Method and apparatus for penetrating tissue

• US 20070191737A1
• Filed: 03/21/2007
• Published: 08/16/2007
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique
• Granted Patent: US 7,959,582 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150251 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 5/150435 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 5/150809 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 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• 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 5/15178 : 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 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Claims

1. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator.

a position sensor configured to provide an indication of a position of the penetrating member during actuation; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

2. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator.

wherein said penetrating member is an elongate member without a molded attachment.

a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

3. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator;

a plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator.

a flexible support member coupling said cartridges to define an array, said support member being movable and configured to move each of said cartridges to said launch position associated with said force generator; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

4. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

5. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stoppirg in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

6. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit; and

a user interface coupled to a processor, wherein in response to an input at the human interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

7. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

8. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

9. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte sensors, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a flexible support member coupling said penetrating members to define an array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;

an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.