Method and apparatus for penetrating tissue

• US 7,563,232 B2
• Filed: 12/31/2002
• Issued: 07/21/2009
• 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 M.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): TOWA, RENE T
• Application Number:
  US10/335,215
• Publication Number:
  US 20030199791A1
• Time in Patent Office: 2,394 Days
• Field of Search: 600/573, 600575-579, 600/583, 606181-183
• 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 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• 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: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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

These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. An analyte detecting member is positioned to receive fluid from a wound created by the penetrating member. The detection member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid. 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:

an electrically powered drive force generator;

a penetrating member operatively coupled to said drive force generator, said drive force generator moving said penetrating member 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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber including an analyte detecting member and having a volume no greater than 1 μ

L, the sample chamber being positioned to receive fluid from a wound created by said penetrating member, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3; and

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting,

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having control a algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

2. The system of claim 1, wherein the user interface is configured to provide a user with at least one input selected from, depth of a penetrating member penetration, velocity of a penetrating member, a desired velocity profile, a velocity of a penetrating member into the target tissue site, velocity of the penetrating member out of the target tissue site, dwell time of the penetrating member in a target tissue site, and a target tissue site relaxation parameter.

3. The system of claim 1, wherein the user interface provides at least one output to the user selected from, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration on a target tissue site, stratum corneum thickness, force delivered on a target tissue site , energy used by a penetrating member driver to drive a penetrating member into the target tissue site, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of a penetrating member, information relative to contact of a penetrating member with target tissue site before penetration by the penetrating member, and information relative to a change of speed of a penetrating member as in travels in the target tissue site.

4. The system of claim 1, further comprising:

a data interface configured to couple the tissue site penetrating system to at least one of, support equipment with a data interface and the internet.

5. The system of claim 1, wherein the user interface is coupled to a support equipment selected from at least one of, a base station, home computer, central server, and main processing equipment for storing glucose level information.

6. The system of claim 4, wherein the data interface is selected from at least one of, Serial RS-232, modem interface, USB, HPNA, Ethernet, optical interface, IRDA, RF interface, BLUETOOTH interface, cellular telephone interface, 2 way pager interlace, parallel port interlace standard, near field magnetic coupling, RF transceiver and a telephone systems.

7. The system of claim 1, wherein the user interlace includes a real time clock and one or more alarms to provide a user with a reminder of a next target penetrating event is needed.

8. The system of claim 1, further comprising:

a processor coupled to the penetrating member driver and configured to receive signals from the user interface.

9. The system of claim 1, wherein the processor is configured to assist in an adjustment of force applied to the penetrating member driver in response to a target tissue site parameter.

10. The system of claim 1, further comprising:

a user interlace processor coupled to the user interface.

11. The system of claim 1, further comprising:

a memory for storing a target tissue site parameter.

12. The system of claim 1, further comprising:

a memory for storing data on target tissue site penetrating performance.

13. The system of claim 1, further comprising:

a memory for storing at least one of, a number of penetrating members used, number of target tissue site penetrating events, time and date of the last selected number of target tissue site penetrating events, time interval between alarm and target tissue site penetrating event, stratum corneum thickness, time of day, energy consumed by a penetrating member driver to drive a penetrating member into the target tissue site, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue site, velocity of the penetrating member out of the target tissue site, dwell time of the penetrating member in the target tissue site, a target tissue site relaxation parameter, force delivered on the target tissue site, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue site, a tissue site target tissue site relaxation parameter, information relative to contact of a penetrating member with target tissue site before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue site, information relative to consumed sensors and information relative to consumed penetrating members.

