratory energy into the skin and exciting nerve endings. Retraction of the lancet then occurs and the lancet exits the skin 40 to return into the housing. Velocity cannot be controlled in any meaningful way for this type of spring-powered driver.
  • the rapid cutting minimizes the shock waves produced when the lancet strikes the skin in addition to compressing the skin for efficient cutting. If a controllable driver is used, the need for a mechanical stop can be eliminated. Due to the very light mass of the lancet and lack of a mechanical stop, there is little or no vibrational energy transferred to the finger during cutting.
  • Spontaneous blood yield occurs when blood from the cut vessels flow up the wound tract to the surface of the skin, where it can be collected and tested. Tissue elasticity parameters may force the wound tract to close behind the retracting lancet preventing the blood from reaching the surface. If however, the lancet were to be withdrawn slowly from the wound tract, thus keeping the wound open, blood could flow up the patent channel behind the tip of the lancet as it is being withdrawn (ref. FIGS. 10 and 11). Hence the ability to control the lancet speed into and out of the wound allows the device to compensate for changes in skin thickness and variations in skin hydration and thereby achieves spontaneous blood yield with maximum success rate while minimizing pain.
  • An electromagnetic driver can be coupled directly to the lancet minimizing the mass of the lancet and allowing the driver to bring the lancet to a stop at a predetermined depth without the use of a mechanical stop. Alternatively, if a mechanical stop is required for positive positioning, the energy transferred to the stop can be minimized.
  • the electromagnetic driver allows programmable control over the velocity vs. position profile of the entire lancing process including timing the start of the lancet, tracking the lancet position, measuring the lancet velocity, controlling the distal stop acceleration, and controlling the skin penetration depth.
  • the tissue penetration device includes a controllable force driver in the form of an electromagnetic driver, which can be used to drive a lancet.
  • the term Lancet generally includes any sharp or blunt member, preferably having a relatively low mass, used to puncture the skin for the purpose of cutting blood vessels and allowing blood to flow to the surface of the skin.
  • Electromagnetic driver generally includes any device that moves or drives a tissue penetrating element, such as a lancet under an electrically or magnetically induced force.
  • FIG. 4 is a partially exploded view of an embodiment of an electromagnetic driver. The top half of the driver is shown assembled. The bottom half of the driver is shown exploded for illustrative purposes.
  • the stationary housing assembly consists of a PC board 20, a lower inner insulating housing 22, an upper inner insulating housing 32, an upper PC board 30, and rivets 18 assembled into a single unit.
  • the lower and upper inner insulating housing 22 and 32 are relieved to form a slot so that lancet assembly can be slid into the driver assembly from the side perpendicular to the direction of the lancet's advancement and retraction. This allows the disposal of the lancet assembly and reuse of the stationary housing assembly with another lancet assembly while avoiding accidental lancet launches during replacement.
  • insulating housing 30 are fabricated in a multi-layer printed circuit (PC) board. They may also be conventionally wound wire coils.
  • PC printed circuit
  • a Teflon® material, or other low friction insulating material is used to construct the lower and upper inner insulating housing 22 and 32.
  • Each insulating housing is mounted on the PC board to provide electrical insulation and physical protection, as well as to provide a low- friction guide for the lancet.
  • the lower and upper inner insulating housing 22 and 32 provide a reference surface with a small gap so that the lancet assembly 24 and 26 can align with the drive field coils in the PC board for good magnetic coupling.
  • Rivets 18 connect the lower inner insulating housing 22 to the lower stationary housing 20 and are made of magnetically permeable material such as ferrite or steel, which serves to concentrate the magnetic field. This mirrors the construction of the upper inner insulating housing 32 and upper stationary housing 30. These rivets form the poles of the electric field coils.
  • the PC board is fabricated with multiple layers of coils or with multiple boards. Each layer supports spiral traces around a central hole. Alternate layers spiral from the center outwards or from the edges inward. In this way each layer connects via simple feed-through holes, and the current always travels in the same direction, summing the ampere-turns.
  • Both lower and upper PC boards 20 and 30 contain drive coils so that there is a symmetrical magnetic field above and below the flag 26.
  • a magnetic field is established around the bars between the slits of the magnetically permeable iron on the flag 26.
  • the bars of the flag experience a force that tends to move the magnetically permeable material to a position minimizing the number and length of magnetic field lines and conducting the magnetic field lines between the magnetic poles.
  • the stationary iron housing 40 contains the driver coil pack with a first coil 52 is flanked by iron spacers 50 which concentrate the magnetic flux at the inner diameter creating magnetic poles.
  • the inner insulating housing 48 isolates the lancet 42 and iron core 46 from the coils and provides a smooth, low friction guide surface.
  • the lancet guide 44 further centers the lancet 42 and iron core 46.
  • the lancet 42 is protracted and retracted by alternating the current between the first coil 52, the middle coil, and the third coil to attract the iron core 46. Reversing the coil sequence and attracting the core and lancet back into the housing retracts the lancet.
  • the lancet guide 44 also serves as a stop for the iron core 46 mounted to the lancet 42.
  • tissue penetration devices which employ spring or cam driving methods have a symmetrical or nearly symmetrical actuation displacement and velocity profiles on the advancement and retraction of the lancet as shown in FIGS. 6 and 7.
