US20040236250A1 - Method and device for sampling and analyzing interstitial fluid and whole blood samples - Google Patents

Method and device for sampling and analyzing interstitial fluid and whole blood samples Download PDF

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US20040236250A1
US20040236250A1 US10369120 US36912003A US20040236250A1 US 20040236250 A1 US20040236250 A1 US 20040236250A1 US 10369120 US10369120 US 10369120 US 36912003 A US36912003 A US 36912003A US 20040236250 A1 US20040236250 A1 US 20040236250A1
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chamber
analysis
penetration
probe
device
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Alastair Hodges
Ron Chatelier
Garry Chambers
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Alastair Hodges
Ron Chatelier
Garry Chambers
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213Venting means
    • AHUMAN NECESSITIES
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    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221Valves
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    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
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    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • AHUMAN NECESSITIES
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    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15105Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
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    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving 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
    • A61B5/15117Driving 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142Devices intended for single use, i.e. disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices 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
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/1519Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B2010/008Interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157

Abstract

The invention disclosed in this application is a method and device for combining the sampling and analyzing of sub-dermal fluid samples, e.g., interstitial fluid or whole blood, in a device suitable for hospital bedside and home use. It is applicable to any analyte that exists in a usefully representative concentration in the fluid, and is especially suited to the monitoring of glucose.

