Body fluid sampling module with a continuous compression tissue interface surface

• US 9,226,699 B2
• Filed: 11/09/2010
• Issued: 01/05/2016
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique, Deshmukh, Ajay, Hegener, Jason, Shoup, Thomas, Eaton, Brent, Molho, Joshua, Wang, Amy, Perry, Jeffrey
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M.
• Application Number:
  US12/942,246
• Publication Number:
  US 20110077478A1
• Time in Patent Office: 1,883 Days
• Field of Search: 600/583, 600/584, 606/181, 606/182, 606/183
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 : by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 : by visual feedback
• CPC Class Codes: A61B 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/150954 : Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• 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 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15128 : comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15174 : Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• 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

Abstract

A body fluid sampling device includes a housing, a penetrating member positioned in the housing and a test strip. A compliant front end is coupled to the housing. The compliant front-end includes a rigid member with an interior aperture to receive the body fluid from a wound site.

Claims

1. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing coupled to an electronic controllable penetrating member driver;

a position sensor;

a processor in communication with the position sensor, the processor processing information regarding skin site position for lancing and success rate of a lancing event relative to different skin sites, in response to selection of a profile the processor configured to modulate power from a power supply to the electronic controllable penetrating member driver, an electrical conductor electrically coupling the processor to the position sensor;

a database that stores information and statistics for each user and each profile of a particular user, the processor configured to store results of a lancing event and construct the database; and

a display coupled to the processor and the database that displays information to teach a user skin sites to avoid and use for successful lancing to obtain a good sample of fluid sample during a lancing event.

2. The device of claim 1, wherein the database is updated based on measurements achieved from previous failed and successful measurements of the body fluid.

3. The device of claim 2, wherein multiple targets can be displayed for different skin sites.

4. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing coupled to an electronic controllable penetrating member driver;

a position sensor;

a processor that includes historical penetration data of a user'"'"'s different skin sites, in response to selection of a profile the processor configured to modulate power from the electronic controllable penetrating member driver, an electrical conductor electrically coupling the processor to the position sensor;

a database that stores information and statistics for each user and each profile of a particular user, the processor configured to store results of a lancing event and construct the database; and

a display coupled to the processor that displays a skin site position in response to a measured value as a skin site approaches the position sensor, wherein previous failed and successful measurement attempts are plotted with position corresponding to the measured value, the display coupled to the processor and the database and displaying information to teach a user skin sites to avoid and use for successful lancing to obtain a good sample of fluid sample during a lancing event.

5. The device of claim 4, wherein the display instructs a user to position a finger position in a region with a highest number of successful historical measurements.

6. The device of claim 5, wherein the processor filters the historical data based on skin site location.