Method and apparatus for body fluid sampling and analyte sensing

• US 20060241666A1
• Filed: 06/14/2004
• Published: 10/26/2006
• Est. Priority Date: 06/11/2003
• Status: Abandoned Application

• Current Assignee: Pelikan Technologies, Inc.
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Schulte, Tom, Ross, James, Alden, Don, Freeman, Dominique M., Briggs, Barry Dean, Mauze, Ganapati
• Application Number:
  US10/560,263
• Publication Number:
  US 20060241666A1
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 5/150022 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 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• 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 5/15161 : 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 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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 5/15186 : 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

Abstract

The method comprises providing a lancing device comprising a penetrating member (68) driver having a position sensor (74) and a processor (60) that can determine the relative position and velocity of the penetrating member (18, 72) based on measuring relative position of the penetrating member with respect to time; providing a predetermined velocity control trajectory based on a model of the driver (68) and a model of tissue to be contacted. Furthermore, a feedforward control is able to maintain penetrating member velocity along the trajectory.

Claims

1-6. -6. (canceled)

7. A device for body fluid sampling usable with a cartridge housing a plurality of penetrating members, the device comprising:

a housing;

a penetrating member driver coupled to said housing and for use with said cartridge;

a processor for controlling said penetrating member driver to move at least one of said penetrating members at velocities which conform with a selectable velocity profile.

8. The device of claim 7 comprising a cartridge housing a plurality of penetrating members and a window allowing a user to see the cartridge while the cartridge is in said housing.

9. The device of claim 7 comprising display showing device status.

10. The device of claim 7 comprising display showing lancing performance.

11. The device of claim 7 comprising display showing lancing parameters.

12. The device of claim 7 comprising a single button for actuating said penetrating member driver along an inbound path into tissue and then an outbound path out of the tissue.

13. The device of claim 7 wherein said penetrating member driver moves an active one of said penetrating members along a velocity profile that reduces initial pain and residual pain to levels below that of known devices.

14. The device of claim 7 wherein said penetrating member driver moves an active one of said penetrating members along a velocity profile that reduces initial pain and residual pain to levels at least 1.5 times less than that of known devices.

15. The device of claim 7 wherein said penetrating member driver moves an active one of said penetrating members along a velocity profile that reduces residual pain to levels at least 2 times less than that of known devices.

16-31. -31. (canceled)

32. A body fluid sampling device for use with a cartridge containing a plurality of penetrating members comprising:

a penetrating member driver for moving an active one of said penetrating members from a first position outward to penetrate tissue;

a display that has a screen saver.

33. (canceled)

34. A fluid sampling device comprising:

a housing;

a cartridge defining a plurality of cavities, said cartridge sized to fit within said housing; and

a plurality of penetrating members at least partially contained in said cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from said cartridge to penetrate tissue, said cavities each having a longitudinal opening providing access to an elongate portion of the penetrating member;

a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of the longitudinal openings, wherein the sterility barrier covering the lateral openings is configured to be moved so that the elongate portion may be accessed by the gripper without touching the barrier; and

a slider located on a surface of said housing, said slider movable in a linear direction to rotate said cartridge to bring an unused penetrating member into position for use;

a tooth gear coupled to said slider to control a distance said slider can travel;

a follower coupled to said slider;

a cam surface engaged by said follower to lift said cartridge a desired distance above a first position to allow for rotation of the cartridge without engaging a gripper used to advance the penetrating member.

35. The device of claim 34 wherein said cam surface is aligned parallel to said slider.

36. The device of claim 34 wherein said linear motion of the cam rotates the cartridge and moves a plunger to break the sterility barrier on the cartridge.

37. The device of claim 34 wherein cam surface comprise a linear strip of material with at least two raised portions and two depressed portions.

38-40. -40. (canceled)

41. A device comprising:

a housing;

a penetrating member driver;

a cartridge containing a plurality of penetrating members;

a display on said cartridge;

a linear slider on the housing, said slider coupled to a rod;

said rod moving with said slider, said rod having at least one roller

using the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.

42. A method of indexing comprising:

moving a linear slider;

said linear slider coupled to a rod;

said rod moving with said slider, said rod having at least one roller

using the linear motion of the slider and linear motion of the rod to push at least one linear slider and to roll a roller along a linear cam surfaces to lift clear a drive assembly, rotate the cartridge, punch open a new cavity and load a new penetrating member.