  • the stored energy determines the velocity profile until the energy is dissipated. Controlling impact, retraction velocity, and dwell time of the lancet within the tissue can be useful in order to achieve a high success rate while accommodating variations in skin properties and minimize pain.
  • tissue dwell time is related to the amount of skin deformation as the lancet tries to puncture the surface of the skin and variance in skin deformation from patient to patient based on skin hydration.
  • the ability to control velocity and depth of penetration can be achieved by use of a controllable force driver where feedback is an integral part of driver control.
  • Such drivers can control either metal or polymeric lancets or any other type of tissue penetration element.
  • the dynamic control of such a driver is illustrated in FIG. 8 which illustrates an embodiment of a controlled displacement profile and FIG. 9 which illustrates an embodiment of a the controlled velocity profile. These are compared to FIGS. 6 and 7, which illustrate embodiments of displacement and velocity profiles, respectively, of a harmonic spring/mass powered driver.
  • Retraction of the lancet at a low velocity following the sectioning of the venuole/capillary mesh allows the blood to flood the wound tract and flow freely to the surface, thus using the lancet to keep the channel open during retraction as shown in FIGS. 10 and 11.
  • Low-velocity retraction of the lancet near the wound flap prevents the wound flap from sealing off the channel.
  • the ability to slow the lancet retraction directly contributes to increasing the success rate of obtaining blood.
  • Increasing the sampling success rate to near 100% can be important to the combination of sampling and acquisition into an integrated sampling module such as an integrated glucose-sampling module, which incorporates a glucose test strip.
  • the lancet and lancet driver are configured so that feedback control is based on lancet displacement, velocity, or acceleration.
  • the feedback control information relating to the actual lancet path is returned to a processor such as that illustrated in FIG. 12 that regulates the energy to the driver, thereby precisely controlling the lancet throughout its advancement and retraction.
  • the driver may be driven by electric current, which includes direct current and alternating current.
  • the electromagnetic driver shown is capable of driving an iron core or slug mounted to the lancet assembly using a direct current (DC) power supply and is also capable of determining the position of the iron core by measuring magnetic coupling between the core and the coils.
  • the coils can be used in pairs to draw the iron core into the driver coil pack.
  • the corresponding induced current in the adjacent coil can be monitored.
  • the strength of this induced current is related to the degree of magnetic coupling provided by the iron core, and can be used to infer the position of the core and hence, the relative position of the lancet.
  • the drive voltage can be turned off, allowing the coils to relax, and then the cycle is repeated.
  • the degree of magnetic coupling between the coils is converted electronically to a proportional DC voltage that is supplied to an analog-to-digital converter.
  • the digitized position signal is then processed and compared to a desired "nominal" position by a central processing unit (CPU).
  • the CPU to set the level and/or length of the next power pulse to the solenoid coils uses error between the actual and nominal positions.
  • the driver coil pack has three coils consisting of a central driving coil flanked by balanced detection coils built into the driver assembly so that they surround an actuation or magnetically active region with the region centered on the middle coil at mid-stroke.
  • a current pulse is applied to the central coil, voltages are induced in the adjacent sense coils. If the sense coils are connected together so that their induced voltages oppose each other, the resulting signal will be positive for deflection from mid-stroke in one direction, negative in the other direction, and zero at mid-stroke.
  • This measuring technique is commonly used in Linear Variable Differential Transformers (LVDT). Lancet position is determined by measuring the electrical balance between the two sensing coils.
  • LVDT Linear Variable Differential Transformers
  • a feedback loop can use a commercially available LED/photo transducer module such as the OPB703 manufactured by Optek Technology, Inc., 1215 W. Crosby Road, Carrollton, Texas, 75006 to determine the distance from the fixed module on the stationary housing to a reflective surface or target mounted on the lancet assembly.
  • the LED acts as a light emitter to send light beams to the reflective surface, which in turn reflects the light back to the photo transducer, which acts as a light sensor.
  • Distances over the range of 4 mm or so are determined by measuring the intensity of the reflected light by the photo transducer.
  • a feedback loop can use a magnetically permeable region on the lancet shaft itself as the core of a Linear Variable Differential Transformer (LVDT).
  • LVDT Linear Variable Differential Transformer
  • a permeable region created by selectively annealing a portion of the lancet shaft, or by including a component in the lancet assembly, such as ferrite, with sufficient magnetic permeability to allow coupling between adjacent sensing coils. Coil size, number of windings, drive current, signal amplification, and air gap to the permeable region are specified in the design process.
  • the feedback control supplies a piezoelectric driver, superimposing a high frequency oscillation on the basic displacement profile.
  • the piezoelectric driver provides improved cutting efficiency and reduces pain by allowing the lancet to "saw” its way into the tissue or to destroy cells with cavitation energy generated by the high frequency of vibration of the advancing edge of the lancet.
  • the drive power to the piezoelectric driver is monitored for an impedance shift as the device interacts with the target tissue.
  • the resulting force measurement, coupled with the known mass of the lancet is used to determine lancet acceleration, velocity, and position.
