Method and apparatus for penetrating tissue

• US 8,690,796 B2
• Filed: 09/29/2006
• Issued: 04/08/2014
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Boecker, Dirk, Alden, Don
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US11/536,720
• Publication Number:
  US 20070073188A1
• Time in Patent Office: 2,748 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 5/150152 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,

an electronic penetrating member driver positioned in the housing member for driving each of the plurality of penetrating members, the electronic penetrating member driver providing an electronic stop of penetrating members in a tissue site;

a plurality of non-optical sensors, each of the plurality of non-optical sensors associated with a penetrating member positioned in the housing member, each of the plurality of non-optical sensors configured to receive a body fluid sample in response to a penetrating event of target tissue made with a penetrating member;

a penetrating member transport device for carrying the plurality of penetrating members and moving each of the penetrating members to a launch position, the penetrating member transport device positioned in the housing member;

a processor positioned in the housing member and coupled to a feedback control and to the electronic penetrating member driver and configured to provide for controlled velocity of a penetrating member in and out of a tissue site, the processor including a database that includes user profiles for setting penetration parameters of a penetrating member to create the puncture wound in the target tissue for a successful penetration and achieve a desired blood volume;

wherein in response to the processor selecting a profile, the processor instructing a power delivery to the electronic penetrating member driver; and

a position sensor coupled to the processor and a penetrating member, the position sensor detecting a movement of the penetrating member and generating position data in response thereto, wherein during a rearward displacement of a penetrating member in response to elastic tenting of tissue, the processor reads and stores position data generated by the position sensor and measures an amount of elastic tenting.

2. The system of claim 1, wherein the sensor is a contact sensor.

3. The system of claim 1, wherein the sensor is a penetrating member sensor.

4. The system of claim 1, wherein the processor is configured to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

5. The system of claim 1, wherein the processor is configured to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

6. The system of claim 1, wherein the processor is configured 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.

7. The system of claim 1, wherein the processor is configured to monitor position and speed of a penetrating member as the penetrating member moves in a 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.

8. The system of claim 1, wherein the processor is configured to control a withdraw force to the penetrating member so that each said plurality of penetrating members moves in a second direction away from the target tissue.

9. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in the housing member,

a plurality of non-optical sensors, each of the plurality of non-optical sensors associated with a penetrating member and configured to receive a body fluid in response to a penetrating event of a body in response to a penetration of the body by a penetrating member;

an electronic penetrating member driver positioned in the housing member for driving each of the plurality of penetrating members, the electronic penetrating member driver providing an electronic stop of penetrating members in a tissue site;

a penetrating member transport device for carrying the plurality of penetrating members and moving each penetrating member sequentially to a launch position, the penetrating member transport device positioned in the housing member;

a processor positioned in the housing member and coupled to the electronic penetrating member driver, the processor configured to provide for controlled dwell time of a penetrating member in a tissue site, the processor including a database that includes user profiles for setting penetration parameters of a penetrating member to create the puncture wound for a successful penetration and achieve a desired blood volume;

wherein in response to the processor selecting a profile, the processor instructing a power delivery to the electronic penetrating member driver;

a penetrating member sensor coupled to the processor and a penetrating member, the penetrating member sensor being configured to detect at least one a skin variable and generating a lancing profile dependent on the at least one detected skin variable, wherein in response to elastic tenting of tissue, the processor reads and stores position data generated by the penetrating member sensor; and

a memory positioned in the housing member and coupled to the penetrating member driver.

10. The system of claim 9, further comprising:

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

11. The system of claim 10, wherein a sample chamber has a volume no greater than 1 μ

L.

12. The system of claim 10, wherein the tissue stabilizing member is configured to apply a force to the target tissue and cause the target tissue to press in an inward direction relative to the housing member.

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

14. The system of claim 10, wherein the tissue stabilizing member includes a plurality of protrusions.

15. The system of claim 10, wherein the tissue stabilizing member applies a stimulation to a target tissue.

16. The system of claim 9, wherein the at least one skin variable is a dwell time of the penetrating member in the target tissue.

17. The system of claim 9, wherein the at least one skin variable is a penetration depth of the penetrating member in the target tissue.

18. The system of claim 9, wherein in a first direction the penetrating member moves toward the target tissue at a speed that is different than a speed at which each said plurality of penetrating members moves away from the target tissue.

19. The system of claim 9, wherein in a 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.

20. The system of claim 9, wherein a speed of a penetrating member in a first direction is the range of 0.05 to 60 m/sec.

21. The system of claim 9, wherein a speed of a penetrating member in a first direction is the range of 0.1 to 20.0 m/sec.

22. The system of claim 9, wherein a speed of a penetrating member in a first direction is the range of 1.0 to 10.0 m/sec.

23. The system of claim 9, wherein a speed of a penetrating member in a first direction is the range of 3.0 to 8.0 m/sec.

24. The system of claim 9, wherein a dwell time of each of a plurality of penetrating members in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

25. The system of claim 9, wherein a dwell time of each of a plurality of penetrating members in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

26. The system of claim 9, wherein a dwell time of each of a plurality of penetrating members in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.