Apparatus for penetrating tissue

• US 20140323917A1
• Filed: 07/09/2014
• Published: 10/30/2014
• Est. Priority Date: 04/19/2002
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Alden, Don, Boecker, Dirk
• Application Number:
  US14/326,608
• Publication Number:
  US 20140323917A1
• 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 5/150068 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, C12Q1/54
• 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 μL of the fluid. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Claims

1. An injection device for injecting an agent to a tissue site under a skin surface, comprising:

an electronic drive force generator;

a penetrating member having an elongate portion operatively coupled to said force generator;

a processor coupled to the electronic drive force generator, the processor including a user profile of a user in a memory for setting penetration parameters of a penetrating member to create a successful injection of the agent;

an audio device configured to relay information to a user of the system and to receive audio input from a user, the audio input in operation being configured to modify the user profile based on additional audio user input; and

a user interface coupled to the processor, the user interface including or being coupled to one or more alarms to provide a user with a reminder that a injection event is needed.

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 injection events.

7. The device of claim 6, wherein the internal clock tracks injection events.

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, further comprising:

a database that stores information and statistics for each user and each profile that a particular user uses.

11. The device of claim 1, further comprising:

a sterility barrier covering at least a portion of the penetrating member.

12. The device of claim 1, further comprising:

a feedback loop coupled to the processor to provide signals.

13. The device of claim 1, wherein the processor includes an integrated memory.

14. The device of claim 1, further comprising:

a signal generator coupled to the processor.

15. The device of claim 1, further comprising:

an amplifier coupled to the processor.

16. The device of claim 1, further comprising:

a position sensor coupled to the processor.

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

an electronic drive force generator;

a penetrating member having an elongate portion operatively coupled to said force generator;

a coupler that couples the electronic drive force generator with the penetrating member;

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

L of the fluid;

a processor coupled to the electronic drive force generator, the processor including a user profile of a user in a memory for setting penetration parameters of a penetrating member to create an injection of the agent at desired agent volume;

an audio device configured to relay information to a user of the system and to receive audio input from a user, the audio input in operation being configured to modify the user profile based on additional audio user input; and

a human interface coupled to the processor, the human interface including or coupled to one or more alarms to provide a user with a reminder that a next target penetrating event is needed.

18. The device of claim 17, wherein a user provides user input information to improve the user'"'"'s profile.

19. The device of claim 17, wherein the processor in operation performs a calculation to optimize user profiles.

20. The device of claim 17, further comprising:

a database that stores information and statistics for each user.

21. The device of claim 20, wherein the database stores user profiles and user uses of the device.

22. The device of claim 17, further comprising:

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

23. The device of claim 22, wherein the internal clock tracks injection events.

24. The device of claim 17, wherein the device prompts the user for additional information.

25. The device of claim 17, wherein a user profile is modifiable.

26. The device of claim 17, further comprising:

a database that stores information and statistics for each user and each profile that a particular user uses.

27. The device of claim 17, further comprising:

a sterility barrier covering at least a portion of the penetrating member.

28. The device of claim 17, further comprising:

a feedback loop coupled to the processor to provide signals.

29. The device of claim 17, wherein the processor includes an integrated memory.

30. The device of claim 17, further comprising:

a signal generator coupled to the processor.

31. The device of claim 17, further comprising:

an amplifier coupled to the processor.

32. The device of claim 17, further comprising:

a position sensor coupled to the processor.

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

a drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation;

an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μ

L of the fluid; and

a human interface providing at least one output.