  • the lancet retraction phase further comprises a primary retraction phase E when the skin pushes the lancet out of the wound tract, a secondary retraction phase F when the lancet starts to become dislodged and pulls in the opposite direction of the skin, and lancet exit phase G when the lancet becomes free of the skin.
  • Primary retraction is the result of exerting a decreasing force to pull the lancet out of the skin as the lancet pulls away from the finger.
  • Secondary retraction is the result of exerting a force in the opposite direction to dislodge the lancet. Control is necessary to keep the wound tract open as blood flows up the wound tract.
  • FIG. 14 shows a standard industry lancet for glucose testing which has a three-facet geometry. Taking a rod of diameter 114 and grinding 8 degrees to the plane of the primary axis to create the primary facet 110 produces the lancet 116. The secondary facets 112 are then created by rotating the shaft of the needle 15 degrees, and then rolling over 12 degrees to the plane of the primary facet. Other possible geometry's require altering the lancet's production parameters such as shaft diameter, angles, and translation distance.
  • FIG. 15 illustrates facet and tip geometry 120 and 122, diameter 124, and depth 126 which are significant factors in reducing pain, blood volume and success rate. It is known that additional cutting by the lancet is achieved by increasing the shear percentage or ratio of the primary to secondary facets, which when combined with reducing the lancet's diameter reduces skin tear and penetration force and gives the perception of less pain. Overall success rate of blood yield, however, also depends on a variety of factors, including the existence of facets, facet geometry, and skin anatomy.
  • FIG. 18 shows the use of an embodiment of the invention, which includes a retractable coil on the lancet tip.
  • a coiled helix or tube 140 is attached externally to lancet 116 with the freedom to slide such that when the lancet penetrates the skin 150, the helix or tube 140 follows the trajectory of the lancet 116.
  • the helix begins the lancing cycle coiled around the facets and shaft of the lancet 144. As the lancet penetrates the skin, the helix braces the wound tract around the lancet 146.
  • a position sensor 191 is disposed about a proximal portion 192 of the elongate coupler shaft 184 and an electrical conductor 194 electrically couples a processor 193 to the position sensor 191.
  • the elongate coupler shaft 184 driven by the driver coil pack 188 controlled by the position sensor 191 and processor 193 form the controllable driver, specifically, a controllable electromagnetic driver.
  • the lancing device 180 can be seen in more detail, in partial longitudinal section.
  • the lancet 183 has a proximal end 195 and a distal end 196 with a sharpened point at the distal end 1.96 of the lancet 183 and a drive head 198 disposed at the proximal end 195 of the lancet 183.
  • a lancet shaft 201 is disposed between the drive head 198 and the sharpened point 197.
  • the lancet shaft 201 may be comprised of stainless steel, or any other suitable material or alloy and have a transverse dimension of about 0.1 to about 0.4 mm.
  • the lancet shaft may have a length of about 3 mm to about 50 mm, specifically, about 15 mm to about 20 mm.
  • the drive head 198 of the lancet 183 is an enlarged portion having a transverse dimension greater than a transverse dimension of the lancet shaft 201 distal of the drive head 198. This configuration allows the drive head 198 to be mechanically captured by the drive coupler 185.
  • the drive head 198 may have a transverse dimension of about 0.5 to about 2 mm.
  • An inner lumen of the polymer non-magnetic disc 219" can be configured to allow the magnetic member 202 to pass axially there through while an inner lumen of the disc magnet 219' can be configured to allow the elongate coupler shaft 184 to pass through but not large enough for the magnetic member 202 to pass through. This results in the magnetic member 202 being attracted to the disc magnet 219" and coming to rest with the proximal surface of the magnetic member 202 against a distal surface of the disc magnet 219'. This arrangement provides for a positive and repeatable stop for the magnetic member, and hence the lancet. A similar configuration could also be used for the bar magnet 219 discussed above.
  • the drive coupler 185 can be made from an alloy such as stainless steel, titanium or aluminum, but may also be made from a suitable polymer such as ABS, PVC, polycarbonate plastic or the like.
  • the drive coupler may be open on both sides allowing the drive head and lancet to pass through.
  • the processor 193 In the next operation, represented by the flow diagram box numbered 247, the processor 193 energizes one or more of the coils in the coil pack 188. This should cause the lancet 183 to begin to move (i.e., achieve a non-zero speed) toward the skin target 233. The processor 193 then determines whether or not the lancet is indeed moving, as represented by the decision box numbered 249. The processor 193 can determine whether the lancet 183 is moving by monitoring the position of the lancet 183 to determine whether the position changes overtime.
  • the process proceeds to the operation represented by the flow diagram box numbered 257.
  • the processor 193 causes the lancet 183 to continue to accelerate and launch toward the skin target 233, as indicated by the arrow 235 in FIG. 30.
  • the processor 193 can achieve acceleration of the lancet 183 by sending an electrical current to an appropriate coil 214-217 such that the coil 214-217 exerts an attractive magnetic launching force on the magnetic member 202 and causes the magnetic member 202 and the lancet 183 coupled thereto to move in a desired direction.
  • the processor 193 can cause an electrical current to be sent to the third coil 216 so that the third coil 216 attracts the magnetic member 202 and causes the magnetic member 202 to move from a position adjacent the fourth coil 217 toward the third coil 216.