Description

    RELATED APPLICATIONS
  • [0001]
    This application is a continuation of Application No. 10/166,487, filed Jun. 10, 2002, which is a continuation of Application No. 09/536,235, filed Mar. 27, 2000.
  • FIELD OF THE INVENTION
  • [0002]
    The present invention relates to a method and device for combining the sampling and analyzing of interstitial fluid or whole blood samples which is suitable for hospital bedside and home use.
  • BACKGROUND OF THE INVENTION
  • [0003]
    The management of many medical conditions requires the measurement and monitoring of a variety of analytes in bodily fluid. Historically, the measurement of analytes in blood has required an invasive technique, such as a venipuncture or finger puncture, to obtain blood for sampling purposes. An example of an analyte which is routinely tested by obtaining a blood sample through an invasive technique is glucose. In order to control their condition, diabetics must monitor their glucose levels on a regular basis. Invasive techniques used to obtain a blood sample for analysis have the disadvantage of being painful, which can reduce patient compliance in regular monitoring. Repeated testing, e.g., on a fingertip, can result in scar tissue build-up which makes obtaining a sample in that region more difficult. Moreover, invasive sampling procedures pose a risk of infection or disease transmission.
  • [0004]
    An alternative is to sample interstitial fluid rather than whole blood. Interstitial fluid is the fluid that fills the space between the connective tissue and cells of the dermal layer of the skin. An application where interstitial fluid has been shown to be an appropriate sampling substitute for plasma or whole blood is in the measurement of glucose concentration (J. Lab. Clin. Med. 1997, 130, 436-41).
  • [0005]
    In the patents U.S. Pat. No. 5,879,367, U.S. Pat. No. 5,879,310, U.S. Pat. No. 5,820,570 and U.S. Pat. No. 5,582,184 are disclosed methods of sampling using a fine needle in conjunction with a device to limit the penetration depth to obtain small volumes of interstitial fluid for the purpose of glucose monitoring. However, there is no method disclosed for analyzing the drawn samples that is suitable for home use or hospital bedside use.
  • SUMMARY OF THE INVENTION
  • [0006]
    It is desirable to be able to measure the concentration of analytes in humans or other animals without having to draw a blood sample by conventional methods. It is further desirable to be able to do so with an inexpensive disposable device that is simple enough for home or hospital bedside use.
  • [0007]
    The invention provides a suitable alternative to conventional sampling devices and methods that is less invasive than traditional whole blood sampling techniques and that requires a considerably smaller sample volume than is required in the conventional venipuncture or finger puncture sampling methods. Because of the smaller sample volume required, a smaller wound is necessary to obtain the sample. In the conventional finger stick method, a drop of blood is formed on the tip of a finger, then the sensor sample entrance is wetted with the drop. Because the sample comes into contact with the skin surface, contamination of the sample by material on the skin surface is possible. The devices and methods disclosed herein do not require forming a blood drop on the surface of the skin, and therefore have less risk of sample contamination.
  • [0008]
    In one embodiment of the present invention, a fluid sampling device is provided which includes a body, the body including a dermal layer penetration probe having a penetrating end and a communicating end, and an analysis chamber having a proximal and distal end, the analysis chamber having a volume, wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe toward the analysis chamber. The analysis chamber can have at least one flexible wall which can be compressed to reduce the volume of the analysis chamber. The penetration probe can include, for example, a needle, a lancet, a tube, a channel, or a solid protrusion and can be constructed of a material such as carbon fiber, boron fiber, plastic, metal, glass, ceramic, a composite material, mixtures thereof, and combinations thereof. The penetration probe can include two sheets of material in substantial registration, having a protrusion on each sheet, wherein the sheets are spaced apart such that liquid can be drawn between the sheets by capillary action. The two sheets of material can extend into the device so as to form a pre-chamber. The penetration probe can be positioned within a recess in the proximal end of the device, and the recess can be configured to substantially align with a shape of a selected dermal surface.
  • [0009]
    In a further embodiment, the device can further include a pre-chamber having a volume and a first and second end, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber. The volume of the pre-chamber can be greater than or equal to the volume of the analysis chamber. The pre-chamber can have at least one flexible wall that can be compressed to reduce the volume of the pre-chamber. The pre-chamber can also include a valve at the first end capable of substantially sealing the pre-chamber from the penetration probe.
  • [0010]
    In another embodiment, the device further includes a compressible bladder in communication with the analysis chamber, the compressible bladder being capable of applying a positive or a negative pressure to the analysis chamber.
  • [0011]
    In yet another embodiment, the pre-chamber and the analysis chamber can be capable of exerting different capillary forces. The capillary force exerted by the analysis chamber can be greater than the capillary force exerted by the pre-chamber. The differential capillary force can be derived, at least in part, from a difference between the pre-chamber height and the analysis chamber height. In this embodiment, the interior surface of the pre-chamber can include at least first and second pre-chamber walls spaced apart at a first distance to define a pre-chamber height, and the interior surface of the analysis chamber can include at least first and second analysis chamber walls spaced apart at a second distance to define an analysis chamber height, wherein the height of the analysis chamber is less than the height of the pre-chamber.
  • [0012]
    In yet another further embodiment, at least one of the chambers can include a substance capable of enhancing or diminishing the capillary force exerted by the chamber. The substance can include, for example, a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, or a porous material. Suitable substances include polyethylene glycol, polyvinylpyrrolidone, a surfactant, a hydrophilic block copolymer, and polyvinylacetate.
  • [0013]
    In a further embodiment, the device further includes a releasable actuator capable of supplying a force sufficient to cause the penetration probe to penetrate a dermal layer. The actuator can be external to or integral with the body, and upon release propels the body toward the dermal layer.
  • [0014]
    In a further embodiment, the analysis chamber can include an electrochemical cell including a working electrode and a counter/reference electrode and an interface for communication with a meter, wherein the interface communicates a voltage or a current.
  • [0015]
    In yet another embodiment of the present invention, a method for determining a presence or an absence of an analyte in a fluid sample is provided including the steps of providing a fluid sampling device as described above; penetrating a dermal layer with the penetration probe; substantially filling the analysis chamber with a fluid sample by allowing the sample to flow from the penetration probe toward the analysis chamber; and detecting a presence or an absence of the analyte within the analysis chamber. The sample can include, for example, interstitial fluid and whole blood. A qualitative or quantitative measurement of a characteristic of the sample can be obtained in the detecting step. The characteristic of the sample can include, for example, a reaction product of the analyte, such as a color indicator, an electric current, an electric potential, an acid, a base, a reduced species, a precipitate, and a gas. The analyte can include, for example, an ion such as potassium, an element, a sugar, an alcohol such as ethanol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, a pharmaceutical, and a drug. Cholesterol and lactate are examples of substances that can be analyzed.
  • [0016]
    In a further embodiment, the flow of sample toward the analysis chamber can be driven by a driving force, e.g., capillary force or a pressure differential. Where the analysis chamber has a flexible wall, the wall can be compressed to reduce the volume of the analysis chamber prior to penetrating the dermal, then the compression released to form a partial vacuum in the analysis chamber. Where the fluid sampling device further includes a compressible bladder, the bladder can be compressed to reduce its volume, then after penetration of the dermal layer the compression can be released to form a partial vacuum in the compressible bladder and analysis chamber.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0017]
    [0017]FIG. 1 shows a top view (not to scale) of one embodiment of a sampling device illustrating an arrangement of the penetration probe, pre-chamber, and analysis chamber.
  • [0018]
    [0018]FIG. 2 shows a cross section (not to scale) along the line A-A′ of FIG. 1.
  • [0019]
    [0019]FIG. 3 shows a top view (not to scale) of one embodiment of a sampling device illustrating an arrangement of the penetration probe, pre-chamber, and analysis chamber wherein the proximal edge of the device forms a recess.
  • [0020]
    [0020]FIG. 4 shows a top view (not to scale) of one embodiment of a sampling device illustrating an arrangement of the penetration probe, pre-chamber, and analysis chamber.
  • [0021]
    [0021]FIG. 5 shows a cross section (not to scale) along the line B-B′ of FIG. 4.
  • [0022]
    [0022]FIGS. 6a and 6 b (not to scale) depict an embodiment of the invention wherein the device is loaded in a releasable actuator to facilitate penetration of a dermal layer by the penetration probe. FIG. 6a depicts the device loaded in the actuator, wherein the actuator is in the cocked position, ready to be triggered. FIG. 6b depicts the device and actuator after triggering.
  • [0023]
    [0023]FIG. 7 is a schematic drawing (not to scale) of a first embodiment according to the invention shown in side elevation.
  • [0024]
    [0024]FIG. 8 shows the embodiment of FIG. 7 in plan, viewed from above.
  • [0025]
    [0025]FIG. 9 shows the embodiment of FIG. 7 in plan, viewed from below.
  • [0026]
    [0026]FIG. 10 shows the embodiment of FIG. 7 viewed in end elevation.
  • [0027]
    [0027]FIG. 11 is a schematic drawing (not to scale) of a second embodiment according to the invention in side elevation.
  • [0028]
    [0028]FIG. 12 shows the embodiment of FIG. 11 in plan, viewed from above.
  • [0029]
    [0029]FIG. 13 is a schematic drawing (not to scale) of a third embodiment according to the invention, in side elevation.
  • [0030]
    [0030]FIG. 14 shows the embodiment of FIG. 13 in plan, viewed from above.
  • [0031]
    [0031]FIG. 15 is a schematic drawing (not to scale) according to the invention in plan view, viewed from above.
  • [0032]
    [0032]FIG. 16 shows the embodiment of FIG. 15 in end elevation.
  • [0033]
    [0033]FIG. 17 shows the embodiment of FIG. 15 in side elevation.
  • [0034]
    [0034]FIG. 18 shows a schematic drawing (not to scale) of a hollow cell embodiment according to the invention, viewed in cross section.
  • [0035]
    [0035]FIG. 19 is a graph showing a plot of current (ordinate axis) versus time (co-ordinate axis) during conduct of a method according to the invention.
  • [0036]
    [0036]FIG. 20 is a further graph of use in explaining the method of the invention.
  • [0037]
    In FIGS. 11 to 12, components corresponding in function to components of the embodiment of FIGS. 7 to 10 are identified by identical numerals or indicia.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • [0038]
    Introduction
  • [0039]
    The following description and examples illustrate various embodiments of the present invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a preferred embodiment should not be deemed to limit the scope of the present invention. Methods and devices for optimizing sampling of fluid samples are discussed further in copending U.S. patent application Ser. No. 09/536,234, filed on Mar. 27, 2000, entitled “METHOD OF PREVENTING SHORT SAMPLING OF A CAPILLARY OR WICKING FILL DEVICE,” which is incorporated herein by reference in its entirety.
  • [0040]
    The invention disclosed in this application is a method and device for combining the sampling and analyzing of a fluid sample from sub-dermal tissue in a device suitable for hospital bedside and home use. The fluid sample can comprise, but is not limited to, interstitial fluid or whole blood samples obtained from an animal. Any fluid sample obtained from sub-dermal tissue of a plant or an animal can sampled and analyzed, thus the invention has broad application in the fields of human medicine, veterinary medicine, and horticultural science. The device and method are applicable to any analyte that exists in a usefully representative concentration in the fluid sample. For clarity, the present disclosure will discuss the application to glucose monitoring. However, it is to be understood that the invention is not limited to the monitoring of glucose, and that other analytes, as discussed below, can also be measured.
  • [0041]
    The method utilizes an integrated sampling and analyzing device 10 incorporating a penetration probe 12 capable of penetrating a patient's dermal layers to extract an interstitial fluid or whole blood sample, and a method for transferring the sample from the penetration probe 12 to the analysis chamber 20. In one embodiment, the device 12 can be a one-shot disposable device which can be inserted into a meter which communicates with the analysis chamber 20 to perform the analysis of the sample and present and optionally store the result.
  • [0042]
    In the device 10, a penetration probe 12 for penetrating the subject's dermal layers to collect an interstitial fluid or whole blood sample is integrated with an analysis chamber 20. A property of sampling interstitial fluid is that it can take from several to tens of seconds to collect sufficient sample to analyze. This is often not desirable for an analysis chamber 20 wherein the analyte undergoes a reaction as part of the analysis process, as it can be difficult to obtain an accurate start time for the test as well as achieve an even reacting reagent distribution in the sample. In a second aspect of the current invention a method is disclosed for collecting the sample in a pre-chamber 14 and, when full, transferring the sample quickly to an analysis chamber 20.
  • [0043]
    In this disclosure, unless a different meaning is clear from the context of its usage, “proximal” refers to a region or structure of the device situated toward or adjacent to the dermal surface to be penetrated, and “distal” refers a region or structure of the device situated toward the opposite (non-proximal) end of the device. For example, the penetration probe 12 is at the proximal end of the device.
  • [0044]
    The Penetration Probe
  • [0045]
    The penetration probe 12 can be any device capable of penetrating the patient's dermal layers to the desired extent and capable of transporting a sample to a pre-chamber 14 or analysis chamber 20. The penetration probe 12 comprises two ends, as illustrated in FIG. 1. The penetrating end 11 of the penetration probe 12 is the end inserted into the dermal layer. The communicating end 13 of the penetration probe 12 is the end which is in communication with either the pre-chamber 14 or the analysis chamber 20.
  • [0046]
    One or more protrusions 12 with at least one sharp edge or point are suitable as the penetration probe 12. The penetration probe 12 can be fabricated from materials including plastic, metal, glass, ceramic, a composite material (e.g., a composite of ceramic and metal particles), or mixtures and combinations of these materials. The penetration probe 12 can be in the form of a solid protrusion, a needle, a lancet, a tube or a channel. The channel can optionally be open along one or more of its elongated sides. As illustrated in FIG. 2, a preferred embodiment of the penetration probe 12 is two sheets 30 of material formed so as to have a sharply pointed protrusion 12 on each sheet 30 in substantial registration, with the sheets 30 spaced apart such that liquid can be drawn between the sheets 30 by capillary action. In a particularly preferred embodiment, the two sheets 30 of material extend to and overlap with the analysis chamber 20 to form a pre-chamber 14 for sample collection.
  • [0047]
    When interstitial fluid is sampled, the penetration depth can be controlled by limiting the length the penetration probe 12 protrudes from the proximal surface 34 of the sampling device 10 to less than the thickness of the dermal layer. In a preferred embodiment, the length of the protrusion 12 will be less than 2 to 3 mm, more preferably about 1.5 mm. After penetration to a suitable depth corresponding to the length of the protrusion 12, contact between the surface of the dermal layer and the surface 34 of the analyzing device prevents further penetration. For other uses, such as in sampling interstitial fluid from regions having a thick dermal layer, or for veterinary uses, it can be desirable for the length of the protrusion 12 to be greater than 3 mm. Accordingly, the invention contemplates protrusions 12 of any length, wherein the length is sufficient to sample interstitial fluid. When whole blood is sampled, a slightly longer penetration probe 12 should be used, i.e., one having a length greater than 2 to 3 mm.
  • [0048]
    The diameter or width of the penetration probe 12 depends upon the design of the penetration probe 12. Suitable diameters or widths are those which provide sufficient sample flow. In the case of a protrusion 12 forming a sharp edge or point, or a tube or channel, the minimum diameter or width is typically greater than about 10 μm. When the penetrating means 12 comprises two sheets 30 in substantial registration, each having a sharply pointed protrusion 12, the two protrusions 12 are typically spaced from 1 mm to 10 μm apart.
  • [0049]
    The penetration probe 12 can be located on any suitable part of the test strip 10, i.e., an edge 34, a corner 42, or one of the flat surfaces 44. Protection can be provided to the penetration probe 12 by locating it within a recess formed in the distal edge 34 of the test strip 10, as shown in FIG. 3, or in a depression on the surface 44 of the test strip 10. In a preferred embodiment, the recess in the distal edge 34 of the test strip 10 can be configured to substantially align with the shape of a selected dermal surface, e.g., a fingertip. However, the recess can be configured in other suitable shapes, e.g., a square recess, a V-shaped recess, a curved recess, a polygonal recess, and the like. In a preferred embodiment, the penetration probe 12 does not protrude past the proximal-most portion of the proximal edge 34 or surface 44 of the device 10, but when pressed against the skin, the skin deforms into the recess and is punctured by the penetration probe 12. Such an arrangement aids sampling by compressing the area of the skin around the sampling point. The penetration probe 12 can form an integral part of another component of the test strip 10, e.g., a side of the pre-chamber 54, as shown in FIG. 2. Alternatively, the penetration probe 12 can comprise a separate part which is attached to or incorporated into the test strip 10 by any suitable means, e.g., adhesive, thermal bonding, interlocking parts, pressure, and the like. The penetration probe 12 can be retractable or non-retractable.
  • [0050]
    Penetration itself can be accomplished by any suitable means, including inserting the penetration device 12 manually or by means of a releasable actuator 84 such as, for example, a spring-loaded mechanism 84 as depicted in FIGS. 6a and 6 b. Such a spring-loaded mechanism 84 incorporates a spring 86 which is compressed and held in place by a trigger 88 which can release the force compressing the spring 86 when the triggering mechanism is activated. The trigger 88 can be activated manually, or the device 84 can incorporate a pressure sensor which indicates that sufficient pressure has been applied to obtain the sample, thereby activating the trigger 88. In one embodiment, the distal end of the device 10 is placed in the spring-loaded mechanism 84 such that when the force compressing the spring 86 is released by activating the trigger 88, force is transferred to the device 10, which is ejected from the mechanism 84, thereby inserting the penetrating probe 12 into the dermal layer.
  • [0051]
    Any suitable body part can be used for sampling. In a preferred embodiment, the sampling area is one which does not have a high density of nerve endings, e.g., the forearm. Typically, 5 to 15 seconds is required to obtain sufficient sample. Application of pressure to the sampling area can be needed to extract interstitial fluid or whole blood. To facilitate the appropriate amount of pressure being applied, a pressure sensor can be incorporated into the device 10 which indicates when sufficient pressure has been applied. Sample acquisition time can be improved by applying increased pressure to the area surrounding the direct sampling area. Some of the factors that can affect interstitial fluid or whole blood sample acquisition include the patient's age, skin thickness, temperature, and hydration. The amount of interstitial or whole blood sample collected for testing can preferably be about 0.02 μl or greater, more preferably 0.1 μl or greater, and most preferably about 0.5 μl or greater.
  • [0052]
    In one preferred embodiment, the device 10 can be inserted into a meter prior to sample acquisition. In such an embodiment, the meter serves multiple functions, including supporting the device 10, providing an automated means of initiating sample acquisition, and indicating when sample acquisition is complete.
  • [0053]
    Transfer of Sample from Penetration probe to Analysis Chamber
  • [0054]
    In a preferred embodiment of the sampling device 10, the device comprises two parts—the penetration probe 12 and an analysis chamber 20. In another preferred embodiment, illustrated in FIGS. 1 and 2, the device 10 comprises the penetration probe 12 and a pre-chamber 14. The pre-chamber 14 can then be integrated with or can be interfaced to the analysis chamber 20.
  • [0055]
    In a further embodiment, the analysis chamber 20 is integrated with or can be interfaced to a means for facilitating filling of the analysis chamber 20. This means can comprise a collapsible or compressible bladder 22, as shown in FIGS. 3 and 4, which can be used to apply a positive or negative pressure (i.e., partial vacuum) to the analysis chamber 20. The compressible bladder 22 can comprise any chamber with flexible walls that can be compressed to reduce the volume of the chamber. When the force compressing the compressible bladder 22 is released, a partial vacuum is formed which draws sample into the analysis chamber 20. In a preferred embodiment, the volume of the compressible bladder 22 is sufficiently large so that when the bladder 22 is substantially fully compressed, the reduction in volume of the bladder 22 is larger than or equal to the total volume of the analysis chamber 20, thereby ensuring that the analysis chamber 20 is substantially filled. However, a compressible bladder 22 with a smaller volume than the analysis chamber 20 can also be effective in assisting the filling of the analysis chamber 20.
  • [0056]
    Alternatively, the analysis chamber 20 itself can be collapsible or compressible. In such an embodiment, a piston or other compressing agent, such as a patient's or clinician's fingers, can first compress then release the analysis chamber 20, thereby forming a partial vacuum. When the compressing force is released, the partial vacuum causes the sample to flow from the penetration probe toward the analysis chamber.
  • [0057]
    Pre-chamber
  • [0058]
    In a preferred embodiment, as illustrated in FIGS. 1 and 2, a pre-chamber 14 is provided in the integrated sampling and testing device 10 for accumulation and storage of the collected sample prior to its being transferred to the analysis chamber 20. A pre-chamber 14 is useful when using an analysis method which requires that the sample fill the analysis chamber 20 in a short period of time to return accurate results, i.e., a time shorter than that required to draw sufficient sample from the dermal layer. In a preferred embodiment, the volume of the pre-chamber 14 is larger than that of the analysis chamber 20, thus ensuring that once the pre-chamber 14 is filled, sufficient sample has been collected to completely fill the analysis chamber 20.
  • [0059]
    In a preferred embodiment, as illustrated in FIGS. 1 and 2, the penetration probe 12 opens into the pre-chamber 14 at a first end, and at the second end the pre-chamber 14 opens to the analysis chamber 20. The pre-chamber 14 can be free of reagents or other substances, or can optionally contain one or more substances to enhance or diminish the capillary force exerted by the walls of the pre-chamber 14 or to pre-treat the sample prior to analysis. These substances can include, for example, polymers, resins, powders, meshes, fibrous materials, crystalline materials, porous materials, or a mixture or combination thereof. To facilitate effective filling of the analysis chamber 20, a preferred embodiment utilizes a pre-chamber 14 and analysis chamber 20 of different heights, as shown in FIG. 2. Where the analysis chamber 20 is formed so that its height (typically referring to the smallest chamber dimension) is smaller than the height of the pre-chamber 14, a capillary force is generated that is capable of drawing fluid out of the pre-chamber 14 and into the analysis chamber 20. A first air vent 64 can be formed at the end 70 of the analysis chamber 20 opposite the opening 62 to the pre-chamber 14, facilitating the filling of the analysis chamber 20 by allowing air to be displaced from the analysis chamber 20 as sample enters. Optionally, a second vent 74 can be formed opening into the pre-chamber 14 at the substantially opposite end 60 of the pre-chamber 14 to where the penetration probe 12 opens into the pre-chamber 14. This vent 74 provides air to the pre-chamber 14 to replace the sample as it is transferred from the pre-chamber 14 to the analysis chamber 20. The vent 74 can be placed in any suitable position on the test strip 10. In a preferred embodiment, the vent 74 incorporates a sharp corner, e.g., at a 90° angle, which functions as a “capillary stop” to prevent sample from exiting the device 10 through the vent 74.
  • [0060]
    In another embodiment, the pre-chamber 14 consists of a tube, or other shaped chamber, with flexible walls, attached to the penetration probe 12. In this embodiment, the pre-chamber 14 is either permanently fixed to the analysis chamber 20 or is placed next to and aligned with a port to the analysis chamber 20. Such alignment can occur during use by suitable placement in an external device such as the measurement meter.
  • [0061]
    In one aspect of this embodiment, the pre-chamber 14 further comprises a valve, defined as a device to control the flow of fluid sample between the penetration probe 12 and the pre-chamber 14. The valve can comprise one or more rollers, pistons, or squeezing devices capable of simultaneously closing off the first end 60 of the pre-chamber 14, and compressing the pre-chamber 14 such that the fluid in the pre-chamber 14 is forced towards the second end 62 of the pre-chamber 14 and subsequently into the analysis chamber 20.
