CA2401164C - Combined lancet and electrochemical analyte-testing apparatus - Google Patents
Combined lancet and electrochemical analyte-testing apparatus Download PDFInfo
- Publication number
- CA2401164C CA2401164C CA2401164A CA2401164A CA2401164C CA 2401164 C CA2401164 C CA 2401164C CA 2401164 A CA2401164 A CA 2401164A CA 2401164 A CA2401164 A CA 2401164A CA 2401164 C CA2401164 C CA 2401164C
- Authority
- CA
- Canada
- Prior art keywords
- sample
- skin
- sensor
- user
- housing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150175—Adjustment of penetration depth
- A61B5/150198—Depth adjustment mechanism at the proximal end of the carrier of the piercing element
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150221—Valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150358—Strips for collecting blood, e.g. absorbent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
- A61B5/150809—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by audible feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
- A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150847—Communication to or from blood sampling device
- A61B5/15087—Communication to or from blood sampling device short range, e.g. between console and disposable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
- A61B5/15128—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15149—Arrangement of piercing elements relative to each other
- A61B5/15153—Multiple piercing elements stocked in a single compartment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
- A61B5/15159—Piercing elements stocked in or on a disc
- A61B5/15163—Characterized by propelling the piercing element in an axial direction relative to the disc
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
Abstract
An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte.
Description
COMBINED LANCET AND ELECTROCHEMICAL
ANALYTE-TESTING APPARATUS
Field of the Invention This application relates to an electrochemical apparatus for the detection of analytes, and particularly glucose, in blood or interstitial fluid.
Background of the Invention Glucose monitoring is a fact of everyday life for diabetic individuals, and the accuracy of such monitoring can literally mean the difference between life and death.
To accommodate a normal life style to the need, for frequent monitoring of glucose levels, a number of glucose meters are now available which permit-the individual to test the glucose level in a small amount of blood. Many of these meters detect glucose in a blood sample electrochemically, by detecting the oxidation of blood glucose using an enzyme such as glucose oxidase provided as part of a disposable, single-use electrode system.
Examples of devices of this type are disclosed in European Patent No. 0 127 958, and US
Patents Nos. 5,141,868, 5,286,362, 5,288,636, and 5,437,999.
To use these meters, the user pricks a finger or other body part to produce a small sample of blood or interstitial fluid which is then transferred to the disposable electrode system. This can cause problems, because of the need to take several measurements a day. The biggest drawback to routinely drawing small blood samples is the pain inflicted by the currently available lancets or finger-sticking devices. The most favored site of sampling is the rich capillary bed of the skin of the finger tip which readily yields a drop of blood from a small cut. The finger tip is also rich in pain receptors, and the pain is increased when the incision is too deep, or is too close to a recent incision, or is not deep enough requiring an additional incision. The pain maybe also be increased if the cutting blade penetrates slowly or is withdrawn slowly. Furthermore, the user may be forced to make a larger incision than is necessary in order to get a drop of blood to form for transfer to the measuring strip. Because'of this, different designs for lancing devices have been proposed which are designed to facilitate use of the device and limit the pain associated with the procedure. Examples of lancing devices are described in US
Patents Nos. 4,924,879, 5,201,324, 5,318,584, 5,879,311, and 5,879,367.
International Patent Publication No. W095/10223 describes a device for collection of interstitial fluid. The device can include a membrane on which sample is collected and dried. This membrane is then transferred to an external device for analysis.
Each of these known devices for the electrochemical monitoring of glucose by a diabetic involves a two-step process, in which the skin is first pierced to obtain a sample and this sample is transferred to a sensor for analysis. This presents several drawbacks. First, the user must transfer blood into the detection apparatus which requires a measure of dexterity to align the drop of blood on the finger with the sample-receiving opening of the sensor or meter. Second, because of this transfer, the amount of blood or fluid extracted from the patient may be inappropriate for the sensor, either being too little to provide an accurate measurement or too much, which can increase the amount of pain associated with the procedure.
US Patent No. 4,637,403 discloses a self-contained device for lancing and testing blood glucose using colorimetry. US Patent No. 5,054,499 discloses a colorimetric device in which a lancet punctures an absorbent member which includes reagents for the colorimetric detection of glucose prior to puncturing the skin. US Patents Nos. 5,682,233 and 5,823,973 disclose a sampling device which is sized to allow it to be mated with a testing apparatus for optical analysis of a sample. US Patent No. 5,746,217 discloses a lancet in which a capillary tube is used to capture sample, which is there analyzed by infrared spectroscopy in the capillary. US Patent No. 5,879,310 discloses a device in which a lancet punctures the skin and the sample resulting sample of body fluid is transported for analysis in an optical system.
US Patent No. 4,953,552 discloses a device for electrochemical glucose detection in which reagents for generating the electrochemical signal are coated directly onto the lancet, and thus come into contact with the sample without further user intervention. In this device, there is no spring action to drive the needle, and the needle is simply pressed in by the user. This makes control of the puncture difficult.
Furthermore, replacement of the lancet and reagent are inconvenient in the device as disclosed, and mass production of sensors would be difficult.
Thus, there remains room for improvement in the manner in which fluid samples are collected and analyzed.
Summary of the Invention The present invention provides an improved apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid. The apparatus comprises a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably intended for single-use.
In one embodiment, the meter unit comprises a housing, means disposed within the housing for engaging a lancet and moving an engaged lancet, a connector disposed within the housing for engaging an electro chemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user.
The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor comprises an sample uptaking or accepting member for uptake of a sample of blood or interstitial fluid. In one embodiment of the invention, when a lancet is engaged in the apparatus, the means for engaging and moving the lancet moves the lancet from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position, which may be the same as or different from the initial position. The electrochemical sensor is disposed such that the sample uptaking or accepting member takes up a sample from the pierced skin of the user when it is pierced by the lancet. In an alternative embodiment, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. Thus, in either embodiment, the invention provides an apparatus with single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing the apparatus against the users skin without necessitating movement of the housing. The invention further provides a method including a single step procedure in which both sample acquisition and analysis are achieved.
;3a-In one embodiment, there is provided an apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid. The apparatus includes:
a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user;
wherein the cutting member is engaged within the housing;
the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites.
In another embodiment, there is provided a method for detection and quantification of an electrochemically-detectable analyte in blood or interstitial fluid, comprising the steps of.
(a) positioning an apparatus against the skin of a test subject, said apparatus comprising (i) a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
(ii) a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector =3b-disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user; wherein (iii) the cutting member is engaged within the housing;
(iv) the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and (v) wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites;
(b) triggering the cutting member to initiate piercing of the skin of the test subject, whereby acquisition and analysis are performed as a result of triggering of the cutting member without further need to move the housing until the analysis has been performed.
ANALYTE-TESTING APPARATUS
Field of the Invention This application relates to an electrochemical apparatus for the detection of analytes, and particularly glucose, in blood or interstitial fluid.
Background of the Invention Glucose monitoring is a fact of everyday life for diabetic individuals, and the accuracy of such monitoring can literally mean the difference between life and death.
To accommodate a normal life style to the need, for frequent monitoring of glucose levels, a number of glucose meters are now available which permit-the individual to test the glucose level in a small amount of blood. Many of these meters detect glucose in a blood sample electrochemically, by detecting the oxidation of blood glucose using an enzyme such as glucose oxidase provided as part of a disposable, single-use electrode system.
Examples of devices of this type are disclosed in European Patent No. 0 127 958, and US
Patents Nos. 5,141,868, 5,286,362, 5,288,636, and 5,437,999.
To use these meters, the user pricks a finger or other body part to produce a small sample of blood or interstitial fluid which is then transferred to the disposable electrode system. This can cause problems, because of the need to take several measurements a day. The biggest drawback to routinely drawing small blood samples is the pain inflicted by the currently available lancets or finger-sticking devices. The most favored site of sampling is the rich capillary bed of the skin of the finger tip which readily yields a drop of blood from a small cut. The finger tip is also rich in pain receptors, and the pain is increased when the incision is too deep, or is too close to a recent incision, or is not deep enough requiring an additional incision. The pain maybe also be increased if the cutting blade penetrates slowly or is withdrawn slowly. Furthermore, the user may be forced to make a larger incision than is necessary in order to get a drop of blood to form for transfer to the measuring strip. Because'of this, different designs for lancing devices have been proposed which are designed to facilitate use of the device and limit the pain associated with the procedure. Examples of lancing devices are described in US
Patents Nos. 4,924,879, 5,201,324, 5,318,584, 5,879,311, and 5,879,367.
International Patent Publication No. W095/10223 describes a device for collection of interstitial fluid. The device can include a membrane on which sample is collected and dried. This membrane is then transferred to an external device for analysis.
Each of these known devices for the electrochemical monitoring of glucose by a diabetic involves a two-step process, in which the skin is first pierced to obtain a sample and this sample is transferred to a sensor for analysis. This presents several drawbacks. First, the user must transfer blood into the detection apparatus which requires a measure of dexterity to align the drop of blood on the finger with the sample-receiving opening of the sensor or meter. Second, because of this transfer, the amount of blood or fluid extracted from the patient may be inappropriate for the sensor, either being too little to provide an accurate measurement or too much, which can increase the amount of pain associated with the procedure.
US Patent No. 4,637,403 discloses a self-contained device for lancing and testing blood glucose using colorimetry. US Patent No. 5,054,499 discloses a colorimetric device in which a lancet punctures an absorbent member which includes reagents for the colorimetric detection of glucose prior to puncturing the skin. US Patents Nos. 5,682,233 and 5,823,973 disclose a sampling device which is sized to allow it to be mated with a testing apparatus for optical analysis of a sample. US Patent No. 5,746,217 discloses a lancet in which a capillary tube is used to capture sample, which is there analyzed by infrared spectroscopy in the capillary. US Patent No. 5,879,310 discloses a device in which a lancet punctures the skin and the sample resulting sample of body fluid is transported for analysis in an optical system.
US Patent No. 4,953,552 discloses a device for electrochemical glucose detection in which reagents for generating the electrochemical signal are coated directly onto the lancet, and thus come into contact with the sample without further user intervention. In this device, there is no spring action to drive the needle, and the needle is simply pressed in by the user. This makes control of the puncture difficult.
Furthermore, replacement of the lancet and reagent are inconvenient in the device as disclosed, and mass production of sensors would be difficult.
Thus, there remains room for improvement in the manner in which fluid samples are collected and analyzed.
Summary of the Invention The present invention provides an improved apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid. The apparatus comprises a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably intended for single-use.
In one embodiment, the meter unit comprises a housing, means disposed within the housing for engaging a lancet and moving an engaged lancet, a connector disposed within the housing for engaging an electro chemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user.
The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor comprises an sample uptaking or accepting member for uptake of a sample of blood or interstitial fluid. In one embodiment of the invention, when a lancet is engaged in the apparatus, the means for engaging and moving the lancet moves the lancet from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position, which may be the same as or different from the initial position. The electrochemical sensor is disposed such that the sample uptaking or accepting member takes up a sample from the pierced skin of the user when it is pierced by the lancet. In an alternative embodiment, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. Thus, in either embodiment, the invention provides an apparatus with single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing the apparatus against the users skin without necessitating movement of the housing. The invention further provides a method including a single step procedure in which both sample acquisition and analysis are achieved.
;3a-In one embodiment, there is provided an apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid. The apparatus includes:
a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user;
wherein the cutting member is engaged within the housing;
the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites.
In another embodiment, there is provided a method for detection and quantification of an electrochemically-detectable analyte in blood or interstitial fluid, comprising the steps of.
(a) positioning an apparatus against the skin of a test subject, said apparatus comprising (i) a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
(ii) a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector =3b-disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user; wherein (iii) the cutting member is engaged within the housing;
(iv) the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and (v) wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites;
(b) triggering the cutting member to initiate piercing of the skin of the test subject, whereby acquisition and analysis are performed as a result of triggering of the cutting member without further need to move the housing until the analysis has been performed.
Another aspect of the invention relates to disposable sensor assemblies for use in a meter in accordance with the invention. Such disposable sensor assemblies may contain just the sensor in a support suitable for attachment to the meter or both the sensor and the lancet. In the latter case, the disposable sensor assembly may contain one sensor and one or more lancets, or it may contain a plurality of lancet/sensor pairs.
Brief Description of the Drawings Fig. 1 shows an exterior view of an apparatus in accordance with the invention;
Figs. 2A-C show sectional views of a device in accordance with the invention;
Figs. 3A-C show a schematic representation of an arrangement of the sensor and the lancet in accordance with one embodiment of the invention;
Figs. 3D and E show a sensor for use in an alternative embodiment of the invention;
Fig. 4 shows an exemplary sensor assembly for electrochemical detection of an analyte;
Figs. 5A-C show a specific embodiment of a sensor 32 for incorporation in a sensor assembly in accordance with the invention;
Fig. 5D shows an further embodiment of a sensor assembly in accordance with the invention;
Figs. 6A-C show an schematic representation of an alternative embodiment of the invention;
Fig. 7 shows a cross-section of an embodiment of a sensor assembly for use in the embodiment of the invention shown in Fig. 6;
Figs 8A-G show a further embodiment of the invention;
Figs. 9A and B show the preparation of a sensor with multiple electrode sites;
Fig. 9C shows an apparatus in accordance with the invention; and Fig. 10 shows a schematic representation of the electronics which can incorporated in an apparatus in accordance with the invention.
Brief Description of the Drawings Fig. 1 shows an exterior view of an apparatus in accordance with the invention;
Figs. 2A-C show sectional views of a device in accordance with the invention;
Figs. 3A-C show a schematic representation of an arrangement of the sensor and the lancet in accordance with one embodiment of the invention;
Figs. 3D and E show a sensor for use in an alternative embodiment of the invention;
Fig. 4 shows an exemplary sensor assembly for electrochemical detection of an analyte;
Figs. 5A-C show a specific embodiment of a sensor 32 for incorporation in a sensor assembly in accordance with the invention;
Fig. 5D shows an further embodiment of a sensor assembly in accordance with the invention;
Figs. 6A-C show an schematic representation of an alternative embodiment of the invention;
Fig. 7 shows a cross-section of an embodiment of a sensor assembly for use in the embodiment of the invention shown in Fig. 6;
Figs 8A-G show a further embodiment of the invention;
Figs. 9A and B show the preparation of a sensor with multiple electrode sites;
Fig. 9C shows an apparatus in accordance with the invention; and Fig. 10 shows a schematic representation of the electronics which can incorporated in an apparatus in accordance with the invention.
Detailed Description of the Invention The apparatus of the present invention is an integrated lancing and analysis device which does not require a separate action for the transfer of the sample from the puncture site to a strip for analysis. This apparatus includes a meter unit, in which the electronics for analysis of a sample and display of a result are located, a cutting member (i.e, a lancet or hollow needle) and an electrochemical sensor. The electrochemical sensor includes an "sample uptaking or accepting member" for the uptake of sample. As used in the specification and claims hereof, the term "sample uptaking or accepting member"
encompasses various methods for achieving the direct transfer of a liquid sample from the sampling site to the electrochemical sensor, including but not limited to absorptive materials, such as a wick, sponge or absorptive pad, which take up liquid and cannula's through which liquid is transferred. The uptake of liquid may be a result of inherent capillarity or surface tension forces resulting from the structure of the absorptive material or the size of the analysis chamber or cannula, or it may be an active absorption stimulated by application of suction. In fact, the term "sample uptaking or accepting member"
should be understood to encompass any means that enables transfer of sample from the sample site to the electrode of the sensor. For example, the sample uptaking or accepting member could be the active portion of the sensor itself. The size or volume-uptaking capcity of the sample uptaking or accepting member would be influenced by the volume of sample to be analyzed, which would typically be on the order of 100 nl to 10 l.
Fig. 1 shows an exterior view of an embodiment of an apparatus in accordance with the invention, although it will be appreciated that the overall shape of the device is a matter of design choice and is thus provided here solely for purposes of illustration. The device as shown allows for an easy grip by one hand, while providing good visibility of the display. In addition, it is easy to handle when sampling from alternative sites like the palm of the hand, the arm or the abdomen.
As shown, the device comprises a housing 1 of a size easily held in one hand. A display 2 is visible to the user on the outside of the housing 1. A
skin-contact ring 3 is disposed at the sample end 4 of the device, while a button for activating a sample/measurement cycle is disposed at the opposite end 6. Ejector slide 7 ejects used lancets and electrochemical sensors when it is shifted towards the sample end 4, and is also used to lock the device. Optional button 5 is used to set the penetration depth of the lancet.
Figs. 2A-C show sectional views of the device of Fig 1 showing the internal mechanism for engaging and moving the lancet, the electronics 21 for transfer of an electrical signal from a sensor (not shown in Fig. 2) to the display 2.
An electrical contact 22 is provided near the end of the housing I for making electrical contact with a sensor, and is connected to the electronics via a conductive element 23. The three figures illustrate the operation of the device.
In Fig. 2A, the device is shown in a rest position, prior to sampling, There is no tension on the spring 20. Plunger 24 is attached to the lancet holder 8 and to a cocking button 27. The spring is attached to the lancet and bears on the lancet to allow both pushing out on the lancet from the cocked position and retraction of the lancet from a piercing position. Pores 28 allow air to move out of the space defined by a valve 26 and skin pressed against the skin-contact ring 3. The valve is a one-way valve which permits the flow of air from this space, but not into it. Catch 29 holds the cocking button 27 in place until released manually. To cock the device the cocking button 27 is pushed up to the catch 29, causing the lancet assembly and the valve to move upwards, compressing spring 20 as shown in Fig. 2B. The cocked device is then pressed against the skin and catch 29 is released. This results in the lancet assembly being driven downwards to puncture the skin as shown in Fig. 2C. During this downwards movement, pressure does not increase in the region between the plunger 24 and the skin because of the one-way valve 26. However, because the spring passes through its equilibrium position, there is a backwards motion of the lancet assembly after the skin is pierced and this motion results in the creation of reduced pressure in this region.