  • the processor preferably determines which coil 214-217 should be used to attract the magnetic member 202 based on the position of the magnetic member 202 relative to the coils 214-217. In this manner, the processor 193 provides a controlled force to the lancet that controls the movement of the lancet.
  • the processor 193 may use software to determine whether the lancet 183 has made contact with the patient's skin 233 by measuring for a sudden reduction in velocity of the lancet 183 due to friction or resistance imposed on the lancet 183 by the patient's skin 233.
  • the optical encoder 191 measures displacement of the lancet 183.
  • the position output data provides input to the interrupt input of the processor 193.
  • the processor 193 also has a timer capable of measuring the time between interrupts. The distance between interrupts is known for the optical encoder 191, so the velocity of the lancet 183 can be calculated by dividing the distance between interrupts by the time between the interrupts.
  • contact of the lancet 183 with the patient's skin 233 can be determined by measurement of electrical continuity in a circuit that includes the lancet 183, the patient's finger 234 and an electrical contact pad 240 that is disposed on the patient's skin 233 adjacent the contact site 237 of the lancet 183, as shown in FIG. 31.
  • the circuit 239 is completed and current flows through the circuit 239. Completion of the circuit 239 can then be detected by the processor 193 to confirm skin 233 contact by the lancet 183.
  • the processor 193 considers the length of the lancet 183 (which can be stored in memory) the position of the lancet 183 relative to the magnetic member 202, as well as the distance that the lancet 183 has traveled. With reference again to the decision box 265 in FIG. 29B, if the processor
  • the processor 193 determines that the lancet 183 has contacted the skin 233 (a "Yes" outcome from the decision box 265), then the processor 193 can adjust the speed of the lancet 183 or the power delivered to the lancet 183 for skin penetration to overcome any frictional forces on the lancet 183 in order to maintain a desired penetration velocity of the lancet.
  • the flow diagram box numbered 267 represents this.
  • Penetration measurement can be carried out by a variety of methods that are not dependent on measurement of tenting of the patient's skin.
  • the penetration depth of the lancet 183 in the patient's skin 233 is measured by monitoring the amount of capacitance between the lancet 183 and the patient's skin 233.
  • a circuit includes the lancet 183, the patient's finger 234, the processor 193 and electrical conductors connecting these elements.
  • the lancet 183 penetrates the patient's skin 233, the greater the amount of penetration, the greater the surface contact area between the lancet 183 and the patient's skin 233.
  • the increased capacitance can be easily measured by the processor 193 using methods known in the art and penetration depth can then be correlated to the amount of capacitance.
  • the same method can be used by measuring the electrical resistance between the lancet 183 and the patient's skin.
  • FIG. 29B if the lancet 183 is stuck at a certain depth, then the process proceeds to the operation represented by the flow diagram box numbered 275.
  • the processor 193 causes a braking force to be applied to the lancet to thereby reduce the speed of the lancet 183 to achieve a desired amount of final skin penetration depth 244, as shown in FIG. 26.
  • FIGS. 32 and 33 illustrate the lancet making contact with the patient's skin and deforming or depressing the skin prior to any substantial penetration of the skin.
  • FIG. 42 shows both a velocity versus time graph and a position versus time graph of a lancet tip 196 during a lancing cycle that includes elastic and inelastic tenting.
  • FIG. 42 shows both a velocity versus time graph and a position versus time graph of a lancet tip 196 during a lancing cycle that includes elastic and inelastic tenting.
  • the lancet 183 is being accelerated from the initialization position or zero position.
  • point B the lancet is in ballistic or coasting mode, with no additional power being delivered.
  • the lancet tip 196 contacts the tissue 233 and begins to tent the skin 233 until it reaches a displacement C.
  • FIG. 43 shows a cross sectional view of the layers of the skin 233.
  • the stratum corneum is typically about 0.1 to about 0.6 mm thick and the distance from the top of the dermis to the venuole plexus can be from about 0.3 to about 1.4 mm.
  • Elastic tenting can have a magnitude of up to about 2 mm or so, specifially, about 0.2 to about 2.0 mm, with an average magnitude of about 1 mm.
  • Withdrawal speed of the lancet in some embodiments can be about 0.004 to about 0.5 m/s, specifically, about 0.006 to about 0.01 m/s.
  • useful withdrawal velocities can be about 0.001 to about 0.02 meters per second, specifically, about 0.001 to about 0.01 meters per second.
  • the withdrawal velocity may up to about 0.02 meters per second.
  • a ratio of the average penetration velocity relative to the average withdrawal velocity can be about 100 to about 1000.
  • a withdrawal velocity of about 2 to about 10 meters per second may be used.
  • the processor 193 determines that an error condition is present, as represented by the flow diagram box numbered 284. In such a situation, the processor preferably de-energizes the coils to remove force from the lancet, as the lack of movement may be an indication that the lancet is stuck in the skin of the patient and, therefore, that it may be undesirable to continue to attempt pull the lancet out of the skin.
  • the process proceeds to the operation represented by the flow diagram box numbered 285.