  • [0062]
    Alternatively, the analysis chamber 20 consists of a tube, or other shaped chamber, with flexible walls, attached to the penetration probe 12. In one aspect of this embodiment, the analysis chamber 20, prior to penetration, is compressed by one or more rollers, pistons, or other squeezing devices. After the penetration probe 12 is inserted, the compression is released, forming a vacuum which pulls sample into the analysis chamber 20. In such an embodiment, the pre-chamber 14 can not be necessary if sufficient vacuum is generated for rapid sample acquisition. In such an embodiment, the device 10 can not require a vent 64, 74 if such would interfere with forming a vacuum.
  • [0063]
    In another embodiment, illustrated in FIGS. 3 and 4, a pre-chamber 14 of suitable size is formed which opens to the penetration probe 12 on one end 60 and to the analysis chamber 20 on the other end 62. The end 70 of the analysis chamber 20 opposite to that opening to the pre-chamber 14 opens to a compressible bladder 22. The bladder 22 can be formed separately and attached to the end 70 of the analysis chamber 20. Alternatively, it can be formed by removing a section on the middle laminate 82 in the test strip 10, similar to those described in WO97/00441 (incorporated herein by reference in its entirety), as illustrated in FIGS. 3 and 4.
  • [0064]
    In use, the bladder 22 in the strip 10 is compressed by suitable means prior to the penetration probe 12 being inserted into the patient. Insertion of the penetration probe 12 can be confirmed by use of a sensor, such as a pressure sensor, or the patient can confirm that the penetration probe 12 is inserted either visually or by touch. In the latter case, the patient sensing can signal the meter, such as by pushing a button. At this point, the means compressing the bladder 22 is withdrawn to a halfway position to draw sample into the pre-chamber 14. When the pre-chamber 14 is full, as indicated by a suitable sensor, the meter indicates to the patient to withdraw the penetration probe 12. The compressing means then moves to its fully withdrawn position and so draws the sample from the pre-chamber 14 into the analysis chamber 20. In the case where the initial suction from the bladder 22 causes the sample to be accumulated with sufficient speed, the pre-chamber 14 can be dispensed with and the bladder 22 used to draw sample through the penetration probe 12 directly into the analysis chamber 20. A vent 64, 74 which would interfere with forming a vacuum need not be incorporated into the device in some embodiments.
  • [0065]
    Analysis Chamber
  • [0066]
    In a preferred embodiment, the analysis chamber 20 is contained in an analyzing device 10 comprising a disposable analysis strip similar to that disclosed in WO97/00441. The analysis strip of WO97/00441 contains a biosensor for determining the concentration of an analyte in a carrier, e.g., the concentration of glucose in a fluid sample. The electrochemical analysis cell 20 in this strip has an effective volume of 1.5 μl or less, and can comprise a porous membrane, a working electrode on one side of the membrane, and a counter/reference electrode on the other side. In a preferred embodiment, an analysis cell 20 having an effective volume of about 0.02 μl or greater is used. More preferably, the cell 20 has a volume ranging from about 0.1 μl to about 0.5 μl.
  • [0067]
    In one aspect of this embodiment, the penetration probe 12 is a small needle integrated into the analysis strip 10 by being inserted through a wall of the analysis chamber 20 such that one end of the needle 12 opens into the strip analysis chamber 20. In using a device 10 having this arrangement to obtain and analyze a sample of interstitial fluid, the needle 12 is inserted into the patient's dermal layer and sample is drawn into the needle 12 via capillary action. The sample is then transferred from the needle 12 into the analysis chamber 20 by capillary action whereupon the sample is analyzed. An opening 64 in the analysis chamber 20 to atmosphere, remote from the point where the needle 12 opens into the chamber, acts as a vent 64 to allow the escape of displaced air as the analysis chamber 20 fills with sample. Analysis devices of the type disclosed in WO97/00441 are particularly suited for use with this arrangement because of their ability to utilize the very small volumes of sample typically available with interstitial fluid sampling.
  • [0068]
    The analysis chamber 20 can contain one or more substances to enhance or diminish the capillary force exerted by the walls of analysis chamber 20. Such materials can include polymers, resins, powders, meshes, fibrous materials, crystalline materials, porous materials, or a mixture or combination thereof, as can also be used in the pre-chamber, discussed above. For example, the walls 24 of the analysis chamber 20 can be coated with a hydrophilic material to encourage the flow of fluid sample into the analysis chamber. Suitable hydrophilic materials include polyethylene glycol, polyvinylpyrrolidone, a surfactant, a hydrophilic block copolymer, and polyacrylic acid. The analysis chamber 20 can also contain reagents capable of reacting with the analyte or other substances present in the sample. Such other substances can include substances which interfere in determining the presence or absence of the analyte. In such cases, the reagent will react with the substance so that it no longer interferes with the analysis.
  • [0069]
    Any analyte present in a fluid sample in a detectable amount can be analyzed using the device 10. A typical analytes can include, but is not limited to, an ion, an element, a sugar, an alcohol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, and a drug. In a preferred embodiment, glucose is the analyte to be tested. Typical analytes could include, but are not limited to, ethanol, potassium ion, pharmaceuticals, drugs, cholesterol, and lactate.
  • [0070]
    The presence or absence of the analyte can be determined directly. Alternatively, the analyte can be determined by reacting the analyte with one or more reagents present in the analysis chamber. The product of that reaction, indicative of the presence or absence of the analyte, would then be detected. Suitable reaction products include, but are not limited to, a color indicator, an electric current, an electric potential, an acid, a base, a precipitate, or a gas.
  • [0071]
    Any suitable analytical method can be used for determining the presence or absence of the analyte or a reaction product of the analyte. Suitable analytical methods include, but are not limited to, electrochemical methods, photoabsorption detection methods, photoemission detection methods, and the measurement of magnetic susceptibility. In the case of a reaction product having a different color than the analyte, or the formation of a precipitate or a gas, a visual determination can be a suitable method for determining the presence or absence of the analyte.
  • [0072]
    With reference to FIGS. 7 to 10 there is shown a first embodiment of apparatus of the invention, in this case a biosensor for determining glucose in blood. The embodiment comprises a thin strip membrane 1 having upper and lower surfaces 2, 3 and having a cell zone 4 defined between a working electrode 5 disposed on upper surface 2 and a counter electrode 6 disposed on lower surface 3. The membrane thickness is selected so that the electrodes are separated by a distance “I” which is sufficiently close that the products of electrochemical reaction at the counter electrode migrate to the working electrode during the time of the test and a steady state diffusion profile is substantially achieved. Typically, “I” will be less than 500 μm. A sample deposition or “target” area 7 defined on upper surface 2 of membrane 1 is spaced at a distance greater than the membrane thickness from cell zone 4. Membrane 1 has a diffusion zone 8 extending between target area 7 and cell zone 4. A suitable reagent including a redox mediator “M”, an enzyme “E” and a pH buffer “B” are contained within cell zone 4 of the membrane and/or between cell zone 4 and target area 7. The reagent may also include stabilisers and the like.
  • [0073]
    In some cases it is preferable to locate the enzyme and mediator and/or the buffer in different zones of the membrane. For example the mediator may be initially located within electrochemical cell zone 4 while the enzyme may be situated below target area 7 or in diffusion zone 8.
  • [0074]
    Haemoglobin releases oxygen at low pH's, but at higher pH's it binds oxygen very firmly. Oxygen acts as a redox mediator for glucose oxidase dehydroienase (GOD). In a glucose sensor this competes with the redox mediator leading to low estimates of glucose concentration. Therefore if desired a first pH buffer can be contained in the vicinity of target area 7 to raise the pH to such a level that all the oxygen is bound to haemoglobin. Such a pH would be non-optimal for GOD/glucose kinetics and would consequently be detrimental to the speed and sensitivity of the test.
  • [0075]
    In a preferred embodiment of the invention a second pH buffer is contained as a reagent in the vicinity of the working electrode to restore the pH to kinetically optimal levels.
  • [0076]
    The use of a second buffer does not cause oxygen to be released from the haemoglobin as the haemoglobin is contained within the blood cells which are retained near blood target area 7 or are retarded in diffusion in comparison with the plasma and therefore not influenced by the second buffer. In this manner oxygen interference may be greatly reduced or eliminated.
  • [0077]
    In use of the sensor a drop of blood containing a concentration of glucose to be determined is placed on target zone 7. The blood components wick towards cell zone 4, the plasma component diffusing more rapidly than red blood cells so that a plasma front reaches cell zone 4 in advance of blood cells.
  • [0078]
    When the plasma wicks into contact with the reagent, the reagent is dissolved and a reaction occurs that oxidises the analyte and reduces the mediator. After allowing a predetermined time to complete this reaction an electric potential difference is applied between the working electrode and the counter electrode. The potential of the working electrode is kept sufficiently anodic such that the rate of electrooxidation of the reduced form of the mediator at the working electrode is determined by the rate of diffusion of the reduced form of the mediator to the working electrode, and not by the rate of electron transfer across the electrode/solution interface.
  • [0079]
    In addition the concentration of the oxidised form of the mediator at the counter electrode is maintained at a level sufficient to ensure that when a current flows in the electrochemical cell the potential of the counter electrode, and thus also the potential of the working electrode, is not shifted so far in the cathodic direction that the potential of the working electrode is no longer in the diffusion controlled region. That is to say, the concentration of the oxidized form at the counter electrode must be sufficient to maintain diffusion controlled electrooxidation of the reduced form of the mediator at the working electrode.
  • [0080]
    The behavior of a thin layer cell is such that if both oxidised and reduced forms of the redox couple are present, eventually a steady state concentration profile is established across the cell. This results in a steady state current. It has been found that by comparing a measure of the steady state current with the rate at which the current varies in the current transient before the steady state is achieved, the diffusion coefficient of the redox mediator can be measured as well as its concentration.
  • [0081]
    More specifically, by solving the diffusion equations for this situation it can be shown that over a restricted time range a plot of ln(i/i-1) vs. time (measured in seconds) is linear and has a slope (denoted by S) which is equal to −4π2D/12, where “i” is the current at time “t”, “V” is the steady state current, “D” is the diffusion coefficient in cm2/sec, “1” is the distance between the electrodes in cm and “π” is approximately 3.14159. The concentration of reduced mediator present when the potential was applied between the electrodes is given by 2π2i /FA1S, where “T” is Faraday's constant, “A” is the working electrode area and the other symbols are as given above. As this later formula uses S it includes the measured value of the diffusion coefficient.
  • [0082]
    Since I is a constant for a given cell, measurement of i as a function of time and i enable the value of the diffusion coefficient of the redox mediator to be calculated and the concentration of the analyte to be determined.
  • [0083]
    Moreover the determination of analyte concentration compensates for any variation to the diffusion coefficient of the species which is electrooxidised or electroreduced at the working electrode. Changes in the value of the diffusion coefficient may occur as a result of changes in the temperature and viscosity of the solution or variation of the membrane permeability. Other adjustments to the measured value of the concentration may be necessary to account for other factors such as changes to the cell geometry, changes to the enzyme chemistry or other factors which may effect the measured concentration. If the measurement is made on plasma substantially free of haematocrit (which if present causes variation in the diffusion coefficient of the redox mediator) the accuracy of the method is further improved.
  • [0084]
    Each of electrodes 5, 6 has a predefined area. In the embodiments of FIGS. 7 to 10 cell zone 4 is defined by edges 9, 10, 11 of the membrane which correspond with edges of electrodes 5, 6 and by leading (with respect to target area 7) edges 12, 13 of the electrodes. In the present example the electrodes are about 600 angstrom thick and are from 1 to 5 mm wide.
  • [0085]
    Optionally, both sides of the membrane are covered with the exception of the target area 7 by laminating layers 14 (omitted from plan views) which serves to prevent evaporation of water from the sample and to provide mechanical robustness to the apparatus. Evaporation of water is undesirable as it concentrates the sample, allows the electrodes to dry out, and allows the solution to cool, affecting the diffusion coefficient and slowing the enzyme kinetics, although diffusion coefficient can be estimated as above.
  • [0086]
    A second embodiment according to the invention, shown in FIGS. 11 and 12, differs from the first embodiment by inclusion of a second working electrode 25 and counter/reference electrode 26 defining a second cell zone 24 therebetween. These electrodes are also spaced apart by less than 500 μm in the present example. Second electrodes 25, 26 are situated intermediate cell zone 4 and target area 7. In this embodiment the redox mediator is contained in the membrane below or adjacent to target area 7 or intermediate target area 7 and first cell zone 4. The enzyme is contained in the membrane in the first cell zone 4 and second cell zone 24. The enzyme does not extend into second cell 24. In this case when blood is added to the target area, it dissolves the redox mediator. This wicks along the membrane so that second electrochemical cell 24 contains redox mediator analyte and serum including electrochemically interfering substances. First electrochemical cell receives mediator, analyte, serum containing electrochemically interfering substances, and enzyme.
  • [0087]
    Potential is now applied between both working electrodes and the counter electrode or electrodes but the change in current with time is measured separately for each pair. This allows the determination of the concentration of reduced mediator in the absence of analyte plus the concentration of electrochemically interfering substances in the second electrochemical cell and the concentration of these plus analyte in the first electrochemical cell. Subtraction of the one value from the other gives the absolute concentration of analyte.
  • [0088]
    The same benefit is achieved by a different geometry in the embodiment of FIGS. 13 and 14 in which the second working electrode and second counter/reference electrode define the second cell 24 on the side of target area 7 remote from first electrochemical cell 4. In this case the enzyme may be contained in the membrane strip between the target area and cell 1. The redox mediator may be in the vicinity of the target area or between the target area and each cell. The diffusion coefficient of mediator is lowered by undissolved enzyme and the arrangement of FIGS. 13 and 14 has the advantage of keeping enzyme out of the thin layer cells and allowing a faster test (as the steady state current is reached more quickly). Furthermore the diffusion constant of redox mediator is then the same in both thin layer cells allowing more accurate subtraction of interference.
  • [0089]
    Although the embodiments of FIGS. 7 to 14 are unitary sensors, it will be understood that a plurality of sensors may be formed on a single membrane as shown in the embodiment of FIGS. 15 to 17. In this case the electrodes of one sensor are conductively connected to those of an adjacent sensor. Sensors may be used successively and severed from the strip after use.
  • [0090]
    In the embodiment of FIGS. 15 to 17 electrode dimensions are defined in the diffusion direction (indicated by arrow) by the width of the electrode in that direction.
  • [0091]
    The effective dimension of the electrode in a direction transverse to diffusion direction is defined between compressed volumes 16 of the membrane in a manner more fully described in co-pending Application PCT/AU96/00210. For clarity optional laminated layer 14 of FIG. 7 has been omitted from FIGS. 15 to 17.
  • [0092]
    In the embodiment of FIG. 18 there is shown a hollow cell according to the invention wherein the electrodes 5, 6 are supported by spaced apart polymer walls 30 to define a hollow cell. An opening 31 is provided on one side of the cell whereby a sample can be admitted into cavity 32. In this embodiment a membrane is not used. As in previous embodiments, the electrodes are spaced apart by less than 500 μm, preferably 20-400 μm and more preferably 20-200 μm. Desirably the effective cell volume is 1.5 microlitres or less.
  • [0093]
    It will be understood that the method of the invention may be performed with a cell constructed in accord with co-pending application PCT/AU95/00207 or cells of other known design, provided these are modified to provide a sufficiently small distance between electrode faces.
  • [0094]
    The method of the invention will now be further exemplified with reference to FIGS. 19 and 20.
  • [0095]
    A membrane 130 microns thick was coated on both sides with a layer of Platinum 60 nanometers thick. An area of 12.6 sq. mm was defined by compressing the membrane. 1.5 microlitres of a solution containing 0.2 Molar potassium ferricyanide and 1% by weight glucose oxidase dehydrotenase was added to the defined area of the membrane and the water allowed to evaporate.
  • [0096]
    The platinum layers were then connected to a potentiostat to be used as the working and counter/reference electrodes. 3 microlitres of an aqueous solution containing 5 millimolar D-glucose and 0.9 wt % NaCl was dropped on to the defined area of the membrane. After an elapse of 20 seconds a voltage of 300 millivolts was applied between the working and counter/reference electrodes and the current recorded for a further 30 seconds at intervals of 0.1 seconds.
  • [0097]
    [0097]FIG. 19 is a graph of current versus time based on the above measurements.
  • [0098]
    Using a value of the steady state current of 26.9 microamps the function ln(i/26.9-1) was computed and plotted versus time. The slope of the graph (FIG. 20) is −0.342 which corresponds to a diffusion coefficient of 1.5×106 cm2 per second and a corrected glucose concentration (subtracting background ferrocyanide) of 5.0 millimolar.
  • [0099]
    The steady state current is one in which no further significant current change occurs during the test. As will be understood by those skilled in the art, a minimum current may be reached after which there may be a drift due to factors such as lateral diffusion, evaporation, interfering electrochemical reactions or the like. However, in practice it is not difficult to estimate the “steady state” current (i). One method for doing so involves approximating an initial value for i. Using the fit of the i versus t data to the theoretical curve a better estimate of i is then obtained. This is repeated reiteratively until the measured value and approximated value converge to within an acceptable difference, thus yielding an estimated i.
  • [0100]
    In practice, the measurements of current i at time t are made between a minimum time t min and a maximum time t max after the potential is applied. The minimum and maximum time are determined by the applicability of the equations and can readily be determined by experiment of a routine nature. If desired the test may be repeated by switching off the voltage and allowing the concentration profiles of the redox species to return towards their initial states.
  • [0101]
    It is to be understood that the analysis of the current v. time curve to obtain values of the Diffusion Coefficient and/or concentration is not limited to the method given above but could also be achieved by other methods.
  • [0102]
    For instance, the early part of the current v. time curve could be analysed by the Cottrell equation to obtain a value of D1/2×Co (Co=Concentration of analyte) and the steady state current analysed to obtain a value of D×Co. These two values can then be compared to obtain D and C separately.
  • [0103]
    It will be understood that in practice of the invention an electrical signal is issued by the apparatus which is indicative of change in current with time. The signal may bean analogue or digital signal or may be a series of signals issued at predetermined time intervals. These signals may be processed by means of a microprocessor or other conventional circuit to perform the required calculations in accordance with stored algorithms to yield an output signal indicative of the diffusion coefficient, analyte concentration, haematocrit concentration or the like respectively. One or more such output signals may be displayed by means of an analogue or digital display.
  • [0104]
    It is also possible by suitable cell design to operate the cell as a depletion cell measuring the current required to deplete the mediator. For example in the embodiment of FIG. 5 the method of the invention may be performed using electrodes 5, 6, which are spaced apart by less than 500 μm. An amperometric or voltammetric depletion measurement may be made using electrodes 5 and 26 which are spaced apart more than 500 μm and such that there is no interference between the redox species being amperometrically determined at electrodes 5, 26.
  • [0105]
    The depletion measurement may be made prior to, during or subsequent to, the measurement of diffusion coefficient by the method of the invention. This enables a substantial improvement in accuracy and reproducibility to be obtained.
  • [0106]
    In the embodiments described the membrane is preferably an asymmetric porous membrane of the kind described in Patent No. 4,629,563 and 4,774,039. However symmetrical porous membranes may be employed. The membrane may be in the form of a sheet, tube, hollow fibre or other suitable form.
  • [0107]
    If the membrane is asymmetric the target area is preferably on the more open side of the asymmetric membrane. The uncompressed membrane desirably has a thickness of from 20 to 500 μm. The minimum thickness is selected having regard to speed, sensitivity, accuracy and cost. If desired a gel may be employed to separate haematocrit from GOD. The gel may be present between the electrodes and/or in the space between the sample application area and the electrodes.
  • [0108]
    The working electrode is of any suitable metal for example gold, silver, platinum, palladium, iridium, lead, a suitable alloy. The working electrode may be preformed or formed in situ by any suitable method for example sputtering, evaporation under partial vacuum, by electrodeless plating, electroplating, or the like. Suitable non-metal conductors may also be used for electrode construction. For example, conducting polymers such as poly(pyrrole), poly(aniline), porphyrin “wires”, poly(isoprene) and poly (cis-butadiene) doped with iodine and “ladder polymers”. Other non-metal electrodes may be graphite or carbon mixed with a binder, or a carbon filled plastic.
  • [0109]
    Inorganic electrodes such as In2O3 or SnO2 may also be used. The counter/reference electrode may for example be of similar construction to the working electrode. Nickel hydroxide or a silver halide may also be used to form the counter/reference electrode.
  • [0110]
    Silver chloride may be employed but it will be understood that chloridisation may not be necessary and silver may be used if sufficient chloride ions are present in the blood sample. Although in the embodiments described the working electrode is shown on the upper surface of the biosensor and the counter/reference electrode is on the lower surface, these may be reversed.
  • [0111]
    It is preferable that the working electrode and counter (or counter/reference) electrodes are of substantially the same effective geometric area.
  • [0112]
    If a separate reference and counter electrode are employed, they may be of similar construction. The reference electrode can be in any suitable location.
  • [0113]
    It will be understood that the features of one embodiment herein described may be combined with those of another. The invention is not limited to use with any particular combination of enzyme and mediator and combinations such as are described in EP0351892 or elsewhere may be employed. The system may be used to determine analytes other than glucose (for example, cholesterol) by suitable adaptation of reagents and by appropriate membrane selection. The system may also be adapted for use with media other than blood. For example the method may be employed to determine the concentration of contaminants such as chlorine, iron, lead, cadmium, copper, etc., in water.
  • [0114]
    Although the cells herein described have generally planar and parallel electrodes it will be understood that other configurations may be employed, for example one electrode could be a rod or needle and the other a concentric sleeve.
  • [0115]
    Display/Storage of Measurement Data
  • [0116]
    In a preferred embodiment, an analysis strip as described above or another embodiment of the sampling device 10 is integrated with a measuring device, e.g., a meter, which can display, store or record test data, optionally in computer-readable format. In such an embodiment, the test strip 10 comprises an interface for communicating with the meter, e.g., conductive leads from the electrodes of the electrochemical cell 20. In the case of obtaining an electrochemical measurement, the interface communicates a voltage or a current to the electrochemical cell 20.
  • [0117]
    The above description discloses several methods and materials of the present invention. This invention is susceptible to modifications in the methods and materials, as well as alterations in the fabrication methods and equipment. Such modifications will become apparent to those skilled in the art from a consideration of this disclosure or practice of the invention disclosed herein. Consequently, it is not intended that this invention be limited to the specific embodiments disclosed herein, but that it cover all modifications and alternatives coming within the true scope and spirit of the invention as embodied in the attached claims.

