US20120330188A1 - Cocking and Advancing Mechanism for Analyte Testing Device - Google Patents

Cocking and Advancing Mechanism for Analyte Testing Device Download PDF

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Publication number
US20120330188A1
US20120330188A1 US13/188,399 US201113188399A US2012330188A1 US 20120330188 A1 US20120330188 A1 US 20120330188A1 US 201113188399 A US201113188399 A US 201113188399A US 2012330188 A1 US2012330188 A1 US 2012330188A1
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US
United States
Prior art keywords
lancet
cartridge
analyte sensor
actuator
analyte
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.)
Abandoned
Application number
US13/188,399
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English (en)
Inventor
Gad Shaanan
Marc Goldman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
YOFIMETER LLC
Original Assignee
GADLIGHT Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/165,621 external-priority patent/US20120330119A1/en
Priority claimed from US13/187,360 external-priority patent/US20120330555A1/en
Priority claimed from US13/187,397 external-priority patent/US8333716B1/en
Priority to US13/188,399 priority Critical patent/US20120330188A1/en
Assigned to GADLIGHT, INC. reassignment GADLIGHT, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GOLDMAN, MARC, SHAANAN, GAD
Application filed by GADLIGHT Inc filed Critical GADLIGHT Inc
Priority to US13/308,315 priority patent/US8292826B1/en
Assigned to YofiMETER, Inc. reassignment YofiMETER, Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GADLIGHT, INC.
Priority to PCT/US2012/043605 priority patent/WO2012177923A1/en
Priority to DK12741408.4T priority patent/DK2723237T3/en
Priority to JP2014517180A priority patent/JP6018629B2/ja
Priority to PL12741408T priority patent/PL2723237T3/pl
Priority to CA2839903A priority patent/CA2839903A1/en
Priority to EP12741408.4A priority patent/EP2723237B1/en
Priority to KR1020147001537A priority patent/KR101596797B1/ko
Priority to ES12741408.4T priority patent/ES2550833T3/es
Assigned to YOFIMETER, LLC reassignment YOFIMETER, LLC CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE'S BUSINESS ENTITY DESIGNATION FROM "INC." TO "LLC" PREVIOUSLY RECORDED ON REEL 028080 FRAME 0570. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNEE'S CORRECT BUSINESS NAME AND ENTITY IS YOFIMETER, LLC. Assignors: GADLIGHT, INC.
Priority to US13/689,618 priority patent/US20130085349A1/en
Publication of US20120330188A1 publication Critical patent/US20120330188A1/en
Priority to US13/868,831 priority patent/US8961432B2/en
Abandoned legal-status Critical Current

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    • 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
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • 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
    • A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
    • 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
    • A61B5/151—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
    • A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
    • 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
    • A61B5/15174—Piercing elements stocked in the form of a stack or pile
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48757—Test elements dispensed from a stack