An important feature of the device of the present invention which enables true one-step operation is use of an arrangement of the lancet and sensor to allow "in situ"
sampling without movement of the apparatus. Figs. 3A-C show a schematic representation of one such arrangement. Fig. 3A shows the device in a ready-to-use state.
in The lancet 31 is disposed within the housing 1 and is engaged with the means for moving the lancet (not shown). The sensor strip 32 is part of a sensor assembly 33 that includes the skin-contact ring 3 and a collar 34 for coupling the assembly to the housing 1. The skin-contact ring 3 is pressed against the skin of the user, which causes an upwelling of tissue in the region surrounded by the skin-contact ring. When the device is activated, the lancet device 31 moves downward, piercing first the sensor 32 and then the skin as shown in Fig. 3B. The lancet 31 is then retracted, and blood or fluid flowing from the pierced skin wicks into the sensor. (Fig. 3C). The sensor may be designed such that the lancet pierces the sensor through a weak spot 98 (see Fig. 3D). This weak spot, which is an integral part of the sensor, may be the sample accepting uptake means.
According to an alternative embodiment of the invention, the lancet device pierces the skin without first piercing the sensor assembly. The sensor is designed to be placed in close proximity to the sample which is obtained by this piercing, so that transfer of the sample to the sensor occurs as part of a single-step sample acquisition and analysis process without movement of the housing. In such an embodiment, the sensor is positioned in relation to the cutting device, and therefore in relation to the position of the sample, such that the sample uptaking or accepting means would be in close proximity to or touching the sample formed as a consequence of the cutting device piercing the skin, such that transfer of the sample to the sensor is enabled. The sample uptaking and accepting member could be an integral part of the sensor, for example as illustrated in Fig.
3D, or it could be an external, part of the sensor, for example wick 97 as shown in Fig. 3E.
The angle of the sensor with respect to the sample can be varied, and can be any angle which facilitates efficient sample transfer.
In the embodiment of the invention as shown in Figs. 3A-3C, the lancet 31 and the sensor assembly 33 are separate. The lancet used in this embodiment may be of conventional design compatible with the means for moving the lancet and the size of the housing. Various forms of lancets and associated means for moving the lancet are known in the art, including for example in US Patents Nos. 4,924,879; 5,196,025;
5,304,193 and 5,318,583. The sensor assembly is a novel component adapted for use in the present invention, and itself forms an aspect of the invention. Fig. 4 shows a cross section in greater detail of an exemplary sensor assembly for electrochemical detection of an analyte. As shown, the sensor 32 has a reagent pad 41 disposed in approximate alignment with one edge of the opening 42 defined by the skin-contact ring 3. The collar 34 has a lip 43 against which the housing 1 of the meter bears when the sensor assembly is attached to the meter. Electrical contacts 44 and 45 are accessible through an opening in the lip 43 . An insulating pad may be provided so that conductivity between the connectors only occurs in the vicinity of the reagent pad when a liquid sample is present. When the housing I .of the meter is inserted in the sensor assembly, electrical contact is made via electrical contacts 44 and 45.
In the sensor assembly of Fig. 4, the sensor 32 is disposed adjacent to the skin-contact ring 3 and extends across one end of the open space 42 defined with the skin-contact ring. The sensor comprises reagents 41 and electrodes for generation of an electrochemical signal in response to the presence of analyte and an adsorptive member for absorbing fluid placed within the central opening of the ring and transporting the fluid into reactive proximity to the reagents, and an electrical contact for transmitting the electrochemical signal from the sensor. The reagents are selected to provide an electrochemical signal in response to the presence of analyte. In the case of glucose, suitable reagents would include an enzyme capable of oxidizing glucose (for example glucose oxidase), and a mediator compound which transfers electrons from the enzyme to the electrode resulting in a measurable current when glucose is present.
Representative mediator compounds include ferricyanide, metallocene compounds such as ferrocene, quinones, phenazinium salts, redox indicator DCPIP, and imidazole-substituted osmium compounds. Working electrodes have been formulated using materials of this type in a number of ways. For example, mixtures of conductive carbon, glucose oxidase and a mediator have been formulated into a paste or ink and applied to a substrate.
See, EP 0 127 958 and US 5,286,362.
Figs. 5A-C show the assembly of a specific embodiment of a sensor 32 for incorporation in a sensor assembly in accordance with the invention. Contacts 53 and leads 55 are formed on a non-conductive substrate 51. In the embodiment shown in Fig.
5A, three set of contacts and three sets of leads are formed to create two working electrodes with reagents 52 and one reference electrode. The contacts and leads are suitably formed from conductive carbon inks, although other conductive materials may A also be used. The electrodes may be formed by printing. Groups of sensors are suitably formed on a sheet of material and then cut apart for use.
encompasses various methods for achieving the direct transfer of a liquid sample from the sampling site to the electrochemical sensor, including but not limited to absorptive materials, such as a wick, sponge or absorptive pad, which take up liquid and cannula's through which liquid is transferred. The uptake of liquid may be a result of inherent capillarity or surface tension forces resulting from the structure of the absorptive material or the size of the analysis chamber or cannula, or it may be an active absorption stimulated by application of suction. In fact, the term "sample uptaking or accepting member"
should be understood to encompass any means that enables transfer of sample from the sample site to the electrode of the sensor. For example, the sample uptaking or accepting member could be the active portion of the sensor itself. The size or volume-uptaking capcity of the sample uptaking or accepting member would be influenced by the volume of sample to be analyzed, which would typically be on the order of 100 nl to 10 l.
Fig. 1 shows an exterior view of an embodiment of an apparatus in accordance with the invention, although it will be appreciated that the overall shape of the device is a matter of design choice and is thus provided here solely for purposes of illustration. The device as shown allows for an easy grip by one hand, while providing good visibility of the display. In addition, it is easy to handle when sampling from alternative sites like the palm of the hand, the arm or the abdomen.
As shown, the device comprises a housing 1 of a size easily held in one hand. A display 2 is visible to the user on the outside of the housing 1. A
skin-contact ring 3 is disposed at the sample end 4 of the device, while a button for activating a sample/measurement cycle is disposed at the opposite end 6. Ejector slide 7 ejects used lancets and electrochemical sensors when it is shifted towards the sample end 4, and is also used to lock the device. Optional button 5 is used to set the penetration depth of the lancet.
Figs. 2A-C show sectional views of the device of Fig 1 showing the internal mechanism for engaging and moving the lancet, the electronics 21 for transfer of an electrical signal from a sensor (not shown in Fig. 2) to the display 2.
An electrical contact 22 is provided near the end of the housing I for making electrical contact with a sensor, and is connected to the electronics via a conductive element 23. The three figures illustrate the operation of the device.
In Fig. 2A, the device is shown in a rest position, prior to sampling, There is no tension on the spring 20. Plunger 24 is attached to the lancet holder 8 and to a cocking button 27. The spring is attached to the lancet and bears on the lancet to allow both pushing out on the lancet from the cocked position and retraction of the lancet from a piercing position. Pores 28 allow air to move out of the space defined by a valve 26 and skin pressed against the skin-contact ring 3. The valve is a one-way valve which permits the flow of air from this space, but not into it. Catch 29 holds the cocking button 27 in place until released manually. To cock the device the cocking button 27 is pushed up to the catch 29, causing the lancet assembly and the valve to move upwards, compressing spring 20 as shown in Fig. 2B. The cocked device is then pressed against the skin and catch 29 is released. This results in the lancet assembly being driven downwards to puncture the skin as shown in Fig. 2C. During this downwards movement, pressure does not increase in the region between the plunger 24 and the skin because of the one-way valve 26. However, because the spring passes through its equilibrium position, there is a backwards motion of the lancet assembly after the skin is pierced and this motion results in the creation of reduced pressure in this region.
An important feature of the device of the present invention which enables true one-step operation is use of an arrangement of the lancet and sensor to allow "in situ"
sampling without movement of the apparatus. Figs. 3A-C show a schematic representation of one such arrangement. Fig. 3A shows the device in a ready-to-use state.
in The lancet 31 is disposed within the housing 1 and is engaged with the means for moving the lancet (not shown). The sensor strip 32 is part of a sensor assembly 33 that includes the skin-contact ring 3 and a collar 34 for coupling the assembly to the housing 1. The skin-contact ring 3 is pressed against the skin of the user, which causes an upwelling of tissue in the region surrounded by the skin-contact ring. When the device is activated, the lancet device 31 moves downward, piercing first the sensor 32 and then the skin as shown in Fig. 3B. The lancet 31 is then retracted, and blood or fluid flowing from the pierced skin wicks into the sensor. (Fig. 3C). The sensor may be designed such that the lancet pierces the sensor through a weak spot 98 (see Fig. 3D). This weak spot, which is an integral part of the sensor, may be the sample accepting uptake means.
According to an alternative embodiment of the invention, the lancet device pierces the skin without first piercing the sensor assembly. The sensor is designed to be placed in close proximity to the sample which is obtained by this piercing, so that transfer of the sample to the sensor occurs as part of a single-step sample acquisition and analysis process without movement of the housing. In such an embodiment, the sensor is positioned in relation to the cutting device, and therefore in relation to the position of the sample, such that the sample uptaking or accepting means would be in close proximity to or touching the sample formed as a consequence of the cutting device piercing the skin, such that transfer of the sample to the sensor is enabled. The sample uptaking and accepting member could be an integral part of the sensor, for example as illustrated in Fig.
3D, or it could be an external, part of the sensor, for example wick 97 as shown in Fig. 3E.
The angle of the sensor with respect to the sample can be varied, and can be any angle which facilitates efficient sample transfer.
In the embodiment of the invention as shown in Figs. 3A-3C, the lancet 31 and the sensor assembly 33 are separate. The lancet used in this embodiment may be of conventional design compatible with the means for moving the lancet and the size of the housing. Various forms of lancets and associated means for moving the lancet are known in the art, including for example in US Patents Nos. 4,924,879; 5,196,025;
5,304,193 and 5,318,583. The sensor assembly is a novel component adapted for use in the present invention, and itself forms an aspect of the invention. Fig. 4 shows a cross section in greater detail of an exemplary sensor assembly for electrochemical detection of an analyte. As shown, the sensor 32 has a reagent pad 41 disposed in approximate alignment with one edge of the opening 42 defined by the skin-contact ring 3. The collar 34 has a lip 43 against which the housing 1 of the meter bears when the sensor assembly is attached to the meter. Electrical contacts 44 and 45 are accessible through an opening in the lip 43 . An insulating pad may be provided so that conductivity between the connectors only occurs in the vicinity of the reagent pad when a liquid sample is present. When the housing I .of the meter is inserted in the sensor assembly, electrical contact is made via electrical contacts 44 and 45.
In the sensor assembly of Fig. 4, the sensor 32 is disposed adjacent to the skin-contact ring 3 and extends across one end of the open space 42 defined with the skin-contact ring. The sensor comprises reagents 41 and electrodes for generation of an electrochemical signal in response to the presence of analyte and an adsorptive member for absorbing fluid placed within the central opening of the ring and transporting the fluid into reactive proximity to the reagents, and an electrical contact for transmitting the electrochemical signal from the sensor. The reagents are selected to provide an electrochemical signal in response to the presence of analyte. In the case of glucose, suitable reagents would include an enzyme capable of oxidizing glucose (for example glucose oxidase), and a mediator compound which transfers electrons from the enzyme to the electrode resulting in a measurable current when glucose is present.
Representative mediator compounds include ferricyanide, metallocene compounds such as ferrocene, quinones, phenazinium salts, redox indicator DCPIP, and imidazole-substituted osmium compounds. Working electrodes have been formulated using materials of this type in a number of ways. For example, mixtures of conductive carbon, glucose oxidase and a mediator have been formulated into a paste or ink and applied to a substrate.
See, EP 0 127 958 and US 5,286,362.
Figs. 5A-C show the assembly of a specific embodiment of a sensor 32 for incorporation in a sensor assembly in accordance with the invention. Contacts 53 and leads 55 are formed on a non-conductive substrate 51. In the embodiment shown in Fig.
5A, three set of contacts and three sets of leads are formed to create two working electrodes with reagents 52 and one reference electrode. The contacts and leads are suitably formed from conductive carbon inks, although other conductive materials may A also be used. The electrodes may be formed by printing. Groups of sensors are suitably formed on a sheet of material and then cut apart for use.
The substrate 51 may advantageously be formed from a material which is sufficiently strong that the lancet will not pierce through the substrate material. This avoids contamination issues in the event of faulty lancet alignment. In this case, however, the substrate 51 needs to have an opening 54 or a weak spot through which the lancet can pass. Suitable materials for the substrate include polyester strips, high density polyethylene and ABS.
After the electrodes have been formed, a wick layer 56 is placed over the opening 54 and the electrodes, including the reagent pads 52 (Fig. 5B). This wick acts as an absorbent member to draw sample into the sensor and guide it to the electrodes.
Suitable materials include nylon mesh. In some cases, however, no separate wick is necessary, as when the hole 54 in the substrate 51 inherently provides a capillary channel to the reagent pads 52 of the electrodes. Polymer film layers could also be used instead of or in combination with a wick to define a capillary channel for absorption of the sample to the electrodes.
Over the wick (if present) and the electrodes a print of an insulation ink 57 is provided. The insulation ink holds the wick in place, and defines the path through which sample can migrate. Thus, the insulation ink includes an opening having a hole 571 in alignment with the hole 54 and a contiguous region 572 extending over the reagent pads 52 of the electrodes. Contacts 53 remain exposed outside the edges of the insulating ink print 57 for making contact with the meter. Optionally, a top cover can be added to protect the reactants. Such a top cover could be made form a polymeric film such as polyester.
The sensor of Figs. 5A-C may be assembled with a skin contact ring and collar as shown in the Fig. 4. Fig. 5D shows an alternative configuration.
Sensor 32 is supported on a skin contact ring 3. A collar 534 is affixed to the edge of the skin contact ring 3 and sized to receive the distal end 535 of the meter unit. O-rings 536 provide a tight seal between the collar 534 and the distal end of the meter unit 535. A
contact 522 on the distal end of the meter unit 535 makes electrical contact directly with the contact portions of the sensor (for example contacts 53 in Fig. 5A).
Figs. 6A and 6 B show a schematic representation of an alternative embodiment of the invention. In this case, the lancet 61 is a hollow cannula disposed adjacent to the sensor 62. The lancet 61 and the sensor 62 can be fabricated as a single unit which is loaded into a housing 1 for use. The housing desirably includes a skin-contact ring 3 which creates pressure to displace blood or interstitial fluid out of a puncture created by the lancet 61. When the device is activated, the lancet and the sensor are driven downwards as a unit to puncture the skin. (Fig. 6B) The sample is then drawn up through the lancet to the sensor. The dwell time in the piercing position is long enough to permit sufficient sample to be drawn into the sensor. Alternatively, the movement of the lancet may be in only one direction, with the entire device being moved away when sufficient sample has been collected. As discussed in more detail below, this latter option can be facilitated by the use of a device which provides an audible or other signal to the user when sufficient sample has been collected.
Fig. 6C shows an apparatus in accordance with the invention including a sensor assembly of the type shown in Figs. 6A and 6B. In this apparatus, the sensor 62 has an integral lancet 61, and is slidably received in a first housing portion 67. The distal end 3 of the first housing portion 67 is pressed against the skin of the user, causing the compression of spring 66 and the exposure of the lancet for piercing of the users skin.
When the apparatus is removed from the skin, the spring 66 causes the first housing portion 67 to move outward, to once again shield the end of the lancet. The sensor 62 is in electrical contact with a contact 22 which in turn is in electrical contact with the electronics 21 via a connector 23. A vacuum plunger 24 is disposed within a second part of the housing 68 for creating a suction to draw in blood or fluid.
Fig. 7 shows a cross-section of an embodiment of a sensor assembly for use in the embodiment of the invention shown in Fig. 6. The assembly includes a collar portion 71 and a base portion 72. These portions can be made as a continuous piece of material or they may be made from separate pieces joined together, for example with an adhesive. A hollow lancet 73 passes through the base portion 72, such that the hollow interior 74 of the lancet is in contact with the sensor 75. The sensor may extend over a greater area than the collar portion, as shown, or a lip extending from the interior surface of the collar may be utilized to hold the sensor 75 in place. The second portion of the housing 68 may bear on this lip, or in the embodiment shown in Fig. 7 on an annular surface 79 surrounding the collar 71. Electrical contact is made through an opening in this annular surface 79, for example via contacts 77, 78. Contacts 77, 78 may also be formed on the interior wall of the collar portion. The sensor 75 may have the same type of structure as shown in Fig. 5. Reagents may also be disposed directly on the lancet, or in a lancet lumen.
Figs. 8A-G shows a further embodiment of the invention. The device can operate manually (no automatic timing function) or perform a test procedure on demand from the meter. In the latter case, the meter housing 81 contains a plurality of lancet/sensor pairs and a timing mechanism for automatically using the pairs at pre-defined time intervals. The length of the pre-defined time interval is related to the number of lancet/sensor pairs and to the frequency with which testing for the target analyte is desired. For example, in a device for testing for blood glucose, with twelve lancet/sensor pairs, the time interval is suitably between one and four hours. This results in a need to replace the lancet/sensors at reasonable intervals, for example twice a day, once a day, or once every other day. The timing can also be shorter, for example every minute, or can be selected using a logic circuit. Thus, for example, in the case of a rapidly changing glucose level (as determined by the difference between two successive measurements), the logic circuit in the meter may be configured to decrease the interval between subsequent measurements until such time as the glucose level stabilizes. The meter may also be configured to take several initial readings at short time intervals to determine a suitable baseline test interval based on the degree of variations in the results. This baseline test interval may be used for all subsequent measurements in the test cycle, or it may be shortened as described above in response to changes in glucose levels.
A suitable format for an embodiment of the invention in which the housing contains a plurality of lancet/sensor pairs is the watch-type format as shown in Figs. 8A
and 8B. The apparatus comprises the housing 81 and a strap 82. The housing has a bottom side 83, through which contact is made between the lancets and the skin of the user (shown in Fig. SA), and a top side 841 (shown in Fig. 8B) on which the test results are displayed. The device may be strapped like a watch around the wrist of a user, as shown in Fig. 8B, or about the forearm or upper arm. Once in place, the device is activated and a number of tests maybe automatically performed without further action by the user and the result are displayed, individually or as a summary of a number of tests on the display.