Claims (64)

    What is claimed is:
  1. 1. A fluid sampling device, the device comprising a body, the body comprising:
    a dermal layer penetration probe having a penetrating end and a communicating end, the penetration probe having a volume; and
    an analysis chamber having a proximal end and a distal end, the analysis chamber having a volume, wherein the volume of the penetration probe is greater than the volume of the analysis chamber, and wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe to the analysis chamber.
  2. 2. The device of claim 1, wherein the penetration probe is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force, and wherein a differential in capillary force exists between the first capillary force and the second capillary force.
  3. 3. The device of claim 2, wherein the second capillary force is greater than the first capillary force.
  4. 4. The device of claim 3, wherein an interior surface of the penetration probe comprises a first penetration probe wall and a second penetration probe wall, wherein the first penetration probe wall and the second penetration probe wall are spaced apart at a first distance to define a penetration probe height, and wherein an interior surface of the analysis chamber comprises a first analysis chamber wall and a second analysis chamber wall, wherein the first analysis chamber wall and the second analysis chamber wall are spaced apart at a second distance to define an analysis chamber height, wherein the analysis chamber height is less than the penetration probe height, and wherein the differential in capillary force derives at least in part from a difference between the penetration probe height and the analysis chamber height.
  5. 5. The device of claim 3, wherein at least one of the penetration probe and the analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.
  6. 6. The device of claim 5, wherein the substance is selected from the group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, and a combination thereof.
  7. 7. The device of claim 6, wherein the substance is selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, a surfactant, a hydrophilic block copolymer, and polyvinylacetate.
  8. 8. The device of claim 1, wherein the penetration probe comprises a first penetration probe wall and a second penetration probe wall and wherein the analysis chamber comprises a first analysis chamber wall and a second analysis chamber wall, and wherein the distance between the first penetration probe wall and the second penetration probe wall is greater than the distance between the first analysis chamber wall and the second analysis chamber wall.
  9. 9. The device of claim 1, wherein the penetration probe comprises a component selected from the group consisting of a needle, a lancet, a tube, a channel, and a solid protrusion.
  10. 10. The device of claim 1, wherein the device has a proximal edge, the proximal edge comprising a recess, wherein the penetration probe is positioned within the recess.
  11. 11. The device of claim 10, wherein the recess is configured to substantially align with a shape of a selected dermal surface.
  12. 12. The device of claim 1, further comprising a releasable actuator, wherein the actuator is capable of supplying a force sufficient to cause the penetration probe to penetrate a dermal layer.
  13. 13. The device of claim 12, wherein the actuator is external to the body, and wherein upon release the actuator propels the body to the dermal layer.
  14. 14. The device of claim 12, wherein the actuator is integral with the body.
  15. 15. The device of claim 14, wherein upon release the actuator propels the penetration probe toward the dermal layer.
  16. 16. The device of claim 1, wherein the analysis chamber comprises an electrochemical cell, the cell comprising a working electrode and a counter/reference electrode.
  17. 17. The device of claim 1, further comprising an interface for communication with a meter.
  18. 18. The device of claim 17, wherein the interface communicates a voltage or a current.
  19. 19. The device of claim 1, wherein the analysis chamber comprises a hollow electrochemical cell, the hollow electrochemical cell comprising a working electrode, a counter or reference electrode, and an opening for admitting an analyte to the cell, the working electrode being spaced from the counter or reference electrode by a distance of less than 500 μm.
  20. 20. The device of claim 19, wherein the penetration probe comprises a component selected from the group consisting of a needle, a lancet, a tube, a channel, and a solid protrusion.
  21. 21. The device of claim 19, wherein the penetration probe is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential exists between the first capillary force and the second capillary force.
  22. 22. The device of claim 21, wherein the second capillary force is greater than the first capillary force.
  23. 23. The device of claim 1, wherein a distal end of the penetration probe is interfaced with the proximal end of the analysis chamber.
  24. 24. The device of claim 1, wherein a distal end of the penetration probe is integrated with the proximal end of the analysis chamber.
  25. 25. A fluid sampling device comprising a body, the body comprising
    a dermal layer penetration probe having a penetrating end and a communicating end;
    an analysis chamber having a proximal end and a distal end, the analysis chamber having a volume, wherein the analysis chamber comprises a hollow electrochemical cell, the hollow electrochemical cell comprising a working electrode, a counter or reference electrode, and an opening for admitting an analyte to the cell, the working electrode being spaced from the counter or reference electrode by a distance of less than 500 μm; and
    a pre-chamber having a proximal end and a distal end, the pre-chamber having a volume, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the proximal end of the pre-chamber is adjacent the communicating end of the penetration probe and the distal end of the pre-chamber is adjacent the proximal end of the analysis chamber, wherein the volume of the pre-chamber is greater than the volume of the analysis chamber, and wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe to the analysis chamber.
  26. 26. The device of claim 25, wherein the penetration probe comprises a component selected from the group consisting of a needle, a lancet, a tube, a channel, and a solid protrusion.
  27. 27. The device of claim 25, wherein the pre-chamber is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential in capillary force exists between the first capillary force and the second capillary force.
  28. 28. The device of claim 27, wherein the second capillary force is greater than the first capillary force.
  29. 29. The device of claim 25, wherein the distal end of the pre-chamber is interfaced with the proximal end of the analysis chamber.
  30. 30. The device of claim 25, wherein the distal end of the pre-chamber is integrated with the proximal end of the analysis chamber.
  31. 31. A method for measuring a quantity of an analyte in a fluid sample, the method comprising the steps of:
    providing a fluid sampling device, the sampling device comprising:
    a dermal layer penetration probe, having a penetrating end and a communicating end;
    an analysis chamber having a proximal end and a distal end, the analysis chamber having a volume, wherein the penetration probe is in fluid communication with the analysis chamber such that a fluid sample can flow from the penetration probe to the analysis chamber; and
    a pre-chamber having a proximal end and a distal end, the pre-chamber having a volume, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the proximal end of the pre-chamber is adjacent the communicating end of the penetration probe and the distal end of the pre-chamber is adjacent the proximal end of the analysis chamber, and wherein the volume of the pre-chamber is greater than the volume of the analysis chamber;
    penetrating a dermal layer with the penetration probe;
    substantially filling the analysis chamber with the fluid sample by allowing the sample to flow from the penetration probe to the analysis chamber; and
    measuring a quantity of an analyte in the fluid sample.
  32. 32. The method of claim 31, wherein the sample is selected from the group consisting of interstitial fluid and whole blood.
  33. 33. The method of claim 31, wherein the analyte is selected from the group consisting of an ion, an element, a sugar, an alcohol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, a pharmaceutical, and a drug.
  34. 34. The method of claim 31, wherein the analyte is selected from the group consisting of potassium ion, ethanol, cholesterol, glucose, and lactate.
  35. 35. The method of claim 31, wherein a flow of fluid sample to the analysis chamber is driven by a driving force, wherein the driving force comprises a force selected from the group consisting of a capillary force and a pressure differential.
  36. 36. The method of claim 31, wherein the pre-chamber is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential in capillary force exists between the first capillary force and the second capillary force.
  37. 37. The method of claim 31, wherein the second capillary force is greater than the first capillary force.
  38. 38. The method of claim 31, wherein an interior surface of the pre-chamber comprises a first pre-chamber wall and a second pre-chamber wall, wherein the first pre-chamber wall and the second pre-chamber wall are spaced apart at a first distance to define a pre-chamber height, and wherein an interior surface of the analysis chamber comprises a first analysis chamber wall and a second analysis chamber wall spaced apart at a second distance to define an analysis chamber height, wherein the analysis chamber height is less than the pre-chamber height, wherein the pre-chamber is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force, and wherein a differential in the first capillary force and the second capillary force derives at least in part from a difference between the pre-chamber height and the analysis chamber height.
  39. 39. The method of claim 31, wherein at least one of the pre-chamber and the analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.
  40. 40. The method of claim 39, wherein the substance is selected from the group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, and a combination thereof.
  41. 41. The method of claim 39, wherein the substance is selected from the group consisting of polyethylene glycol, polyvinyl pyrrolidone, a surfactant, a hydrophilic block copolymer, and polyacrylic acid.
  42. 42. The method of claim 35, wherein the pressure differential comprises a positive pressure applied to the analysis chamber.
  43. 43. The method of claim 35, wherein the pressure differential comprises a negative pressure applied from the analysis chamber.
  44. 44. The method of claim 31, wherein the analysis chamber comprises a hollow electrochemical cell, the hollow electrochemical cell comprising a working electrode, a counter or reference electrode, and an opening for admitting an analyte to the cell, the working electrode being spaced from the counter or reference electrode by a distance of less than 500 μm.
  45. 45. The method of claim 44, wherein the penetration probe comprises a component selected from the group consisting of a needle, a lancet, a tube, a channel, and a solid protrusion.
  46. 46. The method of claim 44, wherein the pre-chamber is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential in capillary force exists between the first capillary force and the second capillary force.
  47. 47. The method of claim 44, wherein the second capillary force is greater than the first capillary force.
  48. 48. A method for measuring a quantity of an analyte in a fluid sample, the method comprising the steps of:
    providing a fluid sampling device, the device comprising:
    a dermal layer penetration probe having a penetrating end and a communicating end, the penetration probe having a volume;
    an analysis chamber having a proximal and distal end, the analysis chamber having a volume, wherein the volume of the penetration probe is greater than the volume of the analysis chamber, wherein the penetration probe is in fluid communication with the analysis chamber such that a fluid sample can flow from the penetration probe to the analysis chamber; penetrating a dermal layer with the penetration probe; substantially filling the analysis chamber with a fluid sample by allowing the
    sample to flow from the penetration probe to the analysis chamber; and measuring a quantity of an analyte in the fluid sample.
  49. 49. The method of claim 48, wherein the sample is selected from the group consisting of interstitial fluid and whole blood.
  50. 50. The method of claim 48, wherein the analyte is selected from the group consisting of an ion, an element, a sugar, an alcohol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, a pharmaceutical, and a drug.
  51. 51. The method of claim 48, wherein the analyte is selected from the group consisting of potassium ion, ethanol, cholesterol, glucose, and lactate.
  52. 52. The method of claim 48, wherein a flow of sample to the analysis chamber is driven by a driving force, wherein the driving force comprises a force selected from the group consisting of a capillary force and a pressure differential.
  53. 53. The method of claim 48, wherein the penetration probe is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential in capillary force exists between the first capillary force and the second capillary force.
  54. 54. The method of claim 48, wherein the second capillary force is greater than the first capillary force.
  55. 55. The method of claim 48, wherein an interior surface of the penetration probe comprises a first penetration probe wall and a second penetration probe wall, wherein the first penetration probe wall and the second penetration probe wall are spaced apart at a first distance to define a penetration probe height, and wherein an interior surface of the analysis chamber comprises a first analysis chamber wall and a second analysis chamber wall, wherein the first analysis chamber wall and the second analysis chamber wall are spaced apart at a second distance to define an analysis chamber height, wherein the height of the analysis chamber is less than the height of the penetration probe, wherein the penetration probe is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential in capillary force exists between the first capillary force and the second capillary force, and wherein the differential capillary force derives at least in part from a difference between the penetration probe height and the analysis chamber height.
  56. 56. The method of claim 48, wherein at least one of the penetration probe and the analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.
  57. 57. The method of claim 56, wherein the substance is selected from the group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, and a combination thereof.
  58. 58. The method of claim 56, wherein the substance is selected from the group consisting of polyethylene glycol, polyvinyl pyrrolidone, a surfactant, a hydrophilic block copolymer, and polyacrylic acid.
  59. 59. The method of claim 52, wherein the pressure differential comprises a positive pressure applied to the analysis chamber.
  60. 60. The method of claim 52, wherein the pressure differential comprises a negative pressure applied from the analysis chamber.
  61. 61. The method of claim 48, wherein the analysis chamber comprises a hollow electrochemical cell, the hollow electrochemical cell comprising a working electrode, a counter or reference electrode, and an opening for admitting an analyte to the cell, the working electrode being spaced from the counter or reference electrode by a distance of less than 500 μm.
  62. 62. The method of claim 61, wherein the penetration probe comprises a component selected from the group consisting of a needle, a lancet, a tube, a channel, and a solid protrusion.
  63. 63. The method of claim 61, wherein the penetration probe is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential in capillary force exists between the first capillary force and the second capillary force.
  64. 64. The method of claim 61, wherein the second capillary force is greater than the first capillary force.
US10369120 2000-03-27 2003-02-13 Method and device for sampling and analyzing interstitial fluid and whole blood samples Abandoned US20040236250A1 (en)

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US09536235 US6612111B1 (en) 2000-03-27 2000-03-27 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US10166487 US6939312B2 (en) 2000-03-27 2002-06-10 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US10369120 US20040236250A1 (en) 2000-03-27 2003-02-13 Method and device for sampling and analyzing interstitial fluid and whole blood samples

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US10369120 US20040236250A1 (en) 2000-03-27 2003-02-13 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US11480587 US20070017805A1 (en) 2000-03-27 2006-06-30 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US11926510 US20080081976A1 (en) 2000-03-27 2007-10-29 Method and device for sampling and analyzing interstitial fluid and whole blood samples

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US10166487 Expired - Fee Related US6939312B2 (en) 2000-03-27 2002-06-10 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US10369120 Abandoned US20040236250A1 (en) 2000-03-27 2003-02-13 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US10914818 Abandoned US20050010137A1 (en) 2000-03-27 2004-08-10 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US11480587 Abandoned US20070017805A1 (en) 2000-03-27 2006-06-30 Method and device for sampling and analyzing interstitial fluid and whole blood samples
US11926510 Abandoned US20080081976A1 (en) 2000-03-27 2007-10-29 Method and device for sampling and analyzing interstitial fluid and whole blood samples

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US11926510 Abandoned US20080081976A1 (en) 2000-03-27 2007-10-29 Method and device for sampling and analyzing interstitial fluid and whole blood samples