Definitions

  • the field of the invention is analyte testing devices.
  • Analyte testing devices play a critical roll in modern diagnosis and management of health-related issues.
  • a sample of human blood, urine, and/or saliva can be tested for glucose, fructosamine, hematocrit, hemoglobin blood oxygen saturation, lactates, iron, pH, cholesterol, liver enzymes (AST, ALT, alkaline phosphatase/GGT, LDH, bilirubin, etc), hormones, and other compounds.
  • glucose monitoring systems For many diabetic patients, monitoring glucose levels and administering appropriate insulin dosages is a daily activity that requires a significant amount of time and mental energy.
  • Current glucose meters and lancing devices often involve multiple devices, components, and supplies, and require numerous steps to monitor glucose levels.
  • conventional glucose monitoring systems may require numerous steps involving reading a test strip, readying a lancet, using the lancet, putting blood on the test strip and inserting the strip into the glucose meter, reading data from a meter, recording the data in a journal and remembering to bring the journal to the next doctor visit, and then putting away the strip and lancet packages, disposing of loose components, and storing the glucose meter.
  • Other needs include a compact analyte testing device and hands-free disposal of test strips.
  • U.S. Pat. No. 7,582,063 to Wurster discloses a glucose meter that includes a plurality of analyte sensors and a plurality of lancets on the same carrier. Each time a new blood test is performed, the carrier is rotated into position, which simultaneously exposes an analyte sensor, advances a lancet for use, and cocks a spring to operate the pre-positioned lancet. Since the analyte sensors and lancets are rotated together on the same carrier, exposing of an analyte sensor is not independent of advancing a lancet. That can be a disadvantage to a user who might want to use more than one sensor for a given stick (or for example where two different readings are desired), or might need to use two or more lancets to secure an adequate sample for a single sensor.
  • Wurster is also designed such that during use, the operative sensor is immediately adjacent (indeed surrounds) the operative lancet tip. That design could be viewed as being inherently problematic because the sensor will tend to sense components in the first amount of blood that is drawn. To avoid that problem it would be more desirable to expose the analyte sensor at a position at least several millimeters away from where the lancet is projected from the housing.
  • U.S. Pat. No. 4,794,926 to Munsch discloses a lancing device that holds a cartridge with a plurality of lancets. Rotating the cartridge in the lancing device simultaneously loads the next lancet into position for ejection while “cocking” the lancet for ejection.
  • Munsch fails to integrate the lancing device with a glucose meter, and also fails to partially expose a test strip when the lancet cartridge is rotated.
  • the POGOTM System by Intuity Medical, Inc. (see http://www.presspogo.com/pogo/system/) is a commercially available glucose and lancing device that is designed to simplify glucose monitoring. While the POGOTM System reduces the steps and components required, and is an improvement over many other systems, the POGO system fails to provide a separate lancet cartridge and test strip cartridge. As such, the user cannot use lancets independently of test strips.
  • an analyte testing device can house a plurality of analyte sensors and a plurality of lancets, where a single operation of an actuator can expose an analyte sensor while advancing a lancet for projection for use, where the sensors are exposed at a distance of at least several millimeters from where the lancets are projected, and/or where the sensors and lancets can be operated independently from each other.
  • an analyte testing device can house a plurality of analyte sensors and a plurality of lancets, where a single operation of an actuator can eject an analyte sensor while advancing a lancet for projection for use.
  • the analyte sensor is included in an analyte sensor cartridge.
  • the cartridge preferably holds a plurality of analyte sensors.
  • each analyte sensor is disposed in a test unit (e.g., a test strip).
  • the lancet is included in a lancet cartridge.
  • the lancet cartridge preferably holds a plurality of lancets.
  • the actuator comprises a manually operated lever.
  • the mechanism is entirely manually operated.
  • the mechanism is operated at least in part by a motor.
  • the mechanism includes a hammer, and the actuator operates to cock the hammer.
  • the hammer can be spring loaded and then released to eject a lancet for drawing a blood sample.
  • the mechanism has a linkage that exposes the analyte sensor, advances the lancet for use, and cocks the hammer, all in a single motion of the actuator.
  • the single motion comprises pulling a lever.
  • the mechanism includes a first link that exposes the analyte sensor, and a second link, different from the first link, that advances the advancing the lancet. Exposing of the analyte sensor is preferably done independently relative to advancing the lancet.
