Tissue penetration device

• US 9,937,298 B2
• Filed: 12/16/2008
• Issued: 04/10/2018
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Alden, Don
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/335,765
• Publication Number:
  US 20090137930A1
• Time in Patent Office: 3,402 Days
• Field of Search: 600583, 606181-183
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• 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 5/15019 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 5/150358 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 5/15146 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 5/15176 : 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 5/15186 : 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: 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 5/46 : having means for controlling depth of insertion
• 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: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• 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 penetration device includes a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source. A magnetic member is disposed at least partially in the magnetically active region. A permanent magnet is disposed at a proximal end of the magnetically active region for zeroing the position of the magnetic member while the tissue penetration device is inactive.

Claims

1. A tissue penetration device for generating a piercing wound in a skin surface to obtain body fluid, comprising:

a housing with an analyzer device that has an exterior surface;

a cartridge with a cartridge body and at least one sampling module portion, the sampling module portion having a housing with an orientation sensitive contact interface for mating with the exterior surface of the analyzer device, the contact interface configured to align the sampling module cartridge with the exterior surface analyzer device;

a penetrating member and the sampling module portion positioned in the cartridge;

an electronic driver configured to be coupled to the penetrating member;

feedback control coupled to the electronic driver;

a processor coupled to the electronic driver and the feedback control that in operation is configured to regulate energy delivery to the electronic driver from a power supply and controls penetrating member advancement and retraction, the processor storing user profile information that is used for future lancing events, the processor in operation being configured to customize user profiles by scaling or modifying the profile based on additional user input information and in response to a customization modulates power from the a power supply; and

wherein the at least one sampling portion including a sample reservoir and a lancet channel with a vent at an outward radial end that allows the sample reservoir to fill with a fluid sample, the sample reservoir being in fluid communication with a respective lancet channel which extends substantially parallel to a longitudinal axis of the cartridge body.

2. The device of claim 1, wherein a user provides user input information to improve the user'"'"'s profile.

3. The device of claim 1, wherein the processor in operation performs a calculation to optimize user profiles.

4. The device of claim 1, further comprising:

a database that stores information and statistics for each user.

5. The device of claim 4, wherein the database stores user profiles and user uses of the device.

6. The device of claim 1, further comprising:

an internal clock that allows generation of a time stamp for lancing events.

7. The device of claim 6, wherein the internal clock provides a time between lancing events to anticipate a user'"'"'s diurnal needs.

8. The device of claim 1, wherein the device prompts the user for additional information.

9. The device of claim 1, wherein a user profile is modifiable.

10. The device of claim 1, a database stores information and statistics for each user and each profile that a particular user uses.

11. A tissue penetration device for generating a piercing wound in a skin surface to obtain body fluid, comprising:

a housing with an analyzer device that has an exterior surface;

a cartridge with a cartridge body and at least one sampling module portion, the sampling module portion having a housing with an orientation sensitive contact interface for mating with the exterior surface of the analyzer device, the contact interface configured to align the sampling module cartridge with the analyzer device;

a penetrating member, the sampling module portion and the analyzer device positioned in the cartridge;

an electronic driver configured to be coupled to the penetrating member;

feedback control coupled to the electronic driver;

a processor coupled to the electronic driver and the feedback control that in operation is configured to regulate energy delivery to the electronic driver from a power supply and controls penetrating member advancement and retraction, the processor storing user profile information that is used for future lancing events the processor in operation being configured to customize user profiles, the processor and feedback control providing for controlled velocity of penetrating member to and through the skin surface and a depth of penetrating member, the processor coupled to or having a database that includes information relative to at least one of, (i) a distance of a penetrating member from the skin surface, (ii) acceleration and displacement of a penetrating member, (iii) a start position of a penetrating member relative to the skin surface, the processor in operation being configured to customize user profile, and (iv) the processor in operation being configured to customize user profiles by scaling or modifying the profile based on additional user input information and in response to a customization modulates power from the power supply; and

wherein the at least one sampling portion including a sample reservoir and a lancet channel with a vent at an outward radial end that allows the sample reservoir to fill with a fluid sample, the sample reservoir being in fluid communication with a respective lancet channel which extends substantially parallel to a longitudinal axis of the cartridge body.

12. The device of claim 11, wherein a user provides user input information to improve the user'"'"'s profile.

13. The device of claim 11, wherein the processor in operation performs a calculation to optimize user profiles.

14. The device of claim 11, further comprising:

a database that stores information and statistics for each user.

15. The device of claim 11, further comprising:

a database that stores user profiles and user uses of the device.

16. The device of claim 11, further comprising:

an internal clock that allows generation of a time stamp for lancing events.

17. The device of claim 11 further comprising:

an internal clock that provides a time between lancing events to anticipate a user'"'"'s diurnal needs.

18. The device of claim 11, wherein the device prompts the user for additional information.

19. The device of claim 11, wherein a user profile is modifiable.

20. The device of claim 11, a database stores information and statistics for each user and each profile that a particular user uses.