METHODS AND APPARATUS FOR LANCET ACTUATION

• US 20080194989A1
• Filed: 01/10/2008
• Published: 08/14/2008
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique, Briggs, Barry Dean
• Granted Patent: US 8,157,748 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 5/150083 by vibration, e.g. ultrasound
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150435 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150832 : by topography of the surface, e.g. Braille, embossed printing
• 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 5/150954 : Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• 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 5/15111 : Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15146 : 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 5/15163 : 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 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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 5/1519 : 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: 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: 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

A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet and a processor coupled to the drive force generator capable of changing the direction and magnitude of force exerted on the lancet during the lancing cycle. The driver further includes a human interface on the housing providing at least one output for communicating with the patient.

Claims

1. A body fluid sampling apparatus, comprising:

a housing including a tissue interface surface;

a penetrating member;

a sampling chamber coupled to the penetrating member, the sampling chamber positioned to receive a body fluid from a tissue site in response to penetration of the tissue site by the penetrating member;

resources including a database that includes pressure profiles of users;

a pressure sensor positioned at the tissue interface surface for sensing and recording a pressure profile of a user.

2. The apparatus of claim 1, wherein the tissue interface surface is a contoured surface adapted for receiving a distal portion of a finger.

3. The apparatus of claim 1, wherein the tissue interface surface is configured to receive pressure applied by a user by pushing down with a finger.

4. The apparatus of claim 3, wherein the pressure applied by the user applies a downward pressure on a sampling module.

5. The apparatus of claim 4, wherein the pressure sensor is used to detect the presence of a finger on the tissue interface surface.

6. The apparatus of claim 1, further comprising:

a processor coupled to a feedback loop.

7. The apparatus of claim 6, further comprising:

a memory coupled to the processor.

8. The apparatus of claim 7, wherein the processor stores user profiles in the memory.

9. The apparatus of claim 8, wherein user profiles and parameters of lancing events are stored in the memory.

10. The apparatus of claim 9, wherein the processor is configured to select a user profile from a set of user profiles that have been preprogrammed in the processor.

11. The apparatus of claim 10, wherein the processor is configured to scale or modify profiles in response to additional user input information.

12. The apparatus of claim 6, wherein the processor is configured to measure a location of the penetrating member.

13. The apparatus of claim 6, wherein the processor uses a position sensing mechanism to measure the location of the penetrating member.

14. The apparatus of claim 6, wherein the processor calculates movement of the penetrating member by comparing an actual profile of the penetrating member to a predetermined profile.

15. The apparatus of claim 6, wherein the processor modulates power to a penetrating member driver to provide that the actual profile of the penetrating member does not exceed the predetermined profile by more than a preset error limit.

16. The apparatus of claim 15, wherein the error limit is an accuracy in the control of the penetrating member.

17. The apparatus of claim 1, wherein the processor stores lancing event information of a user and constructs a database for that user.

18. The apparatus of claim 17, wherein in response to creation of the database for that user, the processor is configured to create profile traits for that user.

19. The apparatus of claim 18, wherein the profile traits are selected from at least one of, painlessness, success rate, and blood volume.

20. The apparatus of claim 19, wherein the profile traits are created in response to penetrating member advancements and retractions from the user.

21. The apparatus of claim 18, wherein the profile traits are used by the processor to optimize profiles for each user.

22. The apparatus of claim 1, wherein the database stores information for each user and each profile that a particular user uses.

23. The apparatus of claim 6, wherein the processor is configured to determine a time and position of tissue contact and a depth of penetration by the penetrating member.

24. The apparatus of claim 6, wherein the processor operates under control of programming steps that are stored in an associated memory.

25. The apparatus of claim 6, wherein the processor is configured to initialize values that the processor stores in a memory relating to control of the penetrating member.

26. The apparatus of claim 6, wherein the processor is configured to set a clock value to zero and a penetrating member position value to an initial value.

27. The apparatus of claim 6, wherein the processor is configured cause the penetrating member to assume an initial stationary position.

28. The apparatus of claim 6, wherein processor is configured if the penetrating member is moving.

29. The apparatus of claim 6, wherein the processor is configured to monitor a position of the penetrating member and determine if penetrating member position changes over time.

30. The apparatus of claim 6, wherein the processor is configured to periodically or continually monitor at least one of position and velocity of the penetrating member

31. The apparatus of claim 6, wherein the processor is configured to determines if a distal tip of the penetrating member is in contact with a skin surface.

32. The apparatus of claim 31, wherein the processor uses at least one parameter that is measured prior to initiation of a lancing cycle to determine if the distal end of the penetrating device has made contact with the skin surface.

33. The apparatus of claim 31, wherein the processor determines that the skin surface has been contacted when the distal end of the penetrating member has moved a predetermined distance with respect to an initial position.

34. The apparatus of claim 31, wherein the processor is configured to assist in providing an accurate measurement of a distance between a distal end of the penetrating member and the skin surface when the penetrating member is in an initial position.

35. The apparatus of claim 6, further comprising:

a position sensor coupled to the penetrating member and the processor.

36. The apparatus of claim 35, wherein the position sensor is configured to measure the distance from the initial point to a point of contact with the skin surface, and wherein at the skin surface to advancement of the penetrating member stops movement of the penetrating member.

37. The apparatus of claim 36, wherein following stopping the movement of the penetrating member, the penetrating member is retracted to the initial point with a distance to the skin surface being measured.

38. The apparatus of claim 6, wherein the processor is configured to determine if the penetrating member has made contact with the skin surface.

39. The apparatus of claim 38, wherein the processor determines if the penetrating member has made contact with the skin surface by measuring a reduction in velocity of the penetrating member at the skin surface.

40. The apparatus of claim 6, wherein the process is configured to determine if the penetrating member has made contact with the skin surface by detection of an acoustic signal.

41. The apparatus of claim 6, wherein the process is configured to determine if the penetrating member has made contact with the skin surface by measurement of electrical continuity.

42. The apparatus of claim 6, in response to determining if the penetrating member has contacted the skin surface, the processor is configured to adjust a speed of the penetrating member or the power delivered to the penetrating member for skin penetration.

43. The apparatus of claim 6, wherein the processor is configured to determine if a distal end of the penetrating member has reached a brake depth.

44. The apparatus of claim 43, wherein the brake depth is pre-determined and programmed into a processor memory or is dynamically determined during actuation of the penetrating member.