  • the mechanism can include a disengagement control that is capable of disengaging the actuator from either exposing the analyze sensor or advancing the lancet.
  • the sensors are ejected at a distance of at least several millimeters from where the lancets are projected.
  • the sensors and lancets can be operated independently from each other.
  • the sensors and lancets are each stored in a separate cartridge and the cartridges couple with the analyte testing device independently of one another.
  • FIG. 1 is a top perspective view of one embodiment of an analyte testing device.
  • FIG. 2 is the device of FIG. 1 , wherein an analyte sensor of a test unit has been exposed.
  • FIG. 3 is a bottom perspective view of the device of FIG. 1 .
  • FIG. 4 is a back perspective view the device of FIG. 1 .
  • FIG. 5 is a perspective views of one embodiment of a lancet cartridge.
  • FIG. 6 is a side view of the lancet cartridge of FIG. 5 .
  • FIG. 7 is a side view of the lancet cartridge of FIG. 5 .
  • FIG. 8 is a perspective view of one embodiment of an analyte sensor cartridge.
  • FIG. 9 is a side view of the analyte sensor cartridge of FIG. 8 .
  • FIG. 10 is a perspective view of one embodiment of a test unit that has an analyte sensor.
  • FIG. 11 shows one embodiment of a linkage mechanism of the device of FIG. 1 engaged with the lancet cartridge of FIG. 5 .
  • the linkage mechanism is shown at four different stages of use: (i) rest position; (ii) lever pulled; (iii) lever released (cocked and ready); and (iv) button pressed to project hammer.
  • FIG. 12 is a side view of the device of FIG. 1 , showing the inner components of the device in a rest position.
  • FIG. 13 is a side view of the device of FIG. 1 , showing the inner components of the device as a lever is being pulled.
  • FIG. 14 is a side view of the device of FIG. 1 , showing the inner compartments of the device after a lever has been pulled and a hammer has been spring-loaded.
  • FIG. 15 is a side view of an analyte device with a motor.
  • FIG. 16 is a side of an analyte device with a first and second disengagement control.
  • FIG. 17 is a schematic of one embodiment of a method of using the device of FIG. 1 .
  • inventive subject matter is considered to include all possible combinations of the disclosed elements.
  • inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
  • FIG. 1 shows an analyte testing device 100 .
  • the housing 105 of device 100 has a first compartment 110 and a second compartment 120 , for storing a lancet cartridge 115 (see FIGS. 5-7 ) and an analyte sensor cartridge 125 (see FIGS. 8-9 ).
  • Device 100 also has an electronics compartment 130 for housing conversion electronics 137 (see FIG. 12 ).
  • Conversion electronics 137 are communicatively coupled to an analyte sensor 126 (see FIGS. 8 and 10 ) within cartridge 125 .
  • Conversion electronics 137 is configured to convert a signal from analyte sensor 126 into readable data (e.g., glucose levels).
  • Device 100 has an actuator 140 comprising a lever.
  • Actuator 140 is configured to (i) ready a lancing device (e.g., cock a hammer, see FIGS. 11 and 14 ), (ii) expose an analyte sensor (see FIGS. 2 and 14 ), and (iii) advance a lancet cartridge for use (see FIGS. 11 and 13 ).
  • Device 100 also has a test unit ejector 160 , which advantageously allows for hands-free disposal of a used test strip.
  • the housing of device 100 can be made of plastic, metal, composite, or any other material with structural and mechanical properties suitable for housing a lancet cartridge, test strip cartridge, electronics, and a linkage mechanism.
  • Device 100 is preferably compact, with a height no more than 50 mm, a width no more than 17 mm, and a length no more than 100 mm. In especially preferred embodiments, the height is no more than 40 mm, a width is no more than 12 mm, and a length is no more than 75 mm.
  • the housing of device 100 comprises an outer protective shell made of molded plastic and an inner desiccant liner to minimize exposure to moisture.
  • FIG. 2 shows device 100 after actuator 140 has been cocked.
  • the cocking of actuator 140 has caused a test unit 127 to be partially ejected from slot 133 , thus exposing analyte sensor 126 (see FIGS. 8 and 10 ).
  • a lancing device within device 100 can be projected by pressing button 150 , causing one of a plurality of lancets 117 (see FIGS. 5 and 6 ) to exit from hole 113 (see FIG. 3 ).
  • Hole 113 and slot 133 are separated by a substantial distance (more than 5 mm), thus allowing a user to bleed out an initial amount of blood before applying a blood sample to an analyte sensor.
  • the operation of device 100 will become more apparent from a discussion of FIGS. 11-14 .
  • FIG. 4 shows a back perspective view of device 100 .
  • a door on the backside of device 100 has been opened to reveal compartment 110 .
  • a lancet cartridge 115 is disposed within compartment 110 .
  • Device 100 has a spring-loaded return slider 690 , which is configured to retract a lancet back into cartridge 115 after the lancet has been partially ejected for drawing a blood sample.
  • FIGS. 5-7 show different views of a lancet cartridge 115 .
  • Cartridge 115 holds a plurality of lancets 117 .