  • the backward movement of the lancet 183 continues until the lancet distal end has been completely withdrawn from the patient's skin 233.
  • the lancet 183 is withdrawn with less force and a lower speed than the force and speed during the penetration portion of the operation cycle.
  • the relatively slow withdrawal of the lancet 183 may allow the blood from the capillaries of the patient accessed by the lancet 183 to follow the lancet 183 during withdrawal and reach the skin surface to reliably produce a usable blood sample. The process then ends.
  • the driver coil pack 295 includes a most distal first coil 305, a second coil 306, which is axially disposed between the first coil
  • Each of the first coil 305, second coil 306, third coil 307 and fourth coil 308 has an axial lumen.
  • the position of the lancet 297 can thereafter be determined by measuring the intensity of reflected light at any given moment.
  • the sensor 296 uses a commercially available LED/photo transducer module such as the OPB703 manufactured by Optek Technology, Inc., 1215 W. Crosby Road, Carrollton, Texas, 75006. This method of analog reflective measurement for position sensing can be used for any of the embodiments of lancet actuators discussed herein.
  • a second end 337 of the coupler linkage 336 is disposed within an opening at a proximal end 338 of a coupler translation member 341.
  • This configuration allows circumferential forces imposed upon the actuator arm 332 to be transferred into linear forces on a drive coupler 342 secured to a distal end 343 of the coupler translation member 341.
  • the materials and dimensions of the drive coupler 342 can be the same or similar to the materials and dimensions of the drive coupler 342 discussed above.
  • the rotational forces imposed on the segments 346 and 347 are transferred to the rotating frame 327 to the actuator arm 332, through the coupler linkage 336 and coupler translation member 341 and eventually to the drive coupler 342.
  • a lancet (not shown) is secured into the drive coupler 342, and the flat coil lancet actuator 325 activated.
  • the electrical current in the flat coil 345 determines the forces generated on the drive coupler 342, and hence, a lancet secured to the coupler 342.
  • the processor 360 controls the electrical current in the flat coil 345 based on the position and velocity of the lancet as measured by the position sensor 357 information sent to the processor 360.
  • the processor 360 is able to control the velocity of a lancet in a manner similar to the processor 193 discussed above and can generate any of the desired lancet velocity profiles discussed above, in addition to others.
  • Assays that are relevant to embodiments of the present invention include those that result in the measurement of individual analytes or enzymes, e.g., glucose, lactate, creatinine kinase, etc, as well as those that measure a characteristic of the total sample, for example, clotting time (coagulation) or complement-dependent lysis.
  • Other embodiments for this invention provide for sensing of sample addition to a test article or arrival of the sample at a particular location within that article.
  • Measuring the arrival of fluid at the site of interest thus indicates the zero- or start-time of the reaction to be performed.
  • these sites may be any of a variety of desired locations along the fluidic pathway.
  • Embodiments of the invention are particularly well suited to a microfluidic cartridge or platform, which provide the user with an assurance that a fluid sample has been introduced and has flowed to the appropriate locations in the platform.
  • Embodiments of the invention accomplish this in a variety of ways.
  • an initial temperature measurement is made at a thermal sensor without the sample present.
  • the arrival of a sample changes causes the thermal sensor to register a new value. These values are then compared.
  • a second hardware implementation requires a separate heating element in or near the flow channel, plus a thermal sensor arrangement in close proximity. Passing a current through the element provides heat to the local environment and establishes a local temperature detected by the thermocouple device. This temperature or its dynamic response is altered by the arrival of the fluid or blood in or near the local environment, similar to the previously described implementation, and the event is detected electronically.
  • the chamber has a first side 620 that has a flat or slightly spherical shape absent of sharp corners and is formed by a smooth polymer.
  • An elastomeric diaphragm 621 is attached to the perimeter of the chamber 616 and preferably is capable of closely fitting to the first side of the chamber 620.
  • a chemical sensor or other testing means is located within the sampling module, and the blood is delivered to the chemical sensor or other testing means via a blood transfer channel in fluid communication with the sample reservoir.
  • the components of the sampling module may be injection molded and the diaphragm may be fused or insertion molded as an integral component.
  • FIG. 67 depicts a portion of the disposable sampling module surrounding the sampling port 627, including a portion of the sampling site cradle surface 628.
  • the housing of the sampling module includes a primary sample flow channel 629 that is a capillary channel connecting the sample input port to the sample reservoir.
  • the primary sample flow channel 629 includes a primary channel lumenal surface 630 and a primary channel entrance 631, the primary channel entrance 631 opening into the sample input port 627.
  • the sampling module may optionally include a supplemental sample flow channel 632 that is also a capillary channel having a supplemental channel lumenal surface 633 and a supplemental channel entrance 634, the supplemental channel entrance 634 opening into the sample
  • FIGS. 68-70 illustrate one implementation of a lancet driver 640 at three different points during the use of the lancet driver.
  • proximal indicates a position relatively close to the site of attachment of the sampling module; conversely, distal indicates a position relatively far from the site of attachment of the sampling module.
  • the lancet driver has a driver handle body 641 defining a cylindrical well 642 within which is a preload spring 643.
  • Proximal to the preload spring 643 is a driver sleeve 644, which closely fits within and is slidably disposed within the well 642.
