Sampling module device and method

• US 9,694,144 B2
• Filed: 12/03/2013
• Issued: 07/04/2017
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M.
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US14/095,196
• Publication Number:
  US 20140100525A1
• Time in Patent Office: 1,309 Days
• 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 medicament injection device includes a device body portion that includes a penetrating member channel. A penetrating member is provided with a sharpened distal tip and shaft portion that is slidably disposed within the penetrating channel to provide for a penetrating to travel in a linear axial movement. A pierceable membrane isolates a penetrating member in an associated penetrating member chamber. A medicament reservoir is in fluid communication with the penetrating member. The medicament reservoir is configured to house a medicament and is coupled to the penetrating member to allow for delivery of medicament to a tissue site.

Claims

1. A medicament injection device for injecting a medicament to a tissue at a skin site of a patient, comprising:

a device body portion that includes a penetrating member channel;

a penetrating member with a sharpened distal tip and a shaft portion which is slidably disposed within the penetrating member channel to provide for the penetrating member to travel in a linear axial movement;

a feedback loop coupled to a processor and to a controllable driver, the processor configured to storing penetrating member driver profiles in a memory, to selecting one of the penetrating member driver profiles from the memory, and actuating the penetrating member in accordance with the selected penetrating member driver profile to release the penetrating member for penetration of the skin site at an injection site, wherein the processor and the controllable driver operate with the feedback loop to control a depth of penetration to the injection site and a velocity of the penetrating member such that an insertion velocity of the penetrating member is greater than a withdrawal velocity of the penetrating member;

a pierceable membrane that isolates the penetrating member in an associated penetrating member chamber; and

a medicament reservoir in fluid communication with the penetrating member, the medicament reservoir configured to house a medicament, the medicament reservoir coupled to the penetrating member to allow for delivery of medicament to the injection site.

2. The device of claim 1, wherein the medicament reservoir is in a form of a collapsible canister.

3. The device of claim 1, wherein the medicament is a drug or a vaccine.

4. The device of claim 1, wherein a plurality of medicament reservoirs are provided.

5. The device of claim 4, wherein the plurality of medicament reservoirs in operation provide for metered doses of long-term medication needs.

6. The device of claim 5, wherein the plurality of medicament reservoirs are included in a cassette positionable with an interior of the device body portion.

7. The device of claim 1, wherein the device body portion includes an area to house used penetrating members for disposal.

8. The device of claim 1, wherein an elongated coupler shaft is provided that is configured to be coupled to the penetrating member.

9. The device of claim 8, wherein the controllable driver and the processor operate together to measure acceleration and displacement of the elongated coupler shaft and the penetrating member from a known start position.

10. The device of claim 1, wherein the processor determines whether a distal end of the penetrating member has reached a brake depth in the tissue at the injection site.

11. The device of claim 10, wherein the brake depth is pre-determined and programmed into the processor.

12. The device of claim 10, wherein the brake depth is determined dynamically during the step of actuating actuation of the penetrating member.

13. The device of claim 1, wherein an amount of penetrating of the penetrating member is measured during an operation cycle of the device.

14. The device of claim 1, wherein a penetration depth of the penetrating member includes an amount of tenting of a patient'"'"'s skin during a penetration event.