14. The system of claim 1, the user interface responds to audio commands.

15. The system of claim 14, wherein the user interface includes a sensor for detecting audio commands.

16. The system of claim 1, wherein the user interface relays information to a user via an audio device.

17. The system of claim 1, wherein the user interface relays information to a user via a wireless device.

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

an electrically powered drive force generator;

a penetrating member operatively coupled to said drive force generator, said drive force generator moving said penetrating member 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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

L and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a human interface providing at least one output, and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

19. The system of claim 18, further comprising:

a processor coupled to the penetrating member driver and configured to change a direction and magnitude of force exerted on a penetrating member as it penetrates or advances through a target tissue site.

20. The system of claim 18, further comprising:

a penetrating member sensor configured to detect a penetrating member position during target tissue site penetration.

21. The system of claim 18, wherein the at least one output is selected from, a penetration event of a penetrating member, number of penetrating members remaining, time of day, alarm, penetrating member trajectory waveform profile information, force for last penetration event, the last penetration event, high or low battery status, analyte status, time to change cassette status, jamming malfunction, and system status.

22. The system of claim 18, wherein the human interface is selected from an LED, an LED digital display, an LCD display, a sound generator, a buzzer, and a vibrating device.

23. The system of claim 18, further comprising:

a housing selected from at least one of, a telephone, a watch, a PDA, electronic device, medical device, point of care device and a decentralized diagnostic device.

24. The system of claim 18, further comprising:

an input device coupled to the housing, the input device selected from one or more pushbuttons, a touch pad independent of a display device, or a touch sensitive screen on a visual display.

25. The system of claim 18, further comprising:

a data exchange device for coupling the tissue site penetrating system to support equipment.

26. The system of claim 25, further comprising:

a data interface configured to couple the tissue site penetrating system to support equipment with a data interface.

27. The system of claim 18, further comprising:

a data exchange device for coupling the tissue site penetrating system to support equipment selected from one of the following;

personal computer, modem, PDA and a computer network.

28. The system of claim 18, wherein the human interface includes a real time clock and one or more alarms a user can set for reminders of when a next target tissue site penetration event is needed.

29. The system of claim 18, wherein the human interface is coupled to receive signals from a human interface processor separate from a processor coupled to the penetrating member driver.

30. The system of claim 29, wherein the human interface processor has a sleep mode and runs intermittently to conserve power.

31. The system of claim 18, further comprising:

a memory for storing at least one of, a number of penetrating members used, number of target tissue site penetrating events, time and date of the last selected number of target tissue site penetrating events, time interval between alarm and target tissue site penetrating event, stratum corneum thickness, time of day, energy consumed by a penetrating member driver to drive a penetrating member into the target tissue site, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue site, velocity of the penetrating member out of the target tissue site, dwell time of the penetrating member in the target tissue site, a target tissue site relaxation parameter, force delivered on the target tissue site, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue site, a tissue site target tissue site relaxation parameter, information relative to contact of a penetrating member with target tissue site before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue site, information relative to consumed sensors and information relative to consumed penetrating members.

32. The system of claim 25, wherein the human interface processor has logic that provides an alarm time set for a first subset of days and a second alarm time set for a second subset of days.

33. The system of claim 32, wherein the first subset of days is Monday thru Friday and the second subset of days is Saturday and Sunday.

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

a drive force generator;

a penetrating member operatively coupled to said drive force generator, said drive force generator moving said penetrating member 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;

said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue site and out of said tissue site;

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting, and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member 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;

said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue site and out of said tissue site;

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber including electrodes and having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a human interface providing at least one output, and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member 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 position sensor positioned to provide an indication of a position of the penetrating member during actuation;

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting; and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member 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 position sensor positioned to provide an indication of a position of the penetrating member during actuation;

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a human interface providing at least one output; and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member 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;

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;

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting; and

a position sensor coupled to a processor and the electrically powered drive force generator the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member 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;

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;

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a human interface providing at least one output; and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

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

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

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting; and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

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

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

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a human interface providing at least one output; and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

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

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting and

a position sensor coupled to a processor and the electrically powered drives force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement is used to drive the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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

a drive force generator;

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

a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μ

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

L of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;

a human interface providing at least one output; and

a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.