  • the driver sleeve 644 defines a cylindrical driver chamber 645 within which is an actuator spring 646.
  • Proximal to the actuator spring 646 is a plunger sleeve 647, which closely fits within and is slidably disposed within the driver sleeve 644.
  • the lancet driver includes a plunger stem 660 having a proximal end 661 and a distal end 662. At its distal end 662, an enlarged plunger head 663 terminates the plunger stem 660. At its proximal end 661 , the plunger stem 660 is fixed to the plunger tip 667 by adhesively bonding, welding, crimping, or threading into a hole 665 in the plunger tip 667. A plunger hook 665 is located on the plunger stem 660 between the plunger head 663 and the plunger tip 667. The plunger head 663 is slidably disposed within the counterbore 651 defined by the preload screw 650.
  • up to three sample reservoirs are present in a single sample acquisition module, each connected via a capillary channel/valving system to one or more sampling ports.
  • Another embodiment has four sample reservoirs (the primary plus three backup) present in a single sample acquisition module, each connected via a capillary channel/valving system to one or more sampling ports. With three or four sample reservoirs, at least an 80% sampling success rate can be achieved for some embodiments.
  • Another embodiment includes a miniaturized version of the tissue penetration sampling device. Several of the miniature lancets may be located in a single sampling site, with corresponding sample flow channels to transfer blood to one or more reservoirs. The sample flow channels may optionally have valves for controlling flow of blood.
  • the device may also include one or more sensors, such as the thermal sensors discussed above, for detecting the presence of blood, e.g. to determine if a sufficient quantity of blood has been obtained.
  • the disposable sampling module, the lancet driver, and the optional module cartridge will have dimensions no larger than about 150 mm long, 60 mm wide, and 25 mm thick.
  • the size of the tissue penetration sampling device including the disposable sampling module, the lancet driver, and the optional cartridge will have dimensions no larger than about 100 mm long, about 50 mm wide, and about 20 mm thick, and in still other embodiments no larger than about 70 mm long, about 30 mm wide, and about 10 mm thick.
  • the size of the tissue penetration sampling device including the disposable sampling module, the lancet driver, and the optional cartridge will generally be at least about 10 mm long, about 5 mm wide, and about 2 mm thick.
  • dimensions of the miniature sampling module without the lancet driver or cartridge are no larger than about 15 mm long, about 10 mm wide, and about 10 mm thick, or no larger than about 10 mm long, about 7 mm wide, and about 7 mm thick, or no larger than about 5 mm long, about 3 mm wide, and about 2 mm thick; dimensions of the miniature sampling module without the lancet driver or cartridge are generally at least about 1 mm long, 0.1 mm wide, and 0.1 mm thick, specifically at least about 2 mm long, 0.2 mm wide, and 0.2 mm thick, or more specifically at least about 4 mm long, 0.4 mm wide, and 0.4 mm thick.
  • sampling module cartridge is radially partitioned into many sampling modules, each sampling module having the components necessary to perform a single blood sampling and testing event.
  • a plurality of sampling modules are present on a sampling module cartridge, generally at least ten sampling modules are present on a single disposable sampling module cartridge; at least about 20, or more on some embodiments, and at least about 34 sampling modules are present on one embodiment, allowing the sampling module cartridge to be maintained in the analyzer device for about a week before replacing with a new sampling module cartridge (assuming five sampling and testing events per day for seven days).
  • the usefulness of such a film is its ability to reseal after the lancet tip has penetrated it without physically affecting the lancet's cutting tip and edges.
  • the MYLAR® film provides structural stability while the thin SYLGARD® silicone laminate is flexible enough to retain its form and close over the hole made in the MYLAR® film.
  • Other similar materials fulfilling the structural stability and flexibility roles may be used in the manufacture of the pierceable membrane in this embodiment.
  • the sampling module cartridge is able to return a valid testing result with less than about 5 microliters of blood taken from the skin of a patient, specifically less than about 1 microliter, more specifically less than about 0.4 microliters, and even more specifically less than about 0.2 microliters. Generally, at least 0.05 microliters of blood is drawn for a sample.
  • a tissue penetration sampling device 180 is shown with the controllable driver 179 of FIG. 20 coupled to a sampling module cartridge 705 and disposed within a driver housing 706.
  • a ratchet drive mechanism 707 is secured to the driver housing 706, coupled to the sampling module cartridge 705 and configured to advance a sampling module belt 708 within the sampling module cartridge 705 so as to allow sequential use of each sampling module 709 in the sampling module belt 708.
  • the ratchet drive mechanism 707 has a drive wheel 711 configured to engage the sampling modules 709 of the sampling module belt 708.
  • the drive wheel 711 is coupled to an actuation lever 712 that advances the drive wheel 711 in increments of the width of a single sampling module 709.
  • FIGS. 80 and 81 show a perspective view of the body portion 731 of the sampling module 709 of FIG. 77 without the flexible polymer cover sheet 727 or lancet 183 shown for purposes of illustration.