After the electrodes have been formed, a wick layer 56 is placed over the opening 54 and the electrodes, including the reagent pads 52 (Fig. 5B). This wick acts as an absorbent member to draw sample into the sensor and guide it to the electrodes.
Suitable materials include nylon mesh. In some cases, however, no separate wick is necessary, as when the hole 54 in the substrate 51 inherently provides a capillary channel to the reagent pads 52 of the electrodes. Polymer film layers could also be used instead of or in combination with a wick to define a capillary channel for absorption of the sample to the electrodes.
Over the wick (if present) and the electrodes a print of an insulation ink 57 is provided. The insulation ink holds the wick in place, and defines the path through which sample can migrate. Thus, the insulation ink includes an opening having a hole 571 in alignment with the hole 54 and a contiguous region 572 extending over the reagent pads 52 of the electrodes. Contacts 53 remain exposed outside the edges of the insulating ink print 57 for making contact with the meter. Optionally, a top cover can be added to protect the reactants. Such a top cover could be made form a polymeric film such as polyester.
The sensor of Figs. 5A-C may be assembled with a skin contact ring and collar as shown in the Fig. 4. Fig. 5D shows an alternative configuration.
Sensor 32 is supported on a skin contact ring 3. A collar 534 is affixed to the edge of the skin contact ring 3 and sized to receive the distal end 535 of the meter unit. O-rings 536 provide a tight seal between the collar 534 and the distal end of the meter unit 535. A
contact 522 on the distal end of the meter unit 535 makes electrical contact directly with the contact portions of the sensor (for example contacts 53 in Fig. 5A).
Figs. 6A and 6 B show a schematic representation of an alternative embodiment of the invention. In this case, the lancet 61 is a hollow cannula disposed adjacent to the sensor 62. The lancet 61 and the sensor 62 can be fabricated as a single unit which is loaded into a housing 1 for use. The housing desirably includes a skin-contact ring 3 which creates pressure to displace blood or interstitial fluid out of a puncture created by the lancet 61. When the device is activated, the lancet and the sensor are driven downwards as a unit to puncture the skin. (Fig. 6B) The sample is then drawn up through the lancet to the sensor. The dwell time in the piercing position is long enough to permit sufficient sample to be drawn into the sensor. Alternatively, the movement of the lancet may be in only one direction, with the entire device being moved away when sufficient sample has been collected. As discussed in more detail below, this latter option can be facilitated by the use of a device which provides an audible or other signal to the user when sufficient sample has been collected.
Fig. 6C shows an apparatus in accordance with the invention including a sensor assembly of the type shown in Figs. 6A and 6B. In this apparatus, the sensor 62 has an integral lancet 61, and is slidably received in a first housing portion 67. The distal end 3 of the first housing portion 67 is pressed against the skin of the user, causing the compression of spring 66 and the exposure of the lancet for piercing of the users skin.
When the apparatus is removed from the skin, the spring 66 causes the first housing portion 67 to move outward, to once again shield the end of the lancet. The sensor 62 is in electrical contact with a contact 22 which in turn is in electrical contact with the electronics 21 via a connector 23. A vacuum plunger 24 is disposed within a second part of the housing 68 for creating a suction to draw in blood or fluid.
Fig. 7 shows a cross-section of an embodiment of a sensor assembly for use in the embodiment of the invention shown in Fig. 6. The assembly includes a collar portion 71 and a base portion 72. These portions can be made as a continuous piece of material or they may be made from separate pieces joined together, for example with an adhesive. A hollow lancet 73 passes through the base portion 72, such that the hollow interior 74 of the lancet is in contact with the sensor 75. The sensor may extend over a greater area than the collar portion, as shown, or a lip extending from the interior surface of the collar may be utilized to hold the sensor 75 in place. The second portion of the housing 68 may bear on this lip, or in the embodiment shown in Fig. 7 on an annular surface 79 surrounding the collar 71. Electrical contact is made through an opening in this annular surface 79, for example via contacts 77, 78. Contacts 77, 78 may also be formed on the interior wall of the collar portion. The sensor 75 may have the same type of structure as shown in Fig. 5. Reagents may also be disposed directly on the lancet, or in a lancet lumen.
Figs. 8A-G shows a further embodiment of the invention. The device can operate manually (no automatic timing function) or perform a test procedure on demand from the meter. In the latter case, the meter housing 81 contains a plurality of lancet/sensor pairs and a timing mechanism for automatically using the pairs at pre-defined time intervals. The length of the pre-defined time interval is related to the number of lancet/sensor pairs and to the frequency with which testing for the target analyte is desired. For example, in a device for testing for blood glucose, with twelve lancet/sensor pairs, the time interval is suitably between one and four hours. This results in a need to replace the lancet/sensors at reasonable intervals, for example twice a day, once a day, or once every other day. The timing can also be shorter, for example every minute, or can be selected using a logic circuit. Thus, for example, in the case of a rapidly changing glucose level (as determined by the difference between two successive measurements), the logic circuit in the meter may be configured to decrease the interval between subsequent measurements until such time as the glucose level stabilizes. The meter may also be configured to take several initial readings at short time intervals to determine a suitable baseline test interval based on the degree of variations in the results. This baseline test interval may be used for all subsequent measurements in the test cycle, or it may be shortened as described above in response to changes in glucose levels.
A suitable format for an embodiment of the invention in which the housing contains a plurality of lancet/sensor pairs is the watch-type format as shown in Figs. 8A
and 8B. The apparatus comprises the housing 81 and a strap 82. The housing has a bottom side 83, through which contact is made between the lancets and the skin of the user (shown in Fig. SA), and a top side 841 (shown in Fig. 8B) on which the test results are displayed. The device may be strapped like a watch around the wrist of a user, as shown in Fig. 8B, or about the forearm or upper arm. Once in place, the device is activated and a number of tests maybe automatically performed without further action by the user and the result are displayed, individually or as a summary of a number of tests on the display.
Alternatively, the device or the sensor disk may be self-attaching (for example using a skin-compatible adhesive). This provides utility on any body surface, and eliminates the need for a strap.
Figs. 8C-F show an exploded view of the component parts of an apparatus m accordance with this embodiment of the invention. Closest to the bottom side 83 of the apparatus is a sensor disk 84. The sensor disk 84 comprises a substrate 810 on which are formed a plurality of sensors 812. Each sensor includes a reagent pad 814 in contact with a pair of electrodes 816, 818. The sensor disk 84 has a central opening to allow the trigger mechanism (the spindle/ramp) to pass through. The sensor as a whole is bonded together with glue, ultrasonic welding or with snap-together fittings.
Above and coaxial with the sensor disk 84 is placed a spacer ring 85 (Fig.
8D). The spacer ring 85 provides a defined area surrounding each sensor 812, so that fluids contacting one sensor will not interact with adjacent sensors.
Alternatively, the insulation print or capillary channels can provide this isolation. As shown, sensor ring 85 has a hub 820, a rim 822 and a plurality of spokes 824. The separator ring 85 is placed over the sensor disk 84 such that one sensor 812 is positioned in the space between each adjacent pair of spokes 824. The rim may include electrical contacts for conducting signal indicative of the amount of analyte from the electrodes 816, 818 of each sensor pair.
Over and coaxial with the separator ring 85 is placed a cam ring 86 (Fig.
8E). The cam ring has a ramp portion 830, such that rotation of the cam ring 85 results in an increase in the thickness of the cam ring 86 when viewed at a fixed location. The cam ring 86 has a central opening through which a screw or similar fastener is inserted to assemble the completed device. The opening preferably has a faceted or toothed edge, however, to allow engagement of the cam ring 86 with a drive mechanism for rotating the cam ring.
Over and coaxial with the cam ring 86 is a lancet ring 87. The lancet ring 87 has a rim 840 and a plurality of lancet spokes 842, each of which has a free center end.
The lancet ring 87 is positioned such that each lancet spoke 842 is aligned with a space between the spokes 824 of the separator ring 85. The lancet spokes 842 are made of a flexible material with substantial memory such as spring steel. A lancet 844 is attached to each lancet spoke 842 near the center-end of the lancet spoke 842, oriented in a downward direction so that the point of the lancet 844 is directed towards the sensor disk 84. The lancet spokes 842 are of a length such that they interact with the cam ring 86 lying beneath the lancet spokes. When the device is first assembled, one of the lancet spokes (arbitrarily referred to as the first lancet spoke) is substantially aligned with highest part of the ramp portion 830 and is thus deflected upwards from its neutral or rest position.
When the cam ring 86 is rotated a partial turn, this first lancet spoke is moved off the end of the ramp and springs downward, piercing through the underlying sensor disk 84 and the skin of the user.
At the same time, the "second" lancet spoke is moved into position at the highest part of the ramp portion 830, and each of the other lancet spokes is shifted to a position of increased deflection. Thus, each partial rotation of the cam ring 86 brings about one sampling and measurement activity.
Fig. 8 G shows a cross section of an assembled device incorporating a sensor system assembly of the type shown in Figs. 8A-F. Spacer ring 85 is received within an opening on the bottom of a housing 801. Sensor disk 84 is disposed exterior to the housing, and has a larger diameter than the spacer ring 85 such that it can make electrical contact with contacts 802 disposed on the bottom of the housing. A
small motor 803, such as a stepper motor, is engaged with the cam ring 86 to rotate it with respect to the sensor assembly, thereby sequentially activating the lancets associated with the sensors. The motor 803 is controlled by electronics 804, which also receive signal from the contacts 802, process the signal and transmit instructions for an appropriate display to the display 805. A small vacuum pump 806 (for example a membrane pump or actuator pump) is also disposed within the housing 801 to create a suction which draws sample into the sensors. This pump may be on continuously, or it may be controlled by the electronics to be active for a period of time spanning the activation of the motor to rotate the cam ring. Alternatively, the vacuum pump could be activated prior to lancing, with a sufficient underpressure acting as a signal to start the lancing cycle.
The sensor disk 84 can be fabricated in much the same way as the sensor shown in Figs. 5A-C. Thus, as illustrated in Figs. 9A and B, contacts 91 are deposited around the periphery of a electrodes are deposited on substrate 92 in sets of three radially outwards from openings (or weak spots) 93. One of the electrodes in each set is a reference electrode, while the other two are working electrodes which include reagents appropriate for generating a signal indicative of the amount of the target analyte. Next, a mesh strip 94 is applied over each opening 93 and each set of electrodes. Over the top of the mesh an insulation layer 95 is formed. Once the sensor disk is formed, it is assembled with the other components to form the complete device.
Fig. 9C provides a further view of such a device, which includes a skin contact ring 96 on the lower surface. The skin contact ring 96 surrounds an opening 97 through which the lancets 98 pass to pierce the skin of the user. This opening 96 moves with the rotation of the spindle 99, such that comes successively into alignment with each of the electrode sets. In the embodiment shown in Fig. 9C, the lancets are pre-tensioned by the spindle when the sensor assembly is put together. Slot 990 in the top of the spindle 99 allows the aligned lancet to drop through the spindle, to pierce the underlying skin.
The upper case 901 of the assembly seals to the base portion 902 with an O-ring 903 seal.
Electrical contact is made between this upper case 901 and contacts 91 via contact 904.
This allow the analytical electronics to be located away from the sensor disk where they are not at risk of being exposed to fluid, and where they can be reused.
Because of the sealing engagement of the upper case 901 with the base portion 902, the contact 904 also rotates and comes into contact with one electrode set at a time. In the case of a device "permanently" attached to the skin there would be as many skin-contact rings as there are sensors. Only the spindle moves, testing with a fresh lancet and a fresh sensor at a different sampling site each time.
Fig. 10 shows a schematic representation of the electronics which can incorporated in a device in accordance with the invention. As shown, input signals are provided from the sensors and from any included skin-contact or sufficient-sample detector systems to a signal processing system. These signals are transmitted via analog circuitry to a processor which performs data analysis. This processor provides a signal to display driver which is connected (via a wired or wireless connection) to an output display. The processor may also provide a signal via a wired or wireless connection to an alarm generator. The display and the alarm generator together constitute the output portion of the device. The data analysis processor also communicates with a memory "' device, for example an EEPROM, in which information including calibration information and previous results may be stored. A timer is also provided which is activated by the data analysis software. This timer provides functional output signals to control a steeper motor (for rotating the sensor disk or spindle) and a vacuum generator (if present).
Values from the timer may also be stored in the memory EEPROM for utilization by the data analysis processor.
The foregoing descriptions of various embodiments of the invention address show specific combinations of features. These descriptions and combinations should be viewed as merely exemplary, however, and do not exclude alternative implementations. For example, while the lancet ring 87 is shown with the free-ends of the lancets towards the center of the ring, it will be appreciated that an alternative geometry could be used in which the lancet ring has a star-like configuration in which the free-ends are pointed outwards. Similarly, the lancet ring could be pre-tensioned, in which case the cam ring would act to release rather than create tension. A further alternative is the use of a single actuating cam or hammer to activate the lancets. one-by-one, in turns, as they rotate through the position of the actuator.
The devices of the present invention may incorporate a variety of additional features which enhance the characteristics of the device and make it easier to use. For example, the devices may include an audible or otherwise detectable alarm which alerts the user that it is time to take a measurement. In the case of the device shown in Fig. 1, this alarm would indicate to the user that they need to insert a new lancet and sensor (if not already done) and take a measurement. In the case of a device such as that shown in Figs 8 or 9, the alarm may actually precede the taking of a sample, so that the user will not be surprised by the lancet and will know to look at the display to observe the result.
The device, particularly the device of the type shown in Fig. 1, may also or additionally include an audible or otherwise detectable alarm which alerts the user that sufficient sample has been collected, and that the device can be removed. An audible alarm could take the form of a click, caused by the release of a detent within the device, or might be a beep generated electronically in the device. One way to achieve sufficient-sample indication is to assume that a pre-defined period of time is sufficient to collect the sample. In this case, the first appearance of a signal between one of the working electrodes and the reference, or between the separate sample-monitoring pair of electrodes starts a timer and the sufficient-sample indication is given some pre-defined period of time (for example 2 seconds) later. Sufficient sample may also be determined using an electrode pair having a spatial location and separation such that an electrical signal is only possible between the electrodes when sufficient sample is present. In either case, the signal which is collected can be any type of electronic signal, including signals based on conductivity, potential differences, or current flow (amperometric).
While the embodiment shown in Fig. 1 incorporates a skin-contact ring as a means to help with the expression of blood or fluid from the puncture, this skin-contact ring is optional, and can be replaced with other components such as a suction force generated by a mechanical or electrical pump for accomplishing the same function. A
variable, user-selected vacuum force can be used to ensure sufficient bulging of the skin.
A feedback mechanism tells the user that the skin made contact with the sensor. Two simple contacts bridged by the skin can achieve this. In an apparatus where the user is creating the vacuum (for example by drawing on a plunger), once the apparatus has detected the skin, the user is alerted, for example by an audible or visual signal that no more vacuum has to be created. In an automated apparatus, the pump mechanism can be shut down in response to this signal.
The device may include capacity for providing counseling to a user when abnormal readings are obtained for the analyte. Such counseling might be in the form of a prompt to call a physician, or might in appropriate cases instruct the user to administer medications. The audible signal can function as a hypoglycemic alarm, particularly in the multiple test embodiments. Such devices can also be used for overnight surveillance to alert the user or other concerned individual (for example a partner, parent or nurse) to changes in glucose levels.
The devices of the present invention offer a variety of advantages over existing devices for the measurement of glucose levels. To advantages flow directly from the incorporation of sampling and analysis functions in a single device.
First, such devices require the user to perform fewer steps. Second, the user is not required to manipulate a small electrode into a slot in the meter. This allows for the utilization of smaller electrodes, which (as described in US Patent No. 6, 241, 862), are both less expensive to make and more accurate in providing glucose measurements. Moreover, for embodiments in which there are a plurality of lancet/sensor pairs, the sampling site can be automatically varied throughout the course of a day, thus reducing injury resulting from repetitive punctures in the same location. The invention also allows the utilization of very small samples, which might otherwise be difficult to transfer to a sensor strip. This not only facilitates the talking of measurements with less pain, it can also provide for a more accurate result because of the benefits associated with small-sample measurements. In addition, the talking of a small sample which is optimally utilized by the device reduces or eliminates disposal issues for sample-contaminated waste.
Figs. 8C-F show an exploded view of the component parts of an apparatus m accordance with this embodiment of the invention. Closest to the bottom side 83 of the apparatus is a sensor disk 84. The sensor disk 84 comprises a substrate 810 on which are formed a plurality of sensors 812. Each sensor includes a reagent pad 814 in contact with a pair of electrodes 816, 818. The sensor disk 84 has a central opening to allow the trigger mechanism (the spindle/ramp) to pass through. The sensor as a whole is bonded together with glue, ultrasonic welding or with snap-together fittings.
Above and coaxial with the sensor disk 84 is placed a spacer ring 85 (Fig.
8D). The spacer ring 85 provides a defined area surrounding each sensor 812, so that fluids contacting one sensor will not interact with adjacent sensors.
Alternatively, the insulation print or capillary channels can provide this isolation. As shown, sensor ring 85 has a hub 820, a rim 822 and a plurality of spokes 824. The separator ring 85 is placed over the sensor disk 84 such that one sensor 812 is positioned in the space between each adjacent pair of spokes 824. The rim may include electrical contacts for conducting signal indicative of the amount of analyte from the electrodes 816, 818 of each sensor pair.
Over and coaxial with the separator ring 85 is placed a cam ring 86 (Fig.
8E). The cam ring has a ramp portion 830, such that rotation of the cam ring 85 results in an increase in the thickness of the cam ring 86 when viewed at a fixed location. The cam ring 86 has a central opening through which a screw or similar fastener is inserted to assemble the completed device. The opening preferably has a faceted or toothed edge, however, to allow engagement of the cam ring 86 with a drive mechanism for rotating the cam ring.
