Method and apparatus for a multi-use body fluid sampling device

• US 7,708,701 B2
• Filed: 12/18/2002
• Issued: 05/04/2010
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Wittig, Michael, Boecker, Dirk, Freeman, Dominique M.
• Primary Examiner(s): Milano; Michael J
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/323,622
• Publication Number:
  US 20040102803A1
• Time in Patent Office: 2,694 Days
• Field of Search: 606171-172, 606181-186, 600/573, 600/583, 600/576, 600/577, 600/584
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150152 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• 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 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15117 : 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 5/1513 : comprising linear sliding guides 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 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• 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 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• 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 37/0015 : by using microneedles

Abstract

A device for use in penetrating tissue to obtain a body fluid sample is provided. A cartridge may be included. A plurality of penetrating members are slidably coupled to the cartridge. Each penetrating member has a distal end that is sufficiently sharp to pierce tissue. Each penetrating member may be moveable relative to the other ones of the penetrating members so that the sharpened distal ends extend radially outward to penetrate tissue. The penetrating members are elongate members without molded attachments.

Claims

1. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

a disposable;

a plurality of penetrating members positioned in said disposable and each of a penetrating member being housing in an associated chamber in the disposable, each of said penetrating members having a distal end sufficiently sharp to pierce tissue, each of said penetrating members being moveable relative to the other ones of the penetrating members so that the sharpened distal ends extend radially outward to penetrate tissue; and

wherein said penetrating members are elongate members without molded attachments, each of a penetrating member being coupled to a penetrating member driver with a coupler that couples a penetrating member to the penetrating member driver when the penetrating member is positioned in its associated chamber, and

a plurality of ratchet surfaces near an inner radial surface of the disposable.

2. The device of claim 1 wherein said disposable defines a plane and said penetrating members are contained in substantially the same plane.

3. The device of claim 1 wherein said disposable defines a plane and said penetrating members are oriented to extend radially outward in substantially the same plane as the disposable.

4. The device of claim 1 wherein said penetrating members are substantially in a common plane.

5. The device of claim 1 wherein said penetrating members are arranged in a radial pattern.

6. The device of claim 1 wherein said penetrating members are coated with a material.

7. The device of claim 1 wherein said penetrating members are coated with a material selected from the following:

Teflon, glass, silicon, or polymer.

8. The device of claim 1 wherein said disposable has a flat radial configuration.

9. The device of claim 1 wherein said disposable comprises a disc-shaped housing.

10. The device of claim 1 wherein said disposable has a plurality of cavities housing said lancets.

11. The device of claim 1 wherein said disposable has a plurality of grooves housing said lancets.

12. The device of claim 1 wherein said disposable comprises a disc-shaped housing with a non-chamfered outer periphery.

13. A device comprising:

a single radial disposable;

a plurality of penetrating members without molded attachments slidably positioned in said disposable and selectively actuatable to penetrate tissue, each of said penetrating members without molded attachments having an longitudinal axis;

wherein the penetrating members without molded attachments are longitudinally oriented to be substantially in a common plane, each of the penetrating members without molded attachments being positioned in an associated chamber in the disposable and encased with a sterility seal, each of the penetrating member without molded attachment being coupled to a penetrating member driver with a coupler and

a plurality of ratchet surfaces near an inner radial surface of the disposable.