Body fluid sampling device with a capacitive sensor

• US 8,784,335 B2
• Filed: 07/25/2008
• Issued: 07/22/2014
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique, Alden, Don, Briggs, Barry Dean
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/179,775
• Publication Number:
  US 20090024009A1
• Time in Patent Office: 2,188 Days
• Field of Search: 600/547, 600/573, 600/583, 600/584, 600/587, 606/172, 606/181, 604/117
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150106 Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
• 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 5/150358 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• 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 5/15126 : Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
• 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 5/15153 : Multiple piercing elements stocked in a single compartment
• 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 5/15174 : Piercing elements stocked in the form of a stack or pile
• 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 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/7485 : Automatic selection of region of interest
• CPC Class Codes: A61M 5/42 : having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
• CPC Class Codes: A61M 5/427 : Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion

Abstract

A body fluid sensing device with a body fluid capture structure and a body fluid measurement sensor positioned in the body fluid capture structure. A capacitance sensor is coupled to the body fluid measurement sensor. The capacitance sensor is used to assist in the positioning of a body part relative to the body fluid capture structure.

Claims

1. A drug delivery system, comprising:

a housing;

a controllable driver positioned in the housing;

a penetrating member configured to be coupled to the controllable driver and positioned in the housing;

a feedback loop coupled to the controllable driver configured to provide for a controlled delivery or removal of an agent or body fluid to or from a selected site of the body;

a processor coupled to the controllable driver, the processor storing user profiles in a memory that are executable by the processor to provide the user with recommendations as to a skin surface location to use for the introduction of the penetrating member, the processor actuating the driver to drive the penetrating member to the skin surface location using the recommendations in response to the user profiles from the memory; and

a canister with a volume sufficient to contain the agent configured to be delivered to a tissue site at a controllable localized site or receipt of the body fluid from a body site, a receptacle configured to be coupled to the penetrating member for delivery or withdrawal of the agent or body fluid.

2. The system of claim 1, wherein the agent is delivered to the tissue site at a specific controlled depth.

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

4. The system of claim 1, wherein the penetrating member is a lancet.

5. The system of claim 1, wherein the agent is a drug.

6. The system of claim 1, wherein the agent is a tumor agent to treat a tumor.

7. The system of claim 1, wherein the controllable driver and feedback loop provide for targeted delivery of the agent.

8. The system of claim 1, wherein the controllable driver and feedback loop provide for agent delivery to a specific depth within the skin or a tissue layer.

9. The system of claim 8, wherein the specific depth provides for precise localized agent delivery.

10. The system of claim 1, wherein the feedback loop is a position feedback loop of the controllable driver coupled to the penetrating member.

11. The system of claim 1, wherein an injection member is provided that includes the penetrating member and the canister.

12. The system of claim 1, wherein the penetrating member is a hypodermic needle and the canister is a collapsible canister.

13. The system of claim 12, wherein the collapsible canister is coupled to an elongated coupler shaft with a drive coupler.

14. The system of claim 12 wherein the hypodermic needle in operation is driven to a desired penetration depth and the agent is passed into an inlet port of the needle through a central lumen of the hypodermic needle, and out of the outlet port at a distal end of the hypodermic needle.

15. The system of claim 1, wherein agent delivery in operation occurs at a point of maximum penetration of the penetrating member.

16. The system of claim 1, wherein agent delivery in operation occurs during retraction of the penetrating member.

17. The system of claim 1, wherein agent delivery in operation occurs in operation during insertion of the penetrating member.

18. The system of claim 1, wherein the controllable driver in operation launches the penetrating member and the receptacle towards a patient'"'"'s skin.

19. The system of claim 1, wherein the penetrating member in operation is advanced to and from the tissue site at different velocities.

20. The system of claim 1, wherein the canister is at least partially collapsible and at least partially included in an interior of the penetrating member.

21. The system of claim 20, wherein the controllable driver in operation launches the penetrating member and the canister towards and into the tissue site.

22. The system of claim 1, wherein a distal tip of the penetrating member in operation is driven to a precise penetration depth in the tissue site.

23. The system of claim 1, wherein the controllable driver and feedback loop in operation provide for precisely defining a position in space of the penetrating member.

24. The system of claim 1, wherein the controllable driver and feedback loop in operation provide for finite placement of the penetrating member in the tissue site for agent delivery and body fluid withdrawal.

25. An agent injection device, comprising:

a controlled driver;

an injection member with an elongated injection shaft, the controlled driver being configured to be coupled to the elongated injection shaft with the injection member in operation dispensing an agent to a known tissue depth; and

a processor coupled to the controlled driver, the processor storing user profiles in a memory that are executable by the processor to provide the user with recommendations as to a skin surface location to use for the introduction of the injection member, the processor actuating the driver to drive the injection member to the skin surface location using the recommendations in response to the user profiles from the memory.

26. The device of claim 25, wherein the agent is dispensed at a controllable time.

27. The device of claim 25, wherein the tissue depth is predetermined.