Over and coaxial with the cam ring 86 is a lancet ring 87. The lancet ring 87 has a rim 840 and a plurality of lancet spokes 842, each of which has a free center end.
The lancet ring 87 is positioned such that each lancet spoke 842 is aligned with a space between the spokes 824 of the separator ring 85. The lancet spokes 842 are made of a flexible material with substantial memory such as spring steel. A lancet 844 is attached to each lancet spoke 842 near the center-end of the lancet spoke 842, oriented in a downward direction so that the point of the lancet 844 is directed towards the sensor disk 84. The lancet spokes 842 are of a length such that they interact with the cam ring 86 lying beneath the lancet spokes. When the device is first assembled, one of the lancet spokes (arbitrarily referred to as the first lancet spoke) is substantially aligned with highest part of the ramp portion 830 and is thus deflected upwards from its neutral or rest position.
When the cam ring 86 is rotated a partial turn, this first lancet spoke is moved off the end of the ramp and springs downward, piercing through the underlying sensor disk 84 and the skin of the user.
At the same time, the "second" lancet spoke is moved into position at the highest part of the ramp portion 830, and each of the other lancet spokes is shifted to a position of increased deflection. Thus, each partial rotation of the cam ring 86 brings about one sampling and measurement activity.
Fig. 8 G shows a cross section of an assembled device incorporating a sensor system assembly of the type shown in Figs. 8A-F. Spacer ring 85 is received within an opening on the bottom of a housing 801. Sensor disk 84 is disposed exterior to the housing, and has a larger diameter than the spacer ring 85 such that it can make electrical contact with contacts 802 disposed on the bottom of the housing. A
small motor 803, such as a stepper motor, is engaged with the cam ring 86 to rotate it with respect to the sensor assembly, thereby sequentially activating the lancets associated with the sensors. The motor 803 is controlled by electronics 804, which also receive signal from the contacts 802, process the signal and transmit instructions for an appropriate display to the display 805. A small vacuum pump 806 (for example a membrane pump or actuator pump) is also disposed within the housing 801 to create a suction which draws sample into the sensors. This pump may be on continuously, or it may be controlled by the electronics to be active for a period of time spanning the activation of the motor to rotate the cam ring. Alternatively, the vacuum pump could be activated prior to lancing, with a sufficient underpressure acting as a signal to start the lancing cycle.
The sensor disk 84 can be fabricated in much the same way as the sensor shown in Figs. 5A-C. Thus, as illustrated in Figs. 9A and B, contacts 91 are deposited around the periphery of a electrodes are deposited on substrate 92 in sets of three radially outwards from openings (or weak spots) 93. One of the electrodes in each set is a reference electrode, while the other two are working electrodes which include reagents appropriate for generating a signal indicative of the amount of the target analyte. Next, a mesh strip 94 is applied over each opening 93 and each set of electrodes. Over the top of the mesh an insulation layer 95 is formed. Once the sensor disk is formed, it is assembled with the other components to form the complete device.
Fig. 9C provides a further view of such a device, which includes a skin contact ring 96 on the lower surface. The skin contact ring 96 surrounds an opening 97 through which the lancets 98 pass to pierce the skin of the user. This opening 96 moves with the rotation of the spindle 99, such that comes successively into alignment with each of the electrode sets. In the embodiment shown in Fig. 9C, the lancets are pre-tensioned by the spindle when the sensor assembly is put together. Slot 990 in the top of the spindle 99 allows the aligned lancet to drop through the spindle, to pierce the underlying skin.
The upper case 901 of the assembly seals to the base portion 902 with an O-ring 903 seal.
Electrical contact is made between this upper case 901 and contacts 91 via contact 904.
This allow the analytical electronics to be located away from the sensor disk where they are not at risk of being exposed to fluid, and where they can be reused.
Because of the sealing engagement of the upper case 901 with the base portion 902, the contact 904 also rotates and comes into contact with one electrode set at a time. In the case of a device "permanently" attached to the skin there would be as many skin-contact rings as there are sensors. Only the spindle moves, testing with a fresh lancet and a fresh sensor at a different sampling site each time.
Fig. 10 shows a schematic representation of the electronics which can incorporated in a device in accordance with the invention. As shown, input signals are provided from the sensors and from any included skin-contact or sufficient-sample detector systems to a signal processing system. These signals are transmitted via analog circuitry to a processor which performs data analysis. This processor provides a signal to display driver which is connected (via a wired or wireless connection) to an output display. The processor may also provide a signal via a wired or wireless connection to an alarm generator. The display and the alarm generator together constitute the output portion of the device. The data analysis processor also communicates with a memory "' device, for example an EEPROM, in which information including calibration information and previous results may be stored. A timer is also provided which is activated by the data analysis software. This timer provides functional output signals to control a steeper motor (for rotating the sensor disk or spindle) and a vacuum generator (if present).
Values from the timer may also be stored in the memory EEPROM for utilization by the data analysis processor.
The foregoing descriptions of various embodiments of the invention address show specific combinations of features. These descriptions and combinations should be viewed as merely exemplary, however, and do not exclude alternative implementations. For example, while the lancet ring 87 is shown with the free-ends of the lancets towards the center of the ring, it will be appreciated that an alternative geometry could be used in which the lancet ring has a star-like configuration in which the free-ends are pointed outwards. Similarly, the lancet ring could be pre-tensioned, in which case the cam ring would act to release rather than create tension. A further alternative is the use of a single actuating cam or hammer to activate the lancets. one-by-one, in turns, as they rotate through the position of the actuator.
The devices of the present invention may incorporate a variety of additional features which enhance the characteristics of the device and make it easier to use. For example, the devices may include an audible or otherwise detectable alarm which alerts the user that it is time to take a measurement. In the case of the device shown in Fig. 1, this alarm would indicate to the user that they need to insert a new lancet and sensor (if not already done) and take a measurement. In the case of a device such as that shown in Figs 8 or 9, the alarm may actually precede the taking of a sample, so that the user will not be surprised by the lancet and will know to look at the display to observe the result.
The device, particularly the device of the type shown in Fig. 1, may also or additionally include an audible or otherwise detectable alarm which alerts the user that sufficient sample has been collected, and that the device can be removed. An audible alarm could take the form of a click, caused by the release of a detent within the device, or might be a beep generated electronically in the device. One way to achieve sufficient-sample indication is to assume that a pre-defined period of time is sufficient to collect the sample. In this case, the first appearance of a signal between one of the working electrodes and the reference, or between the separate sample-monitoring pair of electrodes starts a timer and the sufficient-sample indication is given some pre-defined period of time (for example 2 seconds) later. Sufficient sample may also be determined using an electrode pair having a spatial location and separation such that an electrical signal is only possible between the electrodes when sufficient sample is present. In either case, the signal which is collected can be any type of electronic signal, including signals based on conductivity, potential differences, or current flow (amperometric).
While the embodiment shown in Fig. 1 incorporates a skin-contact ring as a means to help with the expression of blood or fluid from the puncture, this skin-contact ring is optional, and can be replaced with other components such as a suction force generated by a mechanical or electrical pump for accomplishing the same function. A
variable, user-selected vacuum force can be used to ensure sufficient bulging of the skin.
A feedback mechanism tells the user that the skin made contact with the sensor. Two simple contacts bridged by the skin can achieve this. In an apparatus where the user is creating the vacuum (for example by drawing on a plunger), once the apparatus has detected the skin, the user is alerted, for example by an audible or visual signal that no more vacuum has to be created. In an automated apparatus, the pump mechanism can be shut down in response to this signal.
The device may include capacity for providing counseling to a user when abnormal readings are obtained for the analyte. Such counseling might be in the form of a prompt to call a physician, or might in appropriate cases instruct the user to administer medications. The audible signal can function as a hypoglycemic alarm, particularly in the multiple test embodiments. Such devices can also be used for overnight surveillance to alert the user or other concerned individual (for example a partner, parent or nurse) to changes in glucose levels.
The devices of the present invention offer a variety of advantages over existing devices for the measurement of glucose levels. To advantages flow directly from the incorporation of sampling and analysis functions in a single device.
First, such devices require the user to perform fewer steps. Second, the user is not required to manipulate a small electrode into a slot in the meter. This allows for the utilization of smaller electrodes, which (as described in US Patent No. 6, 241, 862), are both less expensive to make and more accurate in providing glucose measurements. Moreover, for embodiments in which there are a plurality of lancet/sensor pairs, the sampling site can be automatically varied throughout the course of a day, thus reducing injury resulting from repetitive punctures in the same location. The invention also allows the utilization of very small samples, which might otherwise be difficult to transfer to a sensor strip. This not only facilitates the talking of measurements with less pain, it can also provide for a more accurate result because of the benefits associated with small-sample measurements. In addition, the talking of a small sample which is optimally utilized by the device reduces or eliminates disposal issues for sample-contaminated waste.
Claims (11)
1. An apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid, comprising:
a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user; wherein the cutting member is engaged within the housing;
the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites.
a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user; wherein the cutting member is engaged within the housing;
the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites.
2. The apparatus of claim 1, wherein the housing is a flattened disk having a top and a bottom surface, and further comprising a strap for holding the bottom surface of the housing against the skin of a user, wherein the electrochemical sensors are disposed adjacent to the bottom surface and the cutting members move to pierce the skin adjacent to the bottom surface.
3. The apparatus of claim 2, wherein the display is visible to the user when the bottom surface is held against the skin of the user.
4. The apparatus of claim 2, further comprising a timer operatively connected to the plurality of cutting members for automatically taking and evaluating a sample at predefined time intervals.
5. The apparatus of claim 4, wherein the time intervals are adjusted in response to amounts of analyte as determined by the apparatus.
6. The apparatus of claim 4, further comprising an alarm for indicating to the user that sufficient sample has been collected.
7. The apparatus of claim 6, further comprising an alarm for indicating to the user that it is time to take a sample.
8. The apparatus of claim 2, further comprising an alarm for indicating measured levels of analyte which are above or below preestablished threshold.
9. The apparatus of claim 8, wherein the alarm transmits a signal to a remote receiver.
10. A method for detection and quantification of an electrochemically-detectable analyte in blood or interstitial fluid, comprising the steps of:
(a) positioning an apparatus against the skin of a test subject, said apparatus comprising (i) a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
(ii) a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user; wherein (iii) the cutting member is engaged within the housing;
(iv) the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and (v) wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites;
(b) triggering the cutting member to initiate piercing of the skin of the test subject, whereby acquisition and analysis are performed as a result of triggering of the cutting member without further need to move the housing until the analysis has been performed.
(a) positioning an apparatus against the skin of a test subject, said apparatus comprising (i) a plurality of electrochemical sensors and equal plurality of corresponding cutting members;
(ii) a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user; wherein (iii) the cutting member is engaged within the housing;
(iv) the electrochemical sensor comprises a sample uptaking or accepting member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user; the sample uptaking or accepting member taking up a sample from the pierced skin of the user when it is pierced by the cutting member without movement of the apparatus; and (v) wherein the cutting members and respective electrochemical sensors are so positioned that they test at different sampling sites;
(b) triggering the cutting member to initiate piercing of the skin of the test subject, whereby acquisition and analysis are performed as a result of triggering of the cutting member without further need to move the housing until the analysis has been performed.
11. The method of claim 11, wherein the apparatus is an apparatus in accordance with any one of claims 2 through 9.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2732195A CA2732195A1 (en) | 2000-03-02 | 2001-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/518,075 | 2000-03-02 | ||
US09/518,075 US6706159B2 (en) | 2000-03-02 | 2000-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
PCT/US2001/007169 WO2001064105A1 (en) | 2000-03-02 | 2001-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2732195A Division CA2732195A1 (en) | 2000-03-02 | 2001-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2401164A1 CA2401164A1 (en) | 2001-09-07 |
CA2401164C true CA2401164C (en) | 2011-04-26 |
Family
ID=24062438
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2732195A Pending CA2732195A1 (en) | 2000-03-02 | 2001-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
CA2401164A Expired - Lifetime CA2401164C (en) | 2000-03-02 | 2001-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2732195A Pending CA2732195A1 (en) | 2000-03-02 | 2001-03-02 | Combined lancet and electrochemical analyte-testing apparatus |
Country Status (14)
Country | Link |
---|---|
US (2) | US6706159B2 (en) |
EP (2) | EP2409644B1 (en) |
JP (1) | JP4727112B2 (en) |
KR (1) | KR100754237B1 (en) |
CN (2) | CN1217624C (en) |
AU (2) | AU2001249100B2 (en) |
CA (2) | CA2732195A1 (en) |
CZ (1) | CZ20022942A3 (en) |
ES (2) | ES2411721T3 (en) |
HK (1) | HK1051957A1 (en) |
IL (2) | IL151559A0 (en) |
PL (1) | PL357279A1 (en) |
RU (1) | RU2002126203A (en) |
WO (1) | WO2001064105A1 (en) |
Families Citing this family (470)
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 |
