Method and apparatus for penetrating tissue

• US 20070073188A1
• Filed: 09/29/2006
• Published: 03/29/2007
• 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
• Granted Patent: US 8,690,796 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 5/150152 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 5/150358 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 5/15113 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 5/15153 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 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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 5/15184 : 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 5/157 : 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 tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claims

1. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in the housing member,

a tissue stabilizing member coupled to the housing and configured to enhance fluid flow from a target tissue to a sample chamber with a volume no greater than1 μ

L; and

a contact sensor that utilizes information of the penetrating member to determine a depth of penetration through a skin surface, the depth of penetration providing a volume of sample of less than1 μ

L in the sample chamber.

2. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in the housing member, and

a sensor that utilizes information of the penetrating member to determine a tissue penetration parameter relative to a target tissue that is accessed through a skin surface.

3. The system of claim 2, further comprising:

a tissue stabilizing member coupled to the housing and configured to enhance fluid flow from the target tissue to a sample chamber.

4. The system of claim 3, wherein the sample chamber has a volume no greater than 1 μ

L;

5. The system of claim 2, wherein the sensor is a contact sensor.

6. The system of claim 2, wherein the sensor is a penetrating member sensor.

7. The system of claim 2, wherein the tissue penetration parameter is a dwell time of the penetrating member in the target tissue.

8. The system of claim 2, wherein the tissue penetration parameter is a penetration depth of the penetrating member in the target tissue.

9. The system of claim 2, wherein the tissue stabilizer member is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

10. The system of claim 2, wherein the tissue stabilizer member creates a stretching of a skin surface.

11. The system of claim 2, wherein the tissue stabilizer member includes a plurality of protrusions.

12. The system of claim 2, wherein the tissue stabilizing device applies a stimulation to a target tissue.

13. The system of claim 2, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

14. The system of claim 2, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

15. The system of claim 2, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

16. The system of claim 2, 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 within a desired range of speed.

17. The system of claim 2, 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.

18. The system of claim 2, wherein the processor is 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.

19. The system of claim 2, wherein in a 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.

20. The system of claim 2, 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.

21. The system of claim 2, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

22. The system of claim 2, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

23. The system of claim 2, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

24. The system of claim 2, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

25. The system of claim 2, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

26. The system of claim 2, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

27. The system of claim 2, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

28. A method for configuring a system for withdrawing body fluid from a body part via a withdrawal site, comprising:

measuring at least one variable dependent on the location and state of the withdrawal site; and

selecting a setting, which is dependent on the value of the measured variable and influences the withdrawal of body fluid, in the system for withdrawing body fluid.

29. The method of claim 28, wherein at least one of the following variables is measured:

position and acceleration.

30. The method of claim 28, wherein at least one of the following settings is selected as a function of the value of the measured variable;

blocking or releasing of a penetrating member;

setting a puncture depth of a penetrating member selected for creating the opening in the body;

setting a geometric shape of a press-on area of the system for withdrawing body fluid;

setting the cross section of an opening in a press-on area of the system for withdrawing body fluid, through which opening a penetrating member can penetrate into the surface of the body part;

selecting one of at least two press-on areas included in the system for withdrawing body fluid;

selecting one of at least two penetrating members contained in the system for withdrawing body fluid;

setting the duration of the withdrawal procedure;

displaying text on a display device; and

displaying or setting evaluation parameters which are used by a system for analyzing body fluid.

31. The method of claim 28, wherein the value of the measured variable is stored on a storage medium using GPS or radio-clock information.