Fluid handling devices

• US 8,343,074 B2
• Filed: 06/30/2004
• Issued: 01/01/2013
• Est. Priority Date: 06/30/2004
• Status: Expired due to Fees

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Weidenhaupt, Klaus Peter, Moffat, James, Böhm, Sebastian
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US10/883,026
• Publication Number:
  US 20060004303A1
• Time in Patent Office: 3,107 Days
• Field of Search: 600/300, 600/301, 600/576, 600/573, 600583-585, 606/181, 606/182, 606/184, 604/48
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• 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 5/15109 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 5/15146 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 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6824 : Arm or wrist
• 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 2300/0645 : Electrodes
• CPC Class Codes: B01L 2400/0481 : squeezing of channels or chambers
• 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: F04B 43/043 : Micropumps
• CPC Class Codes: F04B 43/14 : having plate-like flexible members

Abstract

Devices for determining the concentration of an analyte in a fluid are provided. Also provided are systems and kits for use in practicing the subject methods.

Claims

1. An apparatus adapted to measure analytes in bodily fluids of a user, said apparatus comprising:

(a.) a controller, said controller comprising;

a motor; and

an actuator connected to said motor;

(b) a fluid handling module, said fluid handling module comprising;

a skin piercing element comprising a fluid collection channel;

a pressure disk, a sensor disk and an elastomeric disk between the pressure disk and sensor disk;

the sensor disk comprising an inlet chamber connected to a first end of said fluid collection channel and a pumping chamber;

a membrane connected to said actuator, said membrane forming at least a portion of one wall of said pumping chamber, said membrane being movable in response to movement of said actuator;

a connecting channel connecting said collection channel to an inlet end of said pumping chamber;

the elastomeric disk comprising an inlet channel connecting an outlet end of said pumping chamber to an inlet end of a sensor chamber wherein said sensor chamber includes an electrochemical sensor for detecting said analyte, a waste channel connected to an outlet end of said sensor chamber; and

a vent connected to an outlet end of said waste channel

wherein the apparatus is worn by the user.

2. An apparatus according to claim 1 wherein said analytes comprise glucose.

3. An apparatus according to claim 1, further including a pinching body connected to said actuator.

4. An apparatus according to claim 3, further including a pinch pin adapted to work with said pinching body.

5. An apparatus according to claim 2 wherein said electrochemical sensor utilizes a redox mediator.

6. The apparatus of claim 1, wherein the fluid collection channel is a needle.

7. The apparatus of claim 1, wherein the skin piercing element is affixed to a skin-facing surface of the apparatus for continuous in-dwelling of the skin piercing element in a section of the skin of the user.

8. An apparatus according to claim 1, wherein the pressure and sensor disks are rigid and the elastomeric disk is flexible.

9. An apparatus according to claim 1, wherein the pressure disk further comprises energy directors.

10. An apparatus according to claim 1 or 9, wherein the pressure disk further comprises an access slot suitable to allow the actuator to contact the membrane.