EP1579814A3 (en) * | 1996-05-17 | 2006-06-14 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US7828749B2 (en) | 1996-05-17 | 2010-11-09 | Roche Diagnostics Operations, Inc. | Blood and interstitial fluid sampling device |
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 | セラセンス、インク. | Small volume in vitro analyte sensor |
US6036924A (en) | 1997-12-04 | 2000-03-14 | Hewlett-Packard Company | Cassette of lancet cartridges for sampling blood |
US8071384B2 (en) | 1997-12-22 | 2011-12-06 | Roche Diagnostics Operations, Inc. | Control and calibration solutions and methods for their use |
US6391005B1 (en) | 1998-03-30 | 2002-05-21 | Agilent Technologies, Inc. | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
US8688188B2 (en) | 1998-04-30 | 2014-04-01 | 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 |
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 |
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 |
US9066695B2 (en) | 1998-04-30 | 2015-06-30 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US8465425B2 (en) | 1998-04-30 | 2013-06-18 | Abbott Diabetes Care 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 |
US6338790B1 (en) | 1998-10-08 | 2002-01-15 | Therasense, Inc. | Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator |
US6706049B2 (en) * | 2000-06-09 | 2004-03-16 | Inverness Medical Limited | Cap for a lancing device |
US20040029310A1 (en) * | 2000-08-18 | 2004-02-12 | Adoft Bernds | Organic field-effect transistor (ofet), a production method therefor, an integrated circut constructed from the same and their uses |
JP2004506985A (en) | 2000-08-18 | 2004-03-04 | シーメンス アクチエンゲゼルシヤフト | Encapsulated organic electronic component, method of manufacture and use thereof |
DE10044842A1 (en) * | 2000-09-11 | 2002-04-04 | Siemens Ag | Organic rectifier, circuit, RFID tag and use of an organic rectifier |
PL360978A1 (en) * | 2000-10-13 | 2004-09-20 | Alza Corporation | Microblade array impact applicator |
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 |
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 |
DE10061299A1 (en) * | 2000-12-08 | 2002-06-27 | Siemens Ag | Device for determining and / or forwarding at least one environmental influence, production method and use thereof |
DE10061297C2 (en) * | 2000-12-08 | 2003-05-28 | Siemens Ag | Procedure for structuring an OFET |
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 |
CN101366633B (en) * | 2001-01-19 | 2011-03-30 | 松下电器产业株式会社 | Lancet-integrated sensor, measuring device for lancet-integrated sensor, and cartridge |
CN1525834A (en) | 2001-01-22 | 2004-09-01 | - | Lancet device having capillary action |
DE10105914C1 (en) * | 2001-02-09 | 2002-10-10 | Siemens Ag | Organic field effect transistor with photo-structured gate dielectric and a method for its production |
US20040094771A1 (en) * | 2001-03-26 | 2004-05-20 | Adolf Bernds | Device with at least two organic electronic components and method for producing the same |
CN100339044C (en) * | 2001-03-29 | 2007-09-26 | 因弗内斯医疗有限公司 | Integrated measuring apparatus for testing samples |
EP1397068A2 (en) | 2001-04-02 | 2004-03-17 | Therasense, Inc. | Blood glucose tracking apparatus and methods |
US6549796B2 (en) | 2001-05-25 | 2003-04-15 | Lifescan, Inc. | Monitoring analyte concentration using minimally invasive devices |
WO2002100265A2 (en) * | 2001-06-08 | 2002-12-19 | Roche Diagnostics Gmbh | Control solution packets and methods for calibrating fluid sampling devices |
US20020188223A1 (en) | 2001-06-08 | 2002-12-12 | Edward Perez | Devices and methods for the expression of bodily fluids from an incision |
US9226699B2 (en) | 2002-04-19 | 2016-01-05 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling module with a continuous compression tissue interface surface |
AU2002344825A1 (en) | 2001-06-12 | 2002-12-23 | Pelikan Technologies, Inc. | Method and apparatus for improving success rate of blood yield from a fingerstick |
US8337419B2 (en) * | 2002-04-19 | 2012-12-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7025774B2 (en) * | 2001-06-12 | 2006-04-11 | Pelikan Technologies, Inc. | Tissue penetration device |
US20070100255A1 (en) * | 2002-04-19 | 2007-05-03 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
US9427532B2 (en) | 2001-06-12 | 2016-08-30 | 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 |
CA2448902C (en) | 2001-06-12 | 2010-09-07 | Pelikan Technologies, Inc. | Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties |
WO2002100254A2 (en) | 2001-06-12 | 2002-12-19 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge |
CA2448905C (en) | 2001-06-12 | 2010-09-07 | Pelikan Technologies, Inc. | Blood sampling apparatus and method |
US7981056B2 (en) | 2002-04-19 | 2011-07-19 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
ES2352998T3 (en) | 2001-06-12 | 2011-02-24 | Pelikan Technologies Inc. | LANCETA ELECTRIC ACTUATOR. |
WO2003006980A1 (en) * | 2001-07-13 | 2003-01-23 | Arkray, Inc. | Analyzing apparatus, piercing element integrally installed body for temperature measuring device with analyzing apparatus, and body fluid sampling apparatus |
CN1310618C (en) * | 2001-07-19 | 2007-04-18 | 爱科来株式会社 | Piercing device |
EP1413249B1 (en) | 2001-08-03 | 2013-10-09 | ARKRAY, Inc. | Installation body for body fluid sampling apparatus and method of manufacturing the apparatus |
CA2427973C (en) * | 2001-08-16 | 2012-06-19 | Inverness Medical Limited | In-situ adapter for a testing device |
DE10142232B4 (en) | 2001-08-29 | 2021-04-29 | Roche Diabetes Care Gmbh | Process for the production of an analytical aid with a lancet and test element |
US7163616B2 (en) * | 2001-09-14 | 2007-01-16 | Bayer Corporation | Reagents and methods for detecting analytes, and devices comprising reagents for detecting analytes |
DE10151440C1 (en) | 2001-10-18 | 2003-02-06 | Siemens Ag | Organic electronic component for implementing an encapsulated partially organic electronic component has components like a flexible foil as an antenna, a diode or capacitor and an organic transistor. |
US20040098010A1 (en) * | 2001-10-22 | 2004-05-20 | Glenn Davison | Confuser crown skin pricker |
US20040078028A1 (en) * | 2001-11-09 | 2004-04-22 | Flaherty J. Christopher | Plunger assembly for patient infusion device |
US6872299B2 (en) * | 2001-12-10 | 2005-03-29 | Lifescan, Inc. | Passive sample detection to initiate timing of an assay |
DE10160732A1 (en) | 2001-12-11 | 2003-06-26 | Siemens Ag | OFET used e.g. in RFID tag, comprises an intermediate layer on an active semiconductor layer |
US7004928B2 (en) | 2002-02-08 | 2006-02-28 | Rosedale Medical, Inc. | Autonomous, ambulatory analyte monitor or drug delivery device |
DE20213607U1 (en) * | 2002-02-21 | 2003-07-03 | Hartmann Paul Ag | Blood analyzer for the determination of an analyte |
DE10212640B4 (en) * | 2002-03-21 | 2004-02-05 | Siemens Ag | Logical components made of organic field effect transistors |
DE10212639A1 (en) * | 2002-03-21 | 2003-10-16 | Siemens Ag | Device and method for laser structuring functional polymers and uses |
US20030186446A1 (en) | 2002-04-02 | 2003-10-02 | Jerry Pugh | Test strip containers and methods of using the same |
US6881578B2 (en) | 2002-04-02 | 2005-04-19 | Lifescan, Inc. | Analyte concentration determination meters and methods of using the same |
US7491178B2 (en) * | 2002-04-19 | 2009-02-17 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US9795334B2 (en) | 2002-04-19 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7232451B2 (en) | 2002-04-19 | 2007-06-19 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7371247B2 (en) | 2002-04-19 | 2008-05-13 | Pelikan Technologies, Inc | Method and apparatus for penetrating tissue |
US7563232B2 (en) * | 2002-04-19 | 2009-07-21 | Pelikan Technologies, Inc. | 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 |
US8360992B2 (en) | 2002-04-19 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7892183B2 (en) | 2002-04-19 | 2011-02-22 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
WO2004054455A1 (en) | 2002-12-13 | 2004-07-01 | Pelikan Technologies, Inc. | Method and apparatus for measuring analytes |
US9314194B2 (en) | 2002-04-19 | 2016-04-19 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US20070142748A1 (en) * | 2002-04-19 | 2007-06-21 | Ajay Deshmukh | Tissue penetration device |
US7141058B2 (en) * | 2002-04-19 | 2006-11-28 | Pelikan Technologies, Inc. | Method and apparatus for a body fluid sampling device using illumination |
US8579831B2 (en) * | 2002-04-19 | 2013-11-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7648468B2 (en) | 2002-04-19 | 2010-01-19 | Pelikon Technologies, Inc. | Method and apparatus for penetrating tissue |
US9248267B2 (en) | 2002-04-19 | 2016-02-02 | Sanofi-Aventis Deustchland Gmbh | Tissue penetration device |
US7229458B2 (en) | 2002-04-19 | 2007-06-12 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7297122B2 (en) | 2002-04-19 | 2007-11-20 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8702624B2 (en) | 2006-09-29 | 2014-04-22 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
US7547287B2 (en) | 2002-04-19 | 2009-06-16 | 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 |
US7976476B2 (en) | 2002-04-19 | 2011-07-12 | Pelikan Technologies, Inc. | Device and method for variable speed lancet |
US7291117B2 (en) | 2002-04-19 | 2007-11-06 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7244265B2 (en) * | 2002-04-19 | 2007-07-17 | 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 |
US8221334B2 (en) | 2002-04-19 | 2012-07-17 | 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 |
US7485128B2 (en) * | 2002-04-19 | 2009-02-03 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7674232B2 (en) | 2002-04-19 | 2010-03-09 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7331931B2 (en) | 2002-04-19 | 2008-02-19 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7410468B2 (en) * | 2002-04-19 | 2008-08-12 | 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 |
US7175642B2 (en) | 2002-04-19 | 2007-02-13 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US7524293B2 (en) * | 2002-04-19 | 2009-04-28 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8267870B2 (en) | 2002-04-19 | 2012-09-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling with hybrid actuation |
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 |
US7901362B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7343188B2 (en) * | 2002-05-09 | 2008-03-11 | Lifescan, Inc. | Devices and methods for accessing and analyzing physiological fluid |
US7303726B2 (en) | 2002-05-09 | 2007-12-04 | Lifescan, Inc. | Minimal procedure analyte test system |
US20030143113A2 (en) * | 2002-05-09 | 2003-07-31 | Lifescan, Inc. | Physiological sample collection devices and methods of using the same |
DE10226370B4 (en) * | 2002-06-13 | 2008-12-11 | Polyic Gmbh & Co. Kg | Substrate for an electronic component, use of the substrate, methods for increasing the charge carrier mobility and organic field effect transistor (OFET) |
US20040010207A1 (en) * | 2002-07-15 | 2004-01-15 | Flaherty J. Christopher | Self-contained, automatic transcutaneous physiologic sensing system |
US7018360B2 (en) * | 2002-07-16 | 2006-03-28 | Insulet Corporation | Flow restriction system and method for patient infusion device |
WO2004017439A2 (en) | 2002-07-29 | 2004-02-26 | Siemens Aktiengesellschaft | Electronic component comprising predominantly organic functional materials and method for the production thereof |
JP2005534457A (en) * | 2002-08-08 | 2005-11-17 | ジーメンス アクツィエンゲゼルシャフト | Electronic equipment |
WO2004021256A1 (en) | 2002-08-23 | 2004-03-11 | Siemens Aktiengesellschaft | Organic component for overvoltage protection and associated circuit |
US7192405B2 (en) * | 2002-09-30 | 2007-03-20 | Becton, Dickinson And Company | Integrated lancet and bodily fluid sensor |
IES20020794A2 (en) * | 2002-10-04 | 2003-02-19 | Minroc Techn Promotions Ltd | A down-the-hole hammer |
CA2501512A1 (en) * | 2002-10-09 | 2004-04-22 | Csp Technologies, Inc. | Lancet system including test strips and cassettes |
US20050049522A1 (en) * | 2002-10-30 | 2005-03-03 | Allen John J | Method of lancing skin for the extraction of blood |
PL369766A1 (en) * | 2002-10-30 | 2005-05-02 | Lifescan, Inc. | Method of lancing skin for the extraction of blood |
WO2004041082A1 (en) * | 2002-11-01 | 2004-05-21 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling |
CN100361623C (en) * | 2002-11-01 | 2008-01-16 | 佩利坎技术公司 | Method and apparatus for body fluid sampling |
EP1559148A2 (en) * | 2002-11-05 | 2005-08-03 | Siemens Aktiengesellschaft | Organic electronic component with high-resolution structuring and method for the production thereof |
US7381184B2 (en) | 2002-11-05 | 2008-06-03 | Abbott Diabetes Care Inc. | Sensor inserter assembly |
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 |
DE10253154A1 (en) * | 2002-11-14 | 2004-05-27 | Siemens Ag | Biosensor, used to identify analyte in liquid sample, has test field with detector, where detector registers field changes as electrical signals for evaluation |
US7442954B2 (en) * | 2002-11-19 | 2008-10-28 | Polyic Gmbh & Co. Kg | Organic electronic component comprising a patterned, semi-conducting functional layer and a method for producing said component |
EP1563554B1 (en) * | 2002-11-19 | 2012-01-04 | PolyIC GmbH & Co. KG | Organic electronic component comprising the same organic material for at least two functional layers |
JP4359675B2 (en) | 2002-12-13 | 2009-11-04 | アークレイ株式会社 | Puncture device |
US7265881B2 (en) * | 2002-12-20 | 2007-09-04 | Hewlett-Packard Development Company, L.P. | Method and apparatus for measuring assembly and alignment errors in sensor assemblies |
US7815579B2 (en) * | 2005-03-02 | 2010-10-19 | Roche Diagnostics Operations, Inc. | Dynamic integrated lancing test strip with sterility cover |
US8574895B2 (en) | 2002-12-30 | 2013-11-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus using optical techniques to measure analyte levels |
US8771183B2 (en) | 2004-02-17 | 2014-07-08 | Abbott Diabetes Care Inc. | Method and system for providing data communication in continuous glucose monitoring and management system |
AU2003303597A1 (en) | 2002-12-31 | 2004-07-29 | Therasense, Inc. | Continuous glucose monitoring system and methods of use |
DE10300521A1 (en) * | 2003-01-09 | 2004-07-22 | Siemens Ag | Organoresistive memory |
US7228162B2 (en) | 2003-01-13 | 2007-06-05 | Isense Corporation | Analyte sensor |
US20040138544A1 (en) * | 2003-01-13 | 2004-07-15 | Ward W. Kenneth | Body fluid trap anlyte sensor |
US7120483B2 (en) | 2003-01-13 | 2006-10-10 | Isense Corporation | Methods for analyte sensing and measurement |
CN100398062C (en) * | 2003-01-17 | 2008-07-02 | 松下电器产业株式会社 | Biological component measuring device |
DE10302149A1 (en) * | 2003-01-21 | 2005-08-25 | Siemens Ag | Use of conductive carbon black / graphite blends for the production of low-cost electronics |
EP1586127B1 (en) * | 2003-01-21 | 2007-05-02 | PolyIC GmbH & Co. KG | Organic electronic component and method for producing organic electronic devices |
DE10302501A1 (en) * | 2003-01-23 | 2004-08-05 | Roche Diagnostics Gmbh | Device and method for absorbing a body fluid for analysis purposes |
DE10305831B4 (en) * | 2003-02-12 | 2007-01-04 | Siemens Ag | diagnostic device |
KR100860732B1 (en) | 2003-02-14 | 2008-09-29 | 닛본 덴끼 가부시끼가이샤 | Line element and semiconductor circuit applied with line element |
US20040162573A1 (en) * | 2003-02-19 | 2004-08-19 | Kheiri Mohammad A. | Endcap for lancing device and method of use |
US20060224171A1 (en) * | 2003-03-17 | 2006-10-05 | Arkray, Inc. | Puncture device |
US7052652B2 (en) | 2003-03-24 | 2006-05-30 | Rosedale Medical, Inc. | Analyte concentration detection devices and methods |
US20080149524A1 (en) * | 2003-03-27 | 2008-06-26 | Rademaker William B | Food containers including dental cleaning devices and other personal care items |
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 |
US7225008B1 (en) | 2003-05-21 | 2007-05-29 | Isense Corporation | Multiple use analyte sensing assembly |
US7862519B1 (en) | 2003-05-21 | 2011-01-04 | Isense Corporation | Easy-to-use multi-use body fluid specimen collection and analyte sensing assembly |
US7303573B2 (en) * | 2003-05-29 | 2007-12-04 | Abbott Laboratories | Lancet device |
US7374949B2 (en) * | 2003-05-29 | 2008-05-20 | Bayer Healthcare Llc | Diagnostic test strip for collecting and detecting an analyte in a fluid sample |
EP2238892A3 (en) * | 2003-05-30 | 2011-02-09 | Pelikan Technologies Inc. | Apparatus for body fluid sampling |
US20040248312A1 (en) * | 2003-06-06 | 2004-12-09 | Bayer Healthcare, Llc | Sensor with integrated lancet |
US7258673B2 (en) * | 2003-06-06 | 2007-08-21 | Lifescan, Inc | Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein |