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Cited By (74)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020137998A1 (en) * 2001-03-26 2002-09-26 Wilson Smart Silicon microprobe with integrated biosensor
US20030018282A1 (en) * 2001-07-20 2003-01-23 Carlo Effenhauser System for withdrawing small amounts of body fluid
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US7666149B2 (en) 1997-12-04 2010-02-23 Peliken Technologies, Inc. Cassette of lancet cartridges for sampling blood
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7682318B2 (en) 2001-06-12 2010-03-23 Pelikan Technologies, Inc. Blood sampling apparatus and method
US7699791B2 (en) 2001-06-12 2010-04-20 Pelikan Technologies, Inc. Method and apparatus for improving success rate of blood yield from a fingerstick
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7731729B2 (en) 2002-04-19 2010-06-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7749174B2 (en) 2001-06-12 2010-07-06 Pelikan Technologies, Inc. Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge
US7780631B2 (en) 1998-03-30 2010-08-24 Pelikan Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
WO2010101626A1 (en) * 2009-03-02 2010-09-10 Seventh Sense Biosystems, Inc. Techniques and devices associated with blood sampling
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
US7833171B2 (en) 2002-04-19 2010-11-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7850621B2 (en) 2003-06-06 2010-12-14 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7850622B2 (en) 2001-06-12 2010-12-14 Pelikan Technologies, Inc. Tissue penetration device
US7862520B2 (en) 2002-04-19 2011-01-04 Pelikan Technologies, Inc. Body fluid sampling module with a continuous compression tissue interface surface
US7874994B2 (en) 2002-04-19 2011-01-25 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7892185B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7901365B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7909777B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US7909778B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7914465B2 (en) 2002-04-19 2011-03-29 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US20110174618A1 (en) * 2008-09-30 2011-07-21 Menai Medical Technologies Limited Sample measurement system
US7988645B2 (en) 2001-06-12 2011-08-02 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
US8007446B2 (en) 2002-04-19 2011-08-30 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8079960B2 (en) 2002-04-19 2011-12-20 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US20120014849A1 (en) * 2010-07-19 2012-01-19 Chevron U.S.A. Inc. Multiphase contact and distribution apparatus for hydroprocessing
US20120022352A1 (en) * 2005-10-12 2012-01-26 Masaki Fujiwara Blood sensor, blood testing apparatus, and method for controlling blood testing apparatus
US8197421B2 (en) 2002-04-19 2012-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US20120164026A1 (en) * 2010-12-22 2012-06-28 Agilent Technologies, Inc. Ceramic injection needle
US8221334B2 (en) 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8262614B2 (en) 2003-05-30 2012-09-11 Pelikan Technologies, Inc. Method and apparatus for fluid injection
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US20120238841A1 (en) * 2010-04-15 2012-09-20 Mark Castle Sample capture in one step for test strips
US8282576B2 (en) 2003-09-29 2012-10-09 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US8337421B2 (en) 2001-06-12 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8435190B2 (en) 2002-04-19 2013-05-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8556829B2 (en) 2002-04-19 2013-10-15 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8561795B2 (en) 2010-07-16 2013-10-22 Seventh Sense Biosystems, Inc. Low-pressure packaging for fluid devices
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US8641644B2 (en) 2000-11-21 2014-02-04 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US8668656B2 (en) 2003-12-31 2014-03-11 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US8702624B2 (en) 2006-09-29 2014-04-22 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US8721671B2 (en) 2001-06-12 2014-05-13 Sanofi-Aventis Deutschland Gmbh Electric lancet actuator
US8784335B2 (en) 2002-04-19 2014-07-22 Sanofi-Aventis Deutschland Gmbh Body fluid sampling device with a capacitive sensor
US8808202B2 (en) 2010-11-09 2014-08-19 Seventh Sense Biosystems, Inc. Systems and interfaces for blood sampling
US8821412B2 (en) 2009-03-02 2014-09-02 Seventh Sense Biosystems, Inc. Delivering and/or receiving fluids
US8828203B2 (en) 2004-05-20 2014-09-09 Sanofi-Aventis Deutschland Gmbh Printable hydrogels for biosensors
US8894832B2 (en) 2010-03-30 2014-11-25 Jabil Circuit (Singapore) Pte, Ltd. Sampling plate
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9011658B2 (en) 2010-03-30 2015-04-21 Jabil Circuit (Singapore) Pte, Ltd. Sampling plate
US9033898B2 (en) 2010-06-23 2015-05-19 Seventh Sense Biosystems, Inc. Sampling devices and methods involving relatively little pain
US9041541B2 (en) 2010-01-28 2015-05-26 Seventh Sense Biosystems, Inc. Monitoring or feedback systems and methods
US9119578B2 (en) 2011-04-29 2015-09-01 Seventh Sense Biosystems, Inc. Plasma or serum production and removal of fluids under reduced pressure
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9295417B2 (en) 2011-04-29 2016-03-29 Seventh Sense Biosystems, Inc. Systems and methods for collecting fluid from a subject
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
WO2016025297A3 (en) * 2014-08-11 2016-05-19 The Regents Of The University Of California Continuous analyte sensor
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9775553B2 (en) 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device