  • a slot 116 is disposed on a side of cartridge 115 , so that a hammer 186 (see FIGS. 11-14 ) of a lancing device within device 100 can contact one of the plurality of lancets 117 , thus causing the lancet to partially exit cartridge 115 via slot 118 .
  • the lancet is retracted by return slider 690 of device 100 (see FIG. 4 ).
  • Cartridge 115 also has a molded bump 138 that provides friction to the plurality of lancets 117 and helps to maintain each lancet stationary when not being fired.
  • Cartridge 115 can include any appropriate number of lancets, preferably between 15 and 25 lancets, more preferably between 18 and 22 lancets, and most preferably 20 lancets.
  • the lancets are preferably sterilized and sealed prior to use.
  • FIGS. 8 and 9 show different views of a analyte sensor cartridge 125 .
  • Cartridge 125 holds a plurality of test units 127 (e.g., test strips).
  • Cartridge 125 has electrical contacts 128 for communicatively coupling the analyte sensors to the conversion electronics 137 .
  • contacts 128 could be eliminated and electronics 137 could directly interface with contacts 129 of test unit 127 (see FIG. 10 ) via an open aperture in cartridge 125 .
  • Cartridge 125 also has a slot 129 a that couples with a test unit lateral ejection mechanism of device 100 . When actuator 140 is cocked, the advance mechanism enters slot 129 a and pushes a portion of test unit 127 a out of slot 129 b , thus exposing analyte sensor 126 for use.
  • Cartridge 125 can include any appropriate number of test strips, preferably between 15 and 25 test strips, more preferably between 18 and 22 test strips, and most preferably 20 test strips.
  • Cartridge 125 also has a spring-load base 131 configured to push the plurality of test strips 127 upward, thus repositioning a new test strip into place after test strip 127 a is removed from cartridge 125 .
  • FIG. 10 shows a test unit 127 a having an analyte sensor 126 .
  • Analyte sensors are well known and generally comprise an absorbent material with an analyte-binding reactant. While test unit 127 a is configured as a test “strip”, those of skill in the art will appreciate that other shapes and configurations (e.g., capsules, disks) can be used consistently with the inventive subject matter.
  • Analyte sensor 126 is configured to generate a signal that is sent to electrical contacts 129 . Electrical contacts 129 are communicatively coupled with electrical contacts 128 of cartridge 125 and allows the signal generated by analyte sensor 126 to reach the conversion electronics 137 for analysis. Alternatively, electrical contacts 129 could directly interface with conversion electronics 137 via an open aperture on cartridge 125 .
  • FIG. 11 shows a linkage mechanism 180 of device 100 coupled with lancet cartridge 115 .
  • FIG. 11 provides a summary of the four progressive stages for using linkage 180 and lancet cartridge 115 as a lancing device: (i) initial resting position; (ii) cocking of actuator 140 ; (iii) cocked and ready position; and (iv) releasing and projecting a lancet.
  • a finger or other body part can be placed over hole 113 in order to prick the body part and draw a blood sample.
  • FIG. 12 is a side view of device 100 showing various internal components of device 100 , such as: electronics 137 , linkage mechanism 180 , cartridge 115 , and cartridge 125 .
  • FIG. 12 shows device 100 at a resting position (i.e., before actuator 140 has been cocked).
  • Hammer 186 is in an un-cocked position.
  • FIG. 13 shows the internal components of device 100 as actuator 140 is being cocked.
  • the cocking of actuator 140 has caused link 182 to raise up and compress spring 181 .
  • hammer 186 has been raised via link 183 .
  • the left end of link 182 has been raised over the top of link 187 such that link 182 is maintained in an inclined position and spring 181 is maintained in a compressed position (i.e., hammer 186 has been “cocked” or “readied”).
  • link 183 is driven to the left, pushing test strip 127 a out of slot 133 (see FIG. 1 ).
  • link 184 has been advanced to the left, causing cartridge 115 to advance left and into position.
  • link 183 couples with cartridge 115 such that when cartridge 115 has been completely advanced to the left, link 183 allows the last lancet of cartridge 115 to remain in a usable (i.e., projectable) position.
  • link 183 could release (e.g., de-couple) from cartridge 115 during subsequent cocking of actuator 140 .
  • linkage mechanism 180 allows a lancet to be available for use, even after cartridge 115 has been advanced through each of the plurality of lancets 117 .
  • actuator 140 and linkage mechanism 180 are configured to (i) cock a lancing device (e.g., lift hammer 186 , link 182 , and spring 181 ) (ii) partially expose an analyte sensor on a test unit; and (iii) advance a lancet cartridge into position, all in a single motion (e.g., pulling up actuator 140 ). It is also contemplated that an analyte testing device could have a linkage mechanism that is configured to accomplish the three steps above using two or more motions (e.g., pulling a lever, then pushing a lever).
  • a lancing device e.g., lift hammer 186 , link 182 , and spring 181
  • an analyte testing device could have a linkage mechanism that is configured to accomplish the three steps above using two or more motions (e.g., pulling a lever, then pushing a lever).