US7850621B2 (en) * | 2003-06-06 | 2010-12-14 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
US8066639B2 (en) | 2003-06-10 | 2011-11-29 | Abbott Diabetes Care Inc. | Glucose measuring device for use in personal area network |
WO2006001797A1 (en) | 2004-06-14 | 2006-01-05 | Pelikan Technologies, Inc. | Low pain penetrating |
EP1635700B1 (en) * | 2003-06-13 | 2016-03-09 | Sanofi-Aventis Deutschland GmbH | Apparatus for a point of care device |
US8206565B2 (en) | 2003-06-20 | 2012-06-26 | Roche Diagnostics Operation, 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 |
US7597793B2 (en) * | 2003-06-20 | 2009-10-06 | Roche Operations Ltd. | System and method for analyte measurement employing maximum dosing time delay |
US7452457B2 (en) | 2003-06-20 | 2008-11-18 | Roche Diagnostics Operations, Inc. | System and method for analyte measurement using dose sufficiency electrodes |
US8058077B2 (en) | 2003-06-20 | 2011-11-15 | Roche Diagnostics Operations, Inc. | Method for coding information on a biosensor test strip |
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 |
US7718439B2 (en) | 2003-06-20 | 2010-05-18 | Roche Diagnostics Operations, Inc. | System and method for coding information on a biosensor test strip |
US7645421B2 (en) | 2003-06-20 | 2010-01-12 | Roche Diagnostics Operations, Inc. | System and method for coding information on a biosensor test strip |
DE10345663A1 (en) * | 2003-06-27 | 2005-01-20 | Senslab-Gesellschaft Zur Entwicklung Und Herstellung Bioelektrochemischer Sensoren Mbh | Diagnostic or analytical disposable with integrated lancet |
AU2004203280A1 (en) * | 2003-07-28 | 2005-02-17 | Bayer Healthcare Llc | Swing Lance with Integrated Sensor |
US7223248B2 (en) | 2003-08-13 | 2007-05-29 | Lifescan, Inc. | Packaged medical device with a deployable dermal tissue penetration member |
DE10338277A1 (en) * | 2003-08-20 | 2005-03-17 | Siemens Ag | Organic capacitor with voltage controlled capacity |
US7920906B2 (en) | 2005-03-10 | 2011-04-05 | Dexcom, Inc. | System and methods for processing analyte sensor data for sensor calibration |
DE10339036A1 (en) | 2003-08-25 | 2005-03-31 | Siemens Ag | Organic electronic component with high-resolution structuring and manufacturing method |
DE10340644B4 (en) * | 2003-09-03 | 2010-10-07 | Polyic Gmbh & Co. Kg | Mechanical controls for organic polymer electronics |
DE10340643B4 (en) * | 2003-09-03 | 2009-04-16 | Polyic Gmbh & Co. Kg | Printing method for producing a double layer for polymer electronics circuits, and thereby produced electronic component with double layer |
US20050059166A1 (en) * | 2003-09-11 | 2005-03-17 | Robert Markes | Sampling instrument |
US7617932B2 (en) | 2003-09-19 | 2009-11-17 | Diabetes Diagnostics, Inc. | Medical device package, kit and associated methods |
WO2005033659A2 (en) | 2003-09-29 | 2005-04-14 | Pelikan Technologies, Inc. | Method and apparatus for an improved sample capture device |
JP4334969B2 (en) * | 2003-10-02 | 2009-09-30 | パナソニック株式会社 | Blood component analysis sensor |
WO2005037095A1 (en) | 2003-10-14 | 2005-04-28 | Pelikan Technologies, Inc. | Method and apparatus for a variable user interface |
KR100823946B1 (en) * | 2003-10-29 | 2008-04-22 | 아크레이 인코퍼레이티드 | Lancet and Centesis Instrument |
USD914881S1 (en) | 2003-11-05 | 2021-03-30 | Abbott Diabetes Care Inc. | Analyte sensor electronic mount |
JP2007510524A (en) * | 2003-11-12 | 2007-04-26 | ファセット・テクノロジーズ・エルエルシー | Puncture device and multi-lancet cartridge |
US8221332B2 (en) | 2003-11-12 | 2012-07-17 | Facet Technologies, Llc | Multi-lancet cartridge and lancing device |
US9247900B2 (en) | 2004-07-13 | 2016-02-02 | Dexcom, Inc. | Analyte sensor |
US7822454B1 (en) | 2005-01-03 | 2010-10-26 | Pelikan Technologies, Inc. | Fluid sampling device with improved analyte detecting member configuration |
WO2005065415A2 (en) * | 2003-12-31 | 2005-07-21 | Pelikan Technologies, Inc. | Body fluid sampling device with conductive media |
US9012232B2 (en) * | 2005-07-15 | 2015-04-21 | Nipro Diagnostics, Inc. | Diagnostic strip coding system and related methods of use |
US8668656B2 (en) | 2003-12-31 | 2014-03-11 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for improving fluidic flow and sample capture |
DE102004002024A1 (en) * | 2004-01-14 | 2005-08-11 | Siemens Ag | Self-aligning gate organic transistor and method of making the same |
US20080312555A1 (en) * | 2004-02-06 | 2008-12-18 | Dirk Boecker | Devices and methods for glucose measurement using rechargeable battery energy sources |
US20050187525A1 (en) | 2004-02-19 | 2005-08-25 | Hilgers Michael E. | Devices and methods for extracting bodily fluid |
DE602004011688D1 (en) * | 2004-03-05 | 2008-03-20 | Egomedical Swiss Ag | ANALYSIS TEST SYSTEM FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A PHYSIOLOGICAL LIQUID |
WO2005087103A1 (en) * | 2004-03-15 | 2005-09-22 | Terumo Kabushiki Kaisha | Body fluid collecting device |
US20050247573A1 (en) * | 2004-03-23 | 2005-11-10 | Hideaki Nakamura | Biosensors |
US7516845B2 (en) | 2004-03-31 | 2009-04-14 | Inverness Medical Limited | Medical device package with deformable projections |
JP2007531584A (en) * | 2004-04-01 | 2007-11-08 | バイエル・ヘルスケア・エルエルシー | End cap for vacuum needle stick attachment |
US7351213B2 (en) * | 2004-04-15 | 2008-04-01 | Roche Diagnostics Operation, Inc. | Integrated spot monitoring device with fluid sensor |
US20050240119A1 (en) * | 2004-04-16 | 2005-10-27 | Becton, Dickinson And Company | Blood glucose meter having integral lancet device and test strip storage vial for single handed use and methods for using same |
WO2005102168A1 (en) | 2004-04-16 | 2005-11-03 | Facet Technologies, Llc | Cap displacement mechanism for lancing device and multi-lancet cartridge |
GB0409354D0 (en) * | 2004-04-27 | 2004-06-02 | Owen Mumford Ltd | Removal of needles |
US8792955B2 (en) | 2004-05-03 | 2014-07-29 | Dexcom, Inc. | Transcutaneous analyte sensor |
US7322942B2 (en) | 2004-05-07 | 2008-01-29 | Roche Diagnostics Operations, Inc. | Integrated disposable for automatic or manual blood dosing |
EP1751546A2 (en) | 2004-05-20 | 2007-02-14 | Albatros Technologies GmbH & Co. KG | Printable hydrogel for biosensors |
WO2005120365A1 (en) | 2004-06-03 | 2005-12-22 | Pelikan Technologies, Inc. | Method and apparatus for a fluid sampling device |
WO2005120199A2 (en) * | 2004-06-03 | 2005-12-22 | Pelikan Technologies, Inc. | Methods and apparatus for an integrated sample capture and analysis disposable |
US9775553B2 (en) | 2004-06-03 | 2017-10-03 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling 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 |
IL169171A0 (en) | 2004-06-29 | 2007-07-04 | Lifescan Scotland Ltd | Manufacturing apparatus for the packaging of medical devices including integrated lancets |
US20060006574A1 (en) | 2004-06-29 | 2006-01-12 | Lang David K | Apparatus for the manufacture of medical devices |
US20060000549A1 (en) | 2004-06-29 | 2006-01-05 | Lang David K | Method of manufacturing integrated biosensors |
US7051495B2 (en) | 2004-06-29 | 2006-05-30 | Lifescan Scotland Limited | Method of packaging integrated biosensors |
US20060036187A1 (en) * | 2004-06-30 | 2006-02-16 | Hester Vos | Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein |
US20060000710A1 (en) * | 2004-06-30 | 2006-01-05 | Klaus Peter Weidenhaupt | Fluid handling methods |
JP2008504893A (en) * | 2004-06-30 | 2008-02-21 | ファセット・テクノロジーズ・エルエルシー | Puncture device and multi-lancet cartridge |
US20070045902A1 (en) | 2004-07-13 | 2007-03-01 | Brauker James H | Analyte sensor |
US8886272B2 (en) | 2004-07-13 | 2014-11-11 | Dexcom, Inc. | Analyte sensor |
US8170803B2 (en) | 2004-07-13 | 2012-05-01 | Dexcom, Inc. | Transcutaneous analyte sensor |
US7727166B2 (en) | 2004-07-26 | 2010-06-01 | Nova Biomedical Corporation | Lancet, lancet assembly and lancet-sensor combination |
EA010662B1 (en) * | 2004-08-13 | 2008-10-30 | Эгомедикаль Технологиз Аг | Analyte test system for determining the concentration of an analyte in a physiological or aqueous fluid |
DE102004040831A1 (en) * | 2004-08-23 | 2006-03-09 | Polyic Gmbh & Co. Kg | Radio-tag compatible outer packaging |
EP1794585A1 (en) * | 2004-08-31 | 2007-06-13 | Lifescan Scotland Ltd | Method of manufacturing an auto-calibrating sensor |
ATE383818T1 (en) * | 2004-09-02 | 2008-02-15 | Nipro Corp | LANCET WITH NEEDLE PROTECTION |
US7645241B2 (en) * | 2004-09-09 | 2010-01-12 | Roche Diagnostics Operations, Inc. | Device for sampling bodily fluids |
US8211038B2 (en) | 2004-09-17 | 2012-07-03 | Abbott Diabetes Care Inc. | Multiple-biosensor article |
US7488298B2 (en) * | 2004-10-08 | 2009-02-10 | Roche Diagnostics Operations, Inc. | Integrated lancing test strip with capillary transfer sheet |
JP4167253B2 (en) * | 2004-11-04 | 2008-10-15 | 株式会社タニタ | Urine sugar meter |
DE102004059464A1 (en) * | 2004-12-10 | 2006-06-29 | Polyic Gmbh & Co. Kg | Electronic component with modulator |
DE102004059467A1 (en) * | 2004-12-10 | 2006-07-20 | Polyic Gmbh & Co. Kg | Gate made of organic field effect transistors |
DE102004059465A1 (en) * | 2004-12-10 | 2006-06-14 | Polyic Gmbh & Co. Kg | recognition system |
DE102004063435A1 (en) | 2004-12-23 | 2006-07-27 | Polyic Gmbh & Co. Kg | Organic rectifier |
US7883464B2 (en) | 2005-09-30 | 2011-02-08 | Abbott Diabetes Care Inc. | Integrated transmitter unit and sensor introducer mechanism and methods of use |
US9398882B2 (en) | 2005-09-30 | 2016-07-26 | Abbott Diabetes Care Inc. | Method and apparatus for providing analyte sensor and data processing device |
US9259175B2 (en) | 2006-10-23 | 2016-02-16 | Abbott Diabetes Care, Inc. | Flexible patch for fluid delivery and monitoring body analytes |
US9572534B2 (en) | 2010-06-29 | 2017-02-21 | Abbott Diabetes Care Inc. | Devices, systems and methods for on-skin or on-body mounting of medical devices |
US8545403B2 (en) | 2005-12-28 | 2013-10-01 | Abbott Diabetes Care Inc. | Medical device insertion |
US7697967B2 (en) | 2005-12-28 | 2010-04-13 | Abbott Diabetes Care Inc. | Method and apparatus for providing analyte sensor insertion |
US9351669B2 (en) | 2009-09-30 | 2016-05-31 | Abbott Diabetes Care Inc. | Interconnect for on-body analyte monitoring device |
US9788771B2 (en) | 2006-10-23 | 2017-10-17 | Abbott Diabetes Care Inc. | Variable speed sensor insertion devices and methods of use |
US8512243B2 (en) | 2005-09-30 | 2013-08-20 | Abbott Diabetes Care Inc. | Integrated introducer and transmitter assembly and methods of use |
US8571624B2 (en) | 2004-12-29 | 2013-10-29 | Abbott Diabetes Care Inc. | Method and apparatus for mounting a data transmission device in a communication system |
US20090105569A1 (en) | 2006-04-28 | 2009-04-23 | Abbott Diabetes Care, Inc. | Introducer Assembly and Methods of Use |
US10226207B2 (en) | 2004-12-29 | 2019-03-12 | Abbott Diabetes Care Inc. | Sensor inserter having introducer |
US8029441B2 (en) | 2006-02-28 | 2011-10-04 | Abbott Diabetes Care Inc. | Analyte sensor transmitter unit configuration for a data monitoring and management system |
US8333714B2 (en) | 2006-09-10 | 2012-12-18 | Abbott Diabetes Care Inc. | Method and system for providing an integrated analyte sensor insertion device and data processing unit |
US7731657B2 (en) | 2005-08-30 | 2010-06-08 | Abbott Diabetes Care Inc. | Analyte sensor introducer and methods of use |
US9743862B2 (en) | 2011-03-31 | 2017-08-29 | Abbott Diabetes Care Inc. | Systems and methods for transcutaneously implanting medical devices |
US20080214917A1 (en) * | 2004-12-30 | 2008-09-04 | Dirk Boecker | Method and apparatus for analyte measurement test time |
US8652831B2 (en) | 2004-12-30 | 2014-02-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte measurement test time |
DE102005005017A1 (en) * | 2005-02-03 | 2006-08-17 | Roche Diagnostics Gmbh | Electromechanical lancing device for obtaining liquid samples |
US20060184065A1 (en) * | 2005-02-10 | 2006-08-17 | Ajay Deshmukh | Method and apparatus for storing an analyte sampling and measurement device |
DE102005009819A1 (en) | 2005-03-01 | 2006-09-07 | Polyic Gmbh & Co. Kg | electronics assembly |
DE102005009820A1 (en) * | 2005-03-01 | 2006-09-07 | Polyic Gmbh & Co. Kg | Electronic assembly with organic logic switching elements |
US7935063B2 (en) * | 2005-03-02 | 2011-05-03 | Roche Diagnostics Operations, Inc. | System and method for breaking a sterility seal to engage a lancet |
US8133178B2 (en) | 2006-02-22 | 2012-03-13 | Dexcom, Inc. | Analyte sensor |
EP1709906A1 (en) * | 2005-04-07 | 2006-10-11 | F. Hoffmann-La Roche Ag | Method and device for blood sampling |
DE102005017655B4 (en) | 2005-04-15 | 2008-12-11 | Polyic Gmbh & Co. Kg | Multilayer composite body with electronic function |
US7858384B2 (en) * | 2005-04-29 | 2010-12-28 | Kimberly-Clark Worldwide, Inc. | Flow control technique for assay devices |
US8112240B2 (en) | 2005-04-29 | 2012-02-07 | Abbott Diabetes Care Inc. | Method and apparatus for providing leak detection in data monitoring and management systems |
US7803319B2 (en) | 2005-04-29 | 2010-09-28 | Kimberly-Clark Worldwide, Inc. | Metering technique for lateral flow assay devices |
ATE485001T1 (en) * | 2005-05-20 | 2010-11-15 | Hoffmann La Roche | LANCET SYSTEM WITH STERILE PROTECTION |
US20060281187A1 (en) | 2005-06-13 | 2006-12-14 | Rosedale Medical, Inc. | Analyte detection devices and methods with hematocrit/volume correction and feedback control |
EP1743577A1 (en) | 2005-06-23 | 2007-01-17 | Roche Diagnostics GmbH | Hand-held apparatus for the analysis of bodily fluids |
WO2007001001A1 (en) * | 2005-06-27 | 2007-01-04 | National Institute Of Advanced Industrial Science And Technology | Needle integrating biosensor |
DE102005031448A1 (en) | 2005-07-04 | 2007-01-11 | Polyic Gmbh & Co. Kg | Activatable optical layer |
US8999125B2 (en) | 2005-07-15 | 2015-04-07 | Nipro Diagnostics, Inc. | Embedded strip lot autocalibration |
US7955856B2 (en) | 2005-07-15 | 2011-06-07 | Nipro Diagnostics, Inc. | Method of making a diagnostic test strip having a coding system |
FI121698B (en) * | 2005-07-19 | 2011-03-15 | Ihq Innovation Headquarters Oy | Health monitoring device and sensor cartridge for the health monitoring device |
DE102005035589A1 (en) | 2005-07-29 | 2007-02-01 | Polyic Gmbh & Co. Kg | Manufacturing electronic component on surface of substrate where component has two overlapping function layers |
US20070031293A1 (en) * | 2005-08-04 | 2007-02-08 | Beatty Christopher C | Method and apparatus for collecting and diluting a liquid sample |
WO2007025559A1 (en) * | 2005-08-31 | 2007-03-08 | Egomedical Technologies Ag | Coagulation test system |
US20100035245A1 (en) * | 2005-08-31 | 2010-02-11 | Egomedical Technologies Ag | Analyte test system using non-enzymatic analyte recognition elements |
DE102005044306A1 (en) | 2005-09-16 | 2007-03-22 | Polyic Gmbh & Co. Kg | Electronic circuit and method for producing such |
ES2397289T3 (en) | 2005-09-22 | 2013-03-06 | Biocompatibles Uk Ltd. | GLP-1 fusion polypeptides (glucagon-like peptide 1) with increased peptidase resistance |
WO2007037949A2 (en) * | 2005-09-27 | 2007-04-05 | Bayer Healthcare Llc | Flip-top integrated-diagnostic instrument |
US8801631B2 (en) * | 2005-09-30 | 2014-08-12 | Intuity Medical, Inc. | Devices and methods for facilitating fluid transport |
CA2624059C (en) | 2005-09-30 | 2019-04-02 | Intuity Medical, Inc. | Multi-site body fluid sampling and analysis cartridge |
US9521968B2 (en) | 2005-09-30 | 2016-12-20 | Abbott Diabetes Care Inc. | Analyte sensor retention mechanism and methods of use |
US20070191736A1 (en) * | 2005-10-04 | 2007-08-16 | Don Alden | Method for loading penetrating members in a collection device |
ATE513511T1 (en) * | 2005-10-08 | 2011-07-15 | Hoffmann La Roche | STICKING SYSTEM |
US8057404B2 (en) * | 2005-10-12 | 2011-11-15 | Panasonic Corporation | Blood sensor, blood testing apparatus, and method for controlling blood testing apparatus |
US7704265B2 (en) | 2005-11-03 | 2010-04-27 | Stat Medical Devices, Inc. | Disposable/single-use blade lancet device and method |
US7766829B2 (en) | 2005-11-04 | 2010-08-03 | Abbott Diabetes Care Inc. | Method and system for providing basal profile modification in analyte monitoring and management systems |
US7682341B2 (en) * | 2005-11-09 | 2010-03-23 | Medikit Co., Ltd | Indwelling needle |
US20070112367A1 (en) | 2005-11-17 | 2007-05-17 | Olson Lorin P | Method for lancing a dermal tissue target site using a cap with revolving body |
GB0524604D0 (en) * | 2005-12-02 | 2006-01-11 | Owen Mumford Ltd | Injection method and apparatus |
US7279136B2 (en) * | 2005-12-13 | 2007-10-09 | Takeuchi James M | Metering technique for lateral flow assay devices |
US7618810B2 (en) * | 2005-12-14 | 2009-11-17 | Kimberly-Clark Worldwide, Inc. | Metering strip and method for lateral flow assay devices |
US11298058B2 (en) | 2005-12-28 | 2022-04-12 | Abbott Diabetes Care Inc. | Method and apparatus for providing analyte sensor insertion |