Families Citing this family (201)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020010406A1 (en) 1996-05-17 2002-01-24 Douglas Joel S. Methods and apparatus for expressing body fluid from an incision
US7828749B2 (en) 1996-05-17 2010-11-09 Roche Diagnostics Operations, Inc. Blood and interstitial fluid sampling device
EP1579814A3 (en) 1996-05-17 2006-06-14 Roche Diagnostics Operations, Inc. Methods and apparatus for sampling and analyzing body fluid
US7235056B2 (en) 1996-05-17 2007-06-26 Amira Medical Body fluid sampling device and methods of use
JP3394262B2 (en) 1997-02-06 2003-04-07 イー.ヘラー アンド カンパニー Small volume in vitro analyte sensor
US9757061B2 (en) 2006-01-17 2017-09-12 Dexcom, Inc. Low oxygen in vivo analyte sensor
US7899511B2 (en) * 1997-03-04 2011-03-01 Dexcom, Inc. Low oxygen in vivo analyte sensor
US8148164B2 (en) 2003-06-20 2012-04-03 Roche Diagnostics Operations, Inc. System and method for determining the concentration of an analyte in a sample fluid
US8071384B2 (en) 1997-12-22 2011-12-06 Roche Diagnostics Operations, Inc. Control and calibration solutions and methods for their use
US8465425B2 (en) 1998-04-30 2013-06-18 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8480580B2 (en) 1998-04-30 2013-07-09 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8346337B2 (en) 1998-04-30 2013-01-01 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US9066695B2 (en) 1998-04-30 2015-06-30 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US6175752B1 (en) 1998-04-30 2001-01-16 Therasense, Inc. Analyte monitoring device and methods of use
US8974386B2 (en) 1998-04-30 2015-03-10 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8688188B2 (en) 1998-04-30 2014-04-01 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US6338790B1 (en) 1998-10-08 2002-01-15 Therasense, Inc. Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
US20050103624A1 (en) 1999-10-04 2005-05-19 Bhullar Raghbir S. Biosensor and method of making
US6283982B1 (en) 1999-10-19 2001-09-04 Facet Technologies, Inc. Lancing device and method of sample collection
US6706159B2 (en) * 2000-03-02 2004-03-16 Diabetes Diagnostics Combined lancet and electrochemical analyte-testing apparatus
US6571651B1 (en) * 2000-03-27 2003-06-03 Lifescan, Inc. Method of preventing short sampling of a capillary or wicking fill device
US6612111B1 (en) * 2000-03-27 2003-09-02 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples
US6591125B1 (en) * 2000-06-27 2003-07-08 Therasense, Inc. Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
DE10057832C1 (en) * 2000-11-21 2002-02-21 Hartmann Paul Ag Blood analysis device has syringe mounted in casing, annular mounting carrying needles mounted behind test strip and being swiveled so that needle can be pushed through strip and aperture in casing to take blood sample
US6620310B1 (en) * 2000-12-13 2003-09-16 Lifescan, Inc. Electrochemical coagulation assay and device
US7144495B2 (en) * 2000-12-13 2006-12-05 Lifescan, Inc. Electrochemical test strip with an integrated micro-needle and associated methods
GB0030929D0 (en) 2000-12-19 2001-01-31 Inverness Medical Ltd Analyte measurement
US6560471B1 (en) 2001-01-02 2003-05-06 Therasense, Inc. Analyte monitoring device and methods of use
WO2002056751A3 (en) 2001-01-22 2002-11-07 Roche Diagnostics Corp Lancet device having capillary action
US20070100255A1 (en) * 2002-04-19 2007-05-03 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
WO2002078512A8 (en) 2001-04-02 2004-12-02 Therasense Inc Blood glucose tracking apparatus and methods
US20020188223A1 (en) 2001-06-08 2002-12-12 Edward Perez Devices and methods for the expression of bodily fluids from an incision
US7524293B2 (en) * 2002-04-19 2009-04-28 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7582099B2 (en) * 2002-04-19 2009-09-01 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US7485128B2 (en) * 2002-04-19 2009-02-03 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7374544B2 (en) * 2002-04-19 2008-05-20 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US20070142748A1 (en) * 2002-04-19 2007-06-21 Ajay Deshmukh Tissue penetration device
WO2007070719A3 (en) * 2005-12-14 2009-01-15 Don Alden Tissue penetration device
US7244265B2 (en) * 2002-04-19 2007-07-17 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US6749792B2 (en) * 2001-07-09 2004-06-15 Lifescan, Inc. Micro-needles and methods of manufacture and use thereof
US7776608B2 (en) 2001-07-09 2010-08-17 Bayer Healthcare Llc Volume meter testing device and method of use
JP4736323B2 (en) 2001-07-13 2011-07-27 アークレイ株式会社 Piercing element integral mounting member for density measurement apparatus having an analytical tool, and body fluid sampling tool
EP1407712B1 (en) * 2001-07-19 2013-07-10 ARKRAY, Inc. Piercing device
US20030032874A1 (en) 2001-07-27 2003-02-13 Dexcom, Inc. Sensor head for use with implantable devices
US6749575B2 (en) * 2001-08-20 2004-06-15 Alza Corporation Method for transdermal nucleic acid sampling
DE10142232A1 (en) 2001-08-29 2003-03-20 Roche Diagnostics Gmbh Analytical device with the lancet and test element
US7004928B2 (en) * 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
CA2419200C (en) * 2002-03-05 2015-06-30 Bayer Healthcare Llc Fluid collection apparatus having an integrated lance and reaction area
US20070191736A1 (en) * 2005-10-04 2007-08-16 Don Alden Method for loading penetrating members in a collection device
US7343188B2 (en) * 2002-05-09 2008-03-11 Lifescan, Inc. Devices and methods for accessing and analyzing physiological fluid
US20030212344A1 (en) 2002-05-09 2003-11-13 Vadim Yuzhakov Physiological sample collection devices and methods of using the same
US20030211619A1 (en) * 2002-05-09 2003-11-13 Lorin Olson Continuous strip of fluid sampling and testing devices and methods of making, packaging and using the same
US7060192B2 (en) * 2002-05-09 2006-06-13 Lifescan, Inc. Methods of fabricating physiological sample collection devices
KR101035839B1 (en) * 2002-06-25 2011-05-20 바이엘 헬쓰케어, 엘엘씨 Sensor with intergrated lancet
US6840121B2 (en) * 2002-07-18 2005-01-11 University Of Florida Reasearch Foundation, Inc. Self-powered fluid sampler
FR2843011B1 (en) * 2002-07-31 2006-02-17 Draeger Safety Ag & Co Kgaa Device and method for picking up and deposit saliva
ES2525318T3 (en) * 2002-10-11 2014-12-22 Zbx Corporation Diagnostic Devices
US20050049522A1 (en) * 2002-10-30 2005-03-03 Allen John J Method of lancing skin for the extraction of blood
US7572237B2 (en) 2002-11-06 2009-08-11 Abbott Diabetes Care Inc. Automatic biological analyte testing meter with integrated lancing device and methods of use
US7244264B2 (en) 2002-12-03 2007-07-17 Roche Diagnostics Operations, Inc. Dual blade lancing test strip
EP1570783A4 (en) * 2002-12-13 2009-09-09 Arkray Inc Needle-insertion device
WO2004060160A1 (en) * 2002-12-24 2004-07-22 Roche Diagnostics Gmbh A sampling device utilizing biased capillary action
US20040127818A1 (en) 2002-12-27 2004-07-01 Roe Steven N. Precision depth control lancing tip
US8052926B2 (en) * 2002-12-27 2011-11-08 Roche Diagnostics Operations, Inc. Method for manufacturing a sterilized lancet integrated biosensor
EP1581115B1 (en) 2002-12-30 2009-10-14 Roche Diagnostics GmbH Blood acquisition suspension system
USRE43187E1 (en) * 2003-01-13 2012-02-14 Isense Corporation Methods for analyte sensing and measurement
US7374546B2 (en) * 2003-01-29 2008-05-20 Roche Diagnostics Operations, Inc. Integrated lancing test strip
US7052652B2 (en) 2003-03-24 2006-05-30 Rosedale Medical, Inc. Analyte concentration detection devices and methods
US7473264B2 (en) * 2003-03-28 2009-01-06 Lifescan, Inc. Integrated lance and strip for analyte measurement
US20040193072A1 (en) * 2003-03-28 2004-09-30 Allen John J. Method of analyte measurement using integrated lance and strip
US20040193202A1 (en) * 2003-03-28 2004-09-30 Allen John J. Integrated lance and strip for analyte measurement
US6949816B2 (en) 2003-04-21 2005-09-27 Motorola, Inc. Semiconductor component having first surface area for electrically coupling to a semiconductor chip and second surface area for electrically coupling to a substrate, and method of manufacturing same
US20070032812A1 (en) * 2003-05-02 2007-02-08 Pelikan Technologies, Inc. Method and apparatus for a tissue penetrating device user interface
WO2005006939A3 (en) * 2003-06-11 2005-03-31 Don Alden Method and apparatus for body fluid sampling and analyte sensing
US7718439B2 (en) 2003-06-20 2010-05-18 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US8679853B2 (en) 2003-06-20 2014-03-25 Roche Diagnostics Operations, Inc. Biosensor with laser-sealed capillary space and method of making
US7452457B2 (en) 2003-06-20 2008-11-18 Roche Diagnostics Operations, Inc. System and method for analyte measurement using dose sufficiency electrodes
US7645421B2 (en) 2003-06-20 2010-01-12 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US7645373B2 (en) 2003-06-20 2010-01-12 Roche Diagnostic Operations, Inc. System and method for coding information on a biosensor test strip
US8071030B2 (en) 2003-06-20 2011-12-06 Roche Diagnostics Operations, Inc. Test strip with flared sample receiving chamber
KR100785670B1 (en) * 2003-06-20 2007-12-14 에프. 호프만-라 로슈 아게 Method and reagent for producing narrow, homogenous reagent strips
CA2529579C (en) * 2003-06-20 2011-01-25 F. Hoffmann-La Roche Ag Biosensor with multiple electrical functionalities
US8206565B2 (en) 2003-06-20 2012-06-26 Roche Diagnostics Operation, Inc. System and method for coding information on a biosensor test strip
US8058077B2 (en) 2003-06-20 2011-11-15 Roche Diagnostics Operations, Inc. Method for coding information on a biosensor test strip
US20100185071A1 (en) * 2003-12-05 2010-07-22 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US7774145B2 (en) * 2003-08-01 2010-08-10 Dexcom, Inc. Transcutaneous analyte sensor
US8886272B2 (en) * 2004-07-13 2014-11-11 Dexcom, Inc. Analyte sensor
US7778680B2 (en) 2003-08-01 2010-08-17 Dexcom, Inc. System and methods for processing analyte sensor data
US20100168542A1 (en) * 2003-08-01 2010-07-01 Dexcom, Inc. System and methods for processing analyte sensor data
GB2406794B (en) 2003-10-06 2008-03-05 Inverness Medical Ltd A lancing device using a piezoelectric actuator
US20050228313A1 (en) * 2003-12-04 2005-10-13 University Technologies International Inc. Fluid sampling, analysis and delivery system
US7460898B2 (en) * 2003-12-05 2008-12-02 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
EP2239567B1 (en) 2003-12-05 2015-09-02 DexCom, Inc. Calibration techniques for a continuous analyte sensor
US7424318B2 (en) * 2003-12-05 2008-09-09 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US8287453B2 (en) 2003-12-05 2012-10-16 Dexcom, Inc. Analyte sensor
US7366556B2 (en) * 2003-12-05 2008-04-29 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US8423114B2 (en) 2006-10-04 2013-04-16 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US7467003B2 (en) * 2003-12-05 2008-12-16 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US7831287B2 (en) * 2006-10-04 2010-11-09 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US20050187525A1 (en) * 2004-02-19 2005-08-25 Hilgers Michael E. Devices and methods for extracting bodily fluid
US7807043B2 (en) * 2004-02-23 2010-10-05 Oakville Hong Kong Company Limited Microfluidic test device
US7819822B2 (en) * 2004-03-06 2010-10-26 Roche Diagnostics Operations, Inc. Body fluid sampling device
EP1725168B1 (en) 2004-03-06 2016-04-20 Roche Diagnostics GmbH Body fluid sampling device
EP1737345A1 (en) * 2004-04-15 2007-01-03 Roche Diagnostics GmbH Integrated spot monitoring device with fluid sensor
US7322942B2 (en) * 2004-05-07 2008-01-29 Roche Diagnostics Operations, Inc. Integrated disposable for automatic or manual blood dosing
DE602005024555D1 (en) * 2004-06-03 2010-12-16 Pelikan Technologies Inc Tissue interface on a fluid sample device
US7569126B2 (en) 2004-06-18 2009-08-04 Roche Diagnostics Operations, Inc. System and method for quality assurance of a biosensor test strip
US20050284757A1 (en) * 2004-06-29 2005-12-29 Allen John J Analyte measuring system which prevents the reuse of a test strip
US20050284773A1 (en) * 2004-06-29 2005-12-29 Allen John J Method of preventing reuse in an analyte measuring system
US8452368B2 (en) 2004-07-13 2013-05-28 Dexcom, Inc. Transcutaneous analyte sensor
US20060016700A1 (en) 2004-07-13 2006-01-26 Dexcom, Inc. Transcutaneous analyte sensor
US7497827B2 (en) 2004-07-13 2009-03-03 Dexcom, Inc. Transcutaneous analyte sensor
US7783333B2 (en) * 2004-07-13 2010-08-24 Dexcom, Inc. Transcutaneous medical device with variable stiffness
US8565848B2 (en) 2004-07-13 2013-10-22 Dexcom, Inc. Transcutaneous analyte sensor
US9247900B2 (en) 2004-07-13 2016-02-02 Dexcom, Inc. Analyte sensor
US7201072B1 (en) * 2004-08-26 2007-04-10 Elemental Scientific Inc. Automated sampling device
US7645241B2 (en) 2004-09-09 2010-01-12 Roche Diagnostics Operations, Inc. Device for sampling bodily fluids
US7604604B2 (en) 2004-09-09 2009-10-20 Roche Diagnostics Operations, Inc. Device for sampling bodily fluids
GB0420256D0 (en) * 2004-09-13 2004-10-13 Cassells John M Method and apparatus for sampling and analysis of fluids
US8211038B2 (en) * 2004-09-17 2012-07-03 Abbott Diabetes Care Inc. Multiple-biosensor article
US7608042B2 (en) * 2004-09-29 2009-10-27 Intellidx, Inc. Blood monitoring system
US7488298B2 (en) * 2004-10-08 2009-02-10 Roche Diagnostics Operations, Inc. Integrated lancing test strip with capillary transfer sheet
US20080214917A1 (en) * 2004-12-30 2008-09-04 Dirk Boecker Method and apparatus for analyte measurement test time
WO2006072004A3 (en) * 2004-12-30 2007-05-10 Dirk Boecker Method and apparatus for analyte measurement test time
US20060167382A1 (en) * 2004-12-30 2006-07-27 Ajay Deshmukh Method and apparatus for storing an analyte sampling and measurement device
US20060184065A1 (en) * 2005-02-10 2006-08-17 Ajay Deshmukh Method and apparatus for storing an analyte sampling and measurement device
US7935063B2 (en) * 2005-03-02 2011-05-03 Roche Diagnostics Operations, Inc. System and method for breaking a sterility seal to engage a lancet
US7815579B2 (en) * 2005-03-02 2010-10-19 Roche Diagnostics Operations, Inc. Dynamic integrated lancing test strip with sterility cover
US7695442B2 (en) * 2005-04-12 2010-04-13 Roche Diagnostics Operations, Inc. Integrated lancing test strip with retractable lancet
US20060281187A1 (en) 2005-06-13 2006-12-14 Rosedale Medical, Inc. Analyte detection devices and methods with hematocrit/volume correction and feedback control
US20070031293A1 (en) * 2005-08-04 2007-02-08 Beatty Christopher C Method and apparatus for collecting and diluting a liquid sample
US7887494B2 (en) * 2005-09-30 2011-02-15 Intuity Medical, Inc. Fluid sample transport devices and methods
US7749371B2 (en) 2005-09-30 2010-07-06 Lifescan, Inc. Method and apparatus for rapid electrochemical analysis
EP2989981A1 (en) 2005-09-30 2016-03-02 Intuity Medical, Inc. Multi-site body fluid sampling and analysis cartridge
US8801631B2 (en) 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
US20100145158A1 (en) * 2005-10-06 2010-06-10 Hamilton Scott E Pod Connected Data Monitoring System
EP1772099B8 (en) 2005-10-08 2011-10-05 Roche Diagnostics GmbH Piercing system
US7915005B2 (en) * 2005-11-09 2011-03-29 Washington University In St. Louis Methods for detecting sleepiness
US20070123801A1 (en) * 2005-11-28 2007-05-31 Daniel Goldberger Wearable, programmable automated blood testing system
JPWO2007063948A1 (en) * 2005-12-01 2009-05-07 アークレイ株式会社 Sensor - a lancet-integrated devices, and body fluid sampling method using the same
JP5002266B2 (en) * 2006-01-11 2012-08-15 キヤノン株式会社 The body fluid sampling device
US8133178B2 (en) * 2006-02-22 2012-03-13 Dexcom, Inc. Analyte sensor
GB0605003D0 (en) * 2006-03-13 2006-04-19 Microsample Ltd Method and apparatus for piercing the skin and delivery or collection of liquids
US20070213682A1 (en) * 2006-03-13 2007-09-13 Hans-Peter Haar Penetration device, kit, and method
US20090093735A1 (en) * 2006-03-29 2009-04-09 Stephan Korner Test unit and test system for analyzing body fluids
EP2023802A2 (en) * 2006-05-08 2009-02-18 Bayer Healthcare, LLC Test sensor with under-fill protection
US8092385B2 (en) 2006-05-23 2012-01-10 Intellidx, Inc. Fluid access interface
US20080071157A1 (en) 2006-06-07 2008-03-20 Abbott Diabetes Care, Inc. Analyte monitoring system and method
EP1887355B1 (en) 2006-08-02 2017-09-27 F.Hoffmann-La Roche Ag Coating method for a microfluidic system.
US7846110B2 (en) * 2006-08-03 2010-12-07 Advanced Medical Products Gmbh Self-contained test unit for testing body fluids
US8364231B2 (en) 2006-10-04 2013-01-29 Dexcom, Inc. Analyte sensor
US8852124B2 (en) * 2006-10-13 2014-10-07 Roche Diagnostics Operations, Inc. Tape transport lance sampler
US7955271B2 (en) 2006-10-13 2011-06-07 Roche Diagnostics Operations, Inc. Tape transport lance sampler
US20080097241A1 (en) * 2006-10-18 2008-04-24 California Institute Of Technology Sampling device
RU2470300C2 (en) * 2006-12-07 2012-12-20 А. Менарини Индустрие Фармачеутике Рьюните С.Р.Л. Portable device to measure and control analytes in biological liquids
WO2008078319A1 (en) 2006-12-22 2008-07-03 Medingo Ltd. Fluid delivery with in vivo electrochemical analyte sensing
US7738094B2 (en) * 2007-01-26 2010-06-15 Becton, Dickinson And Company Method, system, and compositions for cell counting and analysis
EP1970006A1 (en) 2007-03-14 2008-09-17 Boehringer Mannheim Gmbh Analysis system for determining a analyte in a body fluid and disposable integrated sample extraction and analysis element
EP2545854B1 (en) 2007-04-30 2014-06-04 Roche Diagnostics GmbH Instrument and system for producing a sample of a body liquid and for analysis thereof
EP2263797B1 (en) * 2007-06-25 2011-09-07 ibidi GmbH Sample chamber
EP2025287A1 (en) * 2007-08-16 2009-02-18 F.Hoffmann-La Roche Ag Diagnostic disposable part and method for its production
US20090076360A1 (en) 2007-09-13 2009-03-19 Dexcom, Inc. Transcutaneous analyte sensor
CN101820816B (en) 2007-10-08 2013-04-24 霍夫曼-拉罗奇有限公司 Analysis system for automatic skin prick analysis
US8417312B2 (en) 2007-10-25 2013-04-09 Dexcom, Inc. Systems and methods for processing sensor data
US20090209883A1 (en) * 2008-01-17 2009-08-20 Michael Higgins Tissue penetrating apparatus
US7766846B2 (en) 2008-01-28 2010-08-03 Roche Diagnostics Operations, Inc. Rapid blood expression and sampling
EP2087840A1 (en) * 2008-02-11 2009-08-12 F.Hoffmann-La Roche Ag Device and method for removing bodily fluids
US8396528B2 (en) 2008-03-25 2013-03-12 Dexcom, Inc. Analyte sensor
FR2929135A1 (en) * 2008-03-31 2009-10-02 Commissariat Energie Atomique An aliquoting and dispensing of a liquid
EP2293719B1 (en) 2008-05-30 2015-09-09 Intuity Medical, Inc. Body fluid sampling device -- sampling site interface
CA2726067A1 (en) 2008-06-06 2009-12-10 Intuity Medical, Inc. Detection meter and mode of operation
WO2010007431A3 (en) 2008-07-15 2010-03-11 L3 Technology Limited Assay test card
EP2181651A1 (en) 2008-10-29 2010-05-05 Boehringer Mannheim Gmbh Instrument and system for producing a sample of a body liquid and for analysis thereof
US20100187132A1 (en) * 2008-12-29 2010-07-29 Don Alden Determination of the real electrochemical surface areas of screen printed electrodes
CA2655017A1 (en) * 2009-02-20 2010-08-20 Abdeltif Essalik Non-invasive biomedical detection and monitoring systems
EP2229886A1 (en) * 2009-03-17 2010-09-22 Roche Diagnostics GmbH Lance with plastic attachment element
US8753290B2 (en) 2009-03-27 2014-06-17 Intellectual Inspiration, Llc Fluid transfer system and method
EP2283774A1 (en) 2009-08-13 2011-02-16 Roche Diagnostics GmbH Test element for analysing a body fluid
US20110092854A1 (en) 2009-10-20 2011-04-21 Uwe Kraemer Instruments and system for producing a sample of a body fluid and for analysis thereof
US8919605B2 (en) 2009-11-30 2014-12-30 Intuity Medical, Inc. Calibration material delivery devices and methods
US8771202B2 (en) * 2010-01-19 2014-07-08 Becton Dickinson And Company Electrode layout for blood test sensor strip
KR101090730B1 (en) * 2010-06-24 2011-12-08 (주)일렉켐 A module for gathering the blood for measure of alcohol concentration
KR101123771B1 (en) * 2010-07-29 2012-03-16 주식회사 디에이텍 Apparatus for measuring a blood alcohol concentration
US9125975B2 (en) 2010-08-16 2015-09-08 Becton, Dickinson And Company User-actuated storage assembly for injection device
WO2012046231A3 (en) * 2010-10-04 2012-07-05 Nervomatrix Ltd. Electrode for finding points of low impedance and applying electrical stimulation thereto
WO2013020103A1 (en) 2011-08-03 2013-02-07 Intuity Medical, Inc. Devices and methods for body fluid sampling and analysis
JP6046724B2 (en) * 2011-09-23 2016-12-21 エフ ホフマン−ラ ロッシュ アクチェン ゲゼルシャフト Mask etching method of the pricking element
CN103917870B (en) 2011-11-16 2016-04-13 贝克顿·迪金森公司 Method and system for detecting an analyte in a sample
EP2786141B1 (en) * 2011-11-29 2016-05-18 Teleflex Medical Incorporated Device with integrated allergy testing
US9554736B2 (en) 2011-11-29 2017-01-31 Teleflex Medical Incorporated Device with integrated allergy testing
US20150173662A1 (en) * 2012-08-08 2015-06-25 Koninklijkie Philips N.V. Systems and methods for minimally-invasive arterial blood gas measurement
WO2014037011A1 (en) * 2012-09-05 2014-03-13 Aqm Maxval A/S Blood sampling needle incorporating measuring capabilities
US9341229B1 (en) 2012-09-10 2016-05-17 Elemental Scientific, Inc. Automated sampling device
US20140073992A1 (en) * 2012-09-12 2014-03-13 The Charles Stark Draper Laboratory, Inc. Apparatus and method for manually powered bodily fluid extraction
CN104755925B (en) 2013-01-11 2017-06-23 贝克顿·迪金森公司 Cost point of care measurement device
US9913627B2 (en) * 2013-01-29 2018-03-13 Becton, Dickinson And Company Specimen collection container having a fluid separation chamber
US20150111790A1 (en) * 2013-01-31 2015-04-23 Christopher Ategeka Testing device
FR3003033B1 (en) * 2013-03-07 2015-04-17 Commissariat Energie Atomique Device for extracting a liquid sample by capillarity and analysis METHOD
US9797899B2 (en) 2013-11-06 2017-10-24 Becton, Dickinson And Company Microfluidic devices, and methods of making and using the same
EP3228249A3 (en) 2014-10-14 2017-12-27 Becton, Dickinson and Company Blood mixing and transfer device
US9649061B2 (en) 2015-03-10 2017-05-16 Becton, Dickinson And Company Biological fluid micro-sample management device