  • FIG. 81 is an enlarged view of a portion of the body portion 731 of the sampling module 709 of FIG. 80 illustrating the sampling site 715, sample input cavity 715', sample input port 741, sample flow channel 742, analytical region 743, control chamber 744, vent 762, lancet . channel 736, lancet channel stopping structures 747 and 748 and lancet guides 749-751 of the sampling module 709.
  • the lancet channel 736 has a proximal end 752 and a distal end 753 and includes a series of lancet bearing guide portions 749-751 and sample flow stopping structures 747-748.
  • the lancet guides 749-751 may be configured to fit closely with the shaft of the lancet 183 and confine the lancet 183 to substantially axial movement.
  • the distal-most lancet guide portion 749 is disposed adjacent the sample input port 741 and includes at its distal-most extremity, the lancet exit port 754 which is disposed adjacent the sample input cavity 715'.
  • Proximal of the distal-most lancet guide portion 749 is a distal sample flow stop 747 that includes a chamber adjacent the distal-most lancet 749.
  • the chamber has a transverse dimension that is significantly larger than the transverse dimension of the distal-most lancet guide 749.
  • the chamber can have a width of about 600 to about 800 microns, and a depth of about 400 to about 600 microns and a length of about 2000 to about 2200 microns.
  • the rapid transition of transverse dimension and cross sectional area between the distal-most lancet bearing guide 749 and the distal sample flow stop 747 interrupts the capillary action that draws a fluid sample through the sample input cavity 715' and into the lancet channel 736.
  • a distal fracturable seal (not shown) can be disposed between the lancet 183 and the distal-most lancet guide 749 of the sampling module 709 to seal the distal end 753 of the lancet channel 736 and sample input port 741 to maintain sterility of the interior portion of the sampling module 709 until the lancet 183 is driven forward during a lancing cycle.
  • the analytical region 743 accommodates a blood sample that travels by capillary action from the sampling site 715 through the sample input cavity 715' and into the sample input port 741 , through the sample flow channel 742 and into the analytical region 743.
  • the blood can then travel into the control chamber 744.
  • the control chamber 744 and analytical region 743 are both vented by the vent 762 that allows gases to escape and prevents bubble formation and entrapment of a sample in the analytical region 743 and control chamber 744. Note that, in addition to capillary action, flow of a blood sample into the analytical region 743 can be facilitated or accomplished by application of vacuum, mechanical pumping or any other suitable method.
  • Another analytical method uses coulomb metric measurement of glucose concentration. This method is accurate if the sample volume is less than about 1 microliter and the volume of the analytical region is precisely controlled. The accuracy and the speed of the method is dependent on the small and precisely known volume of the analytical region 767 because the rate of the analysis is volume dependent and large volumes slow the reaction time and negatively impact the accuracy of the measurement.
  • Another analytical method uses an optical fluorescence decay measurement that allows very small sample volumes to be analyzed. This method also requires that the volume of the analytical region 767 be precisely controlled.
  • the small volume analytical regions 767 discussed above can meet the criteria of maintaining small accurately controlled volumes when the small volume analytical regions 767 are formed using precision manufacturing techniques. Accurately formed small volume analytical regions 767 can be formed in materials such as PMMA by methods such as molding and stamping. Machining and etching, either by chemical or laser processes can also be used. Vapor deposition and lithography can also be used to achieve the desired results.
  • tissue penetration sampling device 180 of FIG. 74 use of the device 180 begins with the loading of a sampling module cartridge 705 into the controllable driver housing 706 so as to couple the cartridge 705 to the controllable driver housing 706 and engage the sampling module belt 708 with the ratchet drive 707 and drive coupler 713 of the controllable driver 179.
  • the drive coupler 713 can have a T-slot configuration such as shown in FIGS. 84 and 85.
  • the distal end of the elongate coupler shaft 184 is secured to the drive coupler 713 which has a main body portion 779, a first and second guide ramp 780 and 781 and a T-slot 714 disposed within the main body portion 779.
  • the T-slot 714 is configured to accept the drive head 198 of the lancet 183.
  • the sampling module belt 708 is advanced laterally until the drive head 198 of a lancet 183 of one of the sampling modules 709 is fed into the drive coupler 713 as shown in FIGS. 86-88.
  • FIGS. 86-88 also illustrate a lancet crimp device 783 that bends the shaft portion 201 of a used lancet 183 that is adjacent to the drive coupler 713. This prevents the used lancet 183 from moving out through the module body 731 and being reused.
  • the distal end 792 of the drive coupler 791 contacts and sticks to the adhesive 790 of proximal surface of the drive head 198 of the lancet 183 during the beginning of the lancet cycle.
  • the driver coupler 791 pushes the lancet 183 into the target tissue 237 to a desired depth of penetration and stops.
  • the drive coupler 791 then retracts the lancet 183 from the tissue 233 using the adhesive contact between the proximal surface of the drive head 198 of the lancet 183 and distal end surface of the drive coupler 791 , which is shaped to mate with the proximal surface.
  • the L-shaped embodiment of the drive head 798 may be a less expensive option for producing a coupling arrangement that allows serial advancement of a sampling module belt or lancet module belt through the drive coupler 796 of a lancet driver, such as a controllable lancet driver 179.
  • a lancet driver such as a controllable lancet driver 179.
