Method and apparatus for penetrating tissue

• US 7,648,468 B2
• Filed: 12/31/2002
• Issued: 01/19/2010
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique M.
• Primary Examiner(s): Milano; Michael J
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/335,252
• Publication Number:
  US 20030199909A1
• Time in Patent Office: 2,576 Days
• Field of Search: 606/167, 606/172, 606/173, 606/181, 606/182, 606/183, 600/573, 600/583, 604/117
• 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 5/157 : 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, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

A body fluid sampling system for use on a tissue site 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. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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 electrically powered drive force generator and to a processor, said electrically powered 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, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 1 μ

L of a body fluid disposed in the sample chamber;

a penetrating member sensor coupled to said electrically powered force generator and provide depth penetration control of a penetrating member from a known start position, the penetrating member sensor being coupled to a processor with a memory that stores profiles which execute control instructions for the penetrating member driver, for application of a launching force to the penetrating member and control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue, the processor coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and through a transducer measure location of the penetrating member with the penetrating member sensor; and

wherein in the first direction the penetrating member moves toward the target tissue at a speed that is different than a speed at which the penetrating member moves away from the target tissue.

2. The system of claim 1, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

3. The system of claim 1, wherein the driver is a voice coil drive force generator.

4. The system of claim 1, wherein the driver is a rotary voice coil drive force generator.

5. The system of claim 1, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

6. The system of claim 5, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

7. The system of claim 5, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

8. The system of claim 5 , wherein the processor is utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue so that the penetrating member penetrates the target tissue within a desired range of speed.

9. The system of claim 5, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.

10. The system of claim 1, wherein the penetrating member sensor includes an incremental encoder.

11. The system of claim 1, wherein the penetrating member sensor includes an interference encoder.

12. The system of claim 1 further comprising an analyte detecting member.

13. The system of claim 1 further comprising a plurality of analyte detecting members positioned to receive body fluid.

14. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 1.0 μ

L of the body fluid.

15. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 μ

L of the body fluid.

16. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 μ

L of the body fluid.

17. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 μ

L of the body fluid.

18. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 μ

L of the body fluid.

19. The system of claim 1 wherein said seals are formed by a fracturable material between the penetrating member and the cartridge, at least one of said seals being positioned at least one of a distal port or a proximal port of the cartridge.

20. 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 electrically powered drive force generator, said electrically powered 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, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation; and

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μ

L of a body fluid disposed in the sample chamber;

a processor with control instructions for the penetrating member driver, and provide depth penetration control of a penetrating member from a known start position, the processor being coupled to an amplifier to modulate rower from a power supply to the electrically powered drive force generator to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

21. 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 electrically powered drive force generator and to a processor, said electrically powered 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, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μ

L of a body fluid disposed in the sample chamber;

a processor with control instructions for the penetrating member driver and provide depth penetration control of a penetrating member from a known start position, the processor being coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

22. 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 electrically powered drive force generator and to a processor, said electrically powered 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, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to -determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μ

L of a body fluid disposed in the sample chamber;

a processor coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and having control instructions for the penetrating member driver, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

23. 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 electrically powered force generator, said electrically powered 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, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μ

L of a body fluid disposed in the sample chamber;

a processor coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and having control instructions for the penetrating member driver, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member, the processor being utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

24. 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 electrically powered drive force generator and to a processor, said electrically powered 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, the processor causing an electronic braking force to be applied to the penetrating member to reduce a speed of the penetrating member to achieve a desired amount of final skin penetration depth;

a disposable housing said penetrating member, said disposable having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 1 μ

L of a body fluid disposed in the sample chamber;

a penetrating member sensor coupled to said electrically powered force generator and provide depth penetration control of a penetrating member from a known start position, the penetrating member sensor being coupled to a processor with control instructions for the penetrating member driver, for application of a launching force to the penetrating member and control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue; and

wherein in the first direction the penetrating member moves toward the target tissue at a speed that is greater than a speed at which the penetrating member moves away from the target tissue, the processor being coupled to an amplifier to modulate power from a power supply to the electrically powered drive force generator and through a transducer measure location of the penetrating member with the penetrating member sensor.