Method and apparatus for penetrating tissue

• US 7,410,468 B2
• Filed: 12/31/2002
• Issued: 08/12/2008
• Est. Priority Date: 04/19/2002
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique M.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US10/335,182
• Publication Number:
  US 20030199790A1
• Time in Patent Office: 2,051 Days
• Field of Search: 600/583, 600/564, 600/568, 600/573, 600/575, 600/576, 600/577, 600/579, 600/584, 604/318, 604/322, 604/326, 606/181
• 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 5/150152 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 5/150221 Valves
• 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 5/150503 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 5/15087 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 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 5/15153 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 5/15184 : 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 5/15186 : 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, C12Q1/56
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

A skin penetrating system includes a housing member and a penetrating member positioned in the housing member. An analyte detecting member is coupled to a sample chamber. The analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber. A tip of the penetrating member is configured to extend through an opening of the sample chamber.

Claims

1. A skin penetrating system, comprising:

a housing member;

an electronic drive force generator;

a plurality of penetrating members positioned in the housing member, each of a penetrating member being couplable to the drive force generator;

a plurality of sample chambers, each sample chamber including electrodes, having a volume no greater than 1 μ

L and an analyte sensor, each of a sample chamber being positioned to receive fluid from a wound created by a penetrating member, and determine a concentration of an analyte in a fluid using a sample of less than 1 μ

L of the fluid, wherein when the penetrating member is removed from the sample chamber, the electrodes remain in the sample chamber and the volume of the sample chamber is less than 1 μ

L wherein a tip of the penetrating member is configured to extend through an opening of a sample chamber, wherein each penetrating member of the plurality of penetrating members has a packing density of no more than 1.0 cm³/penetrating member;

a single substrate that supports the plurality of penetrating members and the plurality of sample chambers, the single substrate being rotatably positioned in the housing to position each of a penetrating member in a launch position to penetrate a tissue site, and then rotate to a next position for a launch position of a next penetrating member; and

a programmable processor operatively programmed with software that has control instructions for controlling the drive force generator, to keep a wound tract created by a penetrating member open for a sufficient time to provide for spontaneous flow of blood for sample capture into an associated sample chamber, the control instructions selected from at least one of, penetration depth of a penetrating member, velocity of a penetrating member, velocity of a penetrating member in or out of target tissue and a dwell time of a penetrating member in the target tissue.

2. The system of claim 1, further comprising:

a penetrating member sensor coupled to the processor and the plurality of penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

3. The system of claim 1, further comprising:

a plurality of cartridges positioned in a disposable member, each of a cartridge including a penetrating member and a sample chamber, the plurality of cartridges positioned on the single substrate.

4. The system of claim 3, wherein each of a cartridge has an exit port, and upon launch each of an associated penetrating member exits from the exit port.

5. The system of claim 1, wherein each penetrating member of the plurality of penetrating members has a packing density of no more than 0.75 cm³/penetrating member.

6. The system of claim 1, wherein each penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm³/penetrating member.

7. The system of claim 1, wherein each penetrating member of the plurality of penetrating members has a packing density of no more than 0.25 cm³/penetrating member.

8. The system of claim 1, wherein each penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm³/penetrating member.

9. The system of claim 1, wherein each penetrating member of the plurality of penetrating members and each associated sample chamber of the plurality of sample chambers have a combined packing density of no more than 1.0 cm³.

10. The system of claim 1, wherein each penetrating member of the plurality of penetrating members and each associated sample chamber of the plurality of sample chambers have a combined packing density of no more than 0.75 cm³.

11. The system of claim 1, wherein each penetrating member of the plurality of penetrating members and each associated sample chamber of the plurality of sample chambers have a combined packing density of no more than 0.5 cm³.

12. The system of claim 1, wherein each penetrating member of the plurality of penetrating members and each associated sample chamber of the plurality of sample chambers have a combined packing density of no more than 0.25 cm³.

13. The system of claim 1, wherein each penetrating member of the plurality of penetrating members and each associated sample chamber of the plurality of sample chambers have a combined packing density of no more than 0.1 cm³.

14. The system of claim 1, wherein each penetrating member is an elongated member without molded attachments.