JP4956443B2 (en) * | 2006-01-05 | 2012-06-20 | パナソニック株式会社 | Blood test equipment |
GB2434103B (en) | 2006-01-12 | 2009-11-25 | Owen Mumford Ltd | Lancet firing device |
JP5097716B2 (en) | 2006-01-25 | 2012-12-12 | ノヴァ バイオメディカル コーポレイション | Lancet sensor assembly and meter |
CA2640970A1 (en) | 2006-01-31 | 2007-08-09 | Matsushita Electric Industrial Co., Ltd. | Blood test method and blood test apparatus |
CN101374458B (en) * | 2006-01-31 | 2012-04-18 | 松下电器产业株式会社 | Blood sensor and blood test apparatus having the same |
CN101431939A (en) * | 2006-02-01 | 2009-05-13 | 爱科来株式会社 | Lancet |
JP4944803B2 (en) * | 2006-02-09 | 2012-06-06 | パナソニック株式会社 | Blood test equipment |
EP3649925A1 (en) † | 2006-02-22 | 2020-05-13 | DexCom, Inc. | Analyte sensor |
WO2007108519A1 (en) * | 2006-03-22 | 2007-09-27 | Matsushita Electric Industrial Co., Ltd. | Blood test apparatus |
CA2646721A1 (en) * | 2006-03-22 | 2007-09-27 | Matsushita Electric Industrial Co. Ltd. | Blood inspection device |
EP1997432B1 (en) | 2006-03-22 | 2013-05-22 | Panasonic Corporation | Blood test device |
JPWO2007108518A1 (en) * | 2006-03-22 | 2009-08-06 | パナソニック株式会社 | Blood test apparatus and control method thereof |
PL212772B1 (en) * | 2006-03-29 | 2012-11-30 | Htl Strefa Spolka Z Ograniczona Odpowiedzialnoscia | Lancet |
US8226891B2 (en) | 2006-03-31 | 2012-07-24 | Abbott Diabetes Care Inc. | Analyte monitoring devices and methods therefor |
US7620438B2 (en) | 2006-03-31 | 2009-11-17 | Abbott Diabetes Care Inc. | Method and system for powering an electronic device |
US8087680B2 (en) * | 2006-04-03 | 2012-01-03 | Graco Children's Products Inc. | Stroller with car seat attachment |
CN101466846A (en) * | 2006-04-12 | 2009-06-24 | 阿斯利康(瑞典)有限公司 | Method for determining the activity of a protease in a sample |
JP4103963B2 (en) * | 2006-04-19 | 2008-06-18 | 松下電器産業株式会社 | Body fluid collecting device and body fluid measuring device using the same |
EP2010055B1 (en) | 2006-04-25 | 2018-01-10 | Facet Technologies, LLC | Lancing device with independent drive core |
JP5025159B2 (en) * | 2006-04-28 | 2012-09-12 | シスメックス株式会社 | Biological component measuring device |
US7593097B2 (en) * | 2006-05-26 | 2009-09-22 | Lifescan Scotland Limited | Method for determining a test strip calibration code for use in a meter |
US7586590B2 (en) * | 2006-05-26 | 2009-09-08 | Lifescan, Scotland, Ltd. | Calibration code strip with permutative grey scale calibration pattern |
US7474391B2 (en) * | 2006-05-26 | 2009-01-06 | Lifescan Scotland Limited | Method for determining a test strip calibration code using a calibration strip |
US7589828B2 (en) * | 2006-05-26 | 2009-09-15 | Lifescan Scotland Limited | System for analyte determination that includes a permutative grey scale calibration pattern |
US7474390B2 (en) * | 2006-05-26 | 2009-01-06 | Lifescan Scotland Limited | Test strip with permutative grey scale calibration pattern |
US7920907B2 (en) | 2006-06-07 | 2011-04-05 | Abbott Diabetes Care Inc. | Analyte monitoring system and method |
US9119582B2 (en) | 2006-06-30 | 2015-09-01 | Abbott Diabetes Care, Inc. | Integrated analyte sensor and infusion device and methods therefor |
US20080020452A1 (en) * | 2006-07-18 | 2008-01-24 | Natasha Popovich | Diagnostic strip coding system with conductive layers |
EP1880671B1 (en) * | 2006-07-18 | 2010-09-08 | Roche Diagnostics GmbH | Lancet wheel |
US20080065130A1 (en) * | 2006-08-22 | 2008-03-13 | Paul Patel | Elastomeric toroidal ring for blood expression |
US8372015B2 (en) * | 2006-08-28 | 2013-02-12 | Intuity Medical, Inc. | Body fluid sampling device with pivotable catalyst member |
JP2008067743A (en) * | 2006-09-12 | 2008-03-27 | Matsushita Electric Ind Co Ltd | Blood examination device |
JP4871083B2 (en) * | 2006-09-27 | 2012-02-08 | テルモ株式会社 | Body fluid collection unit |
CA2666207A1 (en) * | 2006-10-13 | 2008-04-17 | Noble House Group Pty. Ltd. | Means for sampling animal blood |
WO2008071218A1 (en) * | 2006-12-14 | 2008-06-19 | Egomedical Swiss Ag | Monitoring device |
JP5043863B2 (en) * | 2006-12-21 | 2012-10-10 | パナソニック株式会社 | Blood test equipment |
US8437828B2 (en) * | 2007-01-17 | 2013-05-07 | Panasonic Corporation | Blood inspection device |
WO2008092470A1 (en) * | 2007-01-29 | 2008-08-07 | Egomedical Swiss Ag | Resealeable container for storing moisture sensitive test elements |
US8930203B2 (en) | 2007-02-18 | 2015-01-06 | Abbott Diabetes Care Inc. | Multi-function analyte test device and methods therefor |
US8732188B2 (en) | 2007-02-18 | 2014-05-20 | Abbott Diabetes Care Inc. | Method and system for providing contextual based medication dosage determination |
US8123686B2 (en) | 2007-03-01 | 2012-02-28 | Abbott Diabetes Care Inc. | Method and apparatus for providing rolling data in communication systems |
US8469986B2 (en) * | 2007-03-30 | 2013-06-25 | Stat Medical Devices, Inc. | Lancet device with combined trigger and cocking mechanism and method |
EP1977686A1 (en) * | 2007-04-04 | 2008-10-08 | F.Hoffmann-La Roche Ag | Disposable diagnostic article |
US20080249383A1 (en) * | 2007-04-04 | 2008-10-09 | Isense Corporation | Analyte sensing device having one or more sensing electrodes |
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 |
US8456301B2 (en) | 2007-05-08 | 2013-06-04 | Abbott Diabetes Care Inc. | Analyte monitoring system and methods |
US8461985B2 (en) | 2007-05-08 | 2013-06-11 | Abbott Diabetes Care Inc. | Analyte monitoring system and methods |
US8665091B2 (en) | 2007-05-08 | 2014-03-04 | Abbott Diabetes Care Inc. | Method and device for determining elapsed sensor life |
US7928850B2 (en) | 2007-05-08 | 2011-04-19 | Abbott Diabetes Care Inc. | Analyte monitoring system and methods |
WO2008150917A1 (en) | 2007-05-31 | 2008-12-11 | Abbott Diabetes Care, Inc. | Insertion devices and methods |
JP5546243B2 (en) | 2007-07-18 | 2014-07-09 | パナソニックヘルスケア株式会社 | Blood test equipment |
EP2174593B1 (en) | 2007-08-03 | 2013-05-15 | Panasonic Corporation | Blood test device and test method |
US9968742B2 (en) | 2007-08-29 | 2018-05-15 | Medtronic Minimed, Inc. | Combined sensor and infusion set using separated sites |
US20120046533A1 (en) | 2007-08-29 | 2012-02-23 | Medtronic Minimed, Inc. | Combined sensor and infusion sets |
WO2009051901A2 (en) * | 2007-08-30 | 2009-04-23 | Pepex Biomedical, Llc | Electrochemical sensor and method for manufacturing |
WO2009032760A2 (en) | 2007-08-30 | 2009-03-12 | Pepex Biomedical Llc | Electrochmical sensor and method for manufacturing |
JP5290974B2 (en) * | 2007-09-04 | 2013-09-18 | パナソニック株式会社 | Blood analyzer |
JP5191990B2 (en) | 2007-09-04 | 2013-05-08 | パナソニック株式会社 | Blood test equipment |
US8961431B2 (en) * | 2009-09-28 | 2015-02-24 | Roche Diagnostics Operations, Inc. | Body fluid lancing, acquiring, and testing cartridge design |
US9186097B2 (en) * | 2007-09-17 | 2015-11-17 | Roche Diabetes Care, Inc. | Body fluid lancing, acquiring, and testing cartridge design |
EP2050392B1 (en) * | 2007-10-15 | 2012-09-05 | Roche Diagnostics GmbH | Lancet wheel |
US8535617B2 (en) * | 2007-11-30 | 2013-09-17 | Kimberly-Clark Worldwide, Inc. | Blood cell barrier for a lateral flow device |
US8755858B2 (en) * | 2008-02-07 | 2014-06-17 | Panasonic Corporation | Blood sensor, blood testing device and blood analysis method |
JP5348707B2 (en) * | 2008-02-27 | 2013-11-20 | モン4ディー リミテッド | Apparatus, system and method for modular analyte monitoring |
BRPI0906017A2 (en) * | 2008-02-27 | 2015-06-30 | Mond4D Ltd | System and device for measuring an analyte from a body fluid over a measuring area, device for controlling an analyte measuring device, method for measuring an analyte from a body fluid, system for monitoring an analyte from a body fluid , specialized analyte measuring element and vehicle |
CA2846168C (en) * | 2008-03-05 | 2016-12-13 | Becton, Dickinson And Company | Capillary action collection device and container assembly |
JP5189161B2 (en) * | 2008-03-10 | 2013-04-24 | パナソニック株式会社 | Blood test equipment |
US9386944B2 (en) | 2008-04-11 | 2016-07-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte detecting device |
EP2113197A1 (en) * | 2008-05-03 | 2009-11-04 | Roche Diagnostics GmbH | Lancet wheel and method for manufacturing a lancet wheel |
WO2009145920A1 (en) | 2008-05-30 | 2009-12-03 | Intuity Medical, Inc. | Body fluid sampling device -- sampling site interface |
US20100069726A1 (en) * | 2008-06-04 | 2010-03-18 | Seventh Sense Biosystems, Inc. | Compositions and methods for rapid one-step diagnosis |
CA2726067C (en) | 2008-06-06 | 2020-10-20 | Intuity Medical, Inc. | Detection meter and mode of operation |
US10383556B2 (en) | 2008-06-06 | 2019-08-20 | Intuity Medical, Inc. | Medical diagnostic devices and methods |
US8956308B2 (en) * | 2008-09-29 | 2015-02-17 | Bayer Healthcare Llc | Integrated-testing system |
AU2009314069A1 (en) * | 2008-11-14 | 2010-05-20 | Pepex Biomedical, Llc | Electrochemical sensor module |
WO2010056876A2 (en) | 2008-11-14 | 2010-05-20 | Pepex Biomedical, Llc | Manufacturing electrochemical sensor module |
US8951377B2 (en) | 2008-11-14 | 2015-02-10 | Pepex Biomedical, Inc. | Manufacturing electrochemical sensor module |
WO2010056878A2 (en) | 2008-11-14 | 2010-05-20 | Pepex Biomedical, Llc | Electrochemical sensor module |
GB2465390A (en) | 2008-11-17 | 2010-05-19 | Owen Mumford Ltd | Syringe needle cover remover |
US20100187132A1 (en) * | 2008-12-29 | 2010-07-29 | Don Alden | Determination of the real electrochemical surface areas of screen printed electrodes |
US9375529B2 (en) * | 2009-09-02 | 2016-06-28 | Becton, Dickinson And Company | Extended use medical device |
WO2010080715A1 (en) | 2009-01-12 | 2010-07-15 | Becton, Dickinson And Company | Infusion set and/or patch pump having at least one of an in-dwelling rigid catheter with flexible features and/or a flexible catheter attachment |
US8103456B2 (en) | 2009-01-29 | 2012-01-24 | Abbott Diabetes Care Inc. | Method and device for early signal attenuation detection using blood glucose measurements |
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 |
US9402544B2 (en) | 2009-02-03 | 2016-08-02 | Abbott Diabetes Care Inc. | Analyte sensor and apparatus for insertion of the sensor |
US8623041B2 (en) * | 2009-02-18 | 2014-01-07 | Panasonic Corporation | Puncture tool, device for measuring biological sample and system for measuring biological sample |
EP2226007A1 (en) * | 2009-02-19 | 2010-09-08 | Roche Diagnostics GmbH | Test element magazine with covered test fields |
EP2398388B1 (en) | 2009-02-19 | 2020-04-08 | Roche Diabetes Care GmbH | Compact storage of auxiliary analytical devices in a cartridge |
EP2226008A1 (en) | 2009-02-19 | 2010-09-08 | Roche Diagnostics GmbH | Method for producing an analytical magazine |
US8827971B2 (en) | 2011-04-29 | 2014-09-09 | Seventh Sense Biosystems, Inc. | Delivering and/or receiving fluids |
US20110105872A1 (en) * | 2009-10-30 | 2011-05-05 | Seventh Sense Biosystems, Inc. | Systems and methods for application to skin and control of actuation, delivery, and/or perception thereof |
US20110172510A1 (en) * | 2010-01-13 | 2011-07-14 | Seventh Sense Biosystems, Inc. | Rapid delivery and/or withdrawal of fluids |
WO2010101620A2 (en) | 2009-03-02 | 2010-09-10 | Seventh Sense Biosystems, Inc. | Systems and methods for creating and using suction blisters or other pooled regions of fluid within the skin |
WO2012018486A2 (en) | 2010-07-26 | 2012-02-09 | Seventh Sense Biosystems, Inc. | Rapid delivery and/or receiving of fluids |
US8758267B2 (en) * | 2009-03-17 | 2014-06-24 | Nova Biomedical Corporation | Modified lancet carrier for single-use lancet sensor assembly |
WO2010127050A1 (en) | 2009-04-28 | 2010-11-04 | Abbott Diabetes Care Inc. | Error detection in critical repeating data in a wireless sensor system |
US9184490B2 (en) | 2009-05-29 | 2015-11-10 | Abbott Diabetes Care Inc. | Medical device antenna systems having external antenna configurations |
KR101104391B1 (en) * | 2009-06-30 | 2012-01-16 | 주식회사 세라젬메디시스 | Sensor for measuring biomaterial used with measuring meter, and measuring device using this sensor |
US8939928B2 (en) * | 2009-07-23 | 2015-01-27 | Becton, Dickinson And Company | Medical device having capacitive coupling communication and energy harvesting |
EP2473963A4 (en) | 2009-08-31 | 2014-01-08 | Abbott Diabetes Care Inc | Medical devices and methods |
EP2473099A4 (en) | 2009-08-31 | 2015-01-14 | Abbott Diabetes Care Inc | Analyte monitoring system and methods for managing power and noise |
WO2011026147A1 (en) | 2009-08-31 | 2011-03-03 | Abbott Diabetes Care Inc. | Analyte signal processing device and methods |
US10092691B2 (en) | 2009-09-02 | 2018-10-09 | Becton, Dickinson And Company | Flexible and conformal patch pump |
US9320461B2 (en) | 2009-09-29 | 2016-04-26 | Abbott Diabetes Care Inc. | Method and apparatus for providing notification function in analyte monitoring systems |
US20110288388A1 (en) | 2009-11-20 | 2011-11-24 | Medtronic Minimed, Inc. | Multi-conductor lead configurations useful with medical device systems and methods for making and using them |
WO2011065972A2 (en) * | 2009-11-24 | 2011-06-03 | Seventh Sense Biosystems, Inc. | Patient-enacted sampling technique |
EP2506768B1 (en) | 2009-11-30 | 2016-07-06 | Intuity Medical, Inc. | Calibration material delivery devices and methods |
IL209760A (en) | 2009-12-11 | 2015-05-31 | Lifescan Scotland Ltd | Fill sufficiency method and system |
US8660628B2 (en) | 2009-12-21 | 2014-02-25 | Medtronic Minimed, Inc. | Analyte sensors comprising blended membrane compositions and methods for making and using them |
CN102791197B (en) * | 2010-01-13 | 2016-03-23 | 第七感生物系统有限公司 | Sampler interface |
US8771202B2 (en) * | 2010-01-19 | 2014-07-08 | Becton Dickinson And Company | Electrode layout for blood test sensor strip |
WO2011094573A1 (en) | 2010-01-28 | 2011-08-04 | Seventh Sense Biosystems, Inc. | Monitoring or feedback systems and methods |
USD924406S1 (en) | 2010-02-01 | 2021-07-06 | Abbott Diabetes Care Inc. | Analyte sensor inserter |
US10448872B2 (en) | 2010-03-16 | 2019-10-22 | Medtronic Minimed, Inc. | Analyte sensor apparatuses having improved electrode configurations and methods for making and using them |
EP2549918B2 (en) | 2010-03-24 | 2023-01-25 | Abbott Diabetes Care, Inc. | Medical device inserters and processes of inserting and using medical devices |
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 |
WO2011163347A2 (en) | 2010-06-23 | 2011-12-29 | Seventh Sense Biosystems, Inc. | Sampling devices and methods involving relatively little pain |
EP2584964B1 (en) | 2010-06-25 | 2021-08-04 | Intuity Medical, Inc. | Analyte monitoring devices |
US11064921B2 (en) | 2010-06-29 | 2021-07-20 | Abbott Diabetes Care Inc. | Devices, systems and methods for on-skin or on-body mounting of medical devices |
TWI527565B (en) * | 2010-07-08 | 2016-04-01 | 賽諾菲阿凡提斯德意志有限公司 | Allowing measurements to be made of a blood sample |
WO2012008370A1 (en) * | 2010-07-12 | 2012-01-19 | グンゼ株式会社 | Biosensor |
JP2013538069A (en) | 2010-07-16 | 2013-10-10 | セブンス センス バイオシステムズ,インコーポレーテッド | Low pressure environment for fluid transfer devices |
WO2012021801A2 (en) | 2010-08-13 | 2012-02-16 | Seventh Sense Biosystems, Inc. | Systems and techniques for monitoring subjects |
EP2613701A2 (en) * | 2010-09-07 | 2013-07-17 | Innova Medical Design LLC | Systems, methods, and devices for reducing the pain of glucose monitoring and insulin adminstration in diabetic patients |
US8808202B2 (en) | 2010-11-09 | 2014-08-19 | Seventh Sense Biosystems, Inc. | Systems and interfaces for blood sampling |
US8814831B2 (en) | 2010-11-30 | 2014-08-26 | Becton, Dickinson And Company | Ballistic microneedle infusion device |
US9950109B2 (en) | 2010-11-30 | 2018-04-24 | Becton, Dickinson And Company | Slide-activated angled inserter and cantilevered ballistic insertion for intradermal drug infusion |
US8795230B2 (en) | 2010-11-30 | 2014-08-05 | Becton, Dickinson And Company | Adjustable height needle infusion device |
US8158428B1 (en) | 2010-12-30 | 2012-04-17 | General Electric Company | Methods, systems and apparatus for detecting material defects in combustors of combustion turbine engines |
US9717452B2 (en) | 2010-12-30 | 2017-08-01 | Roche Diabetes Care, Inc. | Handheld medical diagnostic devices with lancing speed control |
US8852123B2 (en) | 2010-12-30 | 2014-10-07 | Roche Diagnostics Operations, Inc. | Handheld medical diagnostic devices housing with sample transfer |
WO2012106060A2 (en) | 2011-01-06 | 2012-08-09 | Pepex Biomedical, Inc. | Sensor module with enhanced capillary flow |
TW201231964A (en) * | 2011-01-31 | 2012-08-01 | Hmd Biomedical Inc | Test strip |
US8647357B2 (en) | 2011-02-05 | 2014-02-11 | Birch Narrows Development Llc | Lancet device with flexible cover |
