INTEGRATED SPOT MONITORING DEVICE WITH FLUID SENSOR

• US 20090299226A1
• Filed: 08/12/2009
• Published: 12/03/2009
• Est. Priority Date: 04/15/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wong, Daniel, Wiegel, Christopher D.
• Granted Patent: US 8,187,205 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150053 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
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15192 comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing

Abstract

A bodily fluid sampling device is operable to breach the skin surface and allow bodily fluid to emerge from the breach location. The bodily fluid sampling device further evaluates the amount of bodily fluid emerged from breach location and determines whether the amount is sufficient or insufficient for a particular purpose, such as sampling and testing. The determination is accomplished automatically without moving the device. The user may also intervene to perform a variety of tasks following the determination of the amount of bodily fluid.

Claims

1. A body fluid sampling device, comprising:

a meter;

a lancing device configured to create an incision in a surface of tissue, wherein the lancing device includes a lancet;

a fluid detector configured to detect sufficiency of body fluid bled from the incision while on the surface of the tissue;

an analysis device configured to analyze the body fluid once the fluid detector detects that the body fluid on the surface of the tissue is sufficient for analysis, wherein the analysis device includes a test strip;

an integrated lancing test strip including the lancet attached to the test strip;

the integrated lancing test strip being detachably coupled to the meter, the lancet and test strip of the integrated lancing test strip being configured to be removed together from the meter as a single unit;

wherein the fluid detector includes one or more sensors disposed on the integrated lancing test strip to detect sufficiency of the body fluid bled from the incision while on the surface of the tissue;

the test strip defining a capillary channel with a capillary channel opening for drawing the body fluid; and

the test strip having the one or more sensors integrated into the test strip at the capillary channel opening.

2. The body fluid sampling device of claim 1, wherein:

the lancing device includes a lancet coupled to a firing mechanism; and

the fluid detector includes the lancet, the lancet including an electrically conductive material for detecting the body fluid upon the body fluid contacting the lancet.

3. The body fluid sampling device of claim 1, further comprising:

a housing in which the fluid detector is disposed, the housing defining a cavity with an opening where the incision is created; and

wherein the fluid detector includes an ultrasonic detector configured to detect a change in resonance of the cavity in the housing as the body fluid from the incision fills the cavity.

4. The body fluid sampling device of claim 1, wherein the fluid detector includes a position sensing detector configured to detect height of the body fluid from the surface of the tissue by triangulating reflected light from the body fluid.

5. The body fluid sampling device of claim 1, wherein the fluid detector includes a thermal sensor.

6. The body fluid sampling device of claim 1, wherein the fluid detector includes a sensor disposed proximal the tissue to detect the sufficiency of the body fluid by measuring capacitance changes between the tissue and the sensor caused by bleeding of the body fluid from the incision.

7. The body fluid sampling device of claim 6, wherein:

The meter has an expression device that includes one or more electrodes to electrically stimulate the tissue; and

the sensor is configured to detect sufficiency of the body fluid based on electrical signals from the electrodes.

8. The body fluid sampling device of claim 1, further comprising:

a controller operatively coupled to the lancing device and the firing mechanism; and

an output device operatively coupled to the controller, wherein the output device is configured to positively indicate insufficiency of the body fluid when the fluid detector detects the insufficiency of the body fluid.

9. The body fluid sampling device of claim 1, wherein the analysis device includes a test strip with a capillary channel for drawing the body fluid and an actuator coupled to the test strip for positioning the capillary channel to collect the body fluid when the fluid detector detects a sufficient amount of the body fluid on the surface of the tissue.

10. The device of claim 1, further comprising:

a controller;

an expression device operatively coupled to the fluid detector through the controller; and

the controller being configured to activate the expression device to automatically express the body fluid from the incision upon detecting with the fluid detector that the body fluid on the surface of the tissue is insufficient for analysis.

11. The body fluid sampling device of claim 10, further comprising:

the meter including a housing defining a sampling chamber with an opening through which the lancing device creates the incision, the housing having a skin contacting portion around the opening that contacts the tissue during creation of the incision; and

wherein the expression device is configured to express the body fluid without requiring removal of the skin contacting portion of the housing from the tissue.

12. A body fluid sampling device, comprising:

a test strip including a capillary channel for drawing body fluid from tissue and an analysis portion located along the capillary channel for analyzing the body fluid;

wherein the test strip has a fluid detector to sense sufficiency of the body fluid on the tissue before the body fluid is drawn into the capillary channel;

the capillary channel having an opening for receiving the body fluid; and

the test strip having the fluid detector disposed at the opening to sense distance between the opening and the tissue.

13. The body fluid sampling device of claim 12, further comprising:

a lancet coupled to the test strip for creating an incision in the tissue.

14. The body fluid sampling device of claim 13, wherein:

the lancet is fixed to the test strip; and

the capillary channel has an opening that is positioned at an oblique angle relative to the lancet.

15. The body fluid sampling device of claim 13, wherein the lancet is coupled to the test strip in a slidable manner to allow extension of the lancet from the test strip.

16. The body fluid sampling device of claim 12, wherein the fluid detector includes at least one sensor configured to measure changes in capacitance between the tissue and the sensor as the body fluid bleeds from an incision.

17. A body fluid sampling device, comprising:

a test strip comprising

a capillary channel with a capillary channel opening to draw body fluid from tissue, the capillary channel opening being located at an end of the test strip,

an analysis portion located along the capillary channel to analyze the body fluid from the tissue, and

one or more sensors disposed at the capillary channel opening at the end of the test strip configured to detect the position of the capillary channel opening relative to the tissue;

a mechanism coupled to the test strip configured to change the position of the capillary channel opening relative to the tissue; and

a controller operatively coupled to the one or more sensors, the controller being configured to move the capillary channel opening with the mechanism to collect the body fluid from the tissue based on the position of the capillary channel opening detected by the one or more sensors.

18. The device of claim 17, further comprising:

a lancet coupled to the test strip to form an integrated lancing test strip.

19. The device of claim 18, further comprising:

the mechanism including a firing mechanism configured to fire the lancet into the tissue.

20. The device of claim 17, in which the one or more sensors are configured to detect the amount of the body fluid on the surface of the tissue before being drawn into the capillary channel.

21. The device of claim 20, further comprising:

an expression device configured to express additional body fluid from the tissue; and

the controller being configured to activate the expression device upon sensing fluid insufficiency with the one or more sensors.

22. The device of claim 21, in which the expression device comprises one or more electrodes configured to electrically stimulate the tissue.

23. The device of claim 17, in which the one or more sensors are ultrasonic sensors.