ANALYTE TESTING DEVICES

• US 20130245392A1
• Filed: 04/23/2013
• Published: 09/19/2013
• Est. Priority Date: 06/21/2011
• Status: Active Grant

• Current Assignee: Yofimeter, LLC
• Original Assignee: Yofimeter, LLC
• Inventors: Shaanan, Gad, Goldman, Marc
• Granted Patent: US 8,961,432 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15148 Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G01N 33/48757 : Test elements dispensed from a stack

Abstract

Systems, devices, techniques and methods are disclosed for implementing an actuator mechanism of an analyte testing device. In one aspect, a method to test an analyte includes advancing an analyte sensor from a first position within a sensor cartridge of an analyte testing device to a second position that exposes at least a portion of the analyte sensor outside of the device, advancing a lancet projecting component from an initial position to a cocked position for a subsequent projection of a lancet, in which the advancing the analyte sensor and the advancing the lancet projecting component are initiated by a single operation, projecting the lancet to expose at least a portion of the lancet outside of the device, receiving a testing sample including an analyte at the exposed portion of the analyte sensor, processing the testing sample to determine a parameter of the analyte, and ejecting the analyte sensor from the device.

Claims

1. A method for operating an analyte testing device in testing an analyte, comprising:

advancing an analyte sensor from a first position within a sensor cartridge of an analyte testing device to a second position to expose at least a portion of the analyte sensor outside of the device;

advancing a lancet projecting component of the analyte testing device from an initial position to a cocked position for a subsequent projection of a lancet, wherein the advancing the analyte sensor and the advancing the lancet projecting component are initiated by a single operation;

operating the lancet projecting component to project the lancet outside of the device;

operating the device to contact the analyte sensor with a testing sample containing the analyte at the exposed portion of the analyte sensor;

operating the device to process the testing sample to determine a parameter of the analyte; and

ejecting the analyte sensor from the device.

2. The method of claim 1, wherein the single operation includes sliding a button located on an external side of the device.

3. The method of claim 1, wherein the parameter includes the concentration level of the analyte.

4. The method of claim 1, wherein the projecting the lancet outside of the device punctures flesh of a user to draw blood to test glucose concentration in the blood.

5. The method of claim 1, further comprising advancing a lancet cartridge from a previous position within the analyte testing device to a readied position in which the lancet is aligned with the lancet projection component in the cocked position, wherein the advancing the lancet cartridge is initiated by the single operation.

6. The method of claim 1, wherein the lancet is automatically retracted back into the lancet cartridge.

7. The method of claim 1, wherein the method is implemented using a single hand holding the device.

8. The method of claim 1, further comprising operating a lancet depth adjustment component to position a step structure disposed within the device in a projection path of the lancet to control the distance of projection of the lancet.

9. The method of claim 1, wherein the lancet is projected substantially straight to within a particular tolerance, thereby reducing wobble of the lancet during projection.

10. An analyte testing device, comprising:

an analyte sensor module configured to hold a sensor cartridge structured to store analyte sensors, the analyte sensor module including an opening from which an analyte sensor advances to a testing position to expose at least a portion of the analyte sensor to outside of the analyte testing device;

a lancet module configured to hold a lancet cartridge structured to store lancets; and

an actuator including;

a button,

a first linking component coupled to the button and the analyte sensor module, wherein the first linking component moves in response to a movement of the button including a movement between a first position and a second position or a movement between the second position and a third position,

a second linking component coupled to the button and the lancet module, wherein the second linking component moves in response to a movement of the button between the first position and the second position,

a third linking component coupled to the second linking component and moveable in response to a movement of the second linking component, and

a lancet projecting component coupled to the third linking component,

wherein a single operation of the button moves the analyte sensor to the testing position and moves the lancet projecting component from an initial position to a cocked position for projecting a lancet.

11. The device of claim 10, further comprising a door covering the opening and coupled to the first linking component, wherein the door moves to uncover the opening based on a movement of the first linking component.

12. The device of claim 10, wherein the button is a sliding button, and the single operation includes the sliding of the button from the first position to the second position.

13. The device of claim 10, wherein the button is positioned on the analyte testing device to allow the single operation to be carried out using a single hand holding the device.

14. The device of claim 10, wherein the lancet cartridge is structured to include a hollowed chamber for each lancet in the lancet cartridge, the hollowed chamber including an opening structured to allow the lancet projecting component to enter the chamber and impact the lancet for projection, a terminal opening structured to allow a needle component of the lancet to project out of the device, and a track to control a projection path of the lancet.