US8974747B2 (en) | 2011-03-25 | 2015-03-10 | Sanofi-Aventis Deutschland Gmbh | Bodily fluid analysis device |
CA2833175A1 (en) | 2011-04-29 | 2012-11-01 | Seventh Sense Biosystems, Inc. | Devices and methods for collection and/or manipulation of blood spots or other bodily fluids |
WO2012149155A1 (en) | 2011-04-29 | 2012-11-01 | Seventh Sense Biosystems, Inc. | Systems and methods for collecting fluid from a subject |
US20130158468A1 (en) | 2011-12-19 | 2013-06-20 | Seventh Sense Biosystems, Inc. | Delivering and/or receiving material with respect to a subject surface |
US9008744B2 (en) | 2011-05-06 | 2015-04-14 | Medtronic Minimed, Inc. | Method and apparatus for continuous analyte monitoring |
US9504162B2 (en) | 2011-05-20 | 2016-11-22 | Pepex Biomedical, Inc. | Manufacturing electrochemical sensor modules |
US20130085349A1 (en) * | 2011-06-21 | 2013-04-04 | Yofimeter, Llc | Analyte testing devices |
EP4339613A2 (en) | 2011-08-03 | 2024-03-20 | Intuity Medical, Inc. | Body fluid sampling arrangement |
USD667948S1 (en) * | 2011-09-09 | 2012-09-25 | pendiq GmbH | Injection device |
AU2012335830B2 (en) | 2011-11-07 | 2017-05-04 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods |
EP4056105B1 (en) | 2011-12-11 | 2023-10-11 | Abbott Diabetes Care, Inc. | Analyte sensor devices |
RU2644933C2 (en) * | 2012-03-08 | 2018-02-14 | Медтроник Аф Люксембург Сарл | Biomarker samples selection as part of devices for neuromodulation and relevant systems and methods |
WO2013178784A1 (en) * | 2012-06-01 | 2013-12-05 | Sanofi-Aventis Deutschland Gmbh | A testing member for eliciting a blood sample |
US9968306B2 (en) | 2012-09-17 | 2018-05-15 | Abbott Diabetes Care Inc. | Methods and apparatuses for providing adverse condition notification with enhanced wireless communication range in analyte monitoring systems |
WO2014089058A1 (en) | 2012-12-03 | 2014-06-12 | Pepex Biomedical, Inc. | Sensor module and method of using a sensor module |
US9237866B2 (en) | 2013-04-29 | 2016-01-19 | Birch Narrows Development, LLC | Blood glucose management |
US10729386B2 (en) | 2013-06-21 | 2020-08-04 | Intuity Medical, Inc. | Analyte monitoring system with audible feedback |
DE102013014994A1 (en) * | 2013-09-09 | 2015-03-12 | Dräger Safety AG & Co. KGaA | Electrochemical gas sensor, liquid electrolyte and use of a liquid electrolyte in an electrochemical gas sensor |
US10004845B2 (en) | 2014-04-18 | 2018-06-26 | Becton, Dickinson And Company | Split piston metering pump |
CN107003264B (en) | 2014-06-04 | 2020-02-21 | 普佩克斯生物医药有限公司 | Electrochemical sensor and method of manufacturing an electrochemical sensor using advanced printing techniques |
US9416775B2 (en) | 2014-07-02 | 2016-08-16 | Becton, Dickinson And Company | Internal cam metering pump |
US10598624B2 (en) | 2014-10-23 | 2020-03-24 | Abbott Diabetes Care Inc. | Electrodes having at least one sensing structure and methods for making and using the same |
US10213139B2 (en) | 2015-05-14 | 2019-02-26 | Abbott Diabetes Care Inc. | Systems, devices, and methods for assembling an applicator and sensor control device |
CA2984939A1 (en) | 2015-05-14 | 2016-11-17 | Abbott Diabetes Care Inc. | Compact medical device inserters and related systems and methods |
USD787680S1 (en) | 2015-06-18 | 2017-05-23 | Maureen Donohue | Glucose monitor and lancet combination |
US10154809B2 (en) | 2015-06-24 | 2018-12-18 | University Of Virginia Patent Foundation | Test strip device and related methods thereof |
AU2016291720A1 (en) * | 2015-07-13 | 2018-01-25 | Ortho-Clinical Diagnostics, Inc. | Packaging that facilitates sample collection |
CN105388199A (en) * | 2015-12-25 | 2016-03-09 | 张萍 | Electrode blood glucose meter with telecommunication function and high antijamming capability |
US20190209065A1 (en) * | 2016-04-15 | 2019-07-11 | Integrated Nano-Technologies, Inc. | Device system and method for blood sample collection |
US11179078B2 (en) | 2016-06-06 | 2021-11-23 | Medtronic Minimed, Inc. | Polycarbonate urea/urethane polymers for use with analyte sensors |
US11166658B2 (en) * | 2016-07-28 | 2021-11-09 | Invitae Corporation | Blood sampling system and method |
USD824517S1 (en) | 2017-01-19 | 2018-07-31 | Stephen A. Young | Blood sampling device |
CN110461217B (en) | 2017-01-23 | 2022-09-16 | 雅培糖尿病护理公司 | Systems, devices, and methods for analyte sensor insertion |
CN107764881A (en) * | 2017-11-27 | 2018-03-06 | 民康医疗科技(天津)有限公司 | A kind of portable blood test kit device based on electrochemical method |
TWI658268B (en) * | 2017-11-29 | 2019-05-01 | 國立清華大學 | Detecting method for blood |
WO2019222499A1 (en) | 2018-05-16 | 2019-11-21 | Medtronic Minimed, Inc. | Thermally stable glucose limiting membrane for glucose sensors |
USD1002852S1 (en) | 2019-06-06 | 2023-10-24 | Abbott Diabetes Care Inc. | Analyte sensor device |
EP4025128A4 (en) * | 2019-09-03 | 2023-04-12 | Metronom Health, Inc. | Analyte sensor applicator |
CN110579348A (en) * | 2019-09-05 | 2019-12-17 | 山东省医疗器械产品质量检验中心 | Puncture and scrap falling test puncture outfit, device and method |
USD973876S1 (en) | 2020-03-18 | 2022-12-27 | Stephen A. Young | Blood sampling device |
USD999913S1 (en) | 2020-12-21 | 2023-09-26 | Abbott Diabetes Care Inc | Analyte sensor inserter |
US20220240823A1 (en) | 2021-01-29 | 2022-08-04 | Medtronic Minimed, Inc. | Interference rejection membranes useful with analyte sensors |
CN113686941A (en) * | 2021-08-10 | 2021-11-23 | 朱浩奇 | Chemical sensor |
US20230113175A1 (en) | 2021-10-08 | 2023-04-13 | Medtronic Minimed, Inc. | Immunosuppressant releasing coatings |
US20240023849A1 (en) | 2022-07-20 | 2024-01-25 | Medtronic Minimed, Inc. | Acrylate hydrogel membrane for dual function of diffusion limiting membrane as well as attenuation to the foreign body response |
Family Cites Families (62)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2642896C3 (en) | 1976-09-24 | 1980-08-21 | 7800 Freiburg | Precision snapper for setting standard stab wounds in the skin for diagnostic purposes |
US4462405A (en) | 1982-09-27 | 1984-07-31 | Ehrlich Joseph C | Blood letting apparatus |
CA1226036A (en) | 1983-05-05 | 1987-08-25 | Irving J. Higgins | Analytical equipment and sensor electrodes therefor |
US5141868A (en) | 1984-06-13 | 1992-08-25 | Internationale Octrooi Maatschappij "Octropa" Bv | Device for use in chemical test procedures |
US4624253A (en) | 1985-01-18 | 1986-11-25 | Becton, Dickinson And Company | Lancet |
US4627445A (en) | 1985-04-08 | 1986-12-09 | Garid, Inc. | Glucose medical monitoring system |
US4924879A (en) | 1988-10-07 | 1990-05-15 | Brien Walter J O | Blood lancet device |
US4895147A (en) | 1988-10-28 | 1990-01-23 | Sherwood Medical Company | Lancet injector |
US5054499A (en) | 1989-03-27 | 1991-10-08 | Swierczek Remi D | Disposable skin perforator and blood testing device |
US4953552A (en) | 1989-04-21 | 1990-09-04 | Demarzo Arthur P | Blood glucose monitoring system |
DE69020908T2 (en) | 1989-12-15 | 1996-02-15 | Boehringer Mannheim Corp | REDOX MEDIATION REAGENT AND BIOSENSOR. |
US5286362A (en) | 1990-02-03 | 1994-02-15 | Boehringer Mannheim Gmbh | Method and sensor electrode system for the electrochemical determination of an analyte or an oxidoreductase as well as the use of suitable compounds therefor |
US5196025A (en) | 1990-05-21 | 1993-03-23 | Ryder International Corporation | Lancet actuator with retractable mechanism |
JPH04194660A (en) * | 1990-11-27 | 1992-07-14 | Omron Corp | Device for measuring concentration of component in blood |
US5201799A (en) * | 1991-05-20 | 1993-04-13 | United Technologies Corporation | Clip attachment for combustor panel |
FR2677664A1 (en) * | 1991-06-13 | 1992-12-18 | Millipore Sa | Device and process for the microbiological control of liquids under pressure |
DK120991D0 (en) * | 1991-06-21 | 1991-06-21 | Novo Nordisk As | BLOOD SAMPLES |
DE69229180T2 (en) | 1991-11-12 | 1999-10-14 | Urs A Ramel | LANCETTE DEVICE |
DE4212315A1 (en) | 1992-04-13 | 1993-10-14 | Boehringer Mannheim Gmbh | Blood lancet device for drawing blood for diagnostic purposes |
US5318583A (en) | 1992-05-05 | 1994-06-07 | Ryder International Corporation | Lancet actuator mechanism |
US5269799A (en) | 1992-11-05 | 1993-12-14 | Daniel Richard F | Finger pricker |
FR2701117B1 (en) * | 1993-02-04 | 1995-03-10 | Asulab Sa | Electrochemical measurement system with multizone sensor, and its application to glucose measurement. |
US5395387A (en) | 1993-02-26 | 1995-03-07 | Becton Dickinson And Company | Lancet blade designed for reduced pain |
JP3494183B2 (en) | 1993-08-10 | 2004-02-03 | 株式会社アドバンス | Simple blood collection device |
US5304193A (en) | 1993-08-12 | 1994-04-19 | Sam Zhadanov | Blood lancing device |
US5385504A (en) * | 1993-08-30 | 1995-01-31 | Earth Support Systems | Permanent ventilation seal |
US5582184A (en) | 1993-10-13 | 1996-12-10 | Integ Incorporated | Interstitial fluid collection and constituent measurement |
US5458140A (en) * | 1993-11-15 | 1995-10-17 | Non-Invasive Monitoring Company (Nimco) | Enhancement of transdermal monitoring applications with ultrasound and chemical enhancers |
US5497772A (en) * | 1993-11-19 | 1996-03-12 | Alfred E. Mann Foundation For Scientific Research | Glucose monitoring system |
US5437999A (en) | 1994-02-22 | 1995-08-01 | Boehringer Mannheim Corporation | Electrochemical sensor |
DE4415896A1 (en) * | 1994-05-05 | 1995-11-09 | Boehringer Mannheim Gmbh | Analysis system for monitoring the concentration of an analyte in the blood of a patient |
JP2854817B2 (en) * | 1994-12-15 | 1999-02-10 | 韓國電子通信研究院 | ATM multi-channel switch with grouping / trap / routing structure |
IT1271782B (en) * | 1994-12-21 | 1997-06-09 | Whirlpool Italia | METHOD AND ARRANGEMENT TO OBTAIN A BALANCE OF THE LOAD IN THE WASHING MACHINE MACHINES |
JPH08317918A (en) | 1995-05-25 | 1996-12-03 | Advance Co Ltd | Blood drawing device |
JP3638958B2 (en) | 1995-07-28 | 2005-04-13 | アプルス株式会社 | Assembly for adjusting the penetration depth of the lancet |
US6152876A (en) * | 1997-04-18 | 2000-11-28 | Rio Grande Medical Technologies, Inc. | Method for non-invasive blood analyte measurement with improved optical interface |
US5682233A (en) | 1995-09-08 | 1997-10-28 | Integ, Inc. | Interstitial fluid sampler |
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 |
US5711861A (en) * | 1995-11-22 | 1998-01-27 | Ward; W. Kenneth | Device for monitoring changes in analyte concentration |
US5951493A (en) | 1997-05-16 | 1999-09-14 | Mercury Diagnostics, Inc. | Methods and apparatus for expressing body fluid from an incision |
US5879311A (en) | 1996-05-17 | 1999-03-09 | Mercury Diagnostics, Inc. | Body fluid sampling device and methods of use |
DE29723371U1 (en) | 1996-05-17 | 1998-08-06 | Mercury Diagnostics Inc | Device for squeezing body fluid from a puncture |
US5662672A (en) | 1996-05-23 | 1997-09-02 | Array Medical, Inc. | Single use, bi-directional linear motion lancet |
US5613978A (en) | 1996-06-04 | 1997-03-25 | Palco Laboratories | Adjustable tip for lancet device |
US6063039A (en) | 1996-12-06 | 2000-05-16 | Abbott Laboratories | Method and apparatus for obtaining blood for diagnostic tests |
US6071251A (en) | 1996-12-06 | 2000-06-06 | Abbott Laboratories | Method and apparatus for obtaining blood for diagnostic tests |
JP3394262B2 (en) * | 1997-02-06 | 2003-04-07 | セラセンス、インク. | Small volume in vitro analyte sensor |
US5859937A (en) | 1997-04-04 | 1999-01-12 | Neomecs Incorporated | Minimally invasive sensor |
US5984940A (en) | 1997-05-29 | 1999-11-16 | Atrion Medical Products, Inc. | Lancet device |
US5797940A (en) | 1997-05-30 | 1998-08-25 | International Technidyne Corporation | Adjustable skin incision device |
US5916230A (en) | 1997-06-16 | 1999-06-29 | Bayer Corporation | Blood sampling device with adjustable end cap |
US5938679A (en) | 1997-10-14 | 1999-08-17 | Hewlett-Packard Company | Apparatus and method for minimally invasive blood sampling |
US5964718A (en) | 1997-11-21 | 1999-10-12 | Mercury Diagnostics, Inc. | Body fluid sampling device |
US5871494A (en) | 1997-12-04 | 1999-02-16 | Hewlett-Packard Company | Reproducible lancing for sampling blood |
JP3398598B2 (en) | 1998-06-10 | 2003-04-21 | 松下電器産業株式会社 | Substrate quantification method and analytical element and measuring device used for the method |
US6022366A (en) | 1998-06-11 | 2000-02-08 | Stat Medical Devices Inc. | Lancet having adjustable penetration depth |
US6143184A (en) * | 1999-03-02 | 2000-11-07 | United States Filter Corporation | Air and water purification using continuous breakpoint halogenation |
US6096103A (en) * | 1999-06-03 | 2000-08-01 | Leonard Bloom | Alternative fuel for use in a diesel engine-powered emergency generator for intermittent use in fixed installations |
CN1217623C (en) | 1999-12-13 | 2005-09-07 | 爱科来株式会社 | Body fluid measuring apparatus with lancet and lancet holder used for the measuring apparatus |
US6612111B1 (en) * | 2000-03-27 | 2003-09-02 | Lifescan, Inc. | Method and device for sampling and analyzing interstitial fluid and whole blood samples |
US6864986B2 (en) * | 2001-06-01 | 2005-03-08 | Jds Uniphase Corporation | Mixing method and apparatus for characterizing optical modulator |
-
2000
- 2000-03-02 US US09/518,075 patent/US6706159B2/en not_active Expired - Lifetime
-
2001
- 2001-03-02 CA CA2732195A patent/CA2732195A1/en active Pending
- 2001-03-02 CN CN018084907A patent/CN1217624C/en not_active Expired - Fee Related
- 2001-03-02 AU AU2001249100A patent/AU2001249100B2/en not_active Ceased
- 2001-03-02 IL IL15155901A patent/IL151559A0/en active IP Right Grant
- 2001-03-02 PL PL01357279A patent/PL357279A1/en not_active Application Discontinuation
- 2001-03-02 CN CNB2005100844909A patent/CN100398064C/en not_active Expired - Fee Related
- 2001-03-02 JP JP2001563007A patent/JP4727112B2/en not_active Expired - Fee Related
- 2001-03-02 CZ CZ20022942A patent/CZ20022942A3/en unknown
- 2001-03-02 EP EP10180238.7A patent/EP2409644B1/en not_active Expired - Lifetime
- 2001-03-02 KR KR1020027011499A patent/KR100754237B1/en active IP Right Grant
- 2001-03-02 EP EP01922283.5A patent/EP1265530B1/en not_active Expired - Lifetime
- 2001-03-02 ES ES01922283T patent/ES2411721T3/en not_active Expired - Lifetime
- 2001-03-02 WO PCT/US2001/007169 patent/WO2001064105A1/en active IP Right Grant
- 2001-03-02 AU AU4910001A patent/AU4910001A/en active Pending
- 2001-03-02 ES ES10180238.7T patent/ES2604970T3/en not_active Expired - Lifetime
- 2001-03-02 CA CA2401164A patent/CA2401164C/en not_active Expired - Lifetime
- 2001-03-02 RU RU2002126203/14A patent/RU2002126203A/en not_active Application Discontinuation
-
2002
- 2002-09-02 IL IL151559A patent/IL151559A/en not_active IP Right Cessation
-
2003
- 2003-06-16 HK HK03104296.0A patent/HK1051957A1/en not_active IP Right Cessation
- 2003-08-11 US US10/638,752 patent/US7378007B2/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
US20050011759A1 (en) | 2005-01-20 |
HK1051957A1 (en) | 2003-08-29 |
US20020130042A1 (en) | 2002-09-19 |
WO2001064105A9 (en) | 2001-10-25 |
JP2003524496A (en) | 2003-08-19 |
EP1265530A1 (en) | 2002-12-18 |
RU2002126203A (en) | 2004-03-10 |
CZ20022942A3 (en) | 2003-08-13 |
IL151559A (en) | 2007-08-19 |
KR20030004355A (en) | 2003-01-14 |
CN1739450A (en) | 2006-03-01 |
EP2409644A1 (en) | 2012-01-25 |
KR100754237B1 (en) | 2007-09-03 |
AU2001249100B2 (en) | 2004-11-25 |
ES2604970T3 (en) | 2017-03-10 |
WO2001064105A1 (en) | 2001-09-07 |
ES2411721T3 (en) | 2013-07-08 |
CN100398064C (en) | 2008-07-02 |
JP4727112B2 (en) | 2011-07-20 |
AU4910001A (en) | 2001-09-12 |
PL357279A1 (en) | 2004-07-26 |
EP2409644B1 (en) | 2016-09-07 |
CA2401164A1 (en) | 2001-09-07 |
CA2732195A1 (en) | 2001-09-07 |
US6706159B2 (en) | 2004-03-16 |
CN1429087A (en) | 2003-07-09 |
EP1265530B1 (en) | 2013-04-24 |
US7378007B2 (en) | 2008-05-27 |
IL151559A0 (en) | 2003-04-10 |
CN1217624C (en) | 2005-09-07 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CA2401164C (en) | Combined lancet and electrochemical analyte-testing apparatus | |
AU2001249100A1 (en) | Combined lancet and electrochemical analyte-testing apparatus | |
US6352514B1 (en) | Methods and apparatus for sampling and analyzing body fluid | |
US6099484A (en) | Methods and apparatus for sampling and analyzing body fluid | |
US5951492A (en) | Methods and apparatus for sampling and analyzing body fluid | |
EP0955909B1 (en) | Apparatus for sampling and analyzing body fluid | |
US6866675B2 (en) | Lancet device having capillary action | |
US20040225312A1 (en) | Linearly lancing integrated pivot disposable | |
CA2428349A1 (en) | Physiological sample collection devices and methods of using the same | |
AU2002247008A1 (en) | Lancet device having capillary action | |
MXPA02008636A (en) | COMBINED LANCET AND ELECTROCHEMICAL ANALYTEminus;TESTING APPARATUS |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKEX | Expiry |
Effective date: 20210302 |