Integrated spot monitoring device with fluid sensor

• US 7,351,213 B2
• Filed: 04/13/2005
• Issued: 04/01/2008
• 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: Wong, Daniel, Wiegel, Christopher D.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US11/105,209
• Publication Number:
  US 20050234368A1
• Time in Patent Office: 1,084 Days
• Field of Search: 600/584, 600/573, 600/583
• US Class Current: 600/584
• 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 method, comprising:

placing a sampling device against a tissue;

creating an incision in the tissue with the sampling device;

detecting with the sampling device that body fluid bled from the incision on the tissue is insufficient for analysis; and

expressing the body fluid from the incision automatically with the sampling device in response to said detecting while the sampling device remains against the tissue;

wherein the sampling device includes a housing with a cavity and a fluid detector configured to generate ultrasound in the cavity;

wherein said detecting includes monitoring resonance of the ultrasound in the cavity of the housing;

sensing an ultrasonic resonance that indicates the sampling device is placed against the tissue; and

said creating the incision including firing a lancet into the tissue in response to said sensing the ultrasonic resonance that indicates the sampling device is placed against the tissue.

2. The method of claim 1, wherein said detecting includes monitoring rate of bleeding of the body fluid from the incision.

3. The method of claim 1, wherein said detecting includes monitoring amount of body fluid on the tissue.

4. The method of claim 1, further comprising:

determining with the sampling device that the body fluid on the tissue is sufficient for analysis after said expressing; and

analyzing the body fluid with the sampling device after said determining.

5. The method of claim 1, wherein said expressing includes electrically stimulating the tissue with electrodes of the sampling device.

6. The method of claim 1, further comprising:

wherein the sampling device includes an output device; and

activating the output device to indicate insufficiency of the body fluid upon said detecting.

7. The method of claim 1, further comprising:

wherein said detecting includes determining the location of the body fluid bled from the incision; and

extending a test strip to the location of the body fluid by adjusting how far the test strip extends based on said determining the location of the body fluid.

8. The method of claim 1, further comprising:

wherein said detecting includes determining the location of the surface of the tissue; and

extending a test strip to collect the body fluid by adjusting how far the test strip extends based on said determining the location of the surface of the tissue.