15. The device of claim 14, wherein the projection path is structured to be substantially straight to within a particular tolerance, thereby reducing wobble of the needle component as the lancet is projected out of the device.

16. The device of claim 14, wherein the actuator further includes a depth adjustment component structured to include a knob located on the external side of the device connected to a plurality of steps of different lengths disposed within the device, wherein one step is positioned in the projection path within the hollowed chamber to reduce the distance of projection of the lancet.

17. The device of claim 10, wherein the actuator further includes a firing button located on the exterior of the device and coupled to the lancet projecting component when the lancet projecting component is in the cocked position, and a second operation includes the activation of the firing button to release the lancet projecting component to impact the lancet for projection.

18. The device of claim 10, wherein the analyte sensor is disposed in a test strip and receives a testing sample from a user in the testing position.

19. The device of claim 10, wherein the analyte sensor is ejected from the device by a third operation that includes the movement of the button from the second position to the third position.

20. The device of claim 19, wherein the button is a sliding button that includes two separable buttons including a first button and a second button, wherein the first button returns back to the first position after the movement of the button between the first position and the second position, and the second button is moved from the second position to the third position in the third operation, and wherein the actuator further includes a button stop mechanism that prevents the button from returning to the first position when the single operation is initiated and not completed.

21. The device of claim 10, wherein the analyte sensor module further includes a temperature sensor to monitor temperature in the analyte sensor module.

22. The device of claim 10, further comprising one or both of:

a first facility configured to transmit at least one of data obtained from the analyte sensor or information derived from data out of the analyte testing device using at least one wireless protocol, or

a second facility configured to transmit at least one of the data obtained from the analyte sensor or the information derived from the data out of the analyte testing device using a wired path.

23. The device of claim 10, further comprising a processor, the processor configured to perform one or more of the following:

correlate individual instances of at least one of data obtained from the analyte sensor or information derived from data out of the analyte testing device with (a) time stamps and optionally (b) user entered information selected from the group consisting of speech and text,

evaluate at least one of data obtained from the analyte sensor or information derived from data out of the analyte testing device, and to send a notification to a recipient,

keep track of inventory of lancets and analyte sensors, both within and outside the device, wherein the processor is configured to reorder inventory of lancets and analyte sensors,

store voice recordings of diary information selected from the group consisting of supplies used or ordered, food eaten, exercise, medication taken, and estimated calories burned, or

produce a prompt to direct a user to use the device according to at least one of a selected time or a selected time interval.

24. The device of claim 10, further comprising an LCD touch screen display, a first work light positioned to illuminate a lancet exit hole, and a second work like positioned to illuminate an analyte sensor exit slot.

25. The device of claim 10 included in a system, the system comprising a visual interface external to the device, through which a user can view and input data.

26. The device of claim 10, further comprising a pedometer communicatively coupled with a processor configured to calculate a distance traveled and an amount of calories burned associated with the distance traveled.

27. The device of claim 10, further comprising a personal emergency response system (PERS) that includes a button for alerting a third party, wherein the PERS is configured to perform one or more of the following:

contact a third party,

identify the device,

provide health data associated with a user of the device,

automatically contact a third party in response to health data associated with a user of the device,

notify a third party as an urgency level of an emergency, or

determine identity of a third party to be contacted.

28. A method for using an analyte testing device, comprising:

in a first operation, operating a button located on the exterior of an analyte testing device to advance an analyte sensor within a sensor cartridge of the analyte testing device to expose at least a portion of the analyte sensor outside of the analyte testing device and to advance a lancet projecting component of the analyte testing device from an initial position to a cocked position for a subsequent projection of a lancet;

in a second operation, operating a firing button located on the exterior of an analyte testing device to advance the lancet projecting component to contact the lancet to project the lancet from the analyte testing device; and

in a third operation, operating the button to eject the analyte sensor from the device,

wherein the first operation, second operation, and third operation are implemented using a single hand holding the device.

29. The method of claim 28, wherein the operating the button in the first operation includes moving the button from a first position to a second position on the exterior of the analyte testing device, and the operating the button in the third operation includes moving the button from the second position to a third position on the exterior of the analyte testing device.

30. The method of claim 28, wherein, in the first operation, the operating further includes advancing a lancet cartridge from a previous position within the analyte testing device to a readied position in which the lancet is aligned with the lancet projection component in the cocked position.