Integrated spot monitoring device with fluid sensor

• US 7,654,969 B2
• Filed: 02/05/2008
• Issued: 02/02/2010
• Est. Priority Date: 04/15/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wiegel, Christopher D., Wong, Daniel
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/026,190
• Publication Number:
  US 20080161725A1
• Time in Patent Office: 728 Days
• Field of Search: 600/573, 600/583, 600/584
• 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 meter including 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.

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

a controller operatively coupled to the lancing device and a 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.

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

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

the one or more sensors are disposed proximal the capillary channel opening for locating the capillary channel opening during drawing of the body fluid.

4. 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.

5. 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.

6. The body fluid sampling device of claim 5, further comprising:

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.