Citations (66)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3233785A (en) * 1962-09-13 1966-02-08 Dade Reagents Inc Rinsing pipette
US3640388A (en) * 1970-08-20 1972-02-08 Damon Corp Dialyzing liquid-collecting container
US4053381A (en) * 1976-05-19 1977-10-11 Eastman Kodak Company Device for determining ionic activity of components of liquid drops
US4088448A (en) * 1975-09-29 1978-05-09 Lilja Jan Evert Apparatus for sampling, mixing the sample with a reagent and making particularly optical analyses
US4178831A (en) * 1976-07-05 1979-12-18 Ab Bofors Fluid pressure device for supporting and elevating a gun barrel
US4192415A (en) * 1977-04-14 1980-03-11 O.G. Hoyer A/S Apparatus for transferring frozen confections from a supply conveyor to a discharge conveyor
US4233029A (en) * 1978-10-25 1980-11-11 Eastman Kodak Company Liquid transport device and method
US4254083A (en) * 1979-07-23 1981-03-03 Eastman Kodak Company Structural configuration for transport of a liquid drop through an ingress aperture
US4298011A (en) * 1979-09-07 1981-11-03 Mangurten Henry H Blood sample collector
US4301414A (en) * 1979-10-29 1981-11-17 United States Surgical Corporation Disposable sample card and method of making same
US4301412A (en) * 1979-10-29 1981-11-17 United States Surgical Corporation Liquid conductivity measuring system and sample cards therefor
US4303887A (en) * 1979-10-29 1981-12-01 United States Surgical Corporation Electrical liquid conductivity measuring system
US4605629A (en) * 1980-12-23 1986-08-12 Boehringer Mannheim Gmbh Method of eluting reagent from reagent strips for chemical analyses and reagent strip therefor
US4627445A (en) * 1985-04-08 1986-12-09 Garid, Inc. Glucose medical monitoring system
US4654197A (en) * 1983-10-18 1987-03-31 Aktiebolaget Leo Cuvette for sampling and analysis
US4774192A (en) * 1987-01-28 1988-09-27 Technimed Corporation A dry reagent delivery system with membrane having porosity gradient
US4790979A (en) * 1986-08-29 1988-12-13 Technimed Corporation Test strip and fixture
US4900424A (en) * 1986-11-28 1990-02-13 Unilever Patent Holdings B.V. Electrochemical measurement cell
US4983416A (en) * 1985-02-04 1991-01-08 Propper Manufacturing Co., Inc. Manufacturing method for an occult fecal blood test slide
US5120420A (en) * 1988-03-31 1992-06-09 Matsushita Electric Industrial Co., Ltd. Biosensor and a process for preparation thereof
US5126034A (en) * 1988-07-21 1992-06-30 Medisense, Inc. Bioelectrochemical electrodes
US5128015A (en) * 1988-03-15 1992-07-07 Tall Oak Ventures Method and apparatus for amperometric diagnostic analysis
US5135719A (en) * 1986-10-29 1992-08-04 Biotrack, Inc. Blood separation device comprising a filter and a capillary flow pathway exiting the filter
US5141868A (en) * 1984-06-13 1992-08-25 Internationale Octrooi Maatschappij "Octropa" Bv Device for use in chemical test procedures
US5145565A (en) * 1989-05-01 1992-09-08 Spacelabs, Inc. Contamination-free method and apparatus for measuring body fluid chemical parameters
US5225163A (en) * 1989-08-18 1993-07-06 Angenics, Inc. Reaction apparatus employing gravitational flow
US5229282A (en) * 1989-11-24 1993-07-20 Matsushita Electric Industrial Co., Ltd. Preparation of biosensor having a layer containing an enzyme, electron acceptor and hydrophilic polymer on an electrode system
US5231993A (en) * 1991-11-20 1993-08-03 Habley Medical Technology Corporation Blood sampler and component tester with guide member
US5306623A (en) * 1989-08-28 1994-04-26 Lifescan, Inc. Visual blood glucose concentration test strip
US5320732A (en) * 1990-07-20 1994-06-14 Matsushita Electric Industrial Co., Ltd. Biosensor and measuring apparatus using the same
US5346672A (en) * 1989-11-17 1994-09-13 Gene Tec Corporation Devices for containing biological specimens for thermal processing
US5382346A (en) * 1991-05-17 1995-01-17 Kyoto Daiichi Kagaku Co., Ltd. Biosensor and method of quantitative analysis using the same
US5384028A (en) * 1992-08-28 1995-01-24 Nec Corporation Biosensor with a data memory
US5385846A (en) * 1993-06-03 1995-01-31 Boehringer Mannheim Corporation Biosensor and method for hematocrit determination
US5413690A (en) * 1993-07-23 1995-05-09 Boehringer Mannheim Corporation Potentiometric biosensor and the method of its use
US5418142A (en) * 1989-08-28 1995-05-23 Lifescan, Inc. Glucose test strip for whole blood
US5437999A (en) * 1994-02-22 1995-08-01 Boehringer Mannheim Corporation Electrochemical sensor
US5508171A (en) * 1989-12-15 1996-04-16 Boehringer Mannheim Corporation Assay method with enzyme electrode system
US5509410A (en) * 1983-06-06 1996-04-23 Medisense, Inc. Strip electrode including screen printing of a single layer
US5582184A (en) * 1993-10-13 1996-12-10 Integ Incorporated Interstitial fluid collection and constituent measurement
US5628890A (en) * 1995-09-27 1997-05-13 Medisense, Inc. Electrochemical sensor
US5635358A (en) * 1992-05-01 1997-06-03 Trustees Of The University Of Pennsylvania Fluid handling methods for use in mesoscale analytical devices
US5645709A (en) * 1993-12-08 1997-07-08 Van Den Bergh Foods Co., Division Of Conopco, Inc. Methods and apparatus for electrochemical measurements
US5700695A (en) * 1994-06-30 1997-12-23 Zia Yassinzadeh Sample collection and manipulation method
US5731212A (en) * 1994-12-20 1998-03-24 International Technidyne Corporation Test apparatus and method for testing cuvette accommodated samples
US5800420A (en) * 1994-11-04 1998-09-01 Elan Medical Technologies Limited Analyte-controlled liquid delivery device and analyte monitor
US5814522A (en) * 1995-06-24 1998-09-29 Boeringer Mannheim Gmbh Multilayer analytical element for the determination of an analyte in a liquid
US5879310A (en) * 1995-09-08 1999-03-09 Integ, Inc. Body fluid sampler
US5879367A (en) * 1995-09-08 1999-03-09 Integ, Inc. Enhanced interstitial fluid collection
US5922604A (en) * 1997-06-05 1999-07-13 Gene Tec Corporation Thin reaction chambers for containing and handling liquid microvolumes
US5942102A (en) * 1995-11-16 1999-08-24 Usf Filtration And Separations Group Inc. Electrochemical method
US5951492A (en) * 1996-05-17 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for sampling and analyzing body fluid
US5962215A (en) * 1996-04-05 1999-10-05 Mercury Diagnostics, Inc. Methods for testing the concentration of an analyte in a body fluid
US5997817A (en) * 1997-12-05 1999-12-07 Roche Diagnostics Corporation Electrochemical biosensor test strip
US6001307A (en) * 1996-04-26 1999-12-14 Kyoto Daiichi Kagaku Co., Ltd. Device for analyzing a sample
US6014577A (en) * 1995-12-19 2000-01-11 Abbot Laboratories Device for the detection of analyte and administration of a therapeutic substance
US6036924A (en) * 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US6077660A (en) * 1998-06-10 2000-06-20 Abbott Laboratories Diagnostic assay requiring a small sample of biological fluid
US6086545A (en) * 1998-04-28 2000-07-11 Amira Medical Methods and apparatus for suctioning and pumping body fluid from an incision
US6120464A (en) * 1998-10-16 2000-09-19 Integ, Inc. Needle assembly for fluid sampler
US6129823A (en) * 1997-09-05 2000-10-10 Abbott Laboratories Low volume electrochemical sensor
US6143164A (en) * 1997-02-06 2000-11-07 E. Heller & Company Small volume in vitro analyte sensor
US6203841B1 (en) * 1994-02-14 2001-03-20 Rich Products Corporation Organoleptic whippable foods with improved temperature stability and improved whipping performance
US6325975B1 (en) * 1997-08-27 2001-12-04 Arkray, Inc. Suction generating device and sample analysis apparatus using the same
US6368563B1 (en) * 1999-03-12 2002-04-09 Integ, Inc. Collection well for body fluid tester
US6612111B1 (en) * 2000-03-27 2003-09-02 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4299230A (en) * 1979-05-09 1981-11-10 Olympus Optical Co., Ltd. Stabbing apparatus for diagnosis of living body
CA1226036A (en) 1983-05-05 1987-08-25 Irving J. Higgins Analytical equipment and sensor electrodes therefor
CA1231136A (en) 1984-06-13 1988-01-05 Ian A. Shanks Capillary action chemical test device
DE3708031A1 (en) 1986-03-20 1987-11-12 Wolfgang Dr Med Wagner Measurement device or induction device with measurement device, or device for material recovery for a measurement device for metabolic states in the blood by puncturing under reduced pressure in a suction cup with displacement of the measurement zone outside the tip region of the puncturing device
GB8602148D0 (en) 1986-01-29 1986-03-05 Iq Bio Ltd Carrying out biochemical assay
GB8618022D0 (en) 1986-07-23 1986-08-28 Unilever Plc Electrochemical measurements
US5178831A (en) 1986-10-08 1993-01-12 Dai Nippon Insatsu Kab Ushiki Kaisha Device for testing body fluids
US4810470A (en) 1987-06-19 1989-03-07 Miles Inc. Volume independent diagnostic device
EP0345781B1 (en) 1988-06-09 1995-08-30 Boehringer Mannheim Corporation Defined volume test device
US5762770A (en) * 1994-02-21 1998-06-09 Boehringer Mannheim Corporation Electrochemical biosensor test strip
DE69023476D1 (en) 1990-02-22 1995-12-14 Editek Inc Multilayer test device for the determination of substances in liquids.
CA2036435A1 (en) 1990-03-26 1991-09-27 Paul J. Anderson Reagent unit
US5192415A (en) 1991-03-04 1993-03-09 Matsushita Electric Industrial Co., Ltd. Biosensor utilizing enzyme and a method for producing the same
EP0560336B1 (en) 1992-03-12 1998-05-06 Matsushita Electric Industrial Co., Ltd. A biosensor including a catalyst made from phosphate
FR2701117B1 (en) 1993-02-04 1995-03-10 Asulab Sa System of electrochemical measurement multizone sensor, and its application to glucose analysis.
US20010051352A1 (en) 1993-04-15 2001-12-13 Gary Krantz Multilayer test strip
US5348028A (en) * 1993-10-05 1994-09-20 Gustavel Terry L Compact multi-use oral hygiene device
WO1995028634A1 (en) 1994-04-14 1995-10-26 Memtec America Corporation Electrochemical cells
EP0729728A1 (en) * 1995-02-28 1996-09-04 AVL Medical Instruments AG Blood sampling device
CA2198955A1 (en) 1996-03-22 1997-09-22 Serim Research Corporation Pipette for collecting and dispensing material samples
US6071251A (en) * 1996-12-06 2000-06-06 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
DE69841786D1 (en) * 1997-03-21 2010-09-09 Lifescan Inc Connecting means for a sensor
DE69836490T2 (en) 1997-03-25 2007-03-08 Lifescan, Inc., Milpitas Improved electrochemical cell
US6258229B1 (en) * 1999-06-02 2001-07-10 Handani Winarta Disposable sub-microliter volume sensor and method of making