  • the lancet guide wheel 826' then advances the lancet 183 laterally until the drive head 198 of the lancet 183 is loaded into the drive coupler 713 of the controllable driver 179.
  • the controllable driver 179 can then.be activated driving the lancet 183 into the target tissue 233 and retracted to complete the lancing cycle.
  • a device for injecting a drug or other useful material into the tissue of a patient is illustrated.
  • the ability to localize an injection or vaccine to a specific site within a tissue, layers of tissue or organ within the body can be important.
  • epithelial tumors can be treated by injection of antigens, cytokine, or colony stimulating factor by hypodermic needle or high-pressure injection sufficient for the antigen to enter at least the epidermis or the dermis of a patient.
  • the efficacy of a drug or combination drug therapy depends on targeted delivery to localized areas thus affecting treatment outcome.
  • the latch springs 938 shown in the agent injection module 915 of FIGS. 99-101 may be molded with a number of ratchet teeth (not shown) that engage the proximal end 932 of the collapsible canister 917 as it passes by on the penetration stroke. If the predetermined depth of penetration is less than the full stroke, the intermediate teeth retain the proximal end 932 of the collapsible canister 917 during the withdrawal stroke in order to collapse the main chamber 918 of the collapsible canister 917 and dispense the drug or agent 913 as discussed above.
  • sampling cartridge body 947 and lancet cartridge body 946 are disposed adjacent each other in an operative configuration such that each lancet module portion 950 can be readily aligned in a functional arrangement with each sampling module portion 948.
  • the sampling cartridge body 947 is rotatable with respect to the lancet cartridge body 946 in order to align any lancet channel 951 and corresponding lancet 183 of the lancet cartridge body 946 with any of the lancet channels 953 of the sampling module portions 948 of the sampling cartridge body 947.
  • the sampling cartridge body 947 includes a base 961 and a cover sheet
  • the spatial separation of the proximal surface 968 of the cover sheet 962 from the distal surface 969 of the lancet cartridge body 946 is achieved with a boss 970 between the two surfaces 968 and 969 that is formed into the distal surface 969 of the lancet cartridge body as shown in FIG. 105.
  • the sample reservoirs 964 of the sampling cartridge body 947 may include any of the sample detection sensors, testing sensors, sensor contacts or the like discussed above with regard to other sampling module embodiments.
  • the cover sheet 962 may be formed of PMMA and have conductors, sensors or sensor contacts formed on a surface thereof. It may also be desirable to have the cover sheet 962 made from a transparent or translucent material in order to use optical sensing or testing methods for samples obtained in the sample reservoirs.
  • the penetrating member 1012 is aligned with the analyte sensor 1014.
  • the alignment provides that upon penetration by a penetrating member 1012 at a selected tissue site, blood flows into the analyte sensor 1014.
  • This embodiment provides an integrated lancing and sample capture device with analyte sensing.
  • front and rear seals 1022 associated with the analyte sensor 1014, are removed. After the seals 1022 are removed, a penetrating member 1012 can be actuated through or next to an opening in an associated analyte sensor support and enter the finger. In one specific embodiment, the removal and/or opening of the seals

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Abstract

Selon la présente invention, un appareil d’échantillonnage de liquide organique destiné à un site tissulaire comprend un générateur de force motrice. Une pluralité d’éléments pénétrants sont logés dans un corps d’éléments pénétrants. Chaque élément pénétrant est conçu pour un couplage au générateur de force motrice. Une pluralité de capteurs d’analyte sont logés dans un corps de capteurs d’analyte. Chaque capteur d’analyte est associé à un élément pénétrant. Le corps de capteurs d’analyte enveloppe le corps d’éléments pénétrants et est ainsi positionné lors de la commande d’un élément pénétrant, la pénétration d’un tel élément dans un épiderme amenant du sang à s’écouler dans le capteur d’analyte.
PCT/US2006/048129 2005-12-14 2006-12-14 Dispositif de penetration tissulaire Ceased WO2007070719A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06845671A EP1968461A4 (fr) 2005-12-14 2006-12-14 Dispositif de penetration tissulaire

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US75050405P 2005-12-14 2005-12-14
US60/750,504 2005-12-14
US11/318,334 2005-12-22
US11/318,334 US20060195133A1 (en) 2001-06-12 2005-12-22 Tissue penetration device

Publications (2)

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WO2007070719A2 true WO2007070719A2 (fr) 2007-06-21
WO2007070719A3 WO2007070719A3 (fr) 2009-01-15

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US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
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
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US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
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US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
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WO2023067389A1 (fr) * 2021-10-20 2023-04-27 Paulus Holdings Limited Dispositifs de collecte de sang capillaire et méthodes associées

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US9427532B2 (en) 2001-06-12 2016-08-30 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
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
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
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
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9907502B2 (en) 2002-04-19 2018-03-06 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
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus 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
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9339612B2 (en) 2002-04-19 2016-05-17 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
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
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9144401B2 (en) 2003-06-11 2015-09-29 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
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
WO2023067389A1 (fr) * 2021-10-20 2023-04-27 Paulus Holdings Limited Dispositifs de collecte de sang capillaire et méthodes associées

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WO2007070719A3 (fr) 2009-01-15
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