  • FIG. 14 shows the position of linkage 180 after actuator 140 has been cocked. Once actuator 140 has been cocked, button 150 can be pressed to release link 187 from under link 182 , thus causing spring 181 to push link 182 and hammer 186 downward to project a lancet from cartridge 115 .
  • linkage mechanism 180 is controlled and/or actuated by electrical drivers rather than pure mechanical means.
  • pulling actuator 140 could send an electrical signal to conversion electronics 137 , which then operates a motor, or multiple motors, in order to perform any combination of: (i) cocking a lancing device, (ii) partially exposing a test strip for use, and (iii) advancing a lancet cartridge into position.
  • the lancing system is designed such that a cocking step is not required.
  • FIG. 15 shows an analyte testing device 500 that has an actuator 540 and a motor 550 .
  • Actuator 540 comprises a button that sends a signal to motor 550 .
  • Motor 550 operates to drive linkage mechanism 180 upon receiving a signal.
  • Motor 550 and actuator 540 is one embodiment of an analyte testing device that is not purely mechanism.
  • FIG. 16 shows an analyte testing device 600 that has a first disengagement control 610 and a second disengagement control 620 .
  • Control 610 operates to disengage link 182 from link 183 , thus disengaging cartridge 125 from linkage mechanism 180 .
  • Control 620 operates to disengage link 184 from cartridge 115 . In this manner, cartridges 115 and 125 can be disengaged from linkage mechanism 180 , and thus can be used independently of one another.
  • FIG. 17 shows a method of using device 100 , comprising: inserting a lancet cartridge into the device; inserting a test strip cartridge into the device; operating an actuator on the device, which operates a mechanism that (i) readies a lancing device, (ii) advances the lancet cartridge, and (iii) exposes an analyte sensor of a test unit; deploying the lancing device in order to prick a body part and draw a blood sample; and exposing the analyte sensor to the blood sample.
  • 15 can optionally include the steps of: reading an output of the device; ejecting and disposing of the test unit; replacing the lancet cartridge with a refill lancet cartridge; and replacing the analyte sensor cartridge with a refill analyte sensor cartridge.
  • the first two and last two steps are displayed in round boxes and with dotted lines to indicate that these steps need not be repeated at every cycle of usage of the device. For example, in embodiments having twenty lancets and test strips per cartridge, the steps of inserting/removing cartridges need only be performed every twentieth cycle of use.
  • Coupled to is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms “coupled to” and “coupled with” are used synonymously.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
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US13/188,399 US20120330188A1 (en) 2011-06-21 2011-07-21 Cocking and Advancing Mechanism for Analyte Testing Device
US13/308,315 US8292826B1 (en) 2011-06-21 2011-11-30 Cocking and advancing mechanism for analyte testing device
ES12741408.4T ES2550833T3 (es) 2011-06-21 2012-06-21 Mecanismo de montaje y avance para dispositivo de prueba de analitos
KR1020147001537A KR101596797B1 (ko) 2011-06-21 2012-06-21 분석 물질 검사 장치를 위한 메카니즘의 코킹 및 이동
PCT/US2012/043605 WO2012177923A1 (en) 2011-06-21 2012-06-21 Cocking and advancing mechanism for analyte testing device
EP12741408.4A EP2723237B1 (en) 2011-06-21 2012-06-21 Cocking and advancing mechanism for analyte testing device
CA2839903A CA2839903A1 (en) 2011-06-21 2012-06-21 Cocking and advancing mechanism for analyte testing device
PL12741408T PL2723237T3 (pl) 2011-06-21 2012-06-21 Mechanizm naciągający i wysuwający do urządzenia testującego analit
DK12741408.4T DK2723237T3 (en) 2011-06-21 2012-06-21 Clamping and delivery mechanisms analyttestindretning
JP2014517180A JP6018629B2 (ja) 2011-06-21 2012-06-21 被分析物試験デバイス用の操作移動装置
US13/689,618 US20130085349A1 (en) 2011-06-21 2012-11-29 Analyte testing devices
US13/868,831 US8961432B2 (en) 2011-06-21 2013-04-23 Analyte testing devices

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US13/165,621 US20120330119A1 (en) 2011-06-21 2011-06-21 Analyte Testing Device with Lancet Cartridge and Test Strip Cartridge
US13/187,397 US8333716B1 (en) 2011-06-21 2011-07-20 Methods for using an analyte testing device
US13/187,360 US20120330555A1 (en) 2011-06-21 2011-07-20 Analyte Testing System with Docking Station for Data Management
US13/188,399 US20120330188A1 (en) 2011-06-21 2011-07-21 Cocking and Advancing Mechanism for Analyte Testing Device

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US20160374603A1 (en) * 2014-03-12 2016-12-29 Yofimeter, Llc Analyte testing devices with lancet advancement tracking and color touch screen user interface

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JP6018629B2 (ja) 2016-11-02
US8292826B1 (en) 2012-10-23
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PL2723237T3 (pl) 2015-12-31
EP2723237B1 (en) 2015-08-05
ES2550833T3 (es) 2015-11-12
DK2723237T3 (en) 2015-10-19
JP2014516760A (ja) 2014-07-17
WO2012177923A1 (en) 2012-12-27
CA2839903A1 (en) 2012-12-27
KR101596797B1 (ko) 2016-02-23

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