Patent Citations (73)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3233785A (en) * 1962-09-13 1966-02-08 Dade Reagents Inc Rinsing pipette
US3640388A (en) * 1970-08-20 1972-02-08 Damon Corp Dialyzing liquid-collecting container
US4088448A (en) * 1975-09-29 1978-05-09 Lilja Jan Evert Apparatus for sampling, mixing the sample with a reagent and making particularly optical analyses
US4053381A (en) * 1976-05-19 1977-10-11 Eastman Kodak Company Device for determining ionic activity of components of liquid drops
US4178831A (en) * 1976-07-05 1979-12-18 Ab Bofors Fluid pressure device for supporting and elevating a gun barrel
US4192415A (en) * 1977-04-14 1980-03-11 O.G. Hoyer A/S Apparatus for transferring frozen confections from a supply conveyor to a discharge conveyor
US4233029A (en) * 1978-10-25 1980-11-11 Eastman Kodak Company Liquid transport device and method
US4254083A (en) * 1979-07-23 1981-03-03 Eastman Kodak Company Structural configuration for transport of a liquid drop through an ingress aperture
US4298011A (en) * 1979-09-07 1981-11-03 Mangurten Henry H Blood sample collector
US4301414A (en) * 1979-10-29 1981-11-17 United States Surgical Corporation Disposable sample card and method of making same
US4301412A (en) * 1979-10-29 1981-11-17 United States Surgical Corporation Liquid conductivity measuring system and sample cards therefor
US4303887A (en) * 1979-10-29 1981-12-01 United States Surgical Corporation Electrical liquid conductivity measuring system
US4605629A (en) * 1980-12-23 1986-08-12 Boehringer Mannheim Gmbh Method of eluting reagent from reagent strips for chemical analyses and reagent strip therefor
US5509410A (en) * 1983-06-06 1996-04-23 Medisense, Inc. Strip electrode including screen printing of a single layer
US4654197A (en) * 1983-10-18 1987-03-31 Aktiebolaget Leo Cuvette for sampling and analysis
US5141868A (en) * 1984-06-13 1992-08-25 Internationale Octrooi Maatschappij "Octropa" Bv Device for use in chemical test procedures
US4983416A (en) * 1985-02-04 1991-01-08 Propper Manufacturing Co., Inc. Manufacturing method for an occult fecal blood test slide
US4637403A (en) * 1985-04-08 1987-01-20 Garid, Inc. Glucose medical monitoring system
US4627445A (en) * 1985-04-08 1986-12-09 Garid, Inc. Glucose medical monitoring system
US4790979A (en) * 1986-08-29 1988-12-13 Technimed Corporation Test strip and fixture
US5135719A (en) * 1986-10-29 1992-08-04 Biotrack, Inc. Blood separation device comprising a filter and a capillary flow pathway exiting the filter
US4900424A (en) * 1986-11-28 1990-02-13 Unilever Patent Holdings B.V. Electrochemical measurement cell
US4774192A (en) * 1987-01-28 1988-09-27 Technimed Corporation A dry reagent delivery system with membrane having porosity gradient
US5128015A (en) * 1988-03-15 1992-07-07 Tall Oak Ventures Method and apparatus for amperometric diagnostic analysis
US5120420A (en) * 1988-03-31 1992-06-09 Matsushita Electric Industrial Co., Ltd. Biosensor and a process for preparation thereof
US5120420B1 (en) * 1988-03-31 1999-11-09 Matsushita Electric Ind Co Ltd Biosensor and a process for preparation thereof
US5126034A (en) * 1988-07-21 1992-06-30 Medisense, Inc. Bioelectrochemical electrodes
US5145565A (en) * 1989-05-01 1992-09-08 Spacelabs, Inc. Contamination-free method and apparatus for measuring body fluid chemical parameters
US5225163A (en) * 1989-08-18 1993-07-06 Angenics, Inc. Reaction apparatus employing gravitational flow
US5418142A (en) * 1989-08-28 1995-05-23 Lifescan, Inc. Glucose test strip for whole blood
US5306623A (en) * 1989-08-28 1994-04-26 Lifescan, Inc. Visual blood glucose concentration test strip
US5346672A (en) * 1989-11-17 1994-09-13 Gene Tec Corporation Devices for containing biological specimens for thermal processing
US5229282A (en) * 1989-11-24 1993-07-20 Matsushita Electric Industrial Co., Ltd. Preparation of biosensor having a layer containing an enzyme, electron acceptor and hydrophilic polymer on an electrode system
US5508171A (en) * 1989-12-15 1996-04-16 Boehringer Mannheim Corporation Assay method with enzyme electrode system
US5320732A (en) * 1990-07-20 1994-06-14 Matsushita Electric Industrial Co., Ltd. Biosensor and measuring apparatus using the same
US5382346A (en) * 1991-05-17 1995-01-17 Kyoto Daiichi Kagaku Co., Ltd. Biosensor and method of quantitative analysis using the same
US5231993A (en) * 1991-11-20 1993-08-03 Habley Medical Technology Corporation Blood sampler and component tester with guide member
US5635358A (en) * 1992-05-01 1997-06-03 Trustees Of The University Of Pennsylvania Fluid handling methods for use in mesoscale analytical devices
US5384028A (en) * 1992-08-28 1995-01-24 Nec Corporation Biosensor with a data memory
US5385846A (en) * 1993-06-03 1995-01-31 Boehringer Mannheim Corporation Biosensor and method for hematocrit determination
US5413690A (en) * 1993-07-23 1995-05-09 Boehringer Mannheim Corporation Potentiometric biosensor and the method of its use
US5582184A (en) * 1993-10-13 1996-12-10 Integ Incorporated Interstitial fluid collection and constituent measurement
US5820570A (en) * 1993-10-13 1998-10-13 Integ Incorporated Interstitial fluid collection and constituent measurement
US6080116A (en) * 1993-10-13 2000-06-27 Integ Incorporated Interstitial fluid collection and constituent measurement
US5645709A (en) * 1993-12-08 1997-07-08 Van Den Bergh Foods Co., Division Of Conopco, Inc. Methods and apparatus for electrochemical measurements
US6203841B1 (en) * 1994-02-14 2001-03-20 Rich Products Corporation Organoleptic whippable foods with improved temperature stability and improved whipping performance
US5437999A (en) * 1994-02-22 1995-08-01 Boehringer Mannheim Corporation Electrochemical sensor
US5700695A (en) * 1994-06-30 1997-12-23 Zia Yassinzadeh Sample collection and manipulation method
US5800420A (en) * 1994-11-04 1998-09-01 Elan Medical Technologies Limited Analyte-controlled liquid delivery device and analyte monitor
US5731212A (en) * 1994-12-20 1998-03-24 International Technidyne Corporation Test apparatus and method for testing cuvette accommodated samples
US5814522A (en) * 1995-06-24 1998-09-29 Boeringer Mannheim Gmbh Multilayer analytical element for the determination of an analyte in a liquid
US5879310A (en) * 1995-09-08 1999-03-09 Integ, Inc. Body fluid sampler
US5879367A (en) * 1995-09-08 1999-03-09 Integ, Inc. Enhanced interstitial fluid collection
US5628890A (en) * 1995-09-27 1997-05-13 Medisense, Inc. Electrochemical sensor
US5942102A (en) * 1995-11-16 1999-08-24 Usf Filtration And Separations Group Inc. Electrochemical method
US6014577A (en) * 1995-12-19 2000-01-11 Abbot Laboratories Device for the detection of analyte and administration of a therapeutic substance
US5962215A (en) * 1996-04-05 1999-10-05 Mercury Diagnostics, Inc. Methods for testing the concentration of an analyte in a body fluid
US6001307A (en) * 1996-04-26 1999-12-14 Kyoto Daiichi Kagaku Co., Ltd. Device for analyzing a sample
US5951492A (en) * 1996-05-17 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for sampling and analyzing body fluid
US6143164A (en) * 1997-02-06 2000-11-07 E. Heller & Company Small volume in vitro analyte sensor
US5922604A (en) * 1997-06-05 1999-07-13 Gene Tec Corporation Thin reaction chambers for containing and handling liquid microvolumes
US6325975B1 (en) * 1997-08-27 2001-12-04 Arkray, Inc. Suction generating device and sample analysis apparatus using the same
US6129823A (en) * 1997-09-05 2000-10-10 Abbott Laboratories Low volume electrochemical sensor
US6036924A (en) * 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US5997817A (en) * 1997-12-05 1999-12-07 Roche Diagnostics Corporation Electrochemical biosensor test strip
US6086545A (en) * 1998-04-28 2000-07-11 Amira Medical Methods and apparatus for suctioning and pumping body fluid from an incision
US6077660A (en) * 1998-06-10 2000-06-20 Abbott Laboratories Diagnostic assay requiring a small sample of biological fluid
US6120464A (en) * 1998-10-16 2000-09-19 Integ, Inc. Needle assembly for fluid sampler
US20020049390A1 (en) * 1999-03-12 2002-04-25 Integ, Inc. Collection well for body fluid tester
US6368563B1 (en) * 1999-03-12 2002-04-09 Integ, Inc. Collection well for body fluid tester
US6375626B1 (en) * 1999-03-12 2002-04-23 Integ, Inc. Collection well for body fluid tester
US6939312B2 (en) * 2000-03-27 2005-09-06 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples
US6612111B1 (en) * 2000-03-27 2003-09-02 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples

Cited By (152)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7666149B2 (en) 1997-12-04 2010-02-23 Peliken Technologies, Inc. Cassette of lancet cartridges for sampling blood
US8439872B2 (en) 1998-03-30 2013-05-14 Sanofi-Aventis Deutschland Gmbh Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US7780631B2 (en) 1998-03-30 2010-08-24 Pelikan Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US8641644B2 (en) 2000-11-21 2014-02-04 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US20020137998A1 (en) * 2001-03-26 2002-09-26 Wilson Smart Silicon microprobe with integrated biosensor
US7310543B2 (en) 2001-03-26 2007-12-18 Kumetrix, Inc. Silicon microprobe with integrated biosensor
US20080097171A1 (en) * 2001-03-26 2008-04-24 Wilson Smart Silicon microprobe with integrated biosensor
US8206317B2 (en) 2001-06-12 2012-06-26 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7682318B2 (en) 2001-06-12 2010-03-23 Pelikan Technologies, Inc. Blood sampling apparatus and method
US7699791B2 (en) 2001-06-12 2010-04-20 Pelikan Technologies, Inc. Method and apparatus for improving success rate of blood yield from a fingerstick
US8679033B2 (en) 2001-06-12 2014-03-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8123700B2 (en) 2001-06-12 2012-02-28 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US9937298B2 (en) 2001-06-12 2018-04-10 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8721671B2 (en) 2001-06-12 2014-05-13 Sanofi-Aventis Deutschland Gmbh Electric lancet actuator
US7749174B2 (en) 2001-06-12 2010-07-06 Pelikan Technologies, Inc. Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge
US9802007B2 (en) 2001-06-12 2017-10-31 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8641643B2 (en) 2001-06-12 2014-02-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US8622930B2 (en) 2001-06-12 2014-01-07 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7981055B2 (en) 2001-06-12 2011-07-19 Pelikan Technologies, Inc. Tissue penetration device
US8016774B2 (en) 2001-06-12 2011-09-13 Pelikan Technologies, Inc. Tissue penetration device
US8206319B2 (en) 2001-06-12 2012-06-26 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7850622B2 (en) 2001-06-12 2010-12-14 Pelikan Technologies, Inc. Tissue penetration device
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8382683B2 (en) 2001-06-12 2013-02-26 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US8360991B2 (en) 2001-06-12 2013-01-29 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8337421B2 (en) 2001-06-12 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8282577B2 (en) 2001-06-12 2012-10-09 Sanofi-Aventis Deutschland Gmbh Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US8216154B2 (en) 2001-06-12 2012-07-10 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8211037B2 (en) 2001-06-12 2012-07-03 Pelikan Technologies, Inc. Tissue penetration device
US7988645B2 (en) 2001-06-12 2011-08-02 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
US7909775B2 (en) 2001-06-12 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US7993284B2 (en) 2001-07-20 2011-08-09 Roche Diagnostics Operations, Inc. System for withdrawing small amounts of body fluid
US8821413B2 (en) 2001-07-20 2014-09-02 Roche Diagnostics Operations, Inc. System for withdrawing small amounts of body fluid
US20080009767A1 (en) * 2001-07-20 2008-01-10 Roche Diagnostics Operations, Inc. System for withdrawing small amounts of body fluid
US8388552B2 (en) 2001-07-20 2013-03-05 Roche Diagnostics Operations, Inc. System for withdrawing small amounts of body fluid
US7288073B2 (en) 2001-07-20 2007-10-30 Roche Diagnostics Operations, Inc. System for withdrawing small amounts of body fluid
US20030018282A1 (en) * 2001-07-20 2003-01-23 Carlo Effenhauser System for withdrawing small amounts of body fluid
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
US7909777B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US7988644B2 (en) 2002-04-19 2011-08-02 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US8007446B2 (en) 2002-04-19 2011-08-30 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8062231B2 (en) 2002-04-19 2011-11-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7981056B2 (en) 2002-04-19 2011-07-19 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US9795334B2 (en) 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7938787B2 (en) 2002-04-19 2011-05-10 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8157748B2 (en) 2002-04-19 2012-04-17 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US8197421B2 (en) 2002-04-19 2012-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8197423B2 (en) 2002-04-19 2012-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8202231B2 (en) 2002-04-19 2012-06-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7914465B2 (en) 2002-04-19 2011-03-29 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7909778B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7901365B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8221334B2 (en) 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8235915B2 (en) 2002-04-19 2012-08-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8784335B2 (en) 2002-04-19 2014-07-22 Sanofi-Aventis Deutschland Gmbh Body fluid sampling device with a capacitive sensor
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US9724021B2 (en) 2002-04-19 2017-08-08 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
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7892185B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8366637B2 (en) 2002-04-19 2013-02-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8372016B2 (en) 2002-04-19 2013-02-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling and analyte sensing
US7874994B2 (en) 2002-04-19 2011-01-25 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8382682B2 (en) 2002-04-19 2013-02-26 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7875047B2 (en) 2002-04-19 2011-01-25 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US7862520B2 (en) 2002-04-19 2011-01-04 Pelikan Technologies, Inc. Body fluid sampling module with a continuous compression tissue interface surface
US8388551B2 (en) 2002-04-19 2013-03-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus for multi-use body fluid sampling device with sterility barrier release
US8403864B2 (en) 2002-04-19 2013-03-26 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8414503B2 (en) 2002-04-19 2013-04-09 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8430828B2 (en) 2002-04-19 2013-04-30 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US8435190B2 (en) 2002-04-19 2013-05-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7833171B2 (en) 2002-04-19 2010-11-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8491500B2 (en) 2002-04-19 2013-07-23 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8496601B2 (en) 2002-04-19 2013-07-30 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8556829B2 (en) 2002-04-19 2013-10-15 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8562545B2 (en) 2002-04-19 2013-10-22 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9339612B2 (en) 2002-04-19 2016-05-17 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8579831B2 (en) 2002-04-19 2013-11-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US8636673B2 (en) 2002-04-19 2014-01-28 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9907502B2 (en) 2002-04-19 2018-03-06 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7731729B2 (en) 2002-04-19 2010-06-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7713214B2 (en) 2002-04-19 2010-05-11 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US8690796B2 (en) 2002-04-19 2014-04-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US8079960B2 (en) 2002-04-19 2011-12-20 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US8808201B2 (en) 2002-04-19 2014-08-19 Sanofi-Aventis Deutschland Gmbh Methods 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
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US8262614B2 (en) 2003-05-30 2012-09-11 Pelikan Technologies, Inc. Method and apparatus for fluid injection
US7850621B2 (en) 2003-06-06 2010-12-14 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US8251921B2 (en) 2003-06-06 2012-08-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling and analyte sensing
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
US8282576B2 (en) 2003-09-29 2012-10-09 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
US8296918B2 (en) 2003-12-31 2012-10-30 Sanofi-Aventis Deutschland Gmbh Method of manufacturing a fluid sampling device with improved analyte detecting member configuration
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US8668656B2 (en) 2003-12-31 2014-03-11 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
US8828203B2 (en) 2004-05-20 2014-09-09 Sanofi-Aventis Deutschland Gmbh Printable hydrogels 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
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
US20120022352A1 (en) * 2005-10-12 2012-01-26 Masaki Fujiwara Blood sensor, blood testing apparatus, and method for controlling blood testing apparatus
US8702624B2 (en) 2006-09-29 2014-04-22 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
US20110174618A1 (en) * 2008-09-30 2011-07-21 Menai Medical Technologies Limited Sample measurement system
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
US8821412B2 (en) 2009-03-02 2014-09-02 Seventh Sense Biosystems, Inc. Delivering and/or receiving fluids
US20100256524A1 (en) * 2009-03-02 2010-10-07 Seventh Sense Biosystems, Inc. Techniques and devices associated with blood sampling
WO2010101626A1 (en) * 2009-03-02 2010-09-10 Seventh Sense Biosystems, Inc. Techniques and devices associated with blood sampling
US9113836B2 (en) 2009-03-02 2015-08-25 Seventh Sense Biosystems, Inc. Devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications
US9730624B2 (en) 2009-03-02 2017-08-15 Seventh Sense Biosystems, Inc. Delivering and/or receiving fluids
US9775551B2 (en) * 2009-03-02 2017-10-03 Seventh Sense Biosystems, Inc. Devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications
US9041541B2 (en) 2010-01-28 2015-05-26 Seventh Sense Biosystems, Inc. Monitoring or feedback systems and methods
US8894832B2 (en) 2010-03-30 2014-11-25 Jabil Circuit (Singapore) Pte, Ltd. Sampling plate
US9011658B2 (en) 2010-03-30 2015-04-21 Jabil Circuit (Singapore) Pte, Ltd. Sampling plate
US20120238841A1 (en) * 2010-04-15 2012-09-20 Mark Castle Sample capture in one step for test strips
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
US9033898B2 (en) 2010-06-23 2015-05-19 Seventh Sense Biosystems, Inc. Sampling devices and methods involving relatively little pain
US8561795B2 (en) 2010-07-16 2013-10-22 Seventh Sense Biosystems, Inc. Low-pressure packaging for fluid devices
US20120014849A1 (en) * 2010-07-19 2012-01-19 Chevron U.S.A. Inc. Multiphase contact and distribution apparatus for hydroprocessing
US20130082125A1 (en) * 2010-07-19 2013-04-04 Zackory S. Akin Multiphase contact and distribution apparatus for hydroprocessing
US8372354B2 (en) * 2010-07-19 2013-02-12 Chevron U.S.A. Inc. Multiphase contact and distribution apparatus for hydroprocessing
US8597595B2 (en) * 2010-07-19 2013-12-03 Chevron U.S.A. Inc. Multiphase contact and distribution apparatus for hydroprocessing
US8808202B2 (en) 2010-11-09 2014-08-19 Seventh Sense Biosystems, Inc. Systems and interfaces for blood sampling
US20120164026A1 (en) * 2010-12-22 2012-06-28 Agilent Technologies, Inc. Ceramic injection needle
US9134335B2 (en) * 2010-12-22 2015-09-15 Agilent Technologies, Inc. Ceramic injection needle
US8827971B2 (en) 2011-04-29 2014-09-09 Seventh Sense Biosystems, Inc. Delivering and/or receiving fluids
US9295417B2 (en) 2011-04-29 2016-03-29 Seventh Sense Biosystems, Inc. Systems and methods for collecting fluid from a subject
US9119578B2 (en) 2011-04-29 2015-09-01 Seventh Sense Biosystems, Inc. Plasma or serum production and removal of fluids under reduced pressure
WO2016025297A3 (en) * 2014-08-11 2016-05-19 The Regents Of The University Of California Continuous analyte sensor

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US20070017805A1 (en